Patent law is a branch of intellectual property law that grants inventors exclusive rights to their inventions for a limited period, typically 20 years from the filing date of the patent application. The main objectives of patent law are to:
Encourage Innovation: By providing inventors with exclusive rights, patent law incentivizes the development of new technologies, products, and processes. This exclusivity allows inventors to potentially recoup their investment and earn a profit from their invention.
Disseminate Knowledge: In exchange for exclusive rights, inventors must disclose detailed information about their invention in the patent application. This disclosure enriches the public domain with technical knowledge, enabling others to learn from and build upon existing innovations.
Promote Economic Growth: Patents stimulate economic growth by fostering a competitive environment where new and improved technologies can thrive. This leads to the creation of new industries and job opportunities.
Legal Protection: Patent law provides a legal framework to protect inventors from unauthorized use, reproduction, or sale of their inventions, thus ensuring that their intellectual property is safeguarded.
Importance of Secrecy Directions under Patent Law
Secrecy directions are special provisions within patent law designed to protect national security and other critical interests by restricting the disclosure, publication, and processing of certain patent applications. These directions are crucial for several reasons.
National Security Protection: Inventions that have military applications or strategic significance must be protected from unauthorized disclosure to prevent potential adversaries from gaining access to sensitive technologies. Secrecy directions ensure that such information remains confidential and secure.
Public Safety: Certain inventions may pose significant risks to public health and safety if misused. Secrecy directions help prevent the dissemination of information about hazardous technologies until they can be safely managed and controlled.
Economic and Competitive Advantage: Maintaining the secrecy of strategic innovations helps preserve a country’s competitive edge in critical industries. This protection can be vital for maintaining technological superiority and economic stability.
Compliance with International Obligations: Many countries have international agreements that require them to implement secrecy measures for specific types of technologies. Secrecy directions help ensure compliance with these obligations, fostering international cooperation and security.
Intellectual Property Security: Secrecy directions act as a deterrent against industrial espionage and unauthorized access to proprietary technologies. By controlling the disclosure of sensitive inventions, countries can better protect their intellectual property and economic interests.
Definition of secrecy directions in patent law Secrecy directions in patent law refer to official orders issued by patent authorities or relevant government bodies to restrict the disclosure, publication, or processing of a patent application. These directions are typically imposed when an invention is deemed to have implications for national security or other critical interests, and the unrestricted dissemination of its details could potentially harm national interests or public safety.
HISTORICAL CONTEXT AND DEVELOPMENT
Early Beginnings
The concept of secrecy in patent law emerged alongside the advent of modern patent systems. As industrialization accelerated in the 19th century, the potential for technological innovations to impact national security became increasingly evident. Governments began to recognize the need to control the dissemination of sensitive inventions that could have military or strategic applications.
19th and Early 20th Century
Industrial Revolution: The Industrial Revolution (late 18th to early 19th century) saw rapid technological advancements that significantly impacted national economies and defence capabilities. During this period, the importance of protecting strategic inventions became apparent, although formal secrecy provisions were not yet widespread.
World War I: World War I (1914-1918) marked a turning point in the understanding of technological superiority in warfare. Nations began implementing more structured approaches to protect sensitive inventions. For instance, the United Kingdom and other European countries introduced measures to prevent the disclosure of technologies critical to their war efforts.
Mid-20th Century Developments
World War II: World War II (1939-1945) significantly influenced the development of secrecy provisions. The need to safeguard innovations in areas such as cryptography, radar, and nuclear technology led to stricter controls over patent disclosures. This period saw the formalization of secrecy measures to protect national security interests.
Invention Secrecy Act of 1951 (USA): In the United States, the Invention Secrecy Act of 1951 was enacted in response to the critical need for protecting sensitive technological information. This act allowed the government to impose secrecy orders on patent applications deemed detrimental to national security if disclosed. This legislation marked a significant step in the formalization of secrecy measures in the patent system.
Cold War Era: The Cold War (1947-1991) heightened the need for secrecy in technological advancements. Both the United States and the Soviet Union implemented stringent controls to protect innovations related to defence, space exploration, and other strategic areas. Secrecy orders became a common practice to prevent sensitive information from reaching potential adversaries.
Late 20th and Early 21st Century
Globalization and Technological Advancement: The late 20th century saw increased globalization and rapid technological progress. Countries recognized the need for international cooperation to ensure the protection of sensitive technologies across borders.
European Patent Convention (EPC): Established in 1973, the EPC included provisions for member states to impose secrecy orders on patent applications. This allowed European countries to coordinate their efforts in protecting sensitive technologies and maintaining national security.
Digital Age and Cyber security: The rise of the digital age and cyber security threats brought new challenges to the implementation of secrecy provisions. Governments needed to adapt their laws to address vulnerabilities associated with digital technologies and cyber warfare.
Strengthening of National Laws: Countries like China and Japan strengthened their patent laws to include more comprehensive secrecy provisions, reflecting the growing importance of technological protection in national security strategies.
Modern Context and Challenges
Balancing Innovation and Security: Modern patent laws strive to balance the need to promote innovation with the necessity of protecting national security. This involves periodic reviews of secrecy orders and updating regulations to reflect new technological realities.
Harmonization Efforts: Efforts to harmonize secrecy provisions globally have been ongoing, with international treaties and agreements playing a key role. Organizations like the World Intellectual Property Organization (WIPO) facilitate discussions on best practices and harmonization.
Emerging Technologies: The emergence of new technologies such as artificial intelligence, biotechnology, and quantum computing presents new challenges for secrecy provisions. Governments continue to evolve their laws to address these advancements.
SECRECY DIRECTIONS IN DIFFERENT JURISDICTIONS
India
Legislation: Patents Act, 1970
Procedure: When a patent application is filed, it is reviewed by the Indian Patent Office and the Ministry of Defence. If the invention is deemed to have potential implications for national security, the Controller General of Patents may issue a secrecy direction.
Enforcement: The patent application process is halted, and the details of the invention are kept confidential. Inventors are prohibited from disclosing the invention to unauthorized persons or entities. Secrecy directions are periodically reviewed, and can be renewed or lifted based on the assessment of national security risks.
Penalties: Violations of secrecy directions can result in fines, imprisonment, or both, as stipulated by the Patents Act.
USALegislation: Invention Secrecy Act of 1951
Procedure: The United States Patent and Trademark Office (USPTO) forward certain patent applications to defence agencies for review. If an invention is deemed to threaten national security, a secrecy order is imposed.
Enforcement: The application is withheld from publication, and the processing is suspended. The applicant is notified of the secrecy order and must comply with restrictions on disclosure. Secrecy orders are reviewed annually and can be renewed or rescinded based on security assessments.
Penalties: Unauthorized disclosure can lead to significant fines, imprisonment, and the forfeiture of patent rights.
Notable Cases: Historical examples include innovations in cryptography and nuclear technology that were kept under secrecy orders during and after World War II.
Europe
Legislation: European Patent Convention (EPC)
Procedure: National patent offices in EPC member states review patent applications for security concerns. If a national security issue is identified, a secrecy order can be issued.
Enforcement: The patent application is withheld from publication, and processing is suspended. Coordination among member states ensures that secrecy directions are consistently applied. Secrecy orders are reviewed periodically to determine if they should be maintained or lifted.
Penalties: Violations can result in fines, imprisonment, or both, as per the national laws of the member state imposing the secrecy order.
Japan Legislation: Japanese Patent Act
Procedure: Patent applications are screened by the Japan Patent Office (JPO) and relevant security agencies. If an invention poses a national security risk, the Commissioner of the JPO can issue a secrecy order.
Enforcement: The patent application is not published, and examination is suspended. Applicants are prohibited from disclosing the invention to unauthorized parties. Secrecy orders are reviewed periodically and can be extended or lifted based on national security evaluations.
Penalties: Violations of secrecy orders can result in substantial fines, imprisonment, or both.
ChinaLegislation: Patent Law of the People’s Republic of China
Procedure: The China National Intellectual Property Administration (CNIPA) and national security agencies review patent applications for sensitive information. If an invention is considered a threat to national security, a secrecy order is issued.
Enforcement: The patent application is withheld from publication, and processing is halted. Applicants are notified and must comply with non-disclosure requirements. Secrecy orders are periodically reviewed and can be renewed or rescinded based on security assessments.
Penalties: Unauthorized disclosure can lead to severe penalties, including fines, imprisonment, and the loss of patent rights.
KEY CHARACTERISTICS OF SECRECY DIRECTIONS
Secrecy directions are specialized legal provisions designed to protect sensitive inventions that may have implications for national security, public safety, or other critical interests. Here are the key characteristics that define secrecy directions in the context of patent law:
Restriction on Disclosure
Confidentiality: Secrecy directions impose strict confidentiality on the details of the patent application. Inventors and applicants are prohibited from disclosing any information about the invention to unauthorized individuals or entities.
Controlled Access: Only specific, authorized government officials and security agencies can access the details of the invention. This ensures that sensitive information is tightly controlled and not exposed to potential threats.
Prohibition on Publication
Non-Publication: Patent applications subject to secrecy directions are not published in the official patent gazette or made publicly accessible. This prevents the dissemination of sensitive information to the general public and potential adversaries.
Document Handling: All documents related to the patent application are handled with a high level of security to prevent unauthorized access and leaks.
Suspension of Patent Processing
Processing Halt: The examination and grant process of the patent application is suspended while the secrecy order is in effect. This means that the application will not move forward through the usual patent office procedures.
Conditional Resumption: The processing of the patent application may resume only if the secrecy order is lifted or modified, allowing for limited disclosure under controlled conditions.
Periodic Review and Duration
Regular Reviews: Secrecy orders are subject to periodic review by the issuing authority, typically annually. This ensures that the necessity of maintaining the secrecy order is regularly evaluated.
Adjustable Duration: The duration of secrecy orders is not fixed and can be extended or lifted based on the ongoing assessment of national security or public safety risks.
Penalties for Violations
Legal Consequences: Violating a secrecy order can result in severe penalties, including fines, imprisonment, or both. The severity of the penalties underscores the importance of compliance with secrecy directions.
Enforcement Mechanisms: Governments have robust enforcement mechanisms in place to detect and prosecute violations, ensuring that the secrecy of sensitive inventions is maintained.
National Security Considerations
Defence and Military Applications: Secrecy directions are often applied to inventions with potential military or defence applications. This includes technologies related to weapons, surveillance, encryption, and other strategic areas.
Critical Infrastructure: Inventions that could impact critical national infrastructure, such as energy, communications, or transportation systems, may also be subject to secrecy directions to prevent potential sabotage or exploitation.
Balancing Innovation and Security
Innovation Encouragement: While secrecy directions restrict disclosure, they are designed to balance the need for innovation with national security concerns. Inventors are still encouraged to develop new technologies, knowing that their inventions can be protected if necessary.
Temporary Measures: Secrecy orders are generally viewed as temporary measures. The ultimate goal is to lift the secrecy order when it is safe to do so, allowing the inventor to benefit from their innovation while protecting national interests.
International Coordination
Global Security: Secrecy directions are part of a broader effort to coordinate security measures internationally. Countries often work together to ensure that sensitive technologies are protected across borders, reflecting the global nature of modern security threats.
Treaty Obligations: Many secrecy directions are implemented in accordance with international treaties and agreements that require the protection of specific types of sensitive technologies.
IMPORTANCE AND RATIONALE BEHIND SECRECY DIRECTIONS.
Importance of Secrecy Directions
National Security Protection
Defence Technology: Secrecy directions safeguard sensitive inventions that have potential military applications, preventing adversaries from gaining access to advanced defence technologies.
Strategic Assets: Technologies related to national infrastructure, cyber security, and other critical areas are protected to maintain national security and prevent exploitation by hostile entities.
Public Safety
Hazardous Inventions: Some inventions may pose significant risks to public health and safety if their details are disclosed. Secrecy directions ensure such information is controlled and handled appropriately.
Preventing Misuse: Restricting access to sensitive technologies reduces the likelihood of their misuse in ways that could endanger public safety.
Economic and Competitive Advantage
Innovation Protection: Ensuring that proprietary and sensitive technological advancements are protected helps maintain a country’s competitive edge in global markets.
Intellectual Property Security: By keeping strategic inventions secret, countries can secure their investments in research and development, preventing economic espionage.
Regulatory Compliance:
Legal Frameworks: Compliance with national and international laws and regulations necessitates the protection of certain types of inventions. Secrecy directions help align patent processes with these legal requirements.
International Obligations: Countries may have treaties and agreements that require them to implement secrecy measures for certain types of technologies.
Rationale Behind Secrecy Directions
Preventing Technological Leaks
Controlled Dissemination: Secrecy directions ensure that sensitive information is only accessible to authorized personnel and entities, preventing leaks that could compromise national security.
Intellectual Property Theft: They act as a deterrent against industrial espionage and unauthorized access to proprietary technologies.
Strategic Security
Defence and Intelligence: Inventions that can enhance a country’s defence capabilities or intelligence operations need to be protected to maintain strategic advantages.
Cyber security: Protecting advancements in cyber security technologies helps shield national digital infrastructure from potential threats.
Economic Stability
Market Control: By controlling the dissemination of sensitive inventions, countries can influence markets and ensure economic stability, especially in sectors critical to national interests.
Innovation Incentives: Encouraging innovation by ensuring that inventors can work on sensitive technologies without fear of premature disclosure or exploitation.
Public Welfare
Health and Safety: Technologies that could be hazardous if misused are kept under wraps to ensure they are developed and deployed safely.
Environmental Protection: Inventions that might have significant environmental impacts are controlled to prevent misuse and ensure responsible development.
International Relations
Compliance with Global Norms: Secrecy directions help countries comply with international norms and treaties regarding the control of sensitive technologies.
Diplomatic Leverage: By maintaining control over strategic technologies, countries can negotiate and collaborate more effectively on the global stage.
CHALLENGES AND CRITICISMS
While secrecy directions serve vital national security and public safety purposes, they also face several challenges and criticisms. These issues reflect the complex balance between protecting sensitive information and fostering innovation and transparency.
Hindrance to Innovation
Restricted Collaboration: Secrecy orders can limit the ability of inventors to collaborate with other researchers and organizations. This can slow down the development of new technologies and hinder the sharing of knowledge.
Reduced Commercialization: The inability to disclose or market an invention can prevent inventors from commercializing their innovations, potentially reducing their financial incentives and slowing technological progress.
Legal and Administrative Burdens
Complex Procedures: The process of issuing, maintaining, and reviewing secrecy orders can be administratively complex and resource-intensive for patent offices and security agencies.
Inconsistent Application: The criteria and procedures for imposing secrecy orders can vary between jurisdictions, leading to inconsistent application and potential legal uncertainties for inventors operating in multiple countries.
Impact on Patent Rights
Delayed Patent Grant: Secrecy orders suspend the processing of patent applications, delaying the grant of patent rights. This can affect the inventor’s ability to protect their invention against unauthorized use.
Limited Legal Recourse: Inventors subject to secrecy orders may have limited legal recourse to challenge or appeal the order, potentially affecting their rights and interests.
Economic Implications
Financial Losses: Inventors may face financial losses due to the inability to commercialize or license their inventions while a secrecy order is in effect. This can be particularly burdensome for small businesses and individual inventors.
Market Distortion: Secrecy orders can distort markets by preventing the introduction of potentially disruptive technologies, which can impact competition and economic growth.
Transparency and Accountability
Lack of Transparency: The secrecy surrounding these orders can lead to a lack of transparency and accountability in the patent system. Stakeholders may not fully understand the criteria or rationale for imposing secrecy orders.
Potential for Abuse: There is a risk that secrecy orders could be used improperly to suppress information for reasons unrelated to national security or public safety, such as protecting economic interests or preventing public scrutiny.
International Coordination and Compliance
Cross-Border Issues: As technologies and businesses operate globally, coordinating secrecy orders across different jurisdictions can be challenging. Inconsistent rules and enforcement mechanisms can complicate international collaboration and compliance.
Trade and Diplomatic Concerns: Secrecy orders may impact international trade and diplomatic relations, particularly if foreign entities are involved in the development or commercialization of the technology.
Ethical and Social Considerations
Public Interest: There may be ethical concerns about withholding information that could benefit the public, such as medical or environmental technologies. Balancing the public interest with national security needs can be challenging.
Informed Consent: Inventors and stakeholders may not always be fully informed about the implications of secrecy orders, raising questions about informed consent and the fair treatment of inventors.
CASE STUDIES AND EXAMPLES
India: Missile Technology (2018-2020)
Invention: A new missile technology developed by Indian defence scientists.
Secrecy Directions Imposed: In 2018, the Controller of Patents, upon the Central Government’s recommendation, imposed secrecy directions on the patent application due to its potential impact on national defence.
Duration and Review: The secrecy directions were maintained for two years, with periodic reviews.
Revocation: In 2020, after reassessing the threat level, the secrecy directions were revoked as the invention was no longer considered a threat to national security.
Analysis
National Security: The secrecy directions successfully protected sensitive military technology during its critical development phase.
Innovation Impact: The restriction ensured that the missile technology remained confidential, preventing potential adversaries from gaining insights. However, it also delayed potential collaboration and further innovation until the directions were lifted.
Suggestions
Improved Review Mechanisms: Implement more frequent and detailed reviews to assess the necessity of ongoing secrecy directions.
Partial Disclosure: Allow controlled, partial disclosure to trusted collaborators under strict non-disclosure agreements to foster further development without compromising security.
USA: Encryption Algorithm (2016-2021)
Invention: A new encryption algorithm developed by the National Security Agency (NSA).
Secrecy Directions Imposed: In 2016, a secrecy order was issued, restricting foreign filing and disclosure without written consent from the NSA.
Duration and Review: The secrecy order was reviewed annually and remained in place for five years.
Revocation: In 2021, the technology was declassified, and the secrecy order was lifted, allowing the algorithm to be disclosed and utilized publicly.
Analysis
National Security: The secrecy order protected a critical component of national cyber security, preventing potential adversaries from understanding or circumventing the encryption.
Innovation Impact: The prolonged secrecy order limited the algorithm’s application and development in the private sector, potentially delaying advancements in cyber security.
Suggestions
Enhanced Collaboration: Establish secure channels for collaboration with select private sector entities to expedite innovation while maintaining security.
Timely Declassification: Set clear criteria and timelines for declassification to balance national security needs with technological progress.
UK: Radar Jamming System (2019-2022)
Invention: A new radar jamming system.
Secrecy Directions Imposed: In 2019, the UK Intellectual Property Office imposed secrecy restrictions to prevent the disclosure of sensitive national security information.
Duration and Review: The restrictions were reviewed periodically and remained in place for three years.
Revocation: In 2022, the invention was no longer deemed a threat, and the secrecy directions were lifted.
Analysis
National Security: The secrecy restrictions safeguarded a key defence technology, ensuring it did not fall into the hands of potential adversaries.
Innovation Impact: The restrictions limited broader research and development opportunities but ensured the technologies secure advancement within defence circles.
Suggestions
Strategic Partnerships: Form strategic partnerships with trusted defence contractors to continue development under secure conditions.
Flexible Secrecy Policies: Develop more flexible secrecy policies that allow for phased disclosure as the threat level diminishes.
China: Missile Guidance System (2020-2023)
Invention: A new missile guidance system developed by a Chinese defence contractor.
Secrecy Directions Imposed: In 2020, the Chinese Patent Office imposed secrecy directions on the patent application to prevent the disclosure of sensitive national security information.
Duration and Review: The secrecy directions were in place for three years, with periodic reviews.
Revocation: In 2023, the technology was declassified, the restrictions were lifted, and the patent was granted.
Analysis
National Security: The secrecy directions effectively protected a crucial military technology during its sensitive development phase.
Innovation Impact: The restriction ensured that the missile guidance system remained confidential, preventing potential adversaries from accessing the technology. However, it also delayed broader innovation and commercial application until the directions were lifted.
Suggestions
Regular Reviews: Implement more frequent reviews to assess the ongoing necessity of secrecy directions and to potentially lift them sooner if the security threat diminishes.
Controlled Collaboration: Allow limited disclosure to trusted research institutions and defence contractors under strict non-disclosure agreements to promote further development while maintaining security.
Japan: Encryption Algorithm (2018-2023)
Invention: A new encryption algorithm developed by the Ministry of Defence.
Secrecy Directions Imposed: In 2018, a secrecy order was issued, restricting any disclosure or foreign filing of the invention without government approval.
Duration and Review: The secrecy order was reviewed periodically and remained in effect for five years.
Revocation: In 2023, the technology was declassified, and the restrictions were removed.
Analysis
National Security: The secrecy order protected a critical component of Japan’s cyber security infrastructure, preventing potential adversaries from exploiting the encryption technology.
Innovation Impact: The prolonged secrecy restricted broader research and commercial development, but ensured the technologies secure advancement within government-controlled settings.
Suggestions
Secure Development Channels: Develop secure channels for collaboration with select private sector cyber security firms to expedite innovation while maintaining strict security controls.
Timely Declassification: Establish clear criteria and timelines for declassifying technologies to balance national security needs with the benefits of technological progress.
DETAILED ANALYSIS AND SUGGESTIONS
Analysis of Outcomes and Implications
National Security
Effectiveness: Secrecy directions have proven effective in protecting critical technologies from unauthorized disclosure, thereby maintaining national security.
Challenges: The primary challenge is balancing the need for security with the potential stifling of innovation and technological advancement.
Innovation
Initial Impact: Secrecy directions often hinder the immediate commercialization and broader development of technologies.
Long-term Effects: Once lifted, these directions can result in rapid advancements and commercialization as the technologies become available to the private sector and research communities.
Suggestions for Improvement
Periodic and Rigorous Review: Establish more frequent and detailed reviews of secrecy orders to ensure they remain necessary and justified. Use a multi-disciplinary approach involving security experts, industry professionals, and legal advisors.
Partial and Controlled Disclosure: Implement mechanisms for partial disclosure to trusted collaborators under strict non-disclosure agreements, facilitating further innovation without compromising security. Create secure environments for collaboration between government agencies and private entities.
Timely and Clear Declassification: Set clear criteria and timelines for the declassification of technologies to balance security needs with the benefits of technological advancement. Ensure transparency in the declassification process to build trust and encourage compliance.
Enhanced Collaboration Channels: Develop secure channels for collaboration with private sector entities to expedite innovation while maintaining necessary security measures. Foster public-private partnerships to leverage the strengths of both sectors in advancing technology securely.
Flexible Secrecy Policies: Create more flexible secrecy policies that allow for phased disclosure as the threat level diminishes. Tailor secrecy orders to the specific nature of the technology and its potential impact, rather than applying blanket restrictions.
COMPARATIVE ANALYSIS OF SECRECY PROVISIONS AND PRACTICES IN PATENT LAW
Comparison of Secrecy Provisions and Practices
India
Legal Framework: The Indian Patents Act, 1970 (Sections 35-37) allows the Controller of Patents to impose secrecy directions on inventions deemed prejudicial to national security.
Duration and Review: Secrecy directions can be initially imposed for one year, with periodic reviews and possible extensions.
Scope: Primarily used for defence-related technologies and innovations with potential national security implications.
USA
Legal Framework: The Invention Secrecy Act of 1951 empowers the Commissioner of Patents to impose secrecy orders on patent applications that may affect national security.
Duration and Review: Secrecy orders are reviewed annually and can be renewed indefinitely if necessary.
Scope: Broad application, including technologies developed by defence agencies and private entities working on government contracts.
Europe (UK)
Legal Framework: The UK Patents Act 1977 (Sections 22-23) allows the UK Intellectual Property Office to impose secrecy directions on inventions related to defence or other sensitive areas.
Duration and Review: Secrecy directions are reviewed periodically and can be maintained as long as necessary.
Scope: Primarily used for defence and security-related technologies, including innovations by private and public sector entities.
China
Legal Framework: The Patent Law of the People’s Republic of China (Articles 18-19) grants the Chinese Patent Office the authority to impose secrecy orders on inventions related to national security.
Duration and Review: Secrecy orders can be imposed for an initial period, subject to periodic review and renewal.
Scope: Commonly applied to military technologies and other innovations with significant national security implications.
Japan
Legal Framework: The Japanese Patent Act (Article 195) enables the Japanese Patent Office to impose secrecy orders on inventions considered vital to national security.
Duration and Review: Secrecy orders are reviewed periodically and can be extended if necessary.
Scope: Primarily applied to defence and cyber security technologies, particularly those developed by government agencies.
Identification of Similarities and Differences
Similarities
National Security Focus: All jurisdictions impose secrecy directions to protect national security, particularly for defence and military-related technologies.
Periodic Review: Secrecy orders are subject to periodic reviews to assess their necessity and effectiveness.
Government Authority: The power to impose secrecy directions lies with government agencies or patent offices in each jurisdiction.
Confidentiality Requirements: Secrecy orders restrict the disclosure, foreign filing, and publication of sensitive patent applications.
Differences
Duration and Renewal: The duration and renewal processes for secrecy orders vary, with some jurisdictions (like the USA) allowing indefinite renewals, while others have specific initial periods followed by reviews.
Scope and Application: The scope of technologies covered and the criteria for imposing secrecy orders can differ. For instance, the USA has a broad application including private sector innovations, whereas other jurisdictions may focus more narrowly on defence-related inventions.
Legal Frameworks: The specific legal provisions and mechanisms for imposing secrecy orders differ across jurisdictions, reflecting variations in national patent laws and security policies.
Assessment of Effectiveness and Challenges
India
Effectiveness: Secrecy directions effectively protect national defence technologies.
Challenges: The periodic review process can delay the commercialization of innovations, potentially hindering broader technological progress.
USA
Effectiveness: The Invention Secrecy Act is highly effective in safeguarding national security through robust annual review processes.
Challenges: Prolonged secrecy can stifle innovation and delay broader application and collaboration.
Europe (UK)
Effectiveness: The UK system is effective in protecting sensitive technologies.
Challenges: The periodic review process can create administrative burdens and may delay innovation.
China
Effectiveness: Secrecy orders effectively protect critical national security technologies.
Challenges: The lack of transparency and potential for overuse can stifle innovation and create uncertainties for inventors.
Japan
Effectiveness: The Japanese system safeguards national security, particularly in defence and cyber security.
Challenges: Prolonged secrecy can limit broader technological advancements and delay commercialization
Challenges Common to All Jurisdictions
Innovation Stifling: Prolonged secrecy orders can hinder innovation by restricting collaboration and commercial application.
Administrative Burdens: The periodic review and renewal processes can be resource-intensive for patent offices and inventors.
Transparency Issues: The lack of transparency in the imposition and review of secrecy orders can lead to uncertainties and potential misuse.
International Coordination: Differences in secrecy provisions across jurisdictions can complicate international collaboration and compliance for multinational inventors and companies.
10. WAY FORWARD: ENHANCING SECRECY DIRECTIONS IN PATENT LAW
Regular and Rigorous Reviews
Implement Frequent Reviews: Increase the frequency of reviews for secrecy orders to ensure their continued relevance and necessity. This will help in timely lifting of unnecessary restrictions, fostering innovation.
Multi-disciplinary Approach: Involve security experts, industry professionals, and legal advisors in the review process to ensure a balanced assessment of security and innovation needs.
10.2. Transparent and Accountable Processes
10.2.1. Enhance Transparency: Improve transparency in the imposition and review of secrecy orders. Clear criteria and justifications for secrecy directions should be communicated to inventors to reduce uncertainties.
10.2.2. Accountability Mechanisms: Establish accountability mechanisms to prevent misuse or overuse of secrecy orders, ensuring they are only applied when absolutely necessary.
10.3. Controlled Disclosure Mechanism
10.3.1. Partial and Controlled Disclosure: Develop mechanisms for partial disclosure to trusted collaborators under strict non-disclosure agreements. This can facilitate further innovation without compromising security.
10.3.2. Secure Collaboration Channels: Create secure channels for collaboration between government agencies and private sector entities to expedite technological development while maintaining necessary security controls.
10.4. Timely and Clear Declassification
10.4.1. Set Clear Timelines: Establish clear timelines and criteria for declassifying technologies. This ensures that inventions are not unnecessarily held back from commercial application.
10.4.2. Transparency in Declassification: Ensure the declassification process is transparent and predictable, fostering trust and encouraging compliance.
10.5. Flexible Secrecy Policies
10.5.1. Tailored Secrecy Orders: Develop more flexible secrecy policies that allow for phased disclosure based on the diminishing threat level. Tailor secrecy orders to the specific nature of the technology and its potential impact.
10.5.2. Dynamic Policies: Adapt secrecy policies dynamically in response to changes in the technological and security landscape.
10.6. Enhanced Collaboration and Information Sharing
10.6.1. International Collaboration: Promote international collaboration and information sharing on best practices for handling secrecy directions. This can help harmonize approaches and facilitate compliance for multinational entities.
10.6.2. Public-Private Partnerships: Foster public-private partnerships to leverage the strengths of both sectors in advancing technology securely and efficiently.
10.7. Balancing Security and Innovation
10.7.1. Balanced Approach: Strive for a balanced approach that protects national security without unduly stifling innovation. Consider the long-term benefits of technological advancement alongside immediate security concerns.
10.7.2. Incentivize Innovation: Provide incentives for inventors and companies working on sensitive technologies to continue innovation within secure frameworks. This can include grants, tax incentives, and other support mechanisms.
11. IMPLEMENTATION STRATEGY
11.1. Policy Reforms: Governments should review and reform existing patent laws and regulations to incorporate the above recommendations, ensuring a balanced approach to secrecy directions.
11.2. Capacity Building: Invest in training and capacity building for patent office staff, security experts, and legal advisors to handle the complexities of secrecy directions effectively.
11.3. Stakeholder Engagement: Engage with stakeholders, including inventors, industry representatives, and security experts, to gather input and build consensus on the proposed reforms.
11.4. Pilot Programs: Implement pilot programs to test new approaches to secrecy directions, such as controlled disclosure mechanisms and enhanced review processes, before wider adoption.
Monitoring and Evaluation: Establish robust monitoring and evaluation frameworks to assess the effectiveness of secrecy directions and make continuous improvements based on feedback and changing circumstances.
Under Indian Patents Act, 1970 Section 107A (b), allows for parallel importation of patented products if they are sourced from a legally authorized seller, without constituting patent infringement. This provision reflects the Doctrine of Exhaustion, which aligns with the TRIPS agreement. The section has evolved over time i.e, initially in the 2002 amendment required that the source of the product to be authorized by the patentee, but in the 2005 amendment broadened this to include products from anyone authorized under the law, not necessarily the patentee.
Introduction
Judicial precedents on Section 107A (b) in India are sparse. There are two main interpretations, one suggests that “duly authorized under the law” refers to the exporting country’s laws, supporting international exhaustion, while another argues it should be limited to Indian law, protecting domestic patent rights.
In 2012 Customs Circular, the Indian government implied that “under the law” pertains to the exporting country’s regulations. A public interest litigation challenging this circular did not resolve these ambiguities. The case of Strix Limited v. Maharaja Appliances also failed to clarify the term “duly authorized under the law.”
However, during a 2011 WTO trade policy review, India confirmed that it follows international exhaustion principles, meaning that patented products can be imported from any source authorized by the law of the exporting country. This interpretation allows Indian companies to import products from countries where patents are not enforced, potentially raising concerns about compliance with international IP standards.
Article 6 of the TRIPS agreement allows member states to adopt international exhaustion of intellectual property rights in their own laws. Countries can define how this exhaustion applies domestically without breaching TRIPS principles. The exhaustion principle often supports health policies by making expensive lifesaving drugs more affordable through parallel imports. Thus, member states are encouraged to implement parallel import rules as flexibly as possible to improve access to essential medicines.
Before the Patent (Amendment) Act, 2002, the Indian Patent Act, 1970, didn’t address the concept of patent exhaustion. The Doha Declaration highlighted the need for international exhaustion to make medicines more affordable. The 2002 amendment introduced Section 107A (b), allowing parallel imports only if the product was bought from someone authorized by the patentee. This limited the scope of parallel imports and hindered access to cheaper medicines. For example, if Company XYZ buys a machine from India and tries to import it into Japan, it could be blocked if the Indian seller wasn’t authorized by the patentee, even though the product was originally sold at a lower price.
The 2005 amendment revised this by stating that imports from anyone legally allowed to sell or distribute the product are not infringing, even if they are not directly authorized by the patentee. This change removed barriers to parallel imports, aligning better with international exhaustion principles. The principle means that once a patented product is sold anywhere by the patentee or with their consent, their rights are exhausted, and they cannot control further sales or imports of that product. However, if the initial sale wasn’t authorized, subsequent sales may still infringe the patent.
Under WIPO, in economic terms, parallel imports represent cross-border arbitrage. IP owners often set different prices for the same product in various markets based on local factors like purchasing power. When a patented product is sold at a lower price in one market compared to another, third parties may be motivated to import it into the higher-priced market to exploit the price difference. However, several factors and regulations influence whether parallel imports occurs.
Under a national exhaustion regime, once a patented product is sold in a country (Country X), the patentee’s rights are exhausted in that country, preventing them from blocking resale or importation of that product within Country X. However, the patentee can still block imports from other countries (like Countries Y and Z) where the product was not sold.
In a regional exhaustion regime, the patentee’s rights are exhausted when the product is sold in any country within a defined regional market. This means that once a product is sold in one member country, it can be imported and sold in other member countries without infringing on the patent. For example, if Countries X, Y, and Z are part of a regional agreement, a sale in Country X would exhaust patent rights across all three countries, allowing imports from any of these countries. Conversely, a sale in a non-member country would not exhaust patent rights in the member countries, so the patentee could prevent imports into those countries.
Under the international exhaustion rule, a patent owner’s control over a patented product is exhausted once it is sold legally anywhere in the world. This means that in a country with international exhaustion, if a product is sold legally in any country, it can be imported into that country without infringing on the patent. For example, if Country X follows international exhaustion, then patented products sold legally in Countries Y or Z can be imported into Country X without any patent infringement, because the patent rights in Country X are already exhausted for products sold in those other countries.
Comparative Analysis
In Japan, the Tokyo High Court applied the international exhaustion rule in the 1995 case BBS Kraftfahrzeug Technik AG v. Kabushiki Kaisha Racimex Japan and Kabushiki Kaisha JapAuto Prods. This ruling overturned the earlier 1969 Osaka District Court case Brunswick, which had held that parallel imports were illegal if the goods were patented in Japan. However, in 1997, the Japanese Supreme Court did not adopt the international exhaustion principle. Instead, it ruled that a patent holder in Japan could not block the importation of the same product into Japan from another country unless it could prove that the gray market importation was contractually prohibited and there was evidence of such a restriction on the product.
In Brunswick Corp. v. Orion Kogyo, K. K., a 1969 Japanese case, the Osaka District Court addressed the issue of parallel importation of patented goods. The case involved an automatic bowling pin device first sold in Australia by a sublicensee of Brunswick, which held patents in both Australia and Japan. The defendant imported used devices from Australia into Japan and was sued by Brunswick for patent infringement. The court ruled against the defendant, upholding the principle of territoriality of patent rights as outlined in the Paris Convention. It concluded that while patent rights are exhausted in the country of the initial sale (Australia, in this case), this does not affect the enforceability of the patent in Japan. The court rejected the argument for extending international exhaustion to patents, emphasizing that patent rights are distinct and must be individually maintained and enforced in each country. Thus, even though Brunswick was compensated for the devices in Australia, it was entitled to enforce its Japanese patent and collect royalties on the imported goods. The court granted Brunswick’s request for an injunction and the disposal of the infringing devices.
In the E.U. is in force the European Union exhaustion principle. Goods patented (or marked) traded for the first time in the European Union or in the European Economic Area can be freely traded inside European Union (or European Economic Area). The patent or trade mark holder can, instead, opposite to parallel importations inside E.U. or E.E.A.
In the U.S., the doctrine of patent exhaustion is recognized, but the government has consistently opposed the principle of international exhaustion. During TRIPS negotiations, the U.S. argued against international exhaustion, particularly for patents and pharmaceuticals. The U.S. government believes that allowing international exhaustion could harm the research and development capabilities of companies by reducing their ability to control patent exploitation and pricing in different markets. The only exception in U.S. law to this stance is for trademarks, where gray market imports are allowed if the U.S. trademark holder is the same as or affiliated with the foreign trademark holder. This exception is based on the belief that trademark protection does not have the same impact on research incentives as patents do.
A study by NERA in 1999 found that the European Union’s exhaustion principle, which applies within the EU, did not significantly reduce price differences among EU countries. This study suggested that parallel imports from countries like the U.S. and Japan might lower company profits more than they reduce consumer prices.
In theory, international exhaustion could help eliminate market segmentation and lower prices for consumers. However, studies on parallel imports are often based on limited evidence and anecdotal data. Recently, there has been a shift toward restricting parallel imports, especially for drugs, to protect research and development. This shift may be influenced by economic challenges and a move towards protecting businesses and fostering innovation. Balancing the benefits of parallel imports (which reduce prices for consumers) with the need to incentivize innovation (by ensuring adequate returns for patent holders) is challenging. The key is to provide fair compensation to intellectual property holders while avoiding excessive market control.
The interaction between parallel importation and patent infringement involves intricate legal and economic issues. The international exhaustion principle supports market integration and benefits consumers by making IP-protected goods cheaper and more accessible. It also counters monopolistic practices by patent holders and their licensees, fostering competition and leading to lower prices. For consumers, parallel imports expand product availability, increase choices, and promote consumption, particularly benefiting those in developing markets with more affordable options.
There is intersection between parallel imports and patent infringement is complex, reflecting on various nations intellectual property rights. India has a balance innovations and adoption of International exhaustion under Section 107A of Patents act, 1970. While international exhaustion fosters market integration and consumer benefits, it also presents challenges, including potential quality control issues and economic impacts on patent holders. Effective quality controls and informed policy adjustments can help mitigate risks while leveraging the advantages of parallel imports for broader market accessibility and competition.
Augmented Reality Technology (AR) displays a transformative leap in the way of interaction with the digital and physical platforms. By overlaying the computer-generated images, sounds and sensory enhancements onto our everyday real surroundings, AR bridges the gap between the virtual and real by creating a mixed-reality experience thereby enhancing the user’s way of perceiving and interaction.
AR Technology integrates digital information with the user’s environment in the real-time. AR overlays digital content onto our physical world even through devices such as smartphones, tablets, AR glasses etc., unlike Virtual Reality (VR) which immerses the users in a completely different kind of virtual world. The scope of AR extends across various domains like gaming, education, healthcare, manufacturing and navigation etc.
Key components of AR technology include:
Sensors and Cameras, which captures the physical surroundings and tracks the user movements.
Processors which handles the computational load which is required to integrate and display augmented content in the real-time world.
Displays which projects the augmented content onto the user’s view, ranging from simple screens to the advanced displays.
Software Algorithms which facilitates the interaction between the digital and physical realms through object recognition, tracking and the rendering techniques.
AR Technology has penetrated various sectors thereby offering new ways to enhance the user experiences. In healthcare, AR assists in medical training and complex operations while in retail, it enables virtual try-ons and interactive advertisements. In education, it brings subjects to life by using interactive learning modules whereas in the gaming industry, the success of games like Pokémon GO showcases AR’s potential to revolutionize entertainment.
The rapid growth of AR Technology is reflected in the increasing number of the filings of patents. Patents in this domain encompass hardware innovations, software advancements, user interface designs and specific application techniques. Leading technology companies such as Apple, Google, Microsoft and emerging startups are heavily investing in the AR-related R&D thereby resulting in a very competitive patent landscape.
This report delves into the patent landscape of AR technology, providing key insights into key players, technological trends and the competitive dynamics shaping the future of augmented reality. By analyzing patent filings and grant trends, it aims to offer a comprehensive view of the intellectual property landscape that is driving the AR industry forward.
Objective of Patent Landscape
We, at Origiin, prepared this Patent Landscape Report for AR Technology to understand various trends with regard to patent activity in this space. We have analyzed the patents filed, published and granted between 2022 and 2024. The search strategy used to generate the data to prepare the report is based on a combination of predetermined International Patent Classification (IPC) codes, as well as specific keywords.
We observed that the companies based in the India, United States and World Intellectual Property Organization are the major contributors of patent filings in the area of AR Technology. The leading patent filing companies include the Chandigarh University , Chitkara University and RV University.
C. Parameters used for Patent Landscape analysis
In this report, we studied the following parameters and trends:
Patenting Trends for the year 2022 to 2024
Distribution of Patents based on the Assignees
Jurisdiction based Global Patent Filing Trends
Technology classification based on IPC classification
Activities of Competitors based on area of Research (IPC)
Estimated top 10 industries and technology areas between 2022 and 2024
Estimated top 10 owners between 2022 and 2024
Estimated top 10 Assignee Countries between 2022 and 2024
Estimated top 10 priority countries between 2022 and 2024
Estimated top 10 publication countries between 2022 and 2024
D. Patent filing trend between years 2022 to 2024
Figure 1: Patent filing trend between the years 2022 to 2024
The Figure 1 depicts the distribution of patents for AR Technology between the years 2022 to 2024, including both applications filed and granted patents. The graph shows that highest number of applications were filed in 2022 with 26 patents followed by 2023 with 24 patents. However, the lowest number of patents were granted in the year 2023 with 03 patents compared to 2022 with 04 patents and 2024 with 07 patents. Overall, filings for AR Technology patent families is gradually increased in the time period between 2022 and 2024.
E. Distribution of Patents based on the Assignees
Figure 2: Distribution of Patents based on the Assignees
Figure 3: Distribution of Patent based on the jurisdiction
The Figure 3 shows the distribution of patents based on the jurisdiction. The maximum number of patents, i.e, 29, were filed in the IN (India) and rest of the patents were issued in the other jurisdictions, such as, United States (US) with 22 patents, World Intellectual Property Organization (WO) with 13 patents followed by European Patent Office (EP) with 10 patents and Taiwan (TW) with 10 patents, China (CN) with 09 patents, Russia(RU) with 07 patents, Turkey (TR) with 06, Japan (JP) with 04 patents and France (FR) with 03 patents.
G. Technology classification based on IPC classification
Figure 4: AR Technology Patent Distribution based on main IPC Code Classification
The Figure 4 indicates the patent distribution based on main IPC code. The top spot is occupied by the data processing systems or methods, specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes with 30 patents families. Other major players include Electric digital data processing and Image data processing or generation, in general with 28 patent families each followed by educational or demonstration appliances; appliances for teaching, or communicating with, the blind, deaf or mute; models; planetaria; globes; maps; diagrams with 11 patent families. Diagnosis: surgery: identification follows along with Computer systems based on specific computational models with 08 patents each while the next in line i.e., Healthcare Informatics hold 07 patents and Optical elements, systems or apparatus hold 05 patents. Image or video recognition or understanding and Transmission of digital information hold 04 patents each.
H. Activities of Competitors based on Area of Research (IPC)
Figure 5: Augmented Reality Technology (AR) Distribution of Patent based on Competitors and Area of Research (IPC)
The Figure 5 depicts the distribution of patents based on competitors and area of research (IPC). The top spot occupied by IPC G06T19/00 i.e, manipulating 3D models for images for computer graphics holds 24 patents. Other major players includes G06Q30/06 i.e, buying, selling or leasing transactions with 09 patent families and input arrangements or combined input and output arrangements for interaction between user and computer with 08 patent families. IPC G06Q30/02 for marketing with 06 patent families. Sound input: Sound output, using wireless devices, education, editing of 3D images and teaching not covered by other main groups of this subclass with 04 patents each. IPC A61B5/00 Measuring for diagnostic purposes holds 03 patents.
I. Estimated top 10 Industries and Technology areas between 2022 and 2024
Figure 6: Augmented Reality Technology (AR) Distribution of Patent based on Industries & Technology.
The Figure 6 indicates major industries and technology areas between 2022 and 2024. Computers and Peripheral Equipment is the major industry in the field. Computer Programming, Consultancy and Related Activities follows next with 29 patents. The next in line is Medical and Dental Instruments and Supplies with 12 patents. The Manufacturing N.E.C Industry holds 11 patents while the Other General Purpose Machinery has 09 patents. The Communication Equipment has 08 patents followed by Optical Instruments and Photographic Equipment with 05 patents. Other Manufacturing and Specialised Construction Activities holds 03 patents each. The least in number is the Domestic Appliances with 02 patents.
J. Estimated top 10 Owners between 2022 and 2024
Figure 7: AR Technology Distribution of Patent based on Current Owner
K. Estimated top 10 Assignee Countries between 2022 and 2024
Figure 8: Distribution of Patent based on Assignee Countries
The Figure 8 indicates India (IN) is the key assignee country with 28 patents followed by United States (US) with 14 patents, China (CN) and Taiwan (TW) with 07 patents each, Russia (RU) and Turkey (TR) with 05 patents each, while France (FR) with 03 patents. The lowest include Turkcell Technology Arastirma ve Gelistirme A.S (TR), Israel (IL) and Italy (IT) with 01 patents each.
L. Estimated top 10 Priority Countries between 2022 and 2024
Figure 9: Distribution of Patent based on Priority Countries
As indicated in Figure 9, India (IN) is the priority country for the AR with 27 patent family data set. United States (US) is another priority country with 14 patents. Rest priority countries are China (CN) with 08 patents, Turkey (TR) with 06 patents, Taiwan (TW) with 04 patents and France (FR) with 03 patents. The lower half priority country include Germany (DE), Spain (ES), Italy (IT) and Japan (JP) with 01 patents each.
M. Estimated top 10 Publication Countries between 2022 and 2024
Figure 10: Augmented Reality Technology (AR) Distribution based on Publication Countries
The Figure 10 indicates that the maximum patents belongs to the inventors of India (IN) with 27 patents and rest patents are issued to the inventors of other countries, ie United States (US) with 18 patents, Taiwan (TW) with 08 patents, Russia (RU) with 07 patents, Turkey (TR) with 06 patents followed by European Patent Office (EP) with 04 patents, Germany (DE) and Japan (JP) with 02 patents each, and the least i.e, France (FR) and Netherlands (NL) with 01 patents each.
N. Analysis of ECG Suppliers
Analysis was performed in order to obtain the companies involved in Augmented Reality Technology. The list of companies involved in AR Technology comprises the companies from various parts of the world involved in AR production and the irrespective patents and publications. The companies have been mentioned in the analysis of the graphical representation of patent applications under each parameter used for patent landscape analysis.
Apart from the companies list, there are few universities involved in AR Technology (AR) production:
Augmented Reality Technology (AR), one of the most popular industrial instruments widely used in gaming and entertainment, health care, retail and e-commerce, education and training, manufacturing and maintenance, real estate and architecture, navigation, tourism, advertising and marketing, military and defense and automotive industry etc., has opened up new dimensions and vistas for diagnosis on an industrial scale. The study indicates that the substantial number of patents is filed by inventors of the IN (India) and Chandigarh University (Punjab) being the major player. The study also shows that there are very less patents filed when it comes to manufacturing industries when compared to computers and peripheral equipment. This sector is of growing interest as the amount of patenting activity has increased. The data shows that there are maximum published patent families related to the AR Technology worldwide, of which 29 are from IN (India) applicants. Based on the list of top applicants, it is clear the leading patent filers include the Chandigarh University, Chitkara University and RV University.
Robotic vacuum cleaners (RVCs) are devices that autonomously navigate floor plans, utilizing onboard sensors and software to meticulously remove dirt, dust, and debris. The introduction of RVCs has demonstrably revolutionized the home cleaning industry by enhancing efficiency and liberating users from a traditionally time-consuming chore. This allows individuals to dedicate their time to more productive or leisure activities. They also provide consistent cleaning, maintaining a higher standard of cleanliness with regular use. Moreover, their compact design allows them to clean under furniture and in tight spaces that traditional vacuum cleaners might miss.
The technology used by the Robotic Vacuum Cleaner is different from that of the traditional vacuum cleaner. Some of these technological features are as follows:
The Sensor: This allows the device to navigate through the floor and avoid bumping into areas as well as falling from heights.
Short-Range Ultrasonic ToF: This is used to identify if the target surface is hard or soft, it is working on an average amplitude of a reflected ultrasonic signal. This technology senses the type of flooring (tile, carpet, or wood) and adjusts its cleaning effort accordingly.
VSLAM And LiDAR: This technology helps to build a virtual map of the room. Since they are viewing a virtual map of the room that they are going to clean they are capable of cleaning more efficiently covering the entire home.
Inertial Measurement Units (IMU): IMU sensors act like a compass and level for the robot sweeper. They track how it moves in all directions, including forward/backward, tilting, and turning. This allows the sweeper to “know” where it is and what it’s doing while cleaning.
B. Objective of this Patent Landscape
This Patent Landscape Report delves into the industry of robotic vacuum cleaners by analysing trends in patent filings. Our investigation focuses on three key areas: first, identifying emerging technologies and advancements that are shaping the future of robotic cleaning. Second, we examine filing patterns over the past decade (2014-2024) to understand how the industry has evolved and developed. Finally, the report sheds light on the key players who are driving innovation in this dynamic market.
To achieve these goals, we conducted an analysis of patents filed, published, and granted during the specified timeframe. Our search strategy employed a strategic combination of predetermined International Patent Classification (IPC) codes alongside targeted keywords. This approach ensured we captured the most relevant data to create a well-rounded picture of the robotic vacuum cleaner patent landscape.
C. Parameters used for patent landscape analysis
Patenting trends for the years 2014 to 2024
Distribution of patents based on assignees.
Estimated top 10 publication countries
Estimated top 10 assignee countries
Estimated top 10 Priority countries
Estimated top 10 industry areas
Estimated top 10 owners between the years 2014 and 2024
Technological classification based on IPC classification
Activities of Competitors based on Area of Research (IPC)
1. Patenting trends for the years 2014 to 2024
Figure 1: Patent filing trend between the years 2014 to 2024
Figure 1 depicts the distribution of patents for RVC between the years 2014 to 2024, including both applications filed and granted patents. The graph shows that highest number of applications were filed in 2019 with 68 patents followed by 2018 with 61 patents. However, the lowest number of patents were granted in the year 2014 with 16 patents compared to 2022 with 59 patents and 2020 with 55 patents. Overall, filings for RVC patent families saw a gradual increase but a sharp decline as depicted by the 2023 graph.
2. Distribution of patents based on assignees
Figure 2: Distribution of Patents based on the Assignees
3. Estimated top 10 publication countries between the years 2014 & 2024
Figure 3: Distribution of Patents based on Publication Countries
Figure 3 indicates that the maximum patents belongs to the inventors of United States (US) with 183 patents and rest of the patents are issued to the inventors of other countries, ie European Patent Office (EP) with 100 patents, Japan (JP) with 71 patents, Germany (DE) with 53 patents, United Kingdom (GB) with 34 patents, Chinese Taipei (TW) with 26 patents being the prominent followed by Australia (AU) with 22 patents, India (IN) with 11 patents, Canada (CA) with 9 patents and the least Russian Federation (RU) with 8 patents.
4. Estimated top 10 assignee countries between the years 2014 to 2024
Figure 4: Distribution of Patent based on Assignee Countries
The Figure 4 indicates US (United States) is the key assignee country with 131 patents and rest assignee countries are Germany (DE) with 113 patents, Sweden (SE) with 39 patents being the prominent followed by Great Britain (GB) with 34 patents, Korea (KR) with 29 patents, Netherlands (NL) with 27 patents, China (CN) with 16 patents and France (FR) with 11 patents. The final three countries half include France (FR) with 11 patents, Japan (JP) with 11 patents and Canada (CA) with 10 patents.
5. Estimated top 10 priority countries between the years 2014 to 2024
Figure 5: Distribution of Patents based on Priority Countries
Figure 5 indicates that United States (US) is the is the priority country for “RVC “with 169 patents and the rest of the priority countries are Germany (DE) with 107 patents, European Patent Office (EP) with 62 patents, United Kingdom (GB) with 48 patents, Korea (KR) with 30 patents, Japan (JP) with 26 patents, China (CN) with 25 patents, France (FR) with 12 patents, Sweden (SE) with 11 patents and Chinese Taipei (TW) with 11 patents.
6. Estimated top 10 industry areas between the years 2014 to 2024
Figure 6: Top 10 industry areas between 2014-2024
The Figure 6 indicates major industries and technology areas between 2014 and 2024. Domestic Appliances is the major industry in the field with 446 patents. General Purpose Machinery follows next with 110 patents. The next in line is Measuring, Testing and Navigation industry with 63 patents. The Metal forming machinery industry holds 37 patents while the Other General-Purpose Machinery has 34 patents. The Computers and Peripheral Equipment has 28 patents followed by Communication Equipment with 26 patents. Motor Vehicles hold 25 patents while other manufacturing industries hold 20 patents. The least in number is the electric motors and generators industry with 17 patents.
7. Estimated top 10 owners between the years 2014 to 2024
Figure 7: Top 10 industry owners between 2014-2024
As depicted in Figure 7, Miele & CIE KG is the major player with 82 patents. Miele & CIE KG manufacturer of high-end home appliances and commercial equipment, known for their quality and durability.The next key player is Sharkninja Operating LLC. with 52 patents, which is a producer focused on designing and developing innovative household appliances.. The next in line is Electrolux AB. with 46 patents. Dyson James Ltd. industry holds 39 patents while the LG Corp. has 33 patents. Irobot Corp. industry has 24 patents followed by Koninklike Philips Nv. with 23 patents. Vorwerk & Co and Midea Group both holds 18 and 13 patents each followed by Seb Sawith the least number of patents i.e. 12 patents.
8. Technology classifications based on IPC classification
Figure 8: Technological Patent Distribution based on main IPC Code Classification
Figure 8 indicates the patent distribution based on main IPC code. The top spot is occupied by the domestic washing or cleaning with 589 patents families. Other major players include system for controlling or regulating non-electric variables with 126 patent families, manipulators with 69 patent families and radio direction with 32 patent families. Measuring distances, levels or bearings follows with 21 patents along with electric digital data processing with 20 patents . Circuit arrangements or systems for supplying or distributing electric power has 18 patents while the next in line ie. Brushes hold 16 patents. Air conditioning hold 13 patents each followed by Separation with the least number of patents i.e., 12 patents.
9. Activities of Competitors based on Area of Research (IPC)
Figure 9: Distribution of Patent based on Competitors and Area of Research (IPC)
Figure 9 depicts the distribution of patents based on competitors and area of research (IPC). The top spot occupied by IPC A47L9/28 ie installation of electric equipment hold 294 patents. Other major players include A47L9/04 ie driven brushes or agitators with 176 patent families and parts of machines not such as arrangment of switches, skirts, buffers, levers with 135 patent families. IPC A47L9/00 for details or accessories of suction cleaners with 129 patent families. Control of position or course in two dimensions with 121 patent families while next in line is floor sweeping machines and Nozzles with 38 patents. Lastly, we have A47L9/06 with fixed brushes and A47L9/14 with bags or the like at 35 and 34 patent families each.
D. Conclusion
Robotic Vacuum Cleaner (RVC), a newly introduced technology has slowly become one of the most popular pieces of technology and opened up new dimensions for the automated technological industry. The study indicates that the substantial number of patents is filed by inventors of the US (United States) and Miele & CIE KG (Germany) being the major players. The study also shows that there are very less patents filed when it comes to manufacturing industries when Domestic Appliances industry. Data shows that there are maximum published patent families related to the RVC worldwide, of which 131 are from US applicants. In terms of innovation, the RVC industry may be quite competitive despite the presence of a handful of very large companies. Based on the list of top applicants, it is clear the leading patent filers include the Miele & CIE KG, Sharkninja Operating LLC, Electrolux ABand Dyson Technology LTD.
A Patent of addition is a special type of patent allowing the holder to make improvements or modifications to an existing invention without filing a new patent application. It is designed to protect improvements or developments on an original patented invention, providing legal protection to the incremental innovations made by the inventor. The key feature of a Patent of Addition is that it derives its validity from the main patent and typically expires along with the main patent.
The Patents Act of 1970 is primarily based on the recommendations of the Justice N. Rajagopala Ayyangar Committee, as detailed in their report, “Report on the revisions in the patent law.” The Ayyangar Committee proposed the inclusion of a clause allowing for applications for patents of addition, similar to Section 26 of the UK Patent Act of 1949. In the UK, the Lord Swan Committee (1948) recommended provisions in the UK Patent Act 1949 to assist applicants who did not draft their claims comprehensively enough to cover their invention. This provision aimed to offer these applicants a chance to rectify their claims by filing a patent of addition, thus allowing them to address variations of the main application and expand the scope of their invention. The Ayyangar Committee’s recommendations mirrored Section 26 of the UK Patent Act.
The provision for a Patent of Addition offers significant benefits to inventors. It fosters continuous innovation by motivating inventors to enhance their inventions through incremental advancements. It also protects these enhancements, promotes cost and efficiency, and ensures clear legal protection for these improvements, empowering inventors to defend their innovations effectively.
The Indian law for Patent of Addition.
Under the Patents Act of 1970 (Sections 54 to 56), a Patent of Addition is specifically designed to improve or modify an existing invention. This provision allows inventors to protect their incremental advancements without the need to file a new and separate patent application. The key feature of a Patent of Addition in India is that it does not have an independent term; instead, it expires concurrently with the main patent. This ensures that the improvement is protected only as long as the original invention is protected. A Patent of Addition can also be granted even if the main patent is still pending. It provides flexibility and continuous protection for ongoing innovations, reassuring and supporting inventors in their creative journey. The examination process for a Patent of Addition is the same as that for the main patent, ensuring that the improvement meets all patentability requirements, including novelty, inventive step, and industrial applicability.
Section 54 of the Patents Act of 1970 outlines the provisions for patents of addition, which are granted for improvements or modifications to an existing (primary) invention. If an applicant files for a patent covering an improvement or modification of a main invention and has either already applied for it or holds the patent, the Controller may, upon request, grant a patent for the improvement as a patent of addition. In case, the improvement or modification is already patented independently, and the patentee holds the main invention’s patent, the Controller may, upon request, revoke the independent patent and grant an addition patent with the same filing date as the revoked patent. A patent of addition is only be granted if its application date is the same as or later than the filing date of the main invention’s application, and it cannot be granted before the main invention’s patent is granted.
Further, Section 55 states that patent of addition is granted for the same term as the main patent and remains in force until the main patent expires or is revoked. If the main patent is revoked, the addition patent can become an independent patent for the remainder of the original term. No renewal fee is required for an addition patent unless it becomes independent. Lastly, Section 56 states that the grant of an addition patent cannot be refused or invalidated solely because the improvement lacks an inventive step compared to the main invention. The validity of an addition patent cannot be challenged because it should have been an independent patent. Novelty is assessed by considering both the main invention and the patent of addition.
Can a Patent Cooperation Treaty (PCT) application be filed for an addition patent?
Section 54 of the Patents Act does not limit the type of application for which a modification or improvement can be sought, allowing flexibility in its application. According to Section 7(1A) of the Patents Act of 1970, an international application filed under the Patent Cooperation Treaty (PCT) is considered filed in India if a corresponding application was filed before the Controller in India. Furthermore, under Section 138(4) of the Patents Act, an international PCT application designating India is treated as if it were filed under Sections 7 and 54. Form-1, the standard application form for patents in India, includes a specific section dedicated to patents of addition, confirming that such applications can be filed domestically or through international routes.
This interpretation is consistent with the PCT itself. Article 2 of the PCT broadly defines “application” as various types of applications for the protection of inventions, encompassing patents of addition, among others. Therefore, if an applicant wishes to designate an international PCT application as a patent of addition or seek other forms of protection in the designated state, this can be indicated during the national phase entry process. However, it’s essential to consider whether the special privileges granted to patents of addition under Indian law are recognised and applied similarly in other jurisdictions where the PCT application is pursued.
Comparative Analysis in the US, the EU, and Japan
United States
In the United States, the concept similar to a Patent of Addition is known as a Continuation-in-Part (CIP) application, as defined in United States Code, Title 35, Section 253. A continuation-in-part (CIP) application is a refiling of the same specification as the parent application but includes additional features of the invention. The claims are directed to the additional features. A CIP application allows inventors to add new subject matter to an existing patent application while retaining the priority date of the original application for the shared content. This means that while the new material is examined as if it were a separate application, it benefits from the earlier filing date of the original application for the common content. This can be advantageous in securing earlier protection for the innovation. The term of the CIP patent can differ from that of the original patent, depending on the filing date of the new content, providing additional flexibility in managing patent lifecycles.
European Union
The European Patent Convention (EPC) does not have a direct equivalent to a Patent of Addition. Instead, it provides for divisional applications. A divisional application allows an applicant to split an existing patent application into two or more applications, each treated as an independent patent. Divisional applications must be filed while the parent application is still pending. They inherit the parent application’s filing date, ensuring that the priority is maintained. The term for a divisional application is 20 years from its filing date, providing a full patent term independently of the parent application. This approach offers inventors flexibility in managing their patent portfolios and protecting different aspects of their inventions separately.
Japan
In Japan, the concept of a Patent of Addition is provided under Article 44 of the Japanese Patent Act. It is also called “Utility Model Registration” or “Patent of Addition.” This provision allows inventors to patent improvements to an existing invention. Similar to India, the Patent of Addition in Japan does not have an independent term and expires concurrently with the main patent, ensuring that the improvement is protected for the same duration as the original invention. The improvement must meet specific criteria to be eligible, and the examination process is the same as for the main patent. This ensures that the added innovation is patentable and deserves protection.
The Three Pillars of the Comparative Analysis
Term and Expiry: In India and Japan, the Patent of Addition expires with the main patent, ensuring no extension beyond the original patent’s term. This approach simplifies the management of patent durations but limits the protection period for improvements. In contrast, through CIP applications, the US system allows for a potentially different term based on the filing date of the new content, providing flexibility but adding complexity to patent term management. The EU’s divisional applications have independent terms, providing an entire 20-year protection period from the filing date of the divisional application and offering the longest potential protection for improvements.
Application Process: All jurisdictions require that the Patent of Addition or its equivalent undergoes the same rigorous examination process as the main patent. This ensures that the improvements meet all patentability criteria in India and Japan, even if the main patent is still pending. The US CIP application process allows for new subject matter to be examined independently, ensuring that each part of the application is thoroughly vetted. In the EU, divisional applications must be filed while the parent application is pending, maintaining a continuous chain of priority and ensuring that all aspects of the invention are examined appropriately.
Purpose and Use: All jurisdictions aim to encourage and protect incremental innovations and improvements. The US and EU systems provide more flexibility, with independent terms for CIP and divisional applications, allowing inventors to manage their patent portfolios strategically. This flexibility can be beneficial for complex inventions with multiple improvements. On the other hand, India and Japan offer a more straightforward approach, directly linking the term of the Patent of Addition to the main patent, simplifying the process but limiting the protection period for the improvements. This approach is beneficial for ensuring the improvement’s protection is tied to the original invention’s lifecycle, promoting consistent and predictable patent management.
Conclusion
The concept of a Patent of Addition plays a vital role in the global patent system by encouraging and protecting continuous innovation. Despite the varied implementations across different jurisdictions, the core objective remains consistent: incentivising inventors to improve and refine their inventions by providing legal protection for these incremental advancements. In India and Japan, the Patent of Addition ensures that improvements or modifications are protected as long as the main patent is in force. This approach simplifies the patent lifecycle for inventors by directly linking the improvement’s protection to the primary patent’s term, reducing administrative burdens and costs associated with filing multiple patents for related innovations.
The Continuation-in-Part (CIP) application in the United States offers a flexible mechanism for protecting improvements. By allowing the addition of new subject matter to an existing application and examining it independently, the CIP system allows inventors to extend the protection of their innovations while maintaining the original priority date for shared content. This flexibility can be particularly beneficial in industries where rapid technological advancements necessitate frequent updates and improvements to patented inventions. The European Patent Convention (EPC) adopts a different approach through divisional applications. Divisional applications allow inventors to split an existing patent application into separate patents, offering the advantage of independent terms and an entire 20-year protection period for each divisional.
Understanding these differences is crucial for inventors and businesses seeking to protect their innovations in multiple regions. The choice of jurisdiction and the specific type of patent application can significantly impact the scope and duration of protection for incremental improvements. By navigating the varied legal frameworks effectively, inventors can maximise the protection of their innovations, encourage continuous development, and strategically manage their intellectual property portfolios on a global scale. While the implementation of the Patent of Addition varies across India, the US, the EU, and Japan, each system aims to balance the rights of inventors with the public interest, fostering an environment that supports ongoing innovation, economic growth, and technological advancement.
Cisplatin is an alkylating agent that reacts with biological components to form covalent bonds, commonly used in chemotherapy. It is a platinum based coordination complex that damages DNA in an unrepairable way. This halts the excessive growth of cancer cells and induces apoptosis. It is commonly administered for testicular, ovarian, bladder, and lung cancers.
However, one of the major side effects of Cisplatin was reported to be severe nephrotoxicity that is defined by deterioration of the kidneys due to heavy chemicals. To overcome this, a targeted drug delivery system using nanoparticles was devised.
Nanoparticles are spherical polymers with more than one dimension in the nanoscale. By scaling down the dimensions to the nanoscale, a drug’s efficiency can be increased by improving the drug’s absorption. They are biocompatible and biodegradable particles. Due to the nano-dimensions of the nanoparticles, there is an increased surface area that leads to increased absorption in the biological systems.
Cisplatin Nanoparticle formulations involve incorporating the targeted drug molecule with a nanoparticle that are engineered to target cancer cells and minimize side effects by not attacking healthy cells. Nanoparticles release the drug in a controlled manner, improving the drug’s bioavailability. Bioavailability is the extent at which the drug enters the human circulation system and is available for action on the active site. It is a parameter to judge the extent of a particular drug molecule’s absorption by the system and efficiency at the target site.
Cisplatin nanoparticles have been presented as a promising advancement in chemotherapy, offering a large therapeutic effect while minimizing the harmful side effects.
Objective of Patent Landscape
We, at Origiin, prepared this Patent Landscape Report for Cisplatin Nanoparticle Formulation to understand various trends with regard to patent activity in this space. We have analyzed the patents filed, published and granted between 2019 and 2024. The search strategy used to generate the data to prepare the report is based on specific keywords.
PatSeer, a leading research platform for patent insights, was utilised for the landscape report to analyse the patents involving cisplatin nanoparticle formulation from the year 2019 till June of 2024.
The input search query was a combination of keywords and Boolean operators. The time frame was adjusted and an output of 2000+ records was obtained.
Based on this output, the patenting trends, competitors, top industries and top priority countries were analysed, and the data was presented graphically.
Parameters used for Patent Landscape Analysis
In this report, we studied the following parameters and trends:
Patenting Trends from 2019 to 2024
Distribution of Patents based on the Assignees
Global Patent Filing Trends
Technology classification based on IPC classification
Activities of Competitors based on Area of Research (IPC)
Estimated Top 10 industries and technology areas between 2019 and 2024
Estimated Top 10 owners between 2019 and 2024
Estimated Top 10 Assignee Countries between 2019 and 2024
Estimated Top 10 Priority Countries between 2019 and 2024
Estimated Top 10 Publication Countries between 2019 and 2024
Patenting Trends from 2019 to 2024
Figure (1): Patenting Trends from 2019 to 2024
Figure 1 depicts the patents filed for Cisplatin Nanoparticle Formulation from the years 2015 to 2024 and patents granted from 2019 to 2024. The graph indicates the highest number of filed patents in the year 2020 with 330 patents. It was followed by a decrease to 302 patents in 2021. It further reduced to 210 patents in 2022 and 115 in 2023. The filing of patents has gradually decreased from 2020 to 2024.
Distribution of Patents based on the Assignees
Figure (2): Distribution of Patents based on the Assignees
Figure 3 shows the distribution of patents across countries based on their jurisdiction. The maximum number of patents, ie 412, were filed in the US (United States) and rest of the patents were issued in the other jurisdictions, such as, China (CN) with 373 patents, World Property Organization (WO) with 263 patents, Europe (EP) with 212 patents, Japan (JP) with 195, Korea (KR) with 172 patents, Australia (AU) with 144 patents, Canada (CA) with 104 patents, India (IN) with 76 patents and Taiwan (TW) with 51 patents.
Technology classification based on IPC classification
Figure (4): Technology classification based on IPC classification
Figure 4 indicates the patent distribution based on the main IPC code. The top spot is occupied by the preparation for medical, dental or toilet purposes with 1899 patent families. Other major players include therapeutic activity of chemical compounds or medicinal preparations with 1259 patent families, Peptides with 545 patent families and microorganisms or enzymes; preparations thereof with 263 patent families. Heterocyclic compounds follows with 153 patents. Investigating or analyzing materials by determining their chemical or physical properties follows with 140 patents. Specific uses or applications of nanostructures; measurement or analysis of nanostructures; manufacture or treatment of nanostructures has close to 118 patents. Measuring or testing processes involving enzymes holds 68 patents. Methods or apparatus for sterilizing materials or objects in general has 48 patents. Macromolecular compounds obtained otherwise than by reactions only involving unsaturated carbon-to-carbon bonds holds 45 patents, electrotherapy; magnetotherapy; radiation therapy; ultrasound therapy showcases 36 patents, sugars; derivatives thereof; nucleosides; nucleotides; nucleic acids has 31 patents, acyclic or carbocyclic compounds holds 28 patents and finally diagnosis; surgery; identification holds 23 patents.
Activities of Competitors based on Area of Research (IPC)
Figure (5): Activities of Competitors based on Area of Research (IPC)
Figure 5 depicts the distribution of patents based on competitors and area of research (IPC). The top spot is occupied by the Medicinal or veterinary science with 1992 patent families. Other major players include organic chemistry with 751 patent families followed by biochemistry with 307 patent families, measuring with 142 patents. Nanotechnology holds 123 patents, organic macromolecules with 77 patents, physical or chemical preparations with 18 patents, combinatorial technology with 14 patents and at the lower spectrum inorganic chemistry and dyes; paints; polishes with 10 patents each.
Estimated Top 10 industries and technology areas between 2019 and 2024
Figure (6): Estimated Top 10 industries and technology areas between 2019 and 2024
Figure 6 indicates major industries and technology areas between 2019 and 2024. Basic Pharmaceutical Products and Pharmaceutical Preparation holds an overwhelming 2,035 records. This is followed by the Measuring, Testing, and Navigating Instruments industry, which has 137 records, placing it as the second highest. Basic Chemicals, Fertilizers, and Nitrogen Compounds comes next with 123 records, closely trailed by Electronic Components and Boards with 120 records. The Medical and Dental Instruments and Supplies industry has a notable 81 records. Irradiation, Electromedical, and Electrotherapeutic Equipment has 36 records, while Soap, Detergents, Cleaning, and Polishing Preparations accounts for 23 records. Both Other General Purpose Machinery and Other Special Purpose Machinery industries each have 6 records. Lastly, the Food Products industry has the fewest records, totaling 5.
Estimated Top 10 owners between 2019 and 2024
Figure (7): Estimated Top 10 industries and technology areas between 2019 and 2024
Estimated Top 10 Assignee Countries between 2019 and 2024
Figure (8): Estimated Top 10 Assignee Countries between 2019 and 2024
Figure 8 indicates US (United States) is the key assignee country with 899 patents and the rest assignee countries are issued to the inventors, China (CN) with 450 patents, Korea (KR) with 215 patents, Denmark (DE) with 47 patents, India (IN) with 37 patents, Taiwan (TW) with 33 patents, Australia (AU) with 32 patents, France (FR) with 29 patents, Ireland (IR) with 28 patents and Canada (CA) with 24 patents.
Estimated Top 10 Priority Countries between 2019 and 2024
Figure (9): Estimated Top 10 Priority Countries between 2019 and 2024
Figure 9 indicates that the United States (US) is the top priority country for Cisplatin Nanoparticle Formulation with 1,170 patents. China (CN) follows with 412 patents, Korea (KR) holds the third position with 200 patents. The European Patent Office (EP) with 86 records. India (IN) has 48 records, and the United Kingdom (GB) has 30 records.
Estimated Top 10 Publication Countries between 2019 and 2024
Figure (10): Estimated Top 10 Priority Countries between 2019 and 2024
Figure 10 indicates that the United States (US) is the top publication country for Cisplatin Nanoparticle Formulation with 413 patents. China (CN) follows with 373 patents, WO holds the third position with 264 patents. The European Patent Office (EP) with 212 records, Japan (JP) with 195 records, Korea (KR) with 172 patents, Australia (AU) with 145 patents, Canada (CA) with 104 patents, India (IN) has 76 records, and Taiwan (TW) with 51 patents.
Analysis of Major Suppliers
An analysis was performed to study the patents filed for Cisplatin Nanoparticle Formulation for the past five years and list out the major companies involved in the formulation of said patents. From the patent analysis, certain key players working on cisplatin nanoparticle formulation were identified.
The companies have been mentioned in the analysis of the graphical representation of patent applications under each parameter used for patent landscape analysis.
Some of the major companies involved in Cisplatin Nanoparticle Formulations are:
Cisplatin Nanoparticle is emerging as a popular alternative in chemotherapeutics. It has gained popularity in the past five years, with the number of patents filed increasing from the years 2017 to 2020 by the pharmaceutical industries. The study indicates that a major portion of the patents filed belong to the United States followed by China.
The company Hangzhou Dac Biotech emerged as the major player. The study also showed that the Pharmaceutical industry holds the most patents, followed by the Measuring, Testing, and Navigating Instruments industry.
Based on the list of top applicants, it is clear the leading patent filers include the Legochem Bioscience Inc, University of California, Mayo Foundation for Medical Education and Research, University of Chicago, University of Michigan, Massachusetts Institute of Technology, University of North Carolina at Chapel Hill, Gilead Science Inc and the Purdue Research Foundation.
At the time of Merger and Acquisition (M&A) of a company there are manifold considerations that need to be looked at. One such consideration, an important one, is the Intellectual Property (IP) of the company, especially in the form of patents. The due diligence of the patent portfolio plays a crucial role in not only understanding and evaluating the market value of the portfolio, but also to keep in mind the liabilities that may accrue to maintain such patents in various jurisdictions. Due diligence of the portfolio also ensures that all patents including family patents are docketed, screened, valuated, and transferred in an effective manner and to finally evaluate the value, market potential and liabilities of the acquiring patent portfolio. While it is important that due diligence of other IP forms such as trademarks, designs and copyrights are also performed, this article will primarily focus on the patent portfolio of the company.
IP Audits
To initiate due diligence of a patent portfolio, the first and foremost step is conducting an IP Audit wherein all granted patents and filed applications (collectively termed as patent documents) should be listed and compiled, followed by checking the legal status of the patent documents in every country they are filed or granted. In the case of patent applications, it is necessary to check if there are any pending actions against them in terms of responding to any office action or payment of any pending fees.
In case of granted patent applications, it is important to perform legal status checks of those patents. If the patent is expiring soon, it may not be of much value to the company. For granted patents, a check must be performed to see if any action is needed to maintain such patents.
Registered IP should be docketed to keep a watch on important official timelines such as responding to official communication or payment of renewal to maintain it. As part of docketing, it is worthwhile to note down the term of the IP which remains. For instance, if there remain only a few months for a patent to expire, it may not be best decision to transfer the patent to the buyer as transferring a patent requires amendments in its forms which may neither be advantageous to the buyer nor the seller.
Additionally, gathering information related to apposition, revocation, litigation or infringement of the patents of the company is also crucial.
Relevance of Patents for the Business
The patent portfolio that is to be acquired may contain certain patents may be irrelevant to the buyer’s business. In such cases, there may be not much use in transferring such patents the buyers’ company. Instead, alternatives such as out-licensing the IP may be explored, or, if the IP is not strong enough to be registered, it may be published as a research paper as well. Sometimes, companies also consider donating some of their IP or abandoning it or letting it expire, depending on the relevance and importance of such IP for the business.
Categorization of Similar Patents
In order to determine the valuation of patents, similar patents may be categorized together, and appropriate methodologies should be used to ascertain their collective value. Depending upon the value of patent portfolio, the decision to retain or license may be taken.
Transfer of Rights
Acquisition of a patent portfolio is complete only after the amendment is made in the name of the patentee and is done in the respective patent office. Therefore, it is pertinent to get in touch with the attorney who is in charge of the case to ensure that such amendments are made in time. This process also involves payment of certain sums as government and attorney fees.
Understanding Liability
The buyers must be aware of the fact that acquiring IP of another company brings a lot of liabilities with it. In order to get the IP transferred in the name of the buyers, at the time of acquisition, a lot of amendments are to be made in the official records in the office where such IP is registered. Most times buyers prefer in a change in the attorney handling such cases as well, which may lead to additional expenditure for them. Even after the IP is acquired and the required amendments are made in the official records, other liabilities such as annual fees to maintain the IP also have to be assessed regularly. Further, if any of the IPs are undergoing litigation or are opposed, due-diligence must be performed to ascertain the stage and the further course of action.
It is therefore evident that conducting exhaustive due diligence of patent portfolios is extremely important to understand the relevance, importance, value and liabilities before acquiring them.
Author: Bindu Sharma (CEO, Origiin IP Solutions LLP), Bhavya Sharma (BBA, LLB student of Jindal Global Law School)
Please contact us at info@origiin.com to know more about our services (Patent, Trademark, Copyright, Contract, IP Licensing, M&A of companies)
Welcome to the world of Kidventors, our genius Kid-Inventors.
Have you ever imagined that in a world of experienced engineers, scientists, doctors, and brilliant minds; the next big thing in the world comes from the bright minds of kids. As we know, creativity has no age limit and the best ideas come from the unlikeliest places. Yes, you are right! These young inventors are not only thinking of fantastic out-of-the box ideas but are also trying to bring real changes in the world.
When we think of it, what actually helps the Kid-ventors think beyond their age is their boundless imagination and fearless challenging behaviour. Unlike adults, children often approach problems with fresh perspectives and unbridled creativity. They see the world not as it is but as it could be and this vision is the driving force behind their groundbreaking inventions.
According to a great saying, age is just a number. These brilliant young innovators are here to make a difference and their inspiring stories are not only heartwarming but also a reminder that we should always nurture and support the creative potential in every child. After all, today’s curious minds could be tomorrow’s inventors who are set to change the world. Let’s dive into some of the coolest inventions and the incredible stories behind these brilliant and beautiful minds, starting from household items to out of space devices.
Sam Houghton is one of the youngest recognized kid inventors from the United Kingdom who came up with the idea at the age of 3 and became an inventor with a patent, at the age of 5. Sam invented “A sweeping device with two heads”, where the invention claims that the sweeping device for sweeping a surface comprises a combination of two brushes connected by a resilient connector; the first brush comprises a brush head, a plurality of bristles affixed to the brush head and a handle extending from the brush head; the second brush comprises a brush head, a plurality of bristles affixed to the brush head and a handle extending from the brush head, wherein the resilient connector serves to retain said combination of brushes in resiliently moveable relation to one another in use.
Gitanjali Rao was 11 years old when she thought of something incredible arising from her main aim which was to serve the society and help the people in need. When she was 9, she came to know about Flint in Michigan facing a crisis of lead-contaminated tap water. Clean water is a basic human right, she thought, but the water in Flint was poisoned with lead and the kids drinking it had brain damage and several health issues. She came across an article on carbon nanotubes, used to detect food spoilage through resistance created by gases in air, and her mind churned to know if it would also work to detect lead in water. After more than a year of research, brainstorming, prototyping, and testing, Gitanjali invented a device that uses nanotechnology to test water for contaminants and deliver fast, accurate results—all before she turned 11 years old. Gitanjali decided to name the device “Tethys,” for the Greek goddess of fresh water, and on August 10, 2021, she received a patent from the US patent office for her invention.
Her invention is a system and method for detecting contaminants in water, where the device may include: a sensor configured to detect one or more contaminants in a liquid when the sensor is dipped into the liquid; a computing device connected to the sensor, the computing device being configured to determine a resistance of the device when the sensor is dipped into the liquid; and a wireless electronic device connected to the computing device via one or more wireless links and configured to receive the resistance of the device when the sensor is dipped into the liquid from the computing device, and the wireless electronic device determines a level of contamination in the liquid based on a difference between the resistance of the device when the sensor is dipped into the liquid and a set or predetermined resistance.
Anushka Naiknaware, at the age of 13, invented a bandage that monitors the healing process of wounds. Anushka is an Indian-American girl, who with dedication and innovation capabilities, devised a bandage having significant implications for medical care worldwide. Her invention uses biocompatible sensors to track moisture levels in wounds, ensuring optimal healing conditions.
A sensor for detecting moisture comprising a substrate, a pattern made on the substrate using a nanoparticle conductive ink and having at least two conductive terminals to the pattern. The sensor may further include an electronic device to monitor the impedance at the terminals and can provide representative audio or visual output; or may transmit the measured impedance or the corresponding representative status over wired or wireless interface to other electronic devices. The interfaced electronic devices may further transmit all the received data to data servers for additional processing and Internet services.
At the age of ten, Bishop Curry V was inspired to invent a way to prevent the accidental death of children in hot cars after a tragedy involving a young child in his neighbourhood. Bishop came up with an idea for a device that included motion sensors, global positioning, messaging capabilities, and many more to develop a device called Oasis, which is a life-saving device for children left in a hot car. Bishop’s device, Oasis, attaches to the top of a child’s car seat, wherein a motion sensor detects a child in a motionless car, and within minutes sends a message to the parents, then alerts the authorities, including the car’s location. At the same time, the device activates a thermoelectric cooling device to blow cool air on the child until help arrives.
Bishop’s invention is a child passenger safety seat emergency cooling and notification system, for detecting hot car seat situations, manually cooling the child in those situations, and facilitating one or more alert notifications. An apparatus receives sensor data that it uses to detect the presence of a child in a car seat in a vehicle. Multiple sensors provide added security against false positives. When a child is detected, the apparatus activates a cooling flow of air towards the child if the temperature rises above a threshold. The apparatus waits until the vehicle is not moving and off before initiating notifications to one or more subscribing devices. Once off, and once the temperature of the child further rises or has the air flow on for a period of time, the apparatus sends a notification to the subscribing devices. If the child is not removed within a set period of time, then emergency responders are notified.
Rifath Sharook:
Hailing from Tamil Nadu, Rifath Sharook made headlines globally when, at the age of 18, he developed the world’s lightest satellite, named “KalamSat” in honor of the late Indian president and scientist Dr. A.P.J. Abdul Kalam. The satellite weighs only 64 grams and it was launched by NASA, marking a significant achievement for young Indian innovators.
When Shaarook was a child, he’d spend hours staring through the lens of a telescope with his dad. Sadly Mohamed Farook, a local professor and scientist, passed away when his son was in primary school. But Shaarook’s passion for space lived on. As a young teenager he joined Space Kidz India, an organisation dedicated to nurturing young people with a passion for technology and he formed a six-person team and dedicated the next four years to making a satellite, under the guidance of the organisation’s founder and director. Eventually they invented KalamSat: the lightest satellite in the world.
At just 64g, it weighs about as much as a large battery. It’s essentially a 3.8cm-wide cube made from 3D-printed plastic, reinforced with carbon fibres. It contains several different kinds of sensor, including those to measure temperature, magnetism, altitude and any strains on the structure as it hurtles through space. It also has its own power source and a small computer, to turn on all the sensors at the right moment and store their data.
These young inventors demonstrate that age is no barrier to creativity and innovation. Their remarkable achievements at such a young age inspire others to explore their ideas and make a difference in the world.
Author: Megha Nadiger, Origiin IP Solutions LLP
Please contact us at info@origiin.com to know more about our services (Patent, Trademark, Copyright, Contract, IP Licensing, M&A of companies)
An ECG (electrocardiogram) is a test that records the electrical activity of the heart, including its rate and rhythm. An ECG records the electrical signals in the heart and it is a common and painless test used to quickly detect heart problems and monitor the heart’s health.
In a human body, the nerve and muscle cells communicate with each other using electrical and chemical signals. Regular electrical signals also control our heartbeat. These signals are sent by a group of cells in the right atrium of the heart known as the Sinoatrial Node (SA node), and they spread through the heart muscle tissue as tiny electrical impulses. This causes first the atria and then the ventricles of the heart to contract. The way that these signals spread through the heart can also be measured on the surface of our skin. An ECG measures these changes in electrical signals (or, in fact, voltage) on different areas of skin and plots them as a graph.
A health care provider often use an ECG to determine or detect:
Irregular heart rhythms (arrhythmias);
If blocked or narrowed arteries in the heart (coronary artery disease) are causing chest pain or a heart attack;
Previous heart attack (s); or
Efficiency of some certain heart disease treatments, such as a pacemaker.
The three major types of ECG commonly used are:
Resting ECG: The resting ECG involves lying still on the back with a bare chest. It is necessary that the patient lies calmly and comfortably during the test because tensing the muscles, moving, coughing or shaking can affect the results. The measurement needs about one minute, or five minutes.
Exercise ECG: The electrical activity of the heart is measured while the person is physically active. This usually involves riding an exercise bike. The degree of exertion is gradually raised to a high level as the pedals become harder to rotate. If there are irregularities in the ECG, the test is stopped early. In addition to the ECG graph, this test measures the power output in Watts. Your blood pressure is also checked regularly.
Holter monitor: The electrical function of the heart is normally measured over 24 hours. Three or four electrodes are attached to the chest, and a small recording device is worn on a belt. The ECG data is then transferred to a computer later on at the doctor’s office for analysis. A Holter monitor may be utilized if, the person only has an irregular heartbeat some of the time and it doesn’t show up in a “normal” ECG
B. Objective of Patent Landscape
We, at Origiin, prepared this Patent Landscape Report for ECG to understand various trends with regard to patent activity in this space. We analyzed the patents filed, published and granted between the year 2022 and 2024. The search strategy used to generate the data to prepare this report is based on a combination of predetermined International Patent Classification (IPC) codes, as well as specific keywords.
In this report, we studied the following parameters and trends:
Patenting Trends for the year 2022 to 2024
Distribution of Patents based on the Assignees
Jurisdiction based Global Patent Filing Trends
Technology classification based on IPC classification
Activities of Competitors based on area of Research (IPC)
Estimated top 10 industries and technology areas between 2022 and 2024
Estimated top 10 owners between 2022 and 2024
Estimated top 10 Assignee Countries between 2022 and 2024
Estimated top 10 priority countries between 2022 and 2024
Estimated top 10 publication countries between 2022 and 2024
D. Patent filing trend between years 2022 to 2024
Figure 1: Patent filing trend between the years 2022 to 2024
The Figure 1 depicts the distribution of patents for ECG between the years 2022 to 2024, including both applications filed and granted patents. The graph shows that the highest number of applications were filed in 2022 with 1225 patents followed by 2023 with 777 patents. However, the lowest number of patents were granted in the year 2022 with 27 patents compared to 2023 with 159 patents and 2024 with 126 patents. Overall, filings for ECG patent families is gradually decreased in the time period between 2022 and 2024.
E. Distribution of Patents based on the Assignees
Figure 2: Distribution of Patents based on the Assignees
Figure 3: Distribution of Patent based on the jurisdiction
The Figure 3 shows the distribution of patents based on the jurisdiction. The maximum number of patents, i.e., 909, were filed in the US (United States) and rest of the patents were issued in the other jurisdictions, such as, India (IN) with 360 patents, Chinese Taipei (TW) with 87 patents being the prominent followed by Korea (KR) with 67 patents, Israel (IL) with 64 patents, China (CN) with 59 patents, Canada (CA) with 58 patents, Japan (JP) with 53, Germany (DE) with 44 patents and Russia (RU) with 42 patents.
G. Technology classification based on IPC classification
Figure 4: ECG Patent Distribution based on main IPC Code Classification
The Figure 4 indicates the patent distribution based on main IPC code. The top spot is occupied by the diagnosis, surgery indications with 1552 patents families. Other major players include healthcare informatics with 584 patent families, electrotherapy: magnetotherapy with 265 patent families and computer system based on computational models with 172 patent families. Electric digital data processing follows with 155 patents. Devices for introducing media into, or onto, the body has 106 patents while the next in line i.e., Preparations for medical, dental or toilet purposes holds 78 patents. Data processing systems and Image data processing or generation in general hold 73 patents each followed by Transmission of digital information with the least number of patents ie 64 patents.
H. Activities of Competitors based on Area of Research (IPC)
Figure 5: Electrocardiogram (ECG) Distribution of Patent based on Competitors and Area of Research (IPC)
The Figure 5 depicts the distribution of patents based on competitors and Area of Research (IPC). The top spot is occupied by IPC A61B5/00 i.e., measuring for diagnostic purposes with 882 patents. Other major class includes A61B5/0205 ie simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition with 260 patent families and measuring pulse rate or heart rate with 211 patent families. IPC G16H50/20 for computer aided diagnosis e.g. based on medical expert systems with 181 patent families. Heart-related electrical modalities with 176 patent families while the next in line is heart defibrillators with 157 patents. IPC G16H40/67 Remote operation purposes hold 151 patents. IPC G16H50/30 i.e., for calculating health indices ie. for individual health risk assessment purposes hold 147 patents. Measuring movement of the entire body or parts ie. head or hand tremor, mobility of a limb in general hold 142 patents followed by A61B5 is holders for multiple electrodes with the least number of patents ie 133 patents.
I. Estimated top 10 industries and technology areas between 2022 and 2024
Figure 6: Electrocardiogram (ECG) Distribution of Patent based on Industries & technology.
The Figure 6 indicates major industries and technology areas between 2022 and 2024. Medical and Dental instruments and Supplies is the major industry in the field. Computers and Peripheral Equipment follows next with 322 patents. The next in line is Irradiation, Electromedical and Electrotherapeutic Equipment industry with 261 patents. The Communication Equipment industry holds 157 patents while the Measuring, Testing and Navigation Instruments especially Watches and Clocks has 105 patents. The Basic Pharmaceutical Products and Pharmaceutical Preparatory industry has 97 patents followed by other general-purpose machinery with 63 patents. Computer programming, consultancy and related activities hold 52 patents while other manufacturing industries hold 48 patents. The least in number is the manufacturing N.E.C industry with 21 patents.
J. Estimated top 10 owners between 2022 and 2024
Figure 7: Electrocardiogram (ECG)Distribution of Patent based on Current Owner
As indicated in Figure 7, Asahi Kasei Corp is the major player with 84 patents. Asahi Kasei Corp contributes to the advancement of medical treatment worldwide via continuous innovation in various fields, including medical device systems that respond to unmet needs such as chronic and acute renel disease, neurologic and other intractable conditions.The next key player is the Johnson & Johnson Co Ltd with 47 patents, which is a producer of medical devices and pharmaceutical products. The next in line is Baxter International Inc.with 44 patents. Medtronic Inc. industry holds 35 patents while the Samsung Group has 33 patents. Becton Dickinson & Co. industry has 29 patents followed by West Affum holding designated activated company with 28 patents. Apple Inc. and GE Healthcare Technology Inc. both hold 26 patents each followed by West Affum Holding Dac with the least number of patents i.e., 24 patents.
K. Estimated top 10 Assignee Countries between 2022 and 2024
Figure 8: Distribution of Patent based on Assignee Countries
The Figure 8 indicates US (United States) is the key assignee country with 899 patents and rest of the assignee countries are India (IN) with 345 patents, Chinese Taipei (TW) with 84 patents being the prominent followed by Korea (KR) with 72 patents, Israel (IL) with 66 patents, Japan (JP) with 60 patents, Denmark (DN) with 52 patents and China (CN) with 50 patents. The lower half includes Ireland (IE) with 45 patents, Russia (RU) with 41 patents, Canada(CA) and France (FR) with 36 patents each, India with 28 patents, Great Britain (GB) and Netherlands (NL) with 21 patents each.
L. Estimated top 10 priority countries between 2022 and 2024
Figure 9: Distribution of Patent based on Priority Countries
As indicated in Figure 9, US (United States) is the priority country for the ECG with 1108 patent family data set. India (IN) is another priority country with 383 patents. Rest priority countries are Japan (JP) with 141 patents, Korea (KR) with 74 patents, China (CN) and Chinese Taipei (TW) with 54 patents each. The lower half priority country include Germany (DE) with 46 patents, Europe (EP) with 40 patents, Great Britain (GB) with 30 patents and France (FR) with 20 patents.
M. Estimated top 10 publication countries between 2022 and 2024
Figure 10: Electrocardiogram (ECG) Distribution of Patent based on Industries& technology
The Figure 10 indicates that the maximum patents belong to the inventors of US (United States) with 1080 patents and rest patents are issued to the inventors of other countries, such as, India (IN) with 384 patents, European Patent Office (EP) with 156 patents, Japan (JP) with 123 patents, Chinese Taipei (TW) with 90 patents being the prominent followed by Australia (AU) with 67 patents, Canada (CA) with 49 patents, Russian Federation (RU) with 42 patents, Germany (DE) with 31 patents and the least ie United Kingdom (GB) with 26 patents .
N. Analysis of ECG Suppliers
Analysis was performed in order to obtain the companies involved in electrocardiogram (ECG). According to the findings of the survey, the majority of firms manufacture intermediates, and quite a few companies involved in electrocardiograms.
The list of companies involved in ECG comprises the companies from different parts of the world involved in electrocardiograms (ECG) production and the irrespective patents and publications. The companies have been mentioned in the analysis of the graphical representation of patent applications under each parameter used for patent landscape analysis.
Apart from the companies list, there are few major companies involved in electrocardiograms (ECG) production:
Electrocardiogram (ECG), one of the most popular industrial instruments widely used in the field of medicine and dentistry and for measurement purposes, has opened up new dimensions and vistas for diagnosis on an industrial scale. The study indicates that the substantial number of patents is filed by inventors of the US (United States) and Asahi Kasei Corp (JP) being the major player. The study also shows that there are very less patents filed when it comes to manufacturing industries when compared to medical and dental instruments and supplies industries. This sector is of growing interest as the amount of patenting activity has increased. The data shows that there are maximum published patent families related to the ECG worldwide, of which 909 are from US applicants. The analysis found that the top five applicants represent only 12% of the total patenting activity for this sector. In terms of innovation, the ECG industry may be quite competitive despite the presence of a handful of very large companies.
Author: Roshan Elizabeth Daniel
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Claim mapping of patent claims is a technical process used to map one or more claims of a patent to a specific feature, function, component or product featured by the patent to determine if any product or service is allegedly infringing the claims of the patent.
Purpose of Claim Mapping
The primary purpose of a claim map is to determine the occurrence of any form of patent infringement. The patent claim map is generally used during patent infringement analysis, where the claim map provides a clear visualization of all the information analysed in the patent claim.
The claims maps illustrate the infringement of each and every element of the claims of a patent by any existing product or service. The patent claim is infringed when each and every element or component of the patent claim is present in any product or service. It is highly important to interpret the patent claim to determine the patent infringement.
The patent claim mapping process evaluates and identifies the most important patents in a company’s patent portfolio and the level of protection provided by those patents. Claim mapping is highly important during the patent prosecution phase as it is critical to know which claims of the patent need to be retained and which are to be abandoned.
Structure of a Claim map
A claim map is generally a map having a textual and graphical comparison of the claims of a patent and the potentially infringing uses. The claim map may be created by manual examination of the claims, which is time consuming and labour-intensive process. Further, one can use various software tools for examining the claims, which is more efficient and effective than manual examination. The examined claims are used to create the claim map in different forms.
The claim map may be constructed in various forms, such as a map with two columns where the elements of a patent claim and the features of the potentially infringing products or services are mapped along with the related evidence. The claim map may be constructed in three-column forms where the elements of a patent claim, along with supporting citations from the specification of the patent providing interpretations of one or more of the elements of the claim are mapped with the potentially infringing products or services. Further, the claim map can be created in a graphical format where the examined claims are presented on different slides, each focusing on one claim element or a component. The claim maps demonstrate the probable infringement to a patent claim and target to map all the elements of the patent claim to complete the mapping.
Important considerations before mapping the claims
There are several points to be considered before mapping the patent claims. It is important for a claim map to address how the potentially infringing product or service carries out the claim limitation of the patent claim. Also, finding the individual or entity that infringes the patent is critical. In case any wrong individual or entity is accused of infringement, it might lead to unfavorable situations. The claim map must clearly define the infringer along with how or when that infringement has occurred.
Further, it is important not to map inconsequential products as mapping incorrect products may lead to nullifying the claim map. Additionally, while determining the potential infringer and their infringing product or service, care must be taken to map the most significant infringing products or services out of all the infringers. Also, it is critical to include all the evidence in the claim map for a stronger case. Further, it is important to make sure that all relevant evidence present in the claim map is supported by citations.
Conclusion
Claim mapping determines the probability of any form of infringement of a patent by creating a clear visualization of all the similarities between the elements present in a patent claim with potentially infringing products or services. It is important to address a claim’s limitations or requirements in the claim map before concluding that a claim is being infringed. A thoughtfully mapped patent claim map creates valuable intellectual property and facilitates the determination of claims to be retained and abandoned.
Patents serve as powerful instruments within the realm of intellectual property, providing inventors with exclusive rights to their inventions for a specified duration, typically spanning 20 years[1]. These legal tools not only incentivize innovation by shielding inventive work but also contribute to the overall socio-economic development of the country by fostering technological progress and economic development. However, the protection bestowed by patents is not absolute, as statutory provisions like Section 66 of the India Patents Act, 1970[2] introduce a critical layer of regulatory oversight.
Under the ambit of Section 66, the seemingly impenetrable shield provided by patents undergoes legal scrutiny, particularly when the public interest is perceived to clash with the exclusive rights granted to patent holders. Section 66 of the Act runs as follows:
“Where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked.”
Revocation of Patents in India
Revocation, in simple terms, refers to the action of withdrawing something previously granted. The same principle applies to patents, which, despite being granted initially, do not hold a permanent status. Individuals other than the patent holder are granted the right to submit a revocation petition if they encounter issues related to someone else’s patent rights. In this context, “people” encompass any interested party with legally acceptable grounds for challenging the patent’s validity, including the Central Government.
Section 66 of the Patents Act, 1970
Section 66 plays a pivotal role in elaborating on the revoking of patents that are considered mischievous to the State or contravening to the public interest in India. On such occasions, the Central Government holds the power to revoke a patent, given that the patentee is allowed an opportunity to display their case against revocation. If the Government is still not satisfied, it can issue a notification in the Official Gazette regarding the final revocation.
Due to the sensitivity of this provision, it has been used only twice in the country. While the first time was in 1994, the second time was almost two decades later, in the year 2012. In order to understand this Section better, it is pertinent to understand the circumstances that led to the Central government exercising its power of revocation in these two cases.
The first case where the patent was revoked under Section 66 of the Act was related to a process patent to Agracetus, granted to a U.S.-based company, for genetically engineered cotton cell lines. In 1994, this patent faced revocation in the public interest, as it was deemed as detrimental to farmers’ rights. The Government asserted that cotton, a pivotal crop crucial to the national economy, should not be subject to patent rights.
Indian Patent No. 168950, entitled “Method of producing transformed Cotton Cells by tissue culture”, had been granted to Agracetus based on patent application number 919 Cal 87, filed on 24/11/1987, by the Indian Patent Office.
Notably, no pre-grant opposition was raised by any party, leading to the patent being granted successfully. However, the implications of such a patent became evident later, prompting criticism from the farming community. Concerns were raised that the patent adversely affected their interests, impacting a major national crop and potentially harming the Indian economy. India, being the world’s third-largest cotton-producing nation after China and the U.S., has a significant population dependent on cotton cultivation for income.
In response to farmer protests asserting that the patent infringed upon their fundamental right, given the significance of cotton in their livelihoods and its impact on the Indian economy, the Central Government took action. In a historic move, the Government invoked Section 66 of the Patent Act, 1970, to revoke Agracetus’ patent on October 24, 1994 citing that the patent granted was generally preducial to the public. The decision was made through notification No. SO762(E) by the Department of Industrial Policy and Promotion, under the Ministry of Commerce and Industry, Government of India.
The decision was grounded in the belief that the patent would have far-reaching consequences for India’s cotton economy, adversely affecting farmers and the cotton industry, ultimately leading to negative ramifications for the Indian economy.[4] Subsequently, the United States also followed suit and revoked Agracetus’ patent.[5]
The second instance came about when the Government of India utilized the provisions of Section 66 to revoke Avasthagen’s patent in 2012. Avasthagen, a company specializing in producing medicines, had secured patent protection for a diabetes-controlling medicine/tonic incorporating jamun, lavangpatti, and chundun. The patent, granted under application number 1076/CHE/2007, pertained to a “synergistic ayurvedic/functional food bioactive composition”.
Avasthagen also filed a patent application for the same composition with the European Patent Office (EPO). However, during the examination process, the patent examiners cross-referenced the patent with the Traditional Knowledge Digital Library (TKDL) database. It was discovered that the patent claimed subject matter that was disclosed by TKDL, thereby infringing upon traditional knowledge. The Council of Scientific and Industrial Research (CSIR) had made individual intervention for the same as well.
The Indian Patent Office, citing a lack of access to the TKDL database, admitted that its examiners had previously approved the patent without knowledge of this conflicting information related to traditional knowledge. Once informed, the Indian Government, invoking Section 66, revoked the patent. The government’s rationale for revocation emphasized that the use of Jamun for diabetes treatment was long-established in India, and therefore, the patent claimed subject matter already known in the public domain through India’s Traditional Knowledge.
Avasthagen argued that while it might be known in traditional knowledge that these plants were used for treating diabetes individually, the combination’s aggressive effect was not recognized. They asserted that their formulation was innovative, noble, and scientifically screened for efficacy and safety using modern technology. The company defended its patent, stating that it had adopted a different approach by initially selecting about 100 plants for formulation, later shortlisting to 10. Additionally, they claimed their invention was novel and provided scientific validation to Indian Traditional Knowledge, pledging support to Indian farmers and promising employment opportunities.
The Government countered these arguments, asserting that the use of these plants for managing diabetes had been known for centuries, and, therefore, the patent lacked inventiveness. Officials argued that when plants are recognized for their efficacy against a specific disease, extracts would inherently serve the same purpose. The government contended that a patent could not be granted for validating something inherent to Traditional Knowledge.[7]
Ultimately, dissatisfied with Avasthagen’s arguments, the Government revoked the patent on October 18, 2012. The patent which was initially granted in April 2012 was revoked on the grounds of being generally prejudicial to the public. The decision was conveyed through Notification No. SO2517(E) by the Department of Industrial Policy and Promotion, under the Ministry of Commerce and Industry, Government of India.
Traditional Knowledge Digital Library (TKDL) and The Way Forward
While the rationale behind applying Section 66 for the revocation of the Avesthagen patent may be a subject of debate, there is no denying the value of the Traditional Knowledge Digital Library (TKDL) in safeguarding India’s traditional knowledge. The questions now pertain to whether similar inventions grounded in traditional knowledge, which were previously granted, will undergo a similar trajectory as the Avesthagen patent, and if so, how they will be interlinked with the public interest of the country.
Striking a Balance between Public Interest and Honouring Innovation
The incorporation of Section 66 underscores the acknowledgment that certain inventions, despite their innovative value, may have detrimental effects on public interest and welfare. This raises a pivotal question: how can we strike a balance between safeguarding the exclusive rights of inventors and ensuring the overall well-being of the public?
While public interest is paramount, acknowledging the crucial role of innovation in driving economic growth and technological progress is equally important. Innovators invest significant resources in developing novel solutions that can transform industries and enhance lives. Section 66, therefore, demands a balanced approach to ensure that the power of revocation is not exercised arbitrarily, obstructing genuine innovations that could positively contribute to society.
Conclusion
An inherent challenge of Section 66 lies in the subjective nature of assessing what exactly poses a threat to public interest. Achieving a balance requires a nuanced approach that considers the societal impact of the invention, its implications on critical sectors, and the overall potential benefits or harm it may bring about.
As technology and industries continue to evolve, the relevance and application of Section 66 will likely evolve as well. Continuous dialogue among policymakers, legal experts, and stakeholders is essential to refining the interpretation and implementation of this provision, ensuring its ongoing effectiveness in balancing the promotion of innovation and the protection of public interest.
The concept of Intellectual Property Rights (IPR) in these modern times is progressing as people across the globe create more and more intangible assets with the use of their intellect and creativity. IPR protections various Intellectual Properties (IP) and fosters a sustainable mechanism to make it harmonious with growth. Patent is a subset of IPR, and it focuses on technical inventions, their application and process of manufacture. Patent grants exclusive right to prevent third parties from making, using, selling, offering for sale and importing the patented invention in the jurisdiction where patent is granted. But first, there are certain criteria laid out by the Indian Patents Act, 1970, which must be fulfilled for a product or a process to be considered as an invention; they are Novelty, Inventive Step and Industrial Application. In the case of Novartis AG vs. Union of India, we witness the standard requirements and importance of novelty and inventive steps in India. The Honourable Supreme Court of India clarified various terms stated under Section 3(d)[1] and applied the concept of Evergreening of Patents to solve the case effectively. The appeal was dismissed by the court on the basis that “Glivec” failed to show enhanced efficacy when compared to an already patented drug “Imatinib Mesylate”.
Facts
One of the largest multinational pharmaceutical corporations, Novartis AG, based in Switzerland, created a drug called “Imatinib Mesylate” and in 1992 filed it for a patent at the United States Patent and Trademark Office (USPTO), which was granted. In 1997, Novartis AG filed another patent application in the United States for a “Beta Crystalline” form of imatinib mesylate named “Glivec”, which was also granted a patent in the US. This same drug was also granted a patent in 35-plus countries[2]
Then, in 1998, Novartis AG filed a patent application for Glivec at the Madras Patent Office, India, which was facilitated via the TRIPS agreement. The application specified that it was a beta crystalline form of Imatinib mesylate and further illustrated that it helps to treat cancer, specifically Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumors (GIST). Novartis AG claimed the superiority of Glivec over previously patented imatinib mesylate, as it had improved flow properties, thermodynamic stability and lower hygroscopicity[3].
Prior to the Patent (Amendment) Act, 2005, India didn’t grant product patents but only process patents as per Section 5[4] of the Patents Act, 1970. Until the section was repealed, Novartis AG couldn’t pursue a product patent for Glivec.
In 2005, the Madras Patent Office considered and later (in 2006) rejected the product patent application filed by Novartis AG for Glivec on the basis that it was not novel, that is obvious to a person skilled in the art and was anticipated by the prior publication of Zimmermann patent; Novartis AG had also wrongly claimed date of filing of the application in Switzerland as the priority date in India. Further, Section 3(d)[5] of the Patents Act, 1970 was applied, “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.” and the patent office concluded that glivec was a new form of an already known substance which didn’t result in enhanced efficacy.
Aggrieved by the patent office’s rejection, Novartis AG filed multiple (one by the appellant and one by the Indian power of attorney holder) writ petitions in Madras High Court under Article 226[6] of the Constitution of India.
The appeals claimed Section 3(d)[7] of the Patents Act, 1970, to be unconstitutional, as it was alleged to be in contradiction to the TRIPS agreement and in violation of Article 14[8] of the Constitution.
In 2007, the Madras High Court transferred the case to the Intellectual Property Appellate Tribunal (IPAB) after its formation, along with the previous writ petitions challenging the order of the Assistant Controller. IPAB heard the appeal and reversed certain findings of the controller by approving Glivec’s novelty and nonobviousness but still rejected the application for a patent grant as the product was adequately being hit by Section 3(d)[9] of the Patents Act, 1970. As per IPAB reasoning, Section 3(d)[10] establishes high standards for patentability in India and stops the “evergreening of patents”, which is necessary for the benefit of the citizens of India, especially when it comes to life-saving drugs.
In 2009, Novartis AG filed a Special Leave Petition (SLP) under Article 136[11] of the Constitution before the Honourable Supreme Court of India, pleading against the order of IPAB.
Issues Raised
To define “Known Substance”, stated in Section 3(d)[12] of the Patents Act 1970?
To define “Efficacy”, as stated in Section 3(d)# of the Patents Act 1970,
Whether Section 3(d)[13] of the Patents Act, 1970, allow a certain amount of increase in bioavailability to be qualified as increased efficacy?
To compare the stated improvements of glivec with imatinib mesylate properties and judge the patentability?
Relevant Legal Provisions
Section 3(d)[14] of the Patents Act, 1970: “the mere discovery of a new form of a known substance that does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”.
Article 27(1)[15], TRIPS: “Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65[16], paragraph 8 of Article 70[17] and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced”.
Judgment
In 2013, the Hon’ble Supreme Court of India gave its final verdict, wherein the court rejected the patentability claim of Glivec, filed by Novartis AG. The court upheld previous verdicts of Glivec (a beta crystalline form of imatinib mesylate) as being a new form of an already-known substance with minor improvements. The court defined the word “Efficacy” as stated under Section 3(d)[18] of the Patents Act, 1970, apropos to “Therapeutic Efficacy” and “Known Substance” as something in public or traditional knowledge. Addressing the issue of a 30% increase in bioavailability, previously claimed by Novartis AG, the Honourable Supreme Court cleared that it would amount to an increase in efficacy, but Novartis AG failed to produce any proper evidence of the same (30% increase in bioavailability of Glivec when compared to imatinib mesylate). Further, the court tested all the other claims of improved flow properties, thermodynamic stability and lower hygroscopicity of Glivec with Imatinib Mesylate and found them to be of no value regarding enhanced therapeutic efficacy. No further documents were provided by Novartis AG, which claimed enhanced efficacy of Glivec over the previously patented drug imatinib mesylate. Lastly, no violation of the TRIPS agreement was found.
Conclusion
India is a developing country which is making a positive mark on geo-politics despite its demographic drawbacks. India upholds the responsibility of prioritising public health, and this judgment replicates the same. There was no violation of the TRIPS agreement because India successfully adopted Article 27[19] of TRIPS without contradicting it. Furthermore, the TRIPS agreement mandates countries to adopt the stated measures but gives member countries flexibility to adopt them at their convenience. The concept of Evergreening of Patents was used by the Honourable Supreme Court, especially in the context of the pharmaceutical industry, to stop big companies from exploiting public and welfare initiatives. Section 3(d)[20], among other areas, safeguards medicine availability to the public at large on a cheaper by price by stopping pharmaceutical companies from getting their inventions patented in perpetuity upon introducing minor changes; this means once the designated time of protection ends, those medicines will be available to the public for manufacture and trade at a cheaper price, without taking consent from the proprietor. Hence, the Honourable Supreme Court safeguarded all Indian citizens, especially the ones in need, from exploitation by the Pharmaceutical Industry. The high and fair criteria of patent protection in India promote fair competition and harmonise all industries. The court interpreted and defined the term “efficacy” as a tool to analyse the notion of invention and as a criterion to judge novelty and inventive steps. Ultimately, the Honourable Supreme Court gave clearance to Novartis AG to get patients over the drug Glivec, but the company failed to fulfill the established criteria.
When navigating the world of patents and patentable inventions, we come across essential requirements which an invention shall fulfil to get a patent and Section 3[1] of the Indian Patents Act, 1970, which provides a list of inventions which are non-patentable under section 3 (d) of the Act. Section 3(b)[2] restricts the grant of patents for inventions which are injurious to life forms and the environment. Here, the question arises: to what extent can an invention be considered injurious enough to be denied patentability? This article establishes a connection between morality and patents. Further, it aims to clarify the ambiguous words of the provision by analysing the case of Harvard Oncomouse.
Introduction
In today’s age, the scope of Intellectual Property Rights (IPR) is expanding exponentially with the aid of extensive technology and modern equipment. IPR is a concept that is recognised worldwide, granting rights and protection to various established fields of Intellectual Property (IP) such as Copyright, Patents, Trademarks, Designs, Geographical Indications, Semiconductor Integrated Circuits, Plant Varieties and Biological Diversity in order to facilitate fair trade and safeguard the intellectual labour, all while upholding public policy[3].
In India, the law of patents is governed via the Indian Patents Act 1970, with notable amendments in 2002 and 2005. A patent is an exclusive right granted to the true and first inventor of an invention for a period of 20 years from the date of filing. Section 2(1)(j)[4] of the act defines “invention” as a new/novel product or a process that includes an inventive step and is capable of industrial application. The invention also includes an improvement capable of independently meeting the aforestated criteria. Section 2(1)(j)[5] defines inventive step as technical advancement, having economic significance, or both compared to existing knowledge.
It’s not necessary that when a subject matter qualifies all the three criteria of patentability it will benefit society. Hence, various provisions under the act, such as section 3[6] and section 4[7] of the act, lay out criteria for inventions disqualified from grant of patent. In this article, we will understand the bar on the patentability of an invention when it causes some serious prejudice to a life form, against public order and morality.
Morality and Public Policy in Patent
Morality and public policy have a significant role in patents. First of all, the right to patent is granted to the inventor in order to reward his/her intellectual labour fairly. Then the exclusive right protection lasts for a period of 20 years so that upon its expiry, the invention is available to the public at large, and society can also benefit from it. Further, we witness provisions of compulsory licensing (Sections 82 to 94), surrender and revocation of patents (Sections 63 to 66), Section 47[8], and the use and acquisition of patent by the Central Government for their own use; these provisions govern the use of patents on the basis of public policy and morality.
Amendment of 2002 in the Patent Act, 1970
Article 27[9] of the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) establishes general principles of patentability. The exclusion part of the second clause grants member countries certain rights to exclude the following inventions from patentability to protect public order and morality. They include any inventions contrary to human, plant, animal and environment, not limited to exposition defined and barred by the law[10].
Section 3[11] of the act is very important as it lays out a negative list, stating the products or processes that won’t be considered as an invention, despite qualifying the essentials of the patent criteria. Section 3(b)[12] of the act was amended in 2002 to incorporate the regulations laid out in Article 27[13] of TRIPS; it states that any invention whose primary use or intended use or commercial exploitation would go against the public order or morality or the invention causes serious prejudice to human, animal or plant life or health or to the environment will not be considered as an invention. Examples: inventions related to theft, gambling, human cloning, etc.
In the early 1980s a group of researchers at Harvard Medical School invented one of the world’s first transgenic mice for furthering cancer research. They induced an oncogene in the mouse’s DNA, which made the mouse vulnerable to cancer and develop tumours. The creators of “Oncomouse”, on behalf of the institution, filed for a patent in the USA, Canada and the European Patent Office (EPO)[15].
Issues Raised
Upon meeting the essential patentability requirements, should parents be granted regarding living animals and their varieties, specifically for higher stature animals such as mammals?
How should moral implications and public policy be affected in regard to transgenic animals and their suffering?
The case was fought in various jurisdictions, and each country has given different perspectives on the issues raised[16].
United States of America
Harvard University was granted a patent by the US Patent Office in the year 1998. It described the mouse as “a transgenic non-human mammal whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal or an ancestor of said mammal, at an embryonic stage…”. The matter of patents on human beings and modifications to the human genomes was explicitly excluded, considering the legal and moral concerns[17].
European Patent Office
The oncomouse case was considered at length in front of the European Patent Office (EPO), and the final decision was given by the Appellate Board in 2004. The board applied Article 53(a)[18] which states non-grant of a patent for “inventions the commercial exploitation of which would be contrary to “ordre public” or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States” and Article 53(b)[19] stating non-grant of patent for, ”plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof”.
The EPO stated that the oncomouse didn’t qualify under the definition of animal variety, and so it doesn’t qualify under Article 53(b)[20]. It was further stated that a ban on patenting “animal varieties” under the article didn’t implicate a ban on the patenting of animals.
The EPO came up with the Utilitarian test in order to address and balance public order & morality. The test was set out to compare positive aspects with the negative ones. In this case, the positive aspect was the benefits occurring from the use of oncomouse in furtherance of cancer research for humans and was weighed against the morally negative aspect of suffering caused to the oncomice.
In furtherance of the test, other factors were also considered, such as environmental harm, which turned out to be neutral and public discontent, which was also recorded as neutral after considering the evidence based on European demographics.
Thus, the EPO gave its judgment in favour of granting of patent to the oncomouse. Since the test results specified that the positive aspects and utility of oncomouse in furtherance of cancer research greatly overpassed the negative aspect of morality and suffering caused to the oncomice.
Later, in 1992, Upjohn Pharmaceuticals put a similar case of genetically modified mice before the EPO. In this case, the transgenic mouse was being used to advance the treatment of human baldness and wool production mechanisms. This infusion resulted in the loss of all hair in the mouse. EPO used the same utilitarian approach to weigh out the positive aspects and negative aspects, but here, the latter prevailed over the former. The mouse was not guaranteed patent as it was against morality, and the use wasn’t as essential as oncomouse[21].
Canada
When the case was filed in the Canadian patent office, the patent officer rejected the request for patent prima facie on the basis that their law didn’t include animals in the definition of the invention. Regardless, another claim on the patent process for producing the oncomouse was allowed to go forward.
The Supreme Court of Canada gave its final verdict in the year 2002. The court stated that higher life forms and mammals were not subject to the definition of the invention, which mainly focuses on the manufacture or composition of matter, as per the Patent Act 1869. The act previewed “Manufacture” as a non-living mechanical product or a process and “Composition of matter” as a mixture of ingredients or substances by a person. The judges distinguished that the lower life forms were subjected to the composition of matter while the higher life forms were disqualified. So, the court qualified microorganisms and transgenic animals as a composition of matter and approved a patent while rejecting the patent claim on the body of the oncomouse.
The court pointed to the Patent Act, 1869, and stated that the drafters left out the subject matter of the patentability of higher life forms while drafting the act. The court recommended that the patentability of life higher forms was very controversial and the parliament must engage in a public debate to discuss the subject matter’s social standpoint, morality and legislative stance. The court concluded by stating that, scientific alteration of the genetics of an animal (not a higher life form), which doesn’t exist in nature in that altered form, will qualify under “composition of matter” under the Patent Act[22].
Conclusion
Creating and patenting transgenic animals proposes a moral and ethical dilemma in the field of patents. The oncomouse case showcases the diverse reasoning and standpoints of various jurisdictions across the world. The case has outlined patentability requirements, patentable subject matter and ethical dimensions of patentability on life forms which stand controversial with public order. It can be concluded that patentability of higher life forms, such as mammals, is barred across the world as of now. In India, Section 3(b)[23] of the Patent Act, 1970 doesn’t allow an invention to be patented that will drastically affect humans, plants, environment while going against public policy or morality. Upon hitting Section 3(b)[24] of the Indian Patent Act, 1970, the inventor must prove to the controller that the invention’s positive aspects outweigh the negative aspects and ensure he/she has taken the necessary steps to minimise the negative effects, then only the invention will have a chance to be patented, subject to discretion of the controller of patents.
In simple words, patent infringement is the violation of patent rights of a patentee in the country or jurisdiction where the patent has been granted. This violation happens when any third party, makes, uses, sells, offer for sale, a product or process claimed in the patent, granted to the patentee without his/her authorization or license. When a patent is granted, the patentee gets the right to prevent third party (ies) from making, using, selling, offering for sale or importing the patented product in the country where there is patent protection.
To avoid patent infringement, it is highly recommended for the business owners to examine existing patents before launching their new products to ensure that no patent rights are violated in the territory where their product is going to be launched. This investigation to assess patent infringement risk is called as Freedom to Operate (FTO) analysis or clearance search.
How is FTO performed?
Purpose of FTO search is to assess the likelihood of patent infringement upon launch of new product in a specific market. The best time to perform FTO search is at the time of designing the new product because it is easier to make changes in the product specifications and the infringement risk can be minimised or nullified easily at early stage of product development. FTO is a very specialised investigation and analysis of patent documents, done by a skilled attorney, who possesses a good working knowledge of technology as well as law. The final opinion on infringement shall always be rendered by an advocate according to the laws of the jurisdiction. Generally, following steps are taken up to perform FTO analysis:
Identification of components of the product to be launched and listing out nomenclature of the components, as generally used in the industry.
Performing a patent search with all possible synonyms of the product component names along with other search techniques to pull all relevant patents with a timeline of 20-22 years. Patent search here may be global or country-specific depending upon the countries in which the product is going to be launched or sold. The business owner must be very focused and specific with respect to patent search strategies to ensure that the right data is extracted.
For FTO search, generally only “in-force” or live patents are analysed. Therefore, considering very old and expired patents may not be of much use for FTO search. However, expired patents may be extremely helpful to find out technologies or products for which patents have expired. Even though expired patents may not impose any infringement risk but they can certainly provide valuable information otherwise.
After the relevant patent documents are extracted, it is important to segregate them as “expired”, “abandoned” or “in-force” patents. Further, there may be a need to separate out the patent applications and the granted patents. If there are any risky patent applications, it is highly recommended to monitor them periodically to find out the kind of objections that the examiner raises during prosecution and to know if patent application gets granted as a patent or not.
Further, during performing FTO search, if there are any “lapsed patents”, there may be chance of restoring such lapsed patent. Therefore, the legal status of lapsed patent shall be checked periodically and the risk it imposes shall be completely ruled out only after the timeline to restore has lapsed and its legal status reflects as “Expired”.
Patents so extracted during the search shall be analysed in detail by comparing claims of the patents with product features. Generally, patent practitioners prepare claim maps where the portions of the claims with match or overlap with product components are highlighted. Based on the extent of overlap between patent claims and the product components, the patent documents may further be considered as low, moderate or high-risk patents.
How to handle high-risk patents?
In case the FTO analysis reveals high risk patents, using such patents may be detrimental for the business. Following points may be taken into consideration before using such patents:
Check expiry date of the patent. If the patent is going to expire soon, it is worth to wait for the patent to expire before using it.
Carefully read and analyse patent claims and try to understand what is claimed. Often the language used in the claims is very complex and expert advice must be sought.
Perform invalidation search to understand how strong the patent is. This search is performed to identify the grounds on the basis of which a patent may be invalidated. Generally patent search is performed to reveal closest prior art and novelty/inventive step is assessed.
Based on the outcome of invalidation search, opposition to the grant of patent, if patent is not yet granted; or post-grant opposition or even revocation may be filed. The opposition petition shall have all possible statutory grounds of opposition, which help the Controller of Patents to give decision on invalidating or revoking the patent.
In case there is no other way out, obtaining license to use the patent may be obtained from the patentee. This option may not be feasible in most of the cases as granting license is at sole discretion of the patentee.
Above listed are few ways to handle a situation where there is a high risk of patent infringement. If none of the step’s work, it is advisable not to use the patent because if patentee takes a legal action, it may be detrimental for the reputation and good will of the business. In Merck vs. Glenmark case, the Delhi High Court passed an injunction against Glenmark for manufacturing the generic drug Sitagliptin and using patented product of Merck as there was prima facie infringement of patent rights of Merck. Delhi High court passed injunction order against Glenmark from manufacturing and selling of Zita and Zitamet. Thereby, patent rights of Merck were protected and enforced.
Patent infringement risk assessment and mitigation shall be integral part of steps to be followed before new product launch. FTO search can be extremely helpful to understand extent of infringement risk and to take right measure to minimise it.
Patent pruning is a process of analysing the patent portfolio of a company or an institution to identify, categorize, and optimize the patents. The analysis & pruning of the patent portfolio helps to identify and categorize the low-quality patents, so that the low-quality patents are discarded to strengthen the overall worth of the patent portfolio.
Patent pruning refers to the process of refining or simplifying a patent application by removing unnecessary or redundant elements while retaining the essential features and claims. This process aims to improve the clarity, focus, and strength of the patent, making it more likely to be granted and enforceable. Patent pruning process facilitates optimization of the patent portfolio of a company, wherein discarding low-quality patents can prevent the wastage of resources used in the maintenance of low-quality patents for a company and ultimately helps save significant amounts of money. The main benefit of the patent pruning process is cost saving, where a company can substantially reduce the patent maintenance cost by categorizing low-quality and high-quality patents. Let’s discuss the process involved in Patent Pruning.
Patent Pruning process
It is essential to understand the process involved in patent pruning and the importance of patent pruning, to effectively execute the identification and categorization of patents. The patent pruning process involves:
Patent indexing and categorization: The process of patent pruning starts with the indexing of patents and then categorizing them into core and non-core patents. More structured categorization and indexing of patents may be done by performing an IP Audit. Identifying and categorizing a company’s patents into core and non-core patents involves determining the patents that are related to a company’s core technology and products and the patents that are not so related to the company’s core technology. Further, along with determining the core and non-core patents, sides core and non-core classification, the patents can be shortlisted based on the market performance and future scope of the invention.
Patent Mapping: Mapping the patents helps to understand the valuable core patents that can promote and protect the company’s business. Mapping the patents related to profitable end products and important sectors helps in analysing the core patents of higher value.
Patent Grouping: After categorizing the patents, the patents of interest are grouped for further analysis, wherein the grouped patents can be related to core technology having profitable end products. Grouping of similar patents may be achieved by using patent landscape techniques.
Patent Sorting: The sorting of the patent groups can be achieved based on various parameters, including the life of the patents, family size of the patents, citations per year, forward citations and self-citations of the patent etc. Based on these parameters, the grouped patents are sorted to discard the low-quality patents and optimize a company’s patent portfolio.
The life span of a patent is generally 20 years and in order to complete the life span, the patent has to be renewed by paying the required renewal and maintenance fee. As the term of a patent increases, the maintenance fee also increases. Hence, it is very important to identify the relevant and important patent groups to save unnecessary costs spent on patent renewal on low-quality patents. The analysis of patent life for the patent groups is highly critical as the industrial applicability of the patent for 20 years and its relevance for the complete life span helps to prune the irrelevant patents.
Further, the family size of a patent is important as it identifies the patent families comprising a large number of patent members, and it is to be noted that patents with a large number of patent members involve larger filing and maintenance fees. Another important parameter is the citations per year, wherein analysing the patent citations per year helps determine the patents with more citations per year, indicating that the patent has higher market potential. Such patents are important for a company as the increasing market potential indicates that such patents can prevent competitors from entering the market.
The next important parameter is the forward citations and self-citations of a patent, wherein the forward citations help determine the importance of a patent as the patent is cited by the competitors of the same domain. When a patent has a significant number of forward citations, the patent possesses great potential. And similarly, the patents with a very low number of forward citations are low-quality patents, and can be discarded, abandoned, sold or licensed. The self-citation of a patent is done when a patent cited by a company is of higher value. The number of self-citations of a patent determines if the technology protected by a patent is important for a company.
The sorting of the patent groups enables the companies to categorize the irrelevant patents clearly, and the irrelevant patents should be pruned to optimize the patent portfolio.
After completing the patent pruning process, the companies must effectively maintain their patent portfolio by conducting the pruning more often, leading to the selection of high-quality patents, and the selected high-quality patents are maintained, and low-quality patents are discarded.
Patent pruning frequency
Knowing how frequently a company must run the patent pruning process is important. Companies can select their patent pruning frequency based on the number of patents they filed and their profits. Generally, big companies conduct the patent pruning process monthly. The pruning process can be conducted monthly, quarterly or yearly.
Pruning a patent portfolio is often necessary for several reasons:
Cost Reduction: Maintaining a large patent portfolio can be costly in terms of maintenance fees and administrative overhead. Pruning allows companies to reduce these expenses.
Focus on Core Technologies: Companies may choose to focus their patent efforts on technologies that are most relevant to their business strategy and goals. Pruning helps to streamline the portfolio in alignment with these priorities.
Avoiding Infringement Risks: Some patents may carry risks of infringement claims against the company. By pruning patents that pose such risks, companies can reduce their legal exposure.
Enhancing Portfolio Value: A leaner, more focused patent portfolio can be more attractive to potential buyers or licensees, potentially increasing its overall value.
Adaptation to Market Changes: Technologies and markets evolve over time. Pruning allows companies to adapt their patent portfolios to reflect these changes and stay competitive.
Conclusion
The patent pruning process is critical in maintaining a company’s patent portfolio. Pruning the low-quality patents enables the companies to identify, categorize and optimize their patents, thus increasing the overall value of their patent portfolios and reducing the cost involved in the maintenance of the irrelevant patents.
A patent specification is a technical-legal document having a written description of the invention, along with the manner and process of making and using the invention. The patent specification must include the novel and inventive steps of the invention. It must be clear and concise to enable understanding of the invention to any person skilled in the art. Under the Indian patent law, a patent specification defines the boundaries of exclusive rights granted to the inventor.
Before drafting a patent specification, it is highly important to consider several aspects to make sure that the invention is legally protected. The key points before drafting a patent specification are listed below.
Understanding ‘What’ is the invention.
A patent specification must meet the legal requirements in the country in which the patent is to be obtained. The patent attorney can help in the preparation of the patent specification based on the disclosure provided by the inventor. Thus, providing the complete disclosure of the invention to the patent attorney is highly important to make the patent specification preparation easier.
It is also critical to determine if the invention is patentable and to determine if it can be protected. An invention must have patentable subject matter to be eligible for patent protection. The invention must be new, inventive and must have a utility. The invention must not have any prior use before the invention is made public. It is important to know what can and cannot be patented. If the information related to the invention is publicly disclosed, one cannot get a patent for that invention. Therefore, a search of all previous public disclosures should be conducted to identify the prior arts including foreign patents and publications.
The patent specification requires a high level of detail and the patent attorney uses these details to prepare a detailed disclosure of the invention. The patent specification, whether a provisional or complete specification, must present the subject matter of the invention in a clear manner where the disclosure can portray the method of making and using the invention to any person skilled in the art.
The level of detail in the patent specification must demonstrate clearly that the inventor or the applicant is in possession of the invention in the form of the best example. The invention can have any number of applications, which might not be in practice or be implemented at the time of filing the patent application. Importantly, the complete technical disclosure of the invention, along with the expertise in defending the invention during prosecution increases the chances of getting the grant for the patent.
The complete patent specification includes claims that define the key technical aspects and boundaries of the invention for which protection is sought. It is important to construct the claims clearly and precisely, to avoid serious objections during patent prosecution stages. Clearly drafted claims are essential as the claims define the scope and set the boundaries of the patent rights.
Understanding ‘Why’ to file a patent
It is necessary to understand why we must file a patent application, before drafting the patent specification.
It is important to understand why to file a patent application, as once a patent application is filed, it acts as a prior art and dissuades the other inventors from trying to patent the same invention in the future. Whether the patent is issued, published or a pending application, the document acts as a public document.
The reasons for filing a patent application might be to protect the invention from competitors trying to enter the market and to stop the infringement and gain control over the market. The reason can also be securing the exclusive rights over the invention, which can be used for licensing or transferring the rights of the invention, and many more. A patent grant can increase the negotiating power of the inventor with the competitors and licensees; nowadays, filing a patent application is considered necessary by potential investors or businesses looking to acquire your invention.
Understanding ‘Where’ the invention is to be filed.
The inventor must access the market for their invention to determine where to file for the protection of the invention. This requires the inventor or the applicant to study the market related to their invention and seek protection in countries with high demand and value.
If the product or method developed by the inventor is going to revolutionize the related industry, then it is highly critical to prevent their competitors from copying their invention or imitating their invention for a low-priced product. Thus, there is a need for filing a patent application. But patents are territorial rights, meaning the rights for a patent is only applicable in the region where the patent application is filed, which creates a need for foreign patent protection. Foreign patent protection requires the inventor to file a patent application in all the countries where there is a good market for their invention, and it might deter competitors from infringing, but pursuing it comes at a greater cost.
Upon receiving the complete technical disclosure of the invention from the inventors or the applicant, the patent attorney will start preparing a patent specification draft. The patent attorney has to carefully select the terms used in the patent specification, to avoid limiting the scope of the invention. Use of such terms might lead to undesirable consequences during patent prosecution. During patent prosecution, generally, the claims protecting the key aspects of the invention can be amended to redefine the scope of the invention. Still, the patent specification is rarely amended to a greater extent. Thus, drafting the patent specification is highly critical. Taking all the above points into account, a clear and concise document has to be created, as the inventor or the applicant gets only one opportunity to explain their invention.
Conclusion
Patent specification drafting is a complex procedure but can be done precisely with the help of a patent attorney. Considering the complexities of the Indian patent law and rules, the patent attorney considers all the strategies and considerations before drafting a patent specification. A thoughtfully drafted patent specification creates valuable intellectual property and avoids unnecessary time and cost consumed during patent prosecution.
The well-known Android Operating System is a patented product whose patent is held by Google, but smart phone manufacturers such as Motorola, Samsung, HTC, LG, etc are also using it in their products. Similarly, Dolby Atoms, also a patented sound technology, whose patent is held by Dolby Laboratories, is used by service providers and device manufacturers such as Netflix, Amazon Prime Video etc. Ever wondered how? Well, these manufacturing companies are the ‘licensee’ of the patent owners who have licensed their technology to these market players. We will discuss about the concept of patent licensing and related patent validation in detail in this article.
Patent licensing is the process by means of which patent owner grants permission to other party or licensee to use the patented invention for a specific period of time in a particular jurisdiction in lieu of royalty. By granting license to use the patent, the patent owner is able to introduce his patented invention into the new markets through the licensee, who, in most of the cases, is a well-established company. By obtaining a license, the licensee gets to exploit the patented invention in terms of building, marketing and selling innovative products.
The process of patent licensing starts with discussions and negotiations between the patent owner, also called as Licensor and the licensee. Process of arriving at a license fee or royalty may be complicated at times as many factors play a vital role, such as, technical and feasibility of the invention, R&D cost, stage of technology, approvals and compliances for the patented product, market demand, status of patent in India and abroad..
Conducting a legal due diligence of the patent before licensing is an important step and it involves:
Verification of legal status of the patent as well as family patents to confirm if it is a granted patent or not, even though in several cases, licensee may be willing to license the invention at application stage itself.
Freedom to operate search is often performed to confirm if licensee has freedom to manufacture, use, market, sell the patented invention in specific jurisdictions or not.
Prior art search is usually performed to understand strength of the patent. If there is relevant prior art available, this indicates that patent to be licensed is easy to invalidate in court of law.
Invalidation or validation search is a kind of search wherein prior art is compared with the patent to assess the ease or difficulty involved in invalidating the patent. The term ‘Invalidation’ is often used when patent office declares a patent to be invalid as a result of pre/post-grant opposition or revocation of the patent. Before patent is granted and after its publication, there is a chance for third parties to oppose a patent application to prevent it from getting granted on the basis of statutory grounds listed under Section 25 (1) of the Indian patents Act 1970. Likewise, there are statutory grounds for post-grant opposition and revocation of patents also listed under section 25 (2) and Section 64 of the Act, respectively. It is important to note here that the Controller of Patents invalidates the patent only when opposition or revocation petition is filed by the third party (ies). Decision to invalidate the patent is taken by the Controller after reviewing arguments and evidence submitted by both the parties (i.e., opponent and patent owner). The steps and process involved to perform invalidation and validation search are the same but the outcome or opinion may be different. An invalidation search is performed to identify the grounds on the basis of which a patent can be opposed or revoked whereas validation search is primarily performed to find out how strong the patent is compared to the prior art and how strong is it to sustain a litigation. In simple words, we can say that when a search is conducted to validate the claims of a given patent, it is called a Patent Validity search and when it is used to invalidate the claims of a given patent then it is called Patent Invalidity Search. The prior arts which are taken into consideration to perform invalidity/validity search includes patent as well as non-patent literature.
As this search is commonly performed at the time of filing a petition to the Controller of Patents for opposition or revocation of a patent, the search results are really helpful to find out if the patent is strong or weak compared to the existing prior art. This may be useful for the licensee to take right decision with respect to licensing of the patent. If the patent is weak, it may not be able to give competitive advantage to the licensee and it may also prove to be ineffective to block the competitors. In future, if such patent is infringed by the third party(ies), there may be serious issues related to enforcing patent rights.
The ideal time to perform invalidation search is at the outset of the preliminary discussion on patent licensing between patent owner and potential licensee. The results of this search can play a very vital role during negotiation of the terms and conditions of license agreement. However, it is also important to understand that patent licensing is a complex process and in majority of the cases, the agreements are negotiated between relationship between the parties and their preference and hence invalidation search, though critical, is not the only factor that determines the value of the deal.
Conclusion
Invalidation or validation search is helpful to determine strength of the patent to be licensed. If done professionally, it may change direction of negotiations between the parties involved in a potential license agreement., In addition to invalidation search, based on preferences of the parties to the agreement, there may be several other factors responsible to determine deal value and other terms and conditions of the Patent Licensing Agreement, which the author shall discuss in the upcoming article.
Author: Bindu Sharma
Please contact us at info@origiin.com to know more about our services (Patent, Trademark, Copyright, Contract, IP Licensing, M&A of companies)
After decades of legislations attempting to introduce a unitary patent system amongst the European countries, this feat was finally achieved on June 1st, 2023, when the European Commission welcomed the launch of European Unitary Patent System across 17 nations of the European Union, representing about 80% of the Union’s GDP[1]. This is a landmark achievement as this System will significantly simplify the patent processes across the EU borders. The Agreement of Unified Patent Court (UPCA) was signed on 19th February 2013 by 24 EU member states. The legislation did not come into effect until June 1st, 2023, due to many political factors influencing the landscape of the EU such as Brexit (2020) and the issues posed by the German constitutional court with respect to this agreement. Finally, 17 EU countries have ratified this agreement and a detailed legal framework has been laid down to be followed to efficiently execute this system.
The System comprises of the Unitary Patent Protection (UPP) and the Unified Patent Court (UPC) together[2]. The Unitary Patent System (UPS) will strengthen the EU’s innovation and competitiveness in the patent market by introducing a unified registration and enforcement of patents across the 17 countries that have ratified this agreement. It will provide a “one-stop-shop” for patents in Europe. This brings immense benefits to the companies and innovators. This will allow them to receive a ‘unitary’ patent for their innovations and inventions, valid across all participating member states[3]. This will reduce the costs of filing separate patents in different countries. The earlier level of costs for renewing patents every 10 years separately in member states amounted to approximately €29,000. With the introduction of UPS, the costs would come down to €5,000[4], which is a significant reduction which will incentivize companies to file their patents in the member EU nations. Another benefit of this cost reduction is that it will overcome the cost gap for filing patents between European countries and other major players such as USA or Japan.
The most obvious benefit of this agreement is the time-reduction as it has become a “one-stop-shop” for registration of patents[5]. The System also introduces uniformity amongst the Member states making the entire legal process streamlined and more effective. For this very purpose, the Agreement also established the Unified Patent Court (UPC). It is an international Court that has exclusive jurisdiction in “classic” European patents and European Patents with unitary effect[6]. Its jurisdiction in “classic” European patents is not guaranteed and can be excluded entirely and brought to national courts or any competent national authorities instead normally, as well as during the transitional period of seven years. The Court comprises of a Court of First Instance, a Court of Appeal and a Registry. Additionally, a Patent Mediation and Arbitration Centre is established to resolve matters amicably[7]. This entire legal framework will ensure smooth functioning of the System and increase the efficiency of the patent registration, filing, enforcement and renewal of patents in Europe and make the patent landscape more fertile for new innovators and businesses. It will enhance the competitiveness and quality of patents emerging from the EU, while also attracting foreign investments into the EU.
Procedure for filing a ‘unitary’ patent
As is the regular procedure, the applicant must first file a European Patent Application at the European Patent Office (EPO). The EPO then follows standard procedure which remains unchanged, it checks all the necessary details and conducts an examination, if it yields positive results then it will lead to the grant of a European Patent. Then within one month, the applicant has the option of requesting the EPO to grant unitary effect for the participating nations.
In the moment the Unitary Patent System enters into force, two transitional periods are predicted when the patent reaches its final phase of grant procedure. The first transitional measure will allow applicants to file requests for the Unitary Patent even before the start of the Unitary Patent System. Once the System starts, provided that all other prerequisites for the patent registration are met, EPO will register the patent with unitary effect. If there are any deficiencies, the EPO can ask for corrections or reject the request.
The second transitional phase will provide the possibility of the applicant requesting a delay in the issuing of a grant of a European patent until the Unitary Patent System comes into effect. This will postpone the date of issuing of grant until it can get unitary effect, thereby including previous patent requests in the purview of the Unitary Patent System as well[8].
The Unitary Patent System also overcomes the linguistic barriers faced by applicants while filing patent registrations in other countries as they have to translate the text every time. A lot of money, time and additional resources are lost in the process of translation and may lead to ambiguity after translation. With the introduction of the Unitary Patent System, the UPC will conduct all the hearings with regards to unitary patents and the proceedings will take place in English, German or French[9]. While this brings uniformity to the whole process and overcomes the translation issues, the use of a few standardized languages may lead to issues amongst locals who do not conduct business in these languages.
Under this System, since a unified patent is granted in 17 nations, if any violation is to be found, the applicant may lose the protection of the patent in all these states if it is successfully challenged. This is a risk that must be taken up by the applicants which may lead to huge losses to companies and businesses.
The Unitary Patent System is a great stride to achieving maximum efficiency and uniformity in the field of patents in Europe. Many governments in the past and legislations have attempted to bring in this change from 2000, but it is only 23 years later that it has become possible. As of now there are 17 EU nations participating in this system, however the UPCA has provisions to include up to 25 nations of the EU as well. If the UPS is implemented properly and functions smoothly, one can hope that the entire EU is united in the future making the patent landscape highly welcoming for newcomers as well as existing players in the industry.
The first ever aeroplane was introduced to the world in North Caroline on the 17th of December in the year 1903 by Orville and Wilbur Wright, who are popularly known as the Wright Brothers. It is undeniable that the brothers derived a lot of information for their invention from previous inventors like Chanute, Langley, and Lilienthal. Though they did make several discoveries that made the aeroplane fly, The plane simply rose 20 feet above the ground throughout the brief (12-second) flight; nonetheless, the flight was revolutionary. Some contend that the “aerial age” was founded by the Wrights’ discoveries and inventions. Following the development of this original design, the Wrights proceeded quickly to secure the patent rights to their invention by submitting applications in the US, UK, France, and Germany. The patent applications that were submitted in Britain and France were both approved in 1904, but the German patent application proved to be much more challenging. It was first refused, but the initial judgement was overturned with the help of a German advocate. The German courts, meanwhile, found that the patent’s structure was too restrictive.
An Advocate’s Shield
The Wright Brothers had drafted their initial patent application and were unable to show a functional aircraft. The US Patent Office advised them to see a patent attorney after they were refused a patent. They were directed to Harry A. Toulmin in Springfield, Ohio, by friends. Wilbur Wright appointed Toulmin on January 22, 1904, to assist with their patent. Despite 30 lawsuits filed by individuals claiming to be the creators of the aeroplane, Toulmin wrapped up the patent so securely that no one was able to break it throughout the patient’s lifetime. He suggested that the patent should cover the method of flight control rather than trying to protect the complete plane. The three-axis control system employed on the 1902 glider and the wing warping It was a wise choice, as Wright’s control system is still used in every flying aeroplane today.
Detail Patent Study
We must understand the details of the Wright Brothers’ patent to comprehend their legal proceedings. Three years after their first flight, the Wright brothers were awarded a patent for a “flying machine” that focused on their ground-breaking research in aeronautics: their original flight control system. Modifications to what the Wright brothers termed the “lateral margins” of the aeroplane’s wings were used to gain control in their design and in practically every other aircraft that was built after it. In actuality, the Wrights accomplished this by using wires to twist or “warp” the Flyer’s wood and fabric wings, which entailed shifting the rear outer points of the wings in opposite directions. The main development that brought meaningful manned-powered flight was wing warping. Even though other early aircraft could produce lift, all but the Wright Flyer were wildly unstable and extremely dangerous. As a result, Orville and Wilbur had every right to be proud of their intelligence and to seek any legal safeguards for their intellectual property.
However, the Wrights sought to patent not solely their wing-warping procedure but also any potential future device for adjusting the “lateral margins” of an aircraft’s wings, laying legal claim to the aeronautic control principle they had discovered. They would have monopolistic power over the aviation market for many years, provided the patent was read as they desired.
Before the Wright brothers submitted their patent application, Augustus Herring sent them a letter outlining their joint invention of the aircraft. Herring claimed to have created the Chanute-Herring glider, which was a little like the Wright Flyer. Wright elected to move on with the registration of their patent application notwithstanding this letter’s rejection.
The United States granted Wilbur and Orville Wright a patent on “Flying Machines” on May 22, 1906. Due to their ownership of this invention, the Wright Company was able to sue other pilots and aviation businesses for patent infringement.
Litigation Process
To defend their innovation, the Wright Brothers sued Glenn H. Curtiss and the Herring-Curtiss Company in patent courts, alleging infringement. They also filed lawsuits in Europe and the US. The Wrights also filed lawsuits against aviators from England, Claude Grahame-White, and France, Louis Paulhan. Both parties’ attorneys produced extensive, detailed, and complicated material for these trials.
Among all these cases, the Glen Curtiss lawsuit was discussed the most. Glenn Curtiss and Augustus Herring collaborated to establish their own business, the Herring-Curtiss Company, in March 1909. In this particular case, Glen Curtiss refused to pay the Wright Brothers’ cost for an aircraft he sold to the Aeronautical Society of New York in 1909. He had been cautioned against turning a profit on any aircraft that utilised their patent’s technical details. Wright Brothers sued Curtiss after he still did it.
Judge Hazel issued an injunction against the Herring-Curtiss Company and extensively interpreted the Wright patent, which ended in a favourable outcome for the Wright Brothers. Judge Hazel made the important determination that the Wright Patent qualified as a pioneering patent because the Wrights’s idea was so novel and unique that the case qualified under the particular legal standard for pioneering patents. Because the same inventor may not patent improvements on their original, novel, and distinctive patent applications, pioneering patents are entitled to a wide interpretation. Since different patents are to be construed more narrowly, equity requires that the patent be considered as broadly as possible in cases of pioneering patents. The lawsuit against Curtiss was won by the brothers in 1913, but the ruling was challenged.
When Curtiss appealed and was successful due to a technicality, the Wrights suffered a setback. Judge Hazel’s injunction was overturned by the Court of Appeals, and the matter was sent back for more discussion and evidence. When the Wrights corrected the issues raised by the Circuit Court of Appeals, Judge Hazel granted them victory once more. This time, Judge Hazel gave them a favourable decision. Curtiss filed a second appeal with the Circuit Court of Appeals, which unanimously upheld Judge Hazel’s judgement in an unusual decision known as a Per Curium by the Court opinion, only occasionally issued when the court is in agreement and seeks to state that the appeal is particularly frivolous or meritless. The Wrights’ favour was maintained after the judgement in January 1914. The Herring-Curtiss Company then filed for bankruptcy before the Wrights could recover any damages, and Glenn Curtiss then sued Augustus Herring for falsely asserting that he had more patents than the Wrights while failing to provide any supporting documentation or the disputed patents. Before Curtiss got anything from Herring, he passed away.
In the case, Wright v. Paulhan popularly known as the Paulhan case. The Wrights were victorious in their lawsuit against other aircraft displayers. The Paulhan case was distinctive because the ruling was written by Judge Learned Hand, a well-known federal judge who was well-known for the calibre of his jurisprudence and the clarity of his opinions. Many of Judge Hand’s decisions are still considered sound legal precedents and are frequently taught in law schools all over the nation. Judge Hand entirely agreed with Judge Hazel’s assessment of the Wrights’ ground-breaking patent and sided with them, especially in light of their choice to litigate to defend their patent.
Conclusion
In the end, a person only has the rights that he can effectively protect. The Wrights accomplished what no one before them had been able to do through their creativity and brilliance, self-funding, and outspending. They took the necessary legal actions to safeguard their idea because they legitimately anticipated making money off of their very original concept.
There were repercussions from the Wright’s patent conflicts also. Unfortunately, the Wrights were unable to innovate and create new aeroplanes throughout the entire time they spent battling to defend their patent. Their aircraft started to fall short of those made in Europe. The brothers and their business’ reputation suffered as a result of the ongoing legal battles. The tension hurt Wilbur’s health as well. Wilbur passed away from typhoid illness on May 30, 1912.
Innovation and the creation of new aircraft had been stymied in the United States because the Wright Company or Curtiss Company controlled the majority of the important aircraft patents. The US government compelled the aircraft sector to establish a group for granting patent licenses in 1917. Each manufacturer was required to sign up and pay a membership fee. Until their patents expired, the Wright Company or the Curtiss Company received the majority of the fees.
Daniel T. Ronneberg, The Wright Brothers’ Patent Lawsuits, Vol 21, Journal of Aviation/ Aerospace Education and Research, 2023, The Wright Brothers_ Patent Lawsuits.pdf
Rainwater harvesting is an age-old technique that has gained renewed significance in recent years due to growing concerns about water scarcity and environmental sustainability. It involves collecting, storing, and utilizing rainwater for various purposes. This practice is particularly crucial in regions with limited or unreliable water resources.
The process of rainwater harvesting begins with the collection of rainwater from rooftops, open areas, or other surfaces. The collected water is then directed towards a storage system ranging from simple containers to underground tanks or reservoirs. Before usage, it is advisable to filter and purify the harvested water to ensure its quality.
There are numerous benefits associated with rainwater harvesting. Firstly, it provides an additional water source, reducing the strain on existing water supplies and alleviating water scarcity concerns. Secondly, rainwater harvesting helps to mitigate the burden on storm water drainage systems, reducing the risk of flooding and soil erosion. It also promotes self-sufficiency and resilience, as individuals and communities rely less on centralized water distribution systems. Rainwater can be utilized for various purposes, such as irrigation, household chores, livestock watering, and even after proper treatment, for drinking. Utilizing rainwater for non-potable purposes helps conserve precious freshwater resources, which can be reserved for essential needs.
Advantages of rainwater harvesting
Rainwater harvesting offers several advantages that contribute to sustainable water management and environmental conservation:
Water conservation: Rainwater harvesting helps to conserve water by collecting and utilizing rainwater, reducing the dependency on traditional water sources. It provides an additional water supply, particularly useful in regions facing water scarcity or unreliable availability.
Self-sufficiency: By implementing rainwater harvesting systems, individuals and communities become less reliant on centralized water distribution systems. This promotes self-sufficiency and reduces the vulnerability to water shortages or disruptions in water supply.
Cost savings: Harvesting rainwater can lead to significant cost savings, especially in areas where water prices are high. Utilizing harvested rainwater for non-potable purposes such as irrigation, toilet flushing, or laundry reduces the consumption of treated water, resulting in reduced water bills.
Reduced strain on infrastructure: Rainwater harvesting alleviates the burden on stormwater drainage systems by capturing rainwater that would otherwise contribute to runoff. This reduces the risk of flooding, soil erosion, and overloading of sewage treatment plants, thereby reducing infrastructure maintenance costs.
Environmental benefits: By harvesting rainwater, there is a reduced need for groundwater extraction and surface water diversion, which can harm ecosystems. Rainwater harvesting helps preserve natural water sources, maintains water balance in local ecosystems, and minimizes aquatic habitat impacts.
Improved water quality: Rainwater is generally pure and free from chemicals, contaminants, and salts commonly found in other water sources. Harvested rainwater can be treated and used for various purposes, including drinking, after proper filtration and purification.
Educational and community benefits: Rainwater harvesting initiatives can raise awareness about water conservation and sustainable practices. They can foster community engagement, promote environmental stewardship, and provide educational opportunities for individuals, schools, and organizations.
In summary, rainwater harvesting offers advantages such as water conservation, self-sufficiency, cost savings, reduced strain on infrastructure, environmental benefits, improved water quality, and educational/community benefits. Implementing rainwater harvesting systems supports sustainable water management, reduces the demand for traditional water sources, and contributes to long-term water security and environmental sustainability.
Innovative patents related to rainwater harvesting
Title: Method of preserving and harvesting rain water in trench lined with pvc sheet to prevent flood and soil erosion
The invention relates to the ” Method of preserving and harvesting rain water in trench lined with pvc sheet to prevent flood and soil erosion,” More specifically, the invention relates to a solution for rainwater loss caused by evaporation and runoff from topsoil. Patent Number 229617 describes a method of preserving and harvesting rainwater using a PVC sheet to construct bandharas, small earthen dams used to impound water. The invention involves using a PVC sheet to line the inside of the bandhara to prevent water seepage and increase its storage capacity. The sheet is fixed to the walls and bottom of the bandhara using ropes and bamboo poles. The invention also involves using a PVC pipe as an outlet for the harvested water. The harvested water can be used for various purposes such as irrigation, drinking, and household use. This invention provides an effective and affordable method of rainwater harvesting, which can help conserve water resources and provide access to safe drinking water in areas with limited water supply.
Using PVC sheets to construct bandharas has several advantages over traditional methods, such as cement or concrete. PVC sheet is lightweight and easy to transport, which makes it suitable for use in remote areas. It is also easy to install and does not require specialized skills or equipment. The use of PVC sheet also reduces the cost of construction and maintenance compared to traditional methods because of the PVC sheet at the bottom & this percolated water spreads horizontally within the ground, away from the trench in a backward direction, and the water content of the soil significantly increases. Water in the soil travels upward and downward due to capillary action and gravitation, significantly raising the groundwater level. Overall, the patent provides a simple, effective, and affordable method of rainwater harvesting using PVC sheets and pipes. This method can help conserve water resources, improve access to safe drinking water, and promote sustainable development in rural areas.
The rainwater harvesting system collects rainwater from gutters using small and unobtrusive collectors. The collected water is transferred to a storage tank using a standard pumping system that only operates when the amount of water in each collector is greater than or equal to a predetermined level. The system is easy to install and does not require roof modifications or large reservoir installations. It includes sensors and a feed system to transfer the water to the tank, and a standard pumping system to pump the water from the tank to where it is needed. The article also lists several claims related to the system, including the use of rainwater collectors on gutter downpipes, a storage tank located close to the guttering, and a central control computer that receives signals from the sensors in the rainwater collectors and operates the standard pumping system by the received signals. The article concludes that the system is intended to use a more significant number of miniature and unobtrusive collectors that all feed into a larger communal tank that is kept hidden inside the roof of the building rather than having fewer of the larger and somewhat unsightly tanks, which can detract from the overall appearance of a building. The invention is a rainwater harvesting system that collects rainwater from gutters using small, unobtrusive collectors. The collected water is transferred to a storage tank using a standard pumping system that only operates when the amount of water in each collector is greater than or equal to a predetermined level. The system is easy to install and does not require roof modifications or large reservoir installations. It includes sensors and a feed system to transfer the water to the tank, and a standard pumping system to pump the water from the tank to where it is needed. A central computer can control the system and includes safety features such as sensors to stop water transfer when the tank is complete and a ball cock to supply water from the mains when the tank is low.
The rainwater harvesting apparatus and method for installing and operating it in a building. The apparatus includes a chamber for capturing rainwater, a reservoir for storing it, an overflow tank, pumping means, and control means. The pumping means is activated and deactivated based on the water level in the reservoir and pumps rainwater to a remote vessel. The apparatus has sensor means, a heating element, and a filter. A photovoltaic solar panel powers it and includes integrated electronic and smart technology. Installing the rainwater harvesting apparatus involves excising a portion of a rainwater downpipe of a building to provide an excised portion and two spaced apart sections of the pipe, each having an open pipe end. The chamber is then positioned in the space between the spaced apart sections of pipe, and the chamber’s inlet is coupled to one of the pipe ends, while the chamber outlet is coupled to the other of the pipe ends. Conduit means from the pumping means is coupled to the remote vessel, and the apparatus is secured to a surface, such as a building wall. The method of operating the rainwater harvesting apparatus involves determining the level of rainwater in the reservoir and activating and deactivating the pumping means to pump rainwater from the reservoir to the remote vessel according to the level of rainwater in the reservoir. The pumping means is activated when the reservoir is full of rainwater or has sufficient rainwater stored therein. Otherwise, the pumping means is deactivated. Any rainwater that enters the apparatus via the pipe end is allowed to overflow from the reservoir to the overflow tank and returned to the downpipe via outlet. Optionally, the method comprises further determining the level of rainwater in the reservoir and the remote vessel and activating and deactivating the pumping means to pump rainwater from the reservoir to the remote vessel according to the levels of rainwater in the reservoir and the remote vessel. The article concludes by stating that the invention can be modified or added to without departing from the scope of the invention as defined in the appended claims.
Title: Rainwater collection and distribution device
The rainwater collection and distribution device can be installed within downpipes. The device includes an elongated collector tank, a connection conduit, a pump, and a delivery conduit connected to a water storage tank. It also includes rainwater filtration, level detection, and overflow conduit. The device can be powered by a photovoltaic panel and controlled by a central controller. It also includes various sensors and a memory to log data. The pump is submersible and fits within the elongated collector tank.
The device also includes rainwater filtration, level detection, and overflow conduit. The pump is submersible and fits within the elongated collector tank. The device can be powered by a photovoltaic panel and controlled by a central controller. It also includes various sensors and a memory to log data. The device can be installed on a flat roof of a building, with the elongated collector tank installed within a downpipe that projects downwardly from the roof. The connection conduit, the submersible pump, and a portion of the delivery conduit are located within the elongated collector tank, which conceals most of the device from view and does not impact the facade of the building. The rainwater collection and distribution device collect rainwater that falls onto a surface, such as a roof of a building, and into one of the downpipes of the building. The elongated collector tank collects and retains indefinitely rainwater which passes into the downpipe until the rainwater level reaches a predefined upper detection level/point. Once the rainwater level reaches the upper detection point, the central controller activates the pump, which pumps the rainwater to the water storage tank. The device includes various sensors, such as a rainwater level detection unit, temperature sensor, and water quality measurement sensor. The central controller logs all pump activations and data from the various sensors in the device. The information from the central controller or the various sensors directly may be transmitted to a remote location using a wireless communications transmitter or transceiver. The device may also be connected to a mains water supply connection with a motorized valve connected between the mains water supply and the rainwater collection and distribution device so that mains supply water can be fed through the device if required for cleansing and the like.
Title: Rain water harvesting by means of linear elevated tanks
The rainwater harvesting system collects water from the projection or gutter line of a building. The system includes self-cleaning tanks that can be stacked for storage and transport. The water is maintained at a desired temperature and clean state and can be retrieved effectively. The system includes a silt chamber to prevent debris from entering the tanks and a service pipe to bring the filtered water into use within or outside the property. The building structure or a frame can support the tanks and be located inside or outside the building. The system reduces the need for large volumes of pipework and can be used for industrial applications.
The building structure or a frame can support the tanks and be located inside or outside the building. The system includes a silt chamber to prevent debris from entering the tanks and a service pipe to bring the filtered water into use within or outside the property. The water is maintained at a desired temperature and clean state and can be retrieved effectively. The system installation involves fixing the tanks to the building structure or a frame and connecting the service pipe to the tanks. The tanks can be stacked for storage and transport inside or outside the building. The system includes a silt chamber to prevent debris from entering the tanks and a service pipe to bring the filtered water into use within or outside the property. The tanks are self-cleaning and can be easily maintained by opening a cleaning point at either end of the tanks. The functionality of the system involves collecting rainwater from the projection or gutter line of a building, filtering it through the silt chamber, and storing it in the tanks. The water is maintained at a desired temperature and clean state and can be retrieved effectively through the service pipe. The system reduces the need for large volumes of pipework and can be used for industrial applications. The tanks can also be used to thaw snow and ice to replenish the system and relieve weight accumulation on the roof structure.
Title: System for solar and rainwater harvesting in open spaces
The system includes a canopy to capture rainwater, a storage unit, a connecting means, and filtration means. The canopy is designed to direct water toward the discharge opening, and a collapsible solar module can be attached to harvest solar energy. The system can charge the groundwater level in open spaces.
The device is a system for solar and rainwater harvesting in open spaces. It includes a canopy to capture rainwater, a storage unit, a connecting means, and filtration means. The canopy is designed to direct water toward the discharge opening, and a collapsible solar module can be attached to harvest solar energy. The system can be installed above or below ground, charging the groundwater level in open spaces. he captured water from the canopy can be stored in a storage unit, which can be connected to other centralized storage units for storing the captured water. The connecting means extends from the discharge opening of the canopy to the storage unit to allow the captured water to flow from the canopy to the storage unit. The connecting means is designed to maintain the required flow rate of the captured water from the canopy to the storage unit. The filtration device is removably adapted in the connecting means for filtering the captured water to make it partially ready for potable use. The filtration means includes a filtration screen in the form of cuts adopted at the discharge opening of the canopy and a filtration device removably adapted in the connecting means. The system also includes a solar module for harvesting solar energy, which can be removably or fixedly attached to the support mast. The solar module comprises a solar panel and a solar tracking device for orienting the solar panels based on solar light. The inverter and battery are installed at the base of the system. They are connected to the solar module through internal wiring inside the support mast for harvesting the solar power generated from the solar module. The system is designed to be lightweight and efficient, using materials such as PVC, fabric, and anti-rust metals. Overall, the system is designed to capture rainwater and solar energy in open spaces and can be used to charge the groundwater level or store the captured water for future use and provides a sustainable solution for clean water and clean energy generation in open spaces.
Title: Rainwater collection and dispensation system
The automatic rainwater collection and dispensation system for a building includes a main unit, a rainwater reservoir, a water pump control unit, a rainwater storage tank, interconnecting pipes: fittings, and electrical controls. The system collects rainwater from gutters along the bottom edges of roofs of a building after a flush of rainfall. After a delay, it pumps the collected rainwater to a storage tank. The system is fully automatic with electrical controls and indicates the status of the system operations on a main switch panel installed inside a building. The system is designed to pump rainwater from the main unit to the storage tank only when there is sufficient rainwater in the reservoir, and the storage tank is not full. The system also includes a manual bypass to switch on the automatic electrical control valve in case of electricity failure and an indication panel to show the status of system operations.
The rainwater collection and dispensation system are installed by cutting a section of the gutter adjacent to a vertical downpipe to an open drain to accommodate the main unit, which includes a water pump control unit and a rainwater reservoir. Rainwater is collected from the edges of the roof and pumped to a rainwater storage tank after a delay to ensure that the collected rainwater is debris-free. The rainwater storage tank is connected to an existing tap water storage tank, and interconnecting pipes and fittings supply water to the water closets and taps in the building. The system is fully automatic with electrical controls, including a main switch panel that indicates the status of system operations. The system is designed to pump rainwater from the main unit to the storage tank only when there is sufficient rainwater in the reservoir, and the storage tank is not full. The system also includes a manual bypass to switch on the automatic electrical control valve in case of electricity failure. The rainwater storage tank can be formed from several smaller containers with interlocking and interconnecting pipes, allowing existing buildings to install the invention without removing roof trusses or ceilings. The system is designed to save power by collecting only clean rainwater without debris, and the water pump starts to pump only when there is sufficient rainwater in the reservoir. The system is designed to supply water to the water closets and taps in the building, preferably for non-drinking purposes.
The rainwater harvesting system for supplying water to a toilet or urinal. The system includes a catchment area, a water tank, and a flush valve. Rainwater flows directly from the catchment area into the tank and directly from the tank into the waste bowl when the flush valve is activated. The system also includes a sensor for determining the water level in the tank and controlling the flush valve accordingly. The system can be used for multiple waste bowls, including flushing the waste bowl using rainwater or other reclaimed water sources.
The system is configured to vary how the valve is opened depending on the level of water determined to be inside the tank. The system controls the valve to provide a large conduit when the level of water is determined to be low and a small conduit when the level of the water is determined to be high. A user can activate the system or be set to automatically open the flush valve after having detected the presence of a user in the vicinity of the waste bowl and to activate the flush valve at predetermined time intervals automatically. The rainwater catchment area may supply rainwater directly to two or more tanks, each of which supplies water directly to a waste bowl of a sanitary fitting. This invention also describes different types of sensors that can be used to determine the water level in the tank, including float mechanisms, electrodes, and pressure sensors. The system can be installed in a building with downpipes passing inside the building to allow rainwater to flow directly into a closet-flushing cistern. The building can also have a main water supply to fill the cisterns during arid weather conditions.
Conclusion
In conclusion, rainwater harvesting is a valuable and sustainable practice that addresses water scarcity concerns, promotes self-sufficiency, and contributes to environmental conservation. It offers numerous benefits such as water conservation, cost savings, reduced strain on infrastructure, improved water quality, and community engagement.
While patenting rainwater harvesting technology is possible, it involves meeting patentability requirements, including novelty, inventiveness, and industrial applicability. A patent can provide protection, market advantage, and licensing opportunities and incentivize further research and development. However, patenting may only be suitable for some rainwater harvesting technologies, and inventors should carefully consider the costs, time, and potential benefits before pursuing patent protection.
Ultimately, the decision to patent rainwater harvesting technology should be based on individual circumstances, business goals, and the potential advantages it offers. Whether through patents or open-source sharing, the widespread adoption of rainwater harvesting technologies can contribute to a more sustainable and water-secure future, benefiting communities and the environment.
Applying for a patent is often associated with very complicated and breakthrough inventions. Does it mean that simple inventions are not granted patents? Let’s try to understand first what is an invention as per legal definition and what all shall it have in order to get a patent. The section 2 (j) of Indian Patents Act 1970 describes the invention as:
A new product or process involving an inventive step and capable of industrial application;
Analysis of definition of invention depicts that in order to have a patent granted, the invention shall be either a product or a process to prepare or manufacture a product. Invention shall also have inventive step, or we can say that invention shall appear non-obvious to a person skilled in the art and shall have industrial application. In combination the invention shall fulfill the following three conditions:
New or novel meaning that there shall not be any prior patent, publication or use of the invention anywhere in the world.
Industrially useful and such use shall be consistent. Invention shall be capable of being produced or used in an industry any number of times as necessary.
Non-obvious to person skilled in the art or inventive step. This requirement of patentability is the toughest one to be determined and fulfilled. Non-obviousness is judged not from the perspective of a lay individual, but from the perspective of a person having ordinary skill in the art. This hypothetical person of ordinary skill represents a baseline against which the degree of innovation of an invention is measured.
Any invention, whether simple or complex if fulfils the above criteria of patentability may be awarded a patent. For example, post-it, invented and patented by 3M Corporation, basically is nothing but a piece of paper with a re-adherable strip of adhesive on the back. Post-it is a result of an initial discovery which was made by mistake in 1968. The scientist Spencer Silver at 3M Laboratories while conducting research to find a type of strong adhesive came up with the formula for a re-usable substance that adhered lightly to objects but could also be easily removed. However, the particular application of this substance was subsequently thought of by the researcher Arthur Fry. The biggest advantage of Post-it is that it can be used for temporarily attaching notes to documents and to other surfaces such as walls, desks, computer displays etc. It’s simple but extremely useful invention that was awarded a patent.
Looking at patentability of Post-it in terms of novelty, industrial utility and non-obviousness, the invention basically relates to “Small note sheets that have an adhesive strip along one of their edges”. Since there was no existing product prior to post-it, the invention was novel at that point of time. Invention was industrially useful as it gives a solution to a universal problem of inconvenience of having to remember an unending to-do list in both personal and professional life. And post-it enables people to stick notes to any surface without harming it. The basic elements of this invention such as paper and adhesive though existed in the prior art but their combination was found to be non-obvious and became a patentable product. The invention was considered to have fulfilled the criteria of patentability and was awarded a patent irrespective of its simplicity.
Other examples where simple inventions were granted patents are, paper clips which is nothing but a piece of wire bent into a certain shape but still there have been numerous patents on different paperclip designs over the years. Rubber bands, invented in the 1800s were patented in 1845 by Stephen Perry. No one has since improved on the basic rubber band design. The stapler, invented in the 1800s has evolved over the years and each variation has been patented at various times. The mechanism behind the stapler is so useful that today we even have medical staplers, which are used to staple tissue together during surgery. If you’ve ever dealt with a mess of cables coming out of your TV or your computer, you know how useful these Cable ties devices are. Hundreds of variations exist today, including cable organizers made with Velcro, plastic cases, and so on.
All the examples above show that patent is not always a result of high and complicated technology products and processes but the simple inventions do get a patent provided they are new/novel, industrially useful and sound non-obvious to a person skilled in the art. So, watch out the work or research you are doing, you may have something patentable. If it fulfils the criteria of patentability, probably you need to file a patent application for it!!
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In an era of technological advancements, innovations are on a verge of representing the qualitative approach of a changing society. On one hand, innovations have the potential of ameliorating the quality of life by significantly contributing to labor and production. On the other hand, such transitions also demand ground-breaking competitive advancements that can square up to the needs of changing dynamics of developments. The ideology of managing the adoption and flow of knowledge has become a crucial parameter for every country. Therefore, it’s of utmost importance to focus on scientific and technological research methods for fruitful exchange to maintain the aura of competition.
Technology Transfer comprises of transferring skills and knowledge of technological advancements through legal recourse such as licensing and assigning so that the accessibility of innovative developments is assured at a wider range throughout the globe. This phenomenon helps in exploiting the already existing knowledge about technological advancement and at the same time provides scope for further innovations. In the words of the World Intellectual Property Organization (WIPO):
“Technology transfer is a collective term for the mechanisms and processes that enable the development of a product or a technology used to manufacture products from the knowledge formed in public research organizations.”
The main parameters that function alongsidefor a successful technological transfer mechanism are academia and industry. Academia contributes to promoting and generating novel knowledge, whereas industry synthesizes such knowledge into a marketable entity, thereby making the two parameters act directly proportional to each other. This interface has a significant impact on economies driven by knowledge and innovations, which subsequently lead to an advanced modern society.
However, this interface doesn’t exist since time memorial. Educational institutions and industrial sectors had their separate ways, with no intention to cross paths. Their objectives were opposed to each other, back in the times, the former being rigid towards the traditional ways of spreading knowledge and the latter being flexible in adopting ways to generate wealth. Till the 19th century, universities were isolated from the various aspects of society whereas industrial organizations were practically involved in ameliorating the economic conditions. The idea that their interaction could help the country in its growth and development was only figmental.
The very first reason these two sectors started coming together was war. A majority of the technological advancements taking place in the 20th century were driven towards facilitating the war situation prevailing during that era. This led to the diversion of objectives in the academic sectoras scientists and researchers were expected to use their studies catering tothe needs of society. Another factor was the propagation of education as a basic right for all. This allowed education not being limited to only a few but presented as a commodity accessible to all. Research and innovations started developing simultaneously.
Innovations percolated the idea of being protected from infringements through emergence of intellectual property rights. Academic researchers that had the probability of generating industrial products sought protection through patenting their invention, which later were licensed to the preferred industry which would generate marketable products using the invention and would share the profits with the patent owners by paying contracted royalties rates. Hence, this led to the genesis of the technology transfer mechanism.
When talking about innovations, wars, and a leading economy, Israel comes to mind instantly. It has gained a considerable appreciation for its innovation-based economy and serves as an inspiration for all the developing countries. We have covered the innovation model of Israel and the reason behind its journey for becoming the Start-Up Nation in one of our previous articles in the Blog, which can be accessed here. In this article, we will address the successful technology transfer model of Israel and what lessons concerened thereto.
Israel has heavily invested in civilian research and development (R&D) projects and has been inspiringly successful in building a flourishing knowledge-based economy. The concept of technology transfer in Israel dates back to the 1960s and its model has been adopted by great nations such as the United States of America. The success rate of the Israel technology transfer model has led WIPO to consider it as the best practice in existence. Israel has three sectors devoted to R&D and there exists a clear demarcation between all three concerning their methodology of having an impact on the market. These three sectors include industry, academic, and government.
Industrial R&D is led by business entities who indulge in developing a product that can fit the market demand. Owing to the commercialization aspects, it receives a huge amount of funding, both public and private, as compared to the other two sectors. Academic R&D is mostly curiosity-driven, wherein the researcher is free to contribute to the pool of knowledge and embrace academic freedom. It is supported by the research center in academic institutions. Government R&D is devoted to public welfare. The research is generally necessity-oriented focusing on public health, education, agriculture, so on and so forth. Such research is either proposed via tenders or by specific governmental research institutes.
All three sectors operated independently and were concerned with their specific technology transfer mechanism till the late 1950s. The universities started coming up with Technology Transfer Companies (TTC), an independent legal entity, operating as a not-for-profit subsidiary of a particular university. The objectives of such TTC were to commercialize academic research on University’s behalf. These TTCs are regulated by statutes framed by the concerned university that governs the right and obligations of the research.
The first of its kind TTC was started by the Weizmann Institute of Science by the name Yeda Research & Development Co. Ltd. Its success has contributed to a paradigm shift in the technology transfer model in Israel, and at the same time, it has become a vanguard for several other TTCs that were established subsequently. It has also set a benchmark by being among the top universities around the world in terms of generating income from commercialized academic research. Faculties of the University also act as a consultant to private sectors that help in creating a link between academic and industrial sector. Its strategy of creating a harmonious balance between public interest and financial profits has made its technology transfer model exemplary for the rest of the world.
The role of the TTC includes but is limited to the following:
To check if the invention qualifies for patent registration
To deduce the probability of commercializing a particular innovation
To formulate market strategies for introducing a suitable innovation
To propose the innovation to specific industrial bodies who might be willing to introduce the resultant product in the market.
To facilitate the university and the concerned industrial entity with the licensing agreement, in case such proposal is successfully implemented.
To identify any research gap with the registered innovation that can hinder the commercial viability of the invention concerned.
To provide proper guidance to the researcher by suggesting ways that can fill the void created by the research gap, so that the innovation becomes compatible with the marketable standards.
The part of the share received from commercialization of academic research goes to the concerned University, which is utilized as funds for future research.
Israel has come up with another interesting concept called “Technology Entrepreneurship”. It is an amalgamation of technology and business, facilitated by academic institutions to introduce an innovative and marketable product.
Enstorage Inc., founded in 2007, by two business entrepreneurs (Mr. Eran Yarkoni & Mr. Nachman Shelef), and an academician (Prof. Emanuel Peled) was the first of its kind, which led to the genesis of such a concept. Such a business model is formed based on the intellectual properties associated with the technological innovation, which eventually decides the licensees willing to vouch for the result of such innovation. This arrangement has made all three R&D sectors in Israel come together and promote innovations in a manner that minimizes the risk of market failures and at the same time contributes to maintaining information symmetry.
Another major contribution for having such an advanced model of technology transfer is attributed to the Israel Tech Transfer Organization (ITTN). It is a private non-profit organization that provides a platform for technology transfer companies in Israel towards fruitful engagement. It facilitates these companies through synchronized affiliation with world-renowned universities and research institutions. The objective of having such an organization was to set up an authority to represent the interest of member companies before the government. It also helps in bridging the gap between local companies and global institutions, helping them engage in advanced technology transfer. It also promotes the awareness of innovations and research propositions, thereby enhancing the public accessibility of the same. As of now, there are fifteen organizations contributing to the cause for which ITTN was formed.
Israel Advanced Technology Industries (IATI) is yet another player in this field. It is an umbrella organization that aims to connect Israel’s tech ecosystem and act as a medium for integrating governments’ goals with the various sectors of the industry. It also provides accessibility to successful global R&D, business & financial enterprises to promote mutual R&D and engender business opportunities for its members. At present, it has a plethora of members that include academic institutions, incubators, investment entities, service providers MNCs, tech-transfer offices, etc.
Some of the successful technology transfers assisted by IITN are listed below:
An automated onboard driver assistant system. The technology uses algorithms that have an advanced Spatio-temporal classification technique that trains the system with static and dynamic visual information.
MobilEye Vision Technologies Ltd. & Yissum, the Hebrew University Technology Transfer
India has become a preferred destination for many multinational companies to establish and outsource their software development activities. Large investments are being made in the IT sector with expectations of ushering in technology and product development to the market.
A patent is a valuable tool for protecting an innovation. Once a given technology has been patented, the owner of the patent can enjoy a monopoly over the technology for 20 years. The term “patent” was once prevalent solely within the scientific industry but is now slowly gaining prominence in the software industry as well. One of the earliest filed patents on software was filed as early as 1962 for a British patent application entitled “A Computer Arranged for the Automatic Solution of Linear Programming Problems”. The invention disclosed an efficient memory management for the simplex algorithm and may have been implemented by purely software means. The patent was granted on August 17th, 1966 and appears to be one of the first. The patentability of software-related inventions is currently one of the most hotly debated topics within intellectual property circles, with software becoming patentable in recent years in most jurisdictions, with software patentability becoming valid in the US since 1982. The only patentability criteria is that the invention has to produce useful, concrete and tangible results. In Europe and Japan, the invention is patentable if it is sufficiently technical in nature. However, when it comes to India, the criteria for patentability of software inventions seems to be more stringent as compared to the criteria in most other countries.
The Indian Patent Office (IPO) has published the Draft Guidelines for computer-related inventions in 2016. This document is managed as a tool to be used by the IPO for streamlining the procedure of examination of patent applications related to computer-related inventions (CRI). In addition to this, the Draft Guidelines give some clarity on the scope of section 3(k) and section 3(n). According to Section 3(k) of the Indian Patent Act, “a mathematical or business method and a computer program per se or algorithms are not patentable” with the term “per se” relating to a computer program in isolation or standalone software. Thus, computer programs alone are not patentable, even though software products also come under computer program per se. It should also be noted that computer-implemented business methods are not patentable in India, unlike the US. The term “business method” includes all activities in a commercial or industrial enterprise relating to monetary transactions or transaction of goods and services such as marketing or sales-purchase methodology. With the development of e-commerce and associated B2B and B2C business transactions, it is possible to have claims drafted with certain technical features such as internet, networks, telecommunication and so on for business methods. If the claims are drafted with these parameters, the subject matter of the claims is considered while examining the patentability. If the matter of the claims relates to business methods, then such claims are not permitted under Section 3(k) of Indian Patent Act.
For a computer program to be patentable in India, it has to have a technical process or should be combined with hardware. This means that the invention should contain something more than a computer program to be eligible for a patent protection. An invention in which the technological advance is nothing more than a computer program is not patentable if the computer is suitable for the particular purpose without special adoption or modification of hardware or organization. However, an invention that relates to a particular manner of organizing the Central Processing Unit or other peripheral units, regardless of whether the invention is implemented by means of a program or special hardware facilities, is patentable. Thus, if a patent is claimed for some tangible device coupled with a software i.e. an embedded device in such a manner, the patent office considers that it is not computer program per se and is thereby patentable. Software that works with new or novel hardware is also considered as patentable.
The awareness on the importance of software patents in India is on the rise. Indian software giants who were filing patents only in the US are now filing patents in the Indian Patent Office as well. The nature of the software patent not only involves new operating systems and software but also includes inventions that we use in day-to-day life such as conversion of a TIFF into PDF, compression/decompression techniques, provision to have multiple network providers on the same cell phone, remote monitoring of data usage, etc.
In 2009, Apple applied for a patent for a ‘method for browsing data items with respect to a display screen associated with a computing device and an electronic device’ (Application No. 461/KOLNP/2009). The objections against the invention was that it was a merely a software program and thus falling within the scope of computer programs per se i.e., under the provision of section 3(k) of the Act.
In their response, Apple submitted that “the method constitutes a practical application of this computer software to an improved technical effect while presenting advantages and overcoming drawbacks of hitherto known techniques”. The outline of the argument is as follows:
Technical Need
Though a single browse window is sufficient, there is still a desire for improved methods and systems for browsing through media items.
A single browse window may be limiting to users who desire to browse through more than one media group at a given time.
Technical Advancement
The applicant submitted a point-wise response for technical advancement for 3(k) objections as follows:
Apple submitted that the graphical user interface includes an application window generated by the media application programme.
The application window concurrently includes a first browse window and a second browse window.
The first browse window displays descriptive information regarding a media file, while the second browse window displays images associated with one or more media files.
The content shown in the first and second browse windows are automatically synchronised when selections are made.
In May 2017, Kolkata Patent Office granted a patent to Apple for the Application No. 461/KOLNP/2009 titled ‘method for browsing data items with respect to a display screen associated with a computing device and an electronic device’.
Thus, it is concluded that even though guide lines are provided there are many aspects that need to be evolved for a better protection of software inventions in India to remove ambiguity regarding what is patentable or not under software inventions as well as the scope of technical advancement while considering the patentability of software inventions.
By Priyadharshini M
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Knowing the pulse of the competitor is extremely important for any business. In general, competitive benchmarking is performed to compare and measure the philosophies of an organization and practices with other organizations to help them to improve their performance in this competitive space. The current economy is often referred to as a knowledge-based economy where intangible assets have become the main source of revenue for most firms. Consequently, more than 65% of most firms’ value and revenue is sourced straight from intangible assets, such as patents. Competitive Benchmarking is a commonly used term and refers to the practice of comparing business processes, innovations, products/services and performance metrics of the best-performing companies to understand and learn from them to improve own business. In today’s competitive world, generating innovation and having the right business strategies both play a vital role to shape and direct businesses toward success. Competitive benchmarking plays an important role to understand the strategies and approaches of competing organisations. The strategies and approaches could involve processes such as designing a new product, creating an IP portfolio, setting product prices, assessing innovation in existing products, launching new products, compiling litigation data, and so on. Such information can potentially be very important for your business and can help you better position yourself in the market. Competitive benchmarking can additionally help you build the right business strategies to advance past your competitors in your industry. Innovation and IP portfolio are amongst the most valuable pieces of information that one can have about their competitors, offering a glimpse into their arsenal of assets and strengths. After expiry of a specific duration of time after a patent application is filed, the application is published and is made available on the official website of the respective patent offices to be viewed by the public. This timeline may have some variance depending on the country where the application is filed, but ordinarily all patent applications are published and can be viewed using free or paid patent databases. A patent is an extremely valuable source of information, especially with respect to technologies or products of your competitors. If a patent search is performed using technological details, previously unknown competitors may be revealed. In this way, information pertaining to patent portfolios can inadvertently help a company identify previously unknown competitors and their patent assets. New competitors can also help in recognizing new opportunities for licensing and acquiring technology. A typical competitive portfolio benchmarking answers the following questions:
What are my competitors doing?
What are the latest patent trends in my industry?
What is the current phase of innovation of my competitors?
Possible licensing candidates?
A few things to keep in mind:
Competitor profiling includes products in the market & under development.
Products protected by patent nationally and internationally are assessed
Identification of IP assets to visualize and understand their value in relation to their competitive environment is done.
IP portfolio of competitors is procured, with a specific emphasis on recently patented applications to see the current area of interest of competitors.
Periodic assessment of patents filed by the competitors or specific technologies may be done by generating monthly, quarterly or half yearly patent alerts.
Before competitive benchmarking is carried out, it is important to understand the purpose behind it. This ensures that the right steps are performed, and there is a reduced amount of redundant data generated. Identification of direct or indirect competition is done as the competitive benchmarking report solely depends upon the kind of companies chosen as competitors. Information about the competition, based on the driving purpose of competitive benchmarking is extracted and compiled. Threats and opportunities in the existing market may be understood better with competitive benchmarking. There could a great learning from the failure of specific products or businesses in the market as well.
Documentation of the invention before you approach a patent agent to draft the patent specification may be extremely helpful for you to explain the invention details to the patent agent. What all shall be documented and how much details are enough, has to be made clear before you proceed further with drafting specification.
Though one feels lazy writing the disclosure of the invention, honestly speaking, there is no substitute to documentation. Sooner or later, you have to document the invention so that interaction with your attorney is fruitful. It is always advisable to execute Non-Disclosure Agreement with the attorney to whom you will be disclosing the invention. The patent agent or attorney with whom you decide to work, may also make you fill Invention Disclosure Form (IDF) when you approach him to file patent application for you.
What is to be claimed?
Patent is a techno-legal document and you get protection over the subject matter you claim in the specification. Hence, identification of novel elements, which may relate to a product or process or utility, shall be done at first level itself. Once you are clear about what to claim, the detailed description of the invention in patent specification revolves around such novel elements and helps you to fine tune the invention as well as highlight novelty of the invention. The best way to separate out novelty of the invention is to perform a thorough global patent search and then remove the elements that are in public domain. Therefore, while documenting your invention, it is a good idea to list out novel elements of the invention.
Existing technical problem
In order to be patentable, your invention shall have an inventive step. One of the ways to assess inventive step is identification of the technical problem that your invention solves and the way your solution works.
The Indian Patents (Amendment) Act 2005 in Section 2(1)(j) and 2(1)(ja) respectively states invention means a new product or process involving an inventive step and capable of industrial application and inventive step means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.
Hence, you should always be clear about the prior art or existing knowledge or evolution of technology in order to know technical problem precisely and such technical problem shall be explained properly while documenting the invention.
Best mode
As you know that best mode disclosure in a specification is an essential part of a patent application, specifically a complete application that starts with preamble, “The following specification particularly describes the invention and the manner in which it is to be performed”. This clearly indicates that disclosure has to state the best mode of working the invention and at the same time, the disclosure has to be complete, without any gaps in the process.
Section 10 (4) of Patents Act, 1970, clearly states that every specification, whether provisional or complete, shall describe the invention and shall begin with a title sufficiently indicating the subject- matter to which the invention relates to. Every complete specification shall fully and particularly describe the invention and its operation or use and the method by which it is to be performed; disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection; and end with a claim or claims defining the scope of the inventions for which protection is claimed.
The disclosure of the invention shall be sufficient enough that a person skilled in the art shall be able to achieve the results without further experimentation. Incomplete documentation of the invention by inventor resulting in incomplete disclosure of the same in patent specification may be one of the grounds for patent revocation or invalidation. Hence it is important to disclose complete process that is executable.
Specifications often consist of background, description, claims, abstracts and drawings etc. Step wise documentation of the invention assists your agent to draft specification in a better manner. You may always prepare flow charts or drawings for easy understanding even though the drawings submitted by you often would undergo complete re-doing of the work to match standards of the respective patent office.
Documentation/Disclosure of the invention is integral part of the process of patenting. There is no substitute to it. The quality of the patent specification primarily depends upon the precise and clear information you provide to your patent agent. Even though it takes one or two days extra, it makes lots of sense to spend some time and write the invention description patiently.
The world of patents and their relevance is increasing all the time, with newer and more advanced technologies being patented every single day. Research and innovation driven companies must keep themselves updated at all times to keep up with this increase in innovation to best utilize new advancements and understand current scope and limitations of technologies. The purpose of patent alerts is to inform companies about patents that have been filed or published with respect to core technologies of the company. Patent alerts are sent out periodically, and the reports can be sent out monthly, quarterly, or half yearly as per needs of the company.
Patent alerts help companies to keep themselves updated with respect to latest developments in the core areas of their technologies to get valuable information, such as:
New products and processes for which patent applications have been filed, helping companies build their own products in a better manner.
A thorough analysis of existing patents, which may be useful to assess the chances of getting a patent for core technologies or new ideas by gauging the novelty, non-obviousness and industrial applicability of existing inventions.
Information about published applications can help companies who might want to oppose these applications.
New markets or new technologies that other companies are focussing at. This might provide the company with an overview of the kind of products other companies are planning to launch in given markets.
Patent watch can be done primarily in two ways:
Technical Patent Watch: Here, the core technology (ies) of interest may be listed out and related published patent applications or granted patents may be monitored in a technical area of interest. The latest prosecution status of pending patent applications may be monitored making it easier to keep in touch with latest happenings in the industry. Interesting patents that may be used and implemented to add value to existing products or technologies can also be listed out and explored.
Such patents may be considered for in-licensing. However, if they are not filed in the jurisdiction of interest or they don’t have a chance to be filed in the jurisdiction of interest, these patents may be used without any fear of infringement. When proceeding on this route, it is highly recommended to take opinion of an expert on the legal status of such patent (s) before implementation.
Competitor Patent Watch: Understanding the patent portfolio and patent activities of competitors may be of great business value to companies. For this purpose, competitor companies are listed out and their newly published patent applications or granted patents are monitored on a periodic basis. The companies can also monitor the latest prosecution statuses of pending or granted patent applications of competitor companies.
This information obtained by observing periodic patent alerts may prove to be a game changing strategy for any company.
Staying ahead of the competition is critical for sustainability today. With increasing focus on innovation, it becomes important to know about the recent trends in the area of patent filings. It is not only interesting to understand what competitors are doing, but also essential to learn how best to advance past them.
Origiin, with a skilled team of patent agents is one of the best patent companies in India offering patent services like, patent searching and patent filingin India and foreign countries. We provide periodic patent alerts to the innovation and research driven companies that want to keep themselves updated on recent technologies and competitors.
Deliverables: Patent alert report in excel sheet (including patent applications as well as granted patents) along with a PDF copy of all prior arts listed in the report, primarily, monthly, quarterly or half yearly.
Write to us at info@origiin.com to know more about our Patent Alert Service
A patent is a statutory right granted by the Government for a product or process which satisfies certain criteria of patentability. The term of a patent is often 20 years from the date of filing and is subject to certain terms and conditions. The claims of a patent determine the scope and kind of rights the patent grants to the patentee. Patent rights are territorial in nature, which means that an Indian patent for example is valid and enforceable only in India. If one wishes to have patent rights in foreign countries, the patent application must be filed in the required foreign countries within 12 months from the date of priority of the application filed in the home country.
There are few conditions that must be satisfied by an invention for it to be granted a patent. The invention can be a product or process and must have novelty, industrial applicability and must not be obvious to a person skilled in the art. Further, the invention must not fall into any category of inventions that are not patentable, as disclosed in section 3 and 4 of the Act. There are many benefits that a patent holds for patent owners and inventors. For companies and institutions, patents help generate a good image for them and thus enjoy a brand image in the market. If the invention has good potential in the market, patents could be a good source of revenue for the patentee. A patent may add value to a students’ professional records, helping them improve their odds of getting a job or good institutes to pursue higher education. When a patent application is filed, a date of filing is obtained, also called the priority date. The patent rights of a patent are calculated taking this priority date into account, making disclosure of the invention easier after a patent application is filed. This is particularly useful when the inventor is required to publicly disclose their invention at through publications or events. With a priority date secured, it becomes possible for the inventor to disclose their invention, additionally making it easier for business owners to obtain investments for their organization once the patent is filed.
Procedure of obtaining a patent in India
Once a new idea is conceived, the first step should be documenting the novelty of the idea in detail, along with the problems that the invention is attempting to address and solve. A basic understanding of whether similar documentation as the invention exist already must be assessed with a patent search. If the idea is novel, a patent specification must be drafted and filed in India as soon as possible to claim the earliest possible priority date. It must be noted that patent application shall be filed by a registered Indian Patent Agent only. After the publication is filed, it is published on the official website of Indian Patent Office (IPO) after expiry of 18 months from the date of filing, after which the application is examined by the patent examiner. If there are objections submitted by the examiner, the inventor must comply by all the objections. Once everything has been cleared between the inventor and examiner, the patent is granted. A periodic renewal fees is required to be paid by the applicant after patent grant to keep the patent in force.
After the application is published, there may be an opposition to the grant of the application. If such oppositions against the invention are filed within 12 months from the date of filing of the application, the oppositions are called pre-grant oppositions. However, if the same oppositions are filed within 12 months from grant of a patent, the oppositions are called post-grant oppositions. Further, if oppositions are raised after the elapsing of 12 months since filing the patent, the oppositions are called revocations. Oppositions and revocations can be handled by a patent attorney or patent lawyer who may or may not be a patent agent.
Importance of selecting the right patent firm
Selection of the right patent firm or agent is of crucial importance for inventors because a patent document is a highly complex document. It takes both a high level of both technical and legal skill to draft a patent application to accurately capture the essence of an invention. Subsequent prosecution after filing the application is also complex and intricate, further accentuating the need to employ the services of a skilled patent firm or agent. Other processes that the patent firm and agent undertake include maintenance of the patent application, responding to objections raised by the examiner, filing in foreign countries, and so on.
The two terms used most frequently in the industry are “patent attorney” and “patent agent” and is therefore of prime importance to understand the difference between the two. A Patent Agent is someone who possesses at the minimum an undergraduate degree in Science, has cleared the Indian Patent Agent Exam and has registered himself as a registered patent agent with Indian Patent Office. A patent attorney however is an advocate who practices Intellectual Property (IP) law and may or may not be a patent agent. Patent attorney or advocate is required to register himself with the Bar council of India as an advocate. For the processes of drafting, filing and prosecution of a patent application, a registered Patent Agent is required. On the other hand, a patent attorney can assist with handling of oppositions, revocations and lawsuits relating to patent applications. Patent agents and patent attorneys are hence people who have specialized knowledge and qualifications necessary for representing clients in obtaining patents and acting in all matters and procedures relating to patent law and practice. A patent agent may also be appointed by the inventor or applicant to perform various actions before the patent office on behalf of the applicant and in consultation with them.
Qualifications required to become a patent agent/attorney
In order to become a patent agent, the candidate is required to file an application to write the exam. The candidate must sit for the exam and clear it. The candidate must then request the Controller for Form-22, which is then to be filled and submitted along with a fee of 3200 INR for registration of the candidates’ name as a patent agent in the register of patent agents. The candidate must then pay an annual fee of 800 INR to ensure that their name is maintained in the register of patent agents.
Additionally, a person is qualified to have their name entered in the register of patent agent if he/she fulfill the following conditions:
He is citizen of India;
He is above the age of 21;
They have obtained a degree in science, engineering or technology from any university established under law for the time being. The institute must be active in the territory of India or must possess such other equivalent qualifications as the Central Government may specify in this behalf.
The Controller maintains a register called “Register of Patent Agents” in which the names, addresses, phone numbers, fax numbers, E-mail IDs and other relevant particulars of all persons qualified to be registered as patent agent are entered. The list of registered patent agents is available on the official website of IPO.
According to Rule 110, the qualifying examination for patent agents is conducted over a period of 2 days and consists of the following sections:
Paper I : Patents Act and Rules, 100 marks
Paper II: Drafting and interpretation of patent specifications and other documents, 100 marks
Viva Voce: 50 marks
Section 127, dealing with rights of patent agents explains that registered patent agent can draft, file and prosecute patent applications at the IPO (these actions include filing of patent, sending request for early publication or examination, reply to examination report, paying renewal fee, etc.). Every patent agent whose name is entered in the register shall be entitled:
(a) To practice before the Controller during prosecution process such as at the time of opposition to the grant of patent,
(b) To prepare all documents, transact all business and discharge such other functions (such as filing of patent, sending request for early publication or examination, reply to examination report, paying renewal fee, etc.) as may be prescribed in connection with any proceeding before the Controller under this Act.
According to section 128, Subscription and verification of certain documents by patent agents:
A registered patent agent can take authorization from their client on Form-26 [Form of authorization] so that they can act on behalf of their client. All applications and communications to the Controller may be signed by a patent agent.
Form-26 shall be executed on stamp paper of 100 INR denominations.
Factors taken into consideration for choosing the right patent firm/agent:\
When choosing a patent firm or agent, the scientific prowess of the firm or agent must be checked. In the case of a patent agent, they must be a graduate or post graduate in the domain of the invention for which the patent is being filed to ensure that they understand the invention well.
Each patent agent has their own unique ID, obtained from the patent office. Their registration number or even ID card must be checked before working with them.
The patent agent can be asked to show their previous patent applications that have been published or been granted patents which can be verified by checking the patent and publication numbers respectively. If the patents have been granted, a look at the objections raised by the examiner on their patent application can provide valuable insight into the quality of the patent agents’ work.
An essential skill required for drafting of patent specifications is command over the English language. The inventor must speak directly with the patent agent responsible for the drafting of their invention to properly understand whether the patent agent is capable of drafting their specification.
Since some inventions are highly technical in nature, the technical hold of the patent agent over the subject matter of the invention should be judged carefully.
Inventions often belong to more than one scientific domain. Therefore, it must be verified that the patent firm being chosen comprises a diverse group of patent agents, well-equipped to handle any kind of technical query.
Another point to be considered is the pricing that the firm quotes. Filing of a patent application involves official fees that are paid to the IPO and professional fees that are paid to the patent firm that carries out the patenting process.
Conclusion
The process of patent filing is tedious, and the quality of the drafted specifications plays an important role in the prosecution, grant and further commercialization of the invention. Selection of the right patent firm and agent for undertaking this complex procedure is thus crucial to the success of the patent. Experience of the patent firm or agent, quality of the work produced and the number of successful cases are some of the parameters to be considered before selecting the law firm.
Patent is a valuable intangible asset, more important today, as India initiates “Vocal for Local movement” because of which importance of patents is much more than before. Before we proceed further, lets understand what a patent is. Well, patent is a kind of Intellectual Property Right, granted by the Government to the inventor for new, useful and non-obvious inventions for a specific period of time. Patent protection for the invention is for 20 years from the date of filing, provided renewal fee is paid in time and patent is not revoked for any reason. Another interesting thing about a patent is that patent rights are territorial. Indian Patent is valid only in India and in order to get patent protection outside India, you must file separately in the countries where you want to have patent protection.
There are lots of advantages for the business to file for a patent
Disclosure becomes easy: As soon as you file a patent application, the receipt of filing application is generated that contains date of filing patent application, i.e., priority data and application number. Since you obtain date of priority upon filing application, disclosure of the invention becomes easy.
Protects your inventions: You can protect your invention legally by a patent as patent is a statutory right granted by the Government. Once you have a patent, you can prevent third party’s from making, using, offering for sale, importing the patented invention in the country where you have patent protection. Further, once you have patent, you can always license your patent and join hands with a progressive enterprise to bring product in the market.
Branding of company/products: After patent is filed, you can label your products as “Patent Applied for” whereas after grant of a patent, you can label the product as “Patented”. You can put status of “Patent applied for” or “Patented” on your web site, corporate presentations, and it helps you to brand your company/products better.
Better valuation of your company: Like your tangible property, Patent is also a valuable intangible asset. Using specific techniques, value of a patent can be assessed and this adds to overall valuation of your business. This may be useful at the time of acquisition/merging.
Enforcement of patent right: If your patent is infringed by third party, you can enforce your rights to stop using your patent. For example, VirnetX company had four patents (U.S. Patent Nos. 6,502,135, 7,418,504, 7,921,211 and 7,490,151), which Apple Inc infringed in its FaceTime Video calling service. Apple was sued by VirnetX and in this case Apple paid $368 million to VirnetX as damages.
There are several reasons for the companies to file for patents, however, initial due-diligence is important before filing for a patent to ensure that the patent adds value to the business. For any innovation and research driven company, following steps may be useful to set up right steps to create repository of new ideas and channelize them in right way:
Perform an internal Audit to take stock of ongoing research projects
Repository of new ideas shall be created. It is a good idea to create standard Invention Disclosure Form (IDF) where research team can document and submit invention to IP committee
You can screen and prioritize the inventions received and plan to file for patents for the shortlisted them
Identify right legal framework to protect them. There may be possibility of protecting the innovations as patent, copyright, design, trademark etc.
Finally, find out right consultant to help you, based on area of technology and experience of the consultant.
File your patent application to obtain application number and date of filing. To start with, you can file your application in India and later on, within 12 months from the date of Indian filing, you may, based on business needs, international application may be filed.
Patent could be a valuable asset for your company and systematic steps, processes and policies within the organization can help you in a big way.
A patent is statutory grant by Government for the inventions (a Product or a process) that are novel, industrially useful and non-obvious to a person skilled in the art. It gives its owner the exclusive right to prevent or stop others from making, using, offering for sale, selling or importing a product or a process, based on the patented invention, without the owner’s prior permission.
Date of filing patent application is very significant in patent law. The day of first disclosure of the invention to patent office is called as “Priority Date”.
A very famous example to prove importance of first filing or getting earliest priority date is telephone patent controversy in 1870s, where two inventors Elisha Gray and Alexander Graham Bell both independently designed devices that could transmit speech electrically (the telephone) and both men rushed their respective designs to the patent office within hours of each other, Alexander Graham Bell patented his telephone first. Elisha Gray and Alexander Graham Bell entered into a famous legal battle over the invention of the telephone, which Bell won. Today we all know Alexander Graham Bell as inventor of telephone.
In order to claim the earliest priority date, the inventor may be interested in filing provisional patent application. The filing of provisional application enables the inventor to have “Patent Pending” status for the invention. In case, the applicant has filed provisional application, the complete specifications shall be filed within 12 months of filing provisional application. Provisional application can only be filed in Indian Patent Office [National Office] and not at PCT or convention country. Immediately on receiving the Provisional Specification the Patent office accords a filing date and application number to the Application.
The main advantages of filing provisional application are:
Drafting provisional application is less-time consuming compared to drafting complete specifications, hence it is quick method of claiming the earliest priority date
Gives 12-month time to the inventor to take decision on whether he wants to file complete specification or not. This 12-month period is also useful for the inventor to assess the invention commercially.
Applicant has to file complete specifications within 12-months of filing provisional application.
Prime stages from filing patent application till the grant are as follows:
Filing application: You may file complete or provisional application in India to claim earliest priority. However, if you don’t wish to file in India and directly want to file in foreign country, Foreign Filing Permission is required from Indian Patent Office. If provisional application is filed, the complete application shall be filed within 12 months from the date of filing provisional application. The complete specification can be filed directly as a PCT application after taking necessary permission if required.
Publication: The application is published by patent office after expiry of 18 months from the date of filing. Date of publication is very significant as upon publication the invention forms part of prior art. After publication, in case anyone is interested, the application may be opposed on various grounds such as lack of novelty, non-obviousness, industrial application etc. Indian patent law also provides a provision for early publication of application before the expiry of 18 month on request by the applicant.
Examination: After publication, examination of the application takes place and on the basis of examination, examination report is sent by the examiner that has to be replied in a given period of time.
Grant of patent: After replying examination, applicant may hear grant of the patent and this is the time when payment of annual renewal fee to maintain patent is also to be made. Grant of patent is published and in case anyone is interested, the patent may be opposed on various grounds such as lack of novelty, non-obviousness, industrial application etc.
If the applicant is interested in filing patent application in foreign country (ies), it shall be done within 12 months from the date of priority. Once foreign filing is done, we will submit “Priority Document[1]”, obtained from India Patent Office to the foreign country or PCT as the case may be.
Foreign filing of application can be of 2 types:
Convention application: When an application is filed directly in a country which is a member of Paris Convention is called as convention application. For example, if you file in India and then directly file in USPTO, the application filed in USPTO is called as Convention Application.
PCT application: This is application filed though Patent Cooperation Treaty (PCT) which is a filing platform (does not grant patents) and enables you to file application in multiple countries within 30 or 31 months from the priority date. The PCT is only a patent filing procedure and does not provide for the granting of patents. The granting of patents is the responsibility of each individual member countries (Contracting States).
The above timeline provides a graphical representation of the PCT procedure and sequence. Typically, first patent application is filed national or regional patent Office. This patent application is commonly referred to as the local application
Filing a PCT application
PCT application is filed within 12 months from the filing date of local (first) patent application with the Receiving Office of national or regional Patent Office. It can also be filed directly with the Receiving Office of WIPO, if permitted by the national security provisions of applicant’s national law [Refer Section-39 of Indian Patents Act, 1970].
PCT application will have the same legal effect as a separate application filed in each PCT country.
International Search Report (ISR) and Written Opinion of the ISA
Every international patent application is subjected to an “international search” by an International Searching Authority (ISA). An Applicant of an International Patent Application is sometimes given the choice of having a search done on the invention at a patent office other than at the Receiving Office. The patent office which performs the search is called the “International Searching Authority.”
Indeed, not all Receiving Offices are qualified to act as International Searching Authorities, and therefore International Applications filed at such Receiving Offices are regularly referred to a different patent office than where the International Application was initially filed for purposes of having a search of the prior art made. Even when the patent office functioning as the Receiving Office also has the status of an International Searching Authority, agreements may have been entered into which allow another patent office to serve as the International Searching Authority at the election of the Applicant.
An International Search Report and a written opinion from the competent ISA will be provided to the applicant within 16 months from the filing date of local application. The written opinion complements the ISR by providing a preliminary non-binding patentability assessment of the invention taking into consideration the references contained in the ISR.
The recognition as an ISA and IPEA would be beneficial for India in several ways. International applications received by the WIPO under the PCT route sent to India for search and preliminary examination would generate revenues in the form of fees usually paid to ISA and IPEA. The new status would allow Indian companies and inventors to avail patentability search and obtain International Preliminary Examination report (IPER) and written opinions on a much faster and cheaper way.
International Preliminary Report on Patentability (Chapter I of the PCT)
ISA sends report on patentability to the applicant. After having considered the written opinion of the ISA, the applicant may decide not to continue with the assessment of PCT application and not file a demand for international preliminary examination[2]. In this case, WIPO will attach a cover sheet to this written opinion effectively converting it into the international preliminary report on patentability (Chapter I of the PCT). The international preliminary report on patentability (Chapter I of the PCT) is available for public inspection 30 months after the priority date of PCT application (the date of first-filed local patent application).
International Publication
The International Bureau of WIPO will publish PCT application on PATENTSCOPE® shortly after 18 months from the priority date of applicants PCT application. Publication provides technical disclosure of applicant’s invention fuelling greater technological progress and development.
PATENTSCOPE® is a free search service offered by the World Intellectual Property Organization (WIPO). It is made up of two databases, each with its own search interface.
Under PCT system, the applicant is given an option of supplementary international search carried out by participating International Searching Authorities, upon request by the applicant. The request for supplementary international search may be filed any time prior to the expiry of 19 months from the priority date. The supplementary search is completely optional but may be of interest in cases where a more complete overview of the prior art is desired, particularly in respect of specific languages. The supplementary international search service is not available across all International Searching Authorities. Those offering this service do so against the payment of a fee. The supplementary international search report prepared by the International Searching Authority should be available by 28 months from the priority date.
Filing of a Demand for International Preliminary Examination (Chapter II of PCT) (Optional)
This part of the PCT procedure is optional. If the applicant is not entirely satisfied with the contents of the written opinion, he may decide to continue the assessment of invention under the PCT by filing a demand for international preliminary examination with a national or regional patent Office that has been appointed as an International Preliminary Examining Authority (IPEA) under the PCT. Each PCT Member State has appointed at least one IPEA to perform international preliminary examinations for its applicants, referred to in PCT terms as the “competent” IPEA.
Applicant is given at least 22 months from the priority date of his PCT application to file demand for international preliminary examination with the competent IPEA.
International Preliminary Report on Patentability (Chapter II of PCT)
An international preliminary examination may optionally be requested (“demanded”) by the applicant. The international preliminary examination is conducted by an authorized International Preliminary Examination Authority (IPEA). This results in an International Preliminary Examination Report (IPER).
At about 28 months from the priority date, the IPEA sends an international preliminary report on patentability (Chapter II of PCT) containing the opinion of the IPEA for national or regional Offices to use in assessing the patentability of applicants invention. This report is a non-binding opinion on patentability and is only provided to applicants who have filed a demand for international preliminary examination.
National Phase Entry
National phase follows international phase. Entry into the national phase represents the end of the international phase of the PCT procedure and the start of the national patent grant procedure. During national phase the applicant can file patent application in the countries of his choice within prescribed time. A PCT application has to enter into nation phase with in 30 or 31 month from the priority date.
The international preliminary report on patentability (either under Chapter I or Chapter II), received during the international phase of the PCT procedure, will help the applicant to evaluate the chances of obtaining a patent in the countries of his interest. The international preliminary report on patentability also provides guidance to patent Offices on whether a patent should be granted for the invention.
Once entered in to the national phase, the patent application is subjected to the patent laws, regulations and practices of each country. Rejections on form and content may not be raised provided that they conform to the requirements of the PCT.
When a PCT application is filed in India at national phase, it is processed under following stages:
1. On receipt of an application, the Office accords a date and serial number to it. PCT national phase Applications and non-PCT Applications are identified by separate serial numbers.
2. All applications and other documents are digitized, verified, screened, classified and uploaded to the internal server of the Office.
3. Patent applications and other documents are arranged in a file wrapper and the Bibliographic sheet is prepared and pasted on the file cover, so that the files move on for storing in the compactors.
4. The Application is screened for:
a. International Patent Classification.
b. Technical field of invention for allocation to an examiner in the respective field.
d. Correcting/completing the abstract, if required. If found not proper, the abstract will be recasted suitably, so as to provide better information to third parties.
5. Requests for examination are also accorded separate serial number.
Advantages of PCT
The PCT is an important part of the international patent system and application filed at PCT is also called as international application or PCT application. It provides a worldwide system for the simplified filing of patent applications that:
Brings the world within reach
Postpones major costs and provides the applicant with additional time to consider his various patenting options
Provides a strong basis for patenting decisions
Used by the world’s major corporations, universities and research institutions when they seek international patent protection
A single PCT application has the same legal effect as a national patent application in each of the PCT Contracting States. Without the PCT, one may have to file a separate patent application in each country of interest.
[1] It is a certified copy of the application which is issued by Indian Patent Office and it is required by foreign country as a record or Indian filing.
[2] Filing demand for international preliminary examination is optional.
I am a patent attorney based in the U.S. who specializes in obtaining, maintaining, and enforcing patents on computer technologies—including software—for clients worldwide. I have personally written and obtained hundreds of software patents in the U.S. and many other countries over almost two decades. Yet I continue to hear sophisticated technologists, businesspeople, inventors, academics, and others express significant misconceptions about software patents. With this article I hope to clear up the most prominent of these misconceptions.[1] – Robert Plotkin
Myth: Software Is Not Patentable
Many continue to believe that software cannot be patented. This is not true. Patents on software are granted routinely every day and have been granted regularly for decades. There was an explosion in the number of software patent applications filed in the U.S. in the 1990s after a series of court decisions significantly expanded the patentability of software, and software patents have been a staple of the U.S. patent system ever since that time.
Even in Europe, where the European Patent Convention (EPC) prohibits patents on computer programs “per se,” software patents are issued regularly. To overcome the EPC’s apparent prohibition on software patents it is necessary to use expert knowledge of the EPC to draft each software patent to point out clearly the technical effect and contribution of the invention. The same is true in many other jurisdictions. Although certain particularly abstract kinds of software may not be patentable, the assumption that no software is patentable anywhere is false in nearly every jurisdiction and has been so for a long time. The key to obtaining a strong and defensible software patent in any jurisdiction is to retain the services of a patent practitioner who is well-versed in the laws of that jurisdiction as they apply to software.
Myth: Software Patents Are Not Valuable
Even those who understand that software can be patented often falsely assume that software patents are not valuable because they are too vague to enforce or for some other reason. The evidence demonstrates, however, that software patents have proven to be among the most valuable kinds of patents that can be obtained.
For example, consider the near-legendary RSA encryption patent (U.S. Pat. No. 4,405,829), which covered both hardware and software implementations of RSA’s groundbreaking encryption algorithm. This patent was licensed to countless companies for untold millions of dollars over the course of its 17-year lifespan. Several of RSA’s competitors attempted to invalidate the patent in court but none succeeded. Cryptography companies reportedly held parties when the RSA encryption patent expired in celebration of their ability to use the RSA encryption patent without needing to pay licensing fees to RSA any longer.
A well-drafted software patent can cover a wide variety of implementations of a particular invention. Furthermore, a software patent application can be filed based merely on a sufficiently detailed description of how to create a software invention, without the need to have created a working version of the software itself in most cases. As a result, careful planning can enable innovative software companies to file broad software patent applications early, thereby obtaining software patents that can later be used either offensively or defensively against a wide variety of infringing parties. These and other features of software patents can make them particularly valuable assets.
Myth: Copyright Protection is Sufficient for Software
The code of a computer program is protectable by copyright law. As a result, many falsely assume that obtaining copyright protection for a software application is sufficient to provide complete legal protection for that application. This assumption is based on a failure to understand key differences between the protections afforded by copyright and patent law. Copyright law protects only the expression of an idea. In the case of software, this means that copyright law protects the particular way in which a computer program is expressed in code. Copyright law does not, however, protect the functions performed by a computer program. For example, copyright protection for a computer program which uses an innovative algorithm to control a thermostat protects only the particular code contained with the program, leaving others free to write their own software which performs the same algorithm using different code. Furthermore, a copyright on such a program can only be used by the copyright owner to stop others who have access to the copyright owner’s program from copying that program, not to stop others from independently inventing the same program themselves.
In contrast, a patent can cover the functions performed by a computer program, regardless of the particular program code that is used to implement those functions. Furthermore, a patent can be infringed by someone even if that person had no prior knowledge of the patented invention. In the thermostat example above, assuming that the thermostat control algorithm is sufficiently novel and inventive, a patent can be used to obtain protection for the algorithm regardless of the particular code that is used to implement it, and regardless of whether the infringer copied the original inventor’s algorithm or created it independently. As a result, a patent can provide significantly stronger and broader protection for software than copyright. As a result, in many cases it is advantageous to secure both copyright and patent protection for individual computer programs.
Myth: Software Inventions Must Include New Hardware To Be Patented
Although some patents covering software also include innovative hardware, this is not always the case and need not be the case to satisfy the law in the vast majority of jurisdictions. To understand why, keep in mind that the act of programming a computer with a computer program causes the computer to be reconfigured into a new state. This resulting programmed computer contains hardware which has been configured to perform a particular function specified by the software with which it has been programmed. If the computer program is novel and inventive (“nonobvious” under U.S. patent law), then the resulting programmed computer contains inventive hardware. As a result, typically it is not necessary to invent any additional special hardware to satisfy the legal requirements for patentability.
This is not to say that every computer program—even every new computer program—can be patented. A computer program which merely plays a particular song will likely be seen as failing to satisfy the “utility” requirement under U.S. patent law, the “industrial applicability” requirement under the European Patent Convention, and similar requirements in other jurisdictions. That is why a patent firm with expertise in the law of the applicable jurisdiction must be consulted in connection with every software patent. The fact that some computer programs cannot be patented does not, however, alter the general conclusion that most software for performing patentable functions can be patented if it satisfies the applicable legal requirements and if the patent application is written by a competent patent practitioner.
Software patents have been a feature of patent systems worldwide for decades and will continue to remain prominent and valuable assets of leading technology companies. Any organization which develops innovative software must consider software patents as part of its overall intellectual property strategy. The law governing software patents is complex and requires both sophisticated knowledge of computer technology and expertise in the patent law of the relevant legal jurisdiction. Furthermore, the law governing software patents tends to change rapidly in response both to new legislation and decisions rendered by patent offices and courts. As a result, successfully implementing a software patent strategy requires close cooperation with a patent firm with deep experience in software patents to avoid the many pitfalls that can befall the unwary.
Robert Plotkin, Esq. is a U.S. patent attorney specializing in patent protection for software and other computer technologies. He is the founder of the law firm of Robert Plotkin, P.C. (www.rplotkin.com), which represents leading technology companies worldwide. Attorney Plotkin is recognized as an expert in the subject of software patents and has written, spoken, and taught extensively on the topic internationally.
Video games are amongst the most widely enjoyed forms of entertainment today. While video games are predominantly played by people in their adolescence, these games are making their way into a multimillion-dollar full-fledged industry that is based on competitive playing. With this level of involvement of games in the lives of people everywhere, it then comes as no surprise that there have been cases where popular characters of video games have come under the spotlight of intellectual property theft. Let’s take a look at a case riddled with twists featuring some of the world’s most popular movie and video game characters.
The case
When we picture the word “Mario”, we instantly imagine a character wearing a red plumber’s uniform, bouncing on platforms to save his princess from evil forces. And when we hear the phrase “King Kong”, our minds instantly jump to a massive gorilla waving his arms around, swatting at airplanes atop the empire state building. It may come as a surprise that the owning studios of these productions have in fact gone head-to-head in a rather interesting lawsuit regarding the theft of the idea of the popular oversized gorilla.
The movie King Kong was first released in the year 1933 by Merian C. Cooper. The production house for King Kong was RKO, which later went on to release subsequent sequels of King Kong in the following years. The movie franchise went on to do very well, earning their producers and directors large sums of money throughout the runtime of the movie. In the year 1981, Nintendo released their game Donkey Kong, where Donkey Kong was a large ape and would attempt to stop Mario (then called Jumpman) from reaching Pauline (Mario’s romantic interest, then called Lady). The game was a big hit and it was simply a matter of time before the game caught the eye of Universal Studios, who then apparently held the license for King Kong. Outraged at Nintendo and other game studios for blatantly copying the idea of King Kong, Universal Studios sternly ordered every agency selling products under the name of Donkey Kong to pay Universal Studios royalties for the misuse of Donkey Kong by way of cease-and-desist letters. Almost all the agencies reverted back with the royalty payments, except Nintendo.
Nintendo attempted to settle the suit outside the proceedings of a court in the year 1982 to which the Vice President of Universal Studios Robert Hadl responded by asking Nintendo to stop making copies of Donkey Kong. Nintendo’s attorney Howard Lincoln pointed out that the name King Kong had previously been used on multiple products that were in no way affiliated with Universal Studios, claiming that Universal Studios in fact did not have the rights to King Kong in the first place. Hadl then asked Nintendo to brace themselves for a lawsuit, claiming that Universal Studios saw lawsuits as a way of making money.
John Kirby was brought in by Lincoln to represent Nintendo in the case because he had a history of winning big-name lawsuits for companies like Sony. During the proceedings, Universal Studios claimed that Nintendo’s Donkey Kong and Universal Studios’ King Kong could easily be confused with each other and that the story line of the movie and game were also similar. To counterattack, Nintendo asked a representative to assure the court that the gameplay of Donkey Kong was in no way similar to the storyline of King Kong. Additionally, Nintendo went on to claim that Universal Studios did not own the rights for King Kong and shockingly enough, that Universal Studios were aware of this fact and still decided to demand royalties for King Kong despite knowing they did not have the rights for King Kong.
Historically, the rights of King Kong had always been a territory undefined. When King Kong was initially released by Cooper in 1933, the rights were firmly with Cooper. Later on, Cooper realized that other production houses were making movies with the character King Kong, and that he had no clear documents preventing them from doing so. Cooper tried to find papers to authenticate his rights but found that he had given the rights for only 2 movies to a production house called RKO Pictures and for a book written by his friend Delos W. Lovelace sometime in the decade of 1970, a whole decade before the release of donkey Kong by Nintendo. However, Cooper could not find documents stating that the license was given to RKO Pictures. During this time, Universal Studios wanted to make their own series of movies on King Kong but were stopped as the rights to King Kong were with RKO Pictures. Desperate to win King Kong, Universal Studios argued in court that the copyright on Lovelace’s novel (which was the only existing document proving ownership of any kind) had expired by then and that King Kong was therefore a public domain character. The court decided that King Kong was indeed in the public domain and therefore anyone could make their reproductions of the character as long as the story involving the character was not copied.
The presiding judge during the 1982 case of Nintendo versus Universal Studios kept all this in mind and reprimanded Universal Studios for knowing fully well that Universal Studios had themselves contested that King Kong was a public domain character but still asserted that they owned the character and even demanded royalties from agencies making use of King Kong. The presiding judge further ruled that the game Donkey Kong was not similar to the storyline of King Kong in any way and was “a parody” at best, thus solidifying Nintendo’s case against Universal Studios. The judge declared that any agency that had paid royalties to Universal Studios were free to demand the royalty fee back from Universal Studios and that all cease-and-desist letters from Universal Studios were rendered null and void. Further, the court found that a game released by a company called Tiger Electronics was very similar to Donkey Kong and thus ordered Tiger Electronics to pay Nintendo a sum of $58 million.
Universal Studios was the one to push this lawsuit against Nintendo in order to extract money from them by means of a character that they didn’t have the rights for. Universal Studios knew this in fact because a few years ago they themselves had gone to court to prove that King Kong was a public domain character, and anyone was free to use the character. Nintendo had initially planned to settle the matter outside of the court but went against the movie giant Universal Studios and even won with getting money from profits from a by-product of the ruling. This case shows us that it is never a good idea to underestimate the court or your opponents, and to assume that all secrets regarding ownerships and rights are out in the open for everyone to access. Universal Studios underestimated the court and Nintendo and subsequently ended up losing the case.
Bolar exception is one of the exceptional acts where the use of patented invention without consent of the patentee doesn’t constitute infringement.
U/S 107A [Certain acts not to be considered as infringement]of Indian Patents Act 1970, any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product.
Some countries allow manufacturers of generic drugs to use the patented inventions for development and submission of information required under law. For example, from public health authorities, without the patent owner’s permission and before the patent protection expires. The generic producers can then market their version as soon as the patent expires. This provision is called “Bolar Exceptions” or “regulatory exception”.
This is a landmark case in the United States related to the manufacturing of generic pharmaceuticals. Bolar was a generic drug manufacturer and Roche was a brand-name pharmaceutical company which made and sold Valium, the active ingredient of which was protected by patent. Before patent expiration, Bolar used the patented chemical in experiments to determine, if its generic product was bioequivalent to Valium in order to obtain FDA approval for its generic version of Valium. Bolar argued that its use of the patented product was not infringement under the experimental use exception to the patent law.
The Court of Appeals for the Federal Circuit rejected Bolar’s contention holding that the experimental use exception did not apply because Bolar intended to sell its generic product in competition with Roche’s Valium after patent expiration and, therefore, Bolar’s experiments had a business purpose. Bolar also argued that public policy in favor of availability of generic drugs immediately following patent expiration justified the experimental use of the patented chemical because denying such use would extend Roche’s monopoly beyond the date of patent expiration.
The court rejected this argument, stating that such policy decisions should be made by congress. Likewise, the court decided that apparent policy conflicts between statutes such as the Food and Drug Act and the Patent Act should be decided by congress and not the courts. Shortly after Roche v Bolar was decided, congress did pass a law permitting use of patented products in experiments for the purpose of obtaining FDA approval, which established the modern system for FDA approval of generic drugs.
Patent search is a process of identifying relevant patents and depending upon the purpose of patent search, the parameters like timeline, jurisdiction, subject matter can be defined while performing a patent search for a specific purpose. There are different types of prior art searches for different purposes, but broadly patent search can be classified in to six main categories namely:
Patentability or Novelty search (PAS)
Freedom To Operate (FTO)
Validity or Invalidity search
State of the Art search
Technology Landscape Analysis
Evidence of use search
A. Patentability search (PAS) or Novelty search
“Patentability search”, also known as “Novelty search”, is the most common type of search on patent/non-patent literature to assess novelty & patentability of the invention. While patentability search can be performed much earlier during the development of an invention, it is more commonly performed prior to submitting a patent application. Patent search is often done world-wide or globally using various paid or free databases.
B. Freedom To Operate (FTO)
FTO search, also known as “Clearance search” or “Right to use search” is conducted prior to launching a new product to check the patents that are in force in a country to ensure that upon launching the product, the company is not infringing any patent (s) of third party. FTO search is limited to patents that are ‘in-force’ and it requires in-depth analysis of the claims and legal status of patents identified. FTO is usually done jurisdiction-wise because patent rights are specific to jurisdiction, and FTO analysis should relate to particular countries or regions where a company wants to operate. If the company wants to launch products in the US, FTO is required to be done in the US alone but if the products have to be exported to four other countries, FTO shall be done in other four countries as well.
C. Invalidity/Validity Search
The purpose of validity/invalidity search is to determine whether a patent issued on an invention is valid or not in view of prior art. The main reason to perform this search is to either validate or invalidate one or more claims of a patent. In other words, when a search is conducted to validate the claims of a given patent, it is called Patent Validity Search and when it is determined to invalidate the claims of a given patent then it is called Patent Invalidity Search.
D. State of the Art search
The State-of-the-Art search is the broadest and the most general of all types of patent searches. It is essentially a market survey that ideally finds out what technologies already exist. State of the Art search results are valuable in many situations especially when a company is contemplating entry into a particular field of art. The State-of-the-Art search results may provide concrete evidence of the advisability of such a decision. To a company that is currently active in a particular field of art, the State-of-the-Art search results may lay out the path that must be followed to design around the current art.
E. Technology landscape
Technology landscape is an in-depth analysis of patents to understand the technology evolution, major players, current and upcoming competitors and changes in the timeline trend. The main purpose of technology landscape is to identify the white space or gap in the technology, and it provides a comprehensive scope to plan the future R & D, leading to innovative projects to bring out new products/process in an industry. The main purpose of technology landscape study is to understand the technology trends, strength of competitors, to learn latest technology advancement and analyse the patent activity related to technology of interest. Based on technology landscape analysis, appropriate IP strategy in compliance with business strategy is devised for the companies because a good IP strategy is a critical part of business plan and growth at any stage.
F. Evidence of use search
Purpose of Evidence of Use search, also known as EOU, is to identify potential infringement of the existing patents and is helpful at the time of technology transfer as proof of patent infringement can affect the terms and conditions of the transaction.
Patent search is performed to extract valuable data related to specific product or the invention and this data may be used in various ways depending upon the purpose of patent search.
The word “patent search” or “prior-art search” in patent law means any information that exists in the form of publication or patent or prior use, before the date of the filing a patent application. This knowledge (or “prior art” or “state of art”) may be in any form such as patent, scientific literature, publications (such as journal articles, proceedings of conferences, data books and display information from technical exhibitions), public discussions or news from anywhere in the world. The prior-art search is often performed by a patent attorney or a patent agent or a patent searcher and it is conducted through various patent and non-patent databases and other relevant technological websites to identify relevant prior-arts.
Novelty of an invention is always determined before inventive step because the technical contribution of the inventor can be assessed only by knowing the novel elements of the invention. The invention is not considered to be novel if information about the invention has already been disclosed in public.
The right time of doing patent search is at the stage of idea itself. Before investing time and money to develop the idea, it is extremely important to assess whether the idea is novel or already published or claimed by anyone else. Often the inventors assume that the idea is novel by looking at the products which are already in market and comparative analysis of such products with their idea makes them believe that idea is novel. The hard reality is that only small fraction of patents is commercialized, whereas a big chunk of patents, even though are not commercialized, but certainly form part of the prior art and may prevent an inventor from getting a patent on his invention.
Prior art search is performed at various stages of product/process development and the purpose of doing it may vary depending upon the requirements. The main reasons for which prior art search is done are:
1. Before filing for patent
Inventor may perform prior art search for his invention before filing for a patent to make sure that on the day of filing patent application, his invention is novel and there is no existing patent or publication of the invention before he files the patent application.
2. At the time of planning R & D
Due to heavy competition, today companies spend lots of time and resources for Research and Development. Patent search may be performed by researchers in a particular area of technology to assess the work already done and based upon such existing knowledge they can plan R & D in a better and effective manner. Prior art search gives a fair idea on the research already done in a particular area of technology and the inventor can work further on it instead of working again on the same area. Prior art search also provides ideas to refine and improve the invention by identifying whether the invention has significant improvement over existing inventions.
3. Before product launch
A company may perform prior art search before launching product in a specific market to make sure that it is not infringing patent rights of any third parties by the product launch. This search is called as “Freedom To Operate search (FTO Search)” or “Clearance Search”.
4. Technology Landscape studies for devising IP Strategy
The purpose of Technology Landscape study is to understand the technology trend, strength of competitors, to learn latest technology advancement and analyze the patent activity related to technology of interest. Based on Technology Landscape Analysis (also called as Patent Landscape Analysis), appropriate IP strategy, in compliance with business strategy is devised for the companies because a good IP strategy is a critical part of business plan and growth at any stage.
5. During opposition or revocation
If anyone wants to oppose or revoke a patent application or a granted patent, patent search is necessary to identify the grounds on the basis of which validity of a patent/application shall be contested.
6. Patent Licensing
Patent licensing is the process of transferring patent rights to third party by the patent holder for a particular period of time, in a given jurisdiction. At the time of patent license, patent search is performed to understand strength of the patent by comparing the patent to be licensed with the prior art.
The prior art or patent search is essential for innovation driven companies not only to plan research, take decision on patent filing but also to formulate appropriate IP strategies.
Therefore, it is imperative for the inventors to perform patent search at the stage of idea itself, assess chances of patentability as well as infringement of patent right of the third party (ies) before investing money and time in research. For the inventor to make a decision on the patentability of the invention, it is critical to get the search done in time.
A patent is a form of Intellectual Property Rights (IPR) and is a statutory grant by the Government that gives its owner the legal right to exclude others from making, using, selling, offering for sale or importing the patented invention in the territory wherein patent is granted, for a limited period of time.
Invention shall have novelty, inventive step and industrial applicability in order to get a patent granted. Patent is granted to the inventor only if these three conditions are fulfilled. The way to assess patentability of the invention before filing a patent application is by performing patentability search.
Patentability search (also called as novelty search or patent search or prior art search) is a kind of patent search which is often performed to analysis novelty of the invention before filing for a patent wherein prior arts, similar to the invention are identified, analysed and compared with the invention in detail to assess novelty of the invention. This helps further to draft patent claims in a better manner. This search is also sometimes performed to plan further research by analysis of the research which others have already done. It is highly recommended to search non-patent literature (research paper publications) also in addition to patent search, especially when the purpose of search is to assess novelty of the invention.
The search is often performed by patent professionals into several paid or free patent databases by using various search techniques such as key word search, International Patent Classification (IPC) based search, assignee search and so on. Further, patent professionals use various search strategies to yield the most relevant and accurate results corresponding to a particular invention.
In order to perform patentability search, following steps shall be taken:
Step 1: Identification of novel elements of the invention
The novel features may be listed out as novel feature 1, 2 and so on. This listing helps to formulate the key words and set right search strategies.
Step 2: Formulating right key words & framing search strategies
It is important to do basic research on the invention so that it is easy to identify keywords and their synonyms to ensure that prior art search is comprehensive, and no important prior art is missed during the search.
Step 3: Performing search in patent databases
Every patent office maintains its own patent databases comprising published applications and granted patents. Some of the commonly used databases includes espacenet, google patents, patentscope by WIPO and USPTO patent database. Search in these databases is free. However, there are more comprehensive databases, which are paid. Search shall be performed in these databases to extract the relevant prior art. Searcher shall focus on key words and search string formulation otherwise you may get a very high volume of search results and it becomes difficult to screen through it.
Step 4: Screening of prior art and categorizing them based on similarity with the invention
At the time of performing patentability search, the entire patent specification shall be read with special emphasis on the patent claims/embodiments and categorised as most relevant, relevant prior art.
Step 5: Comparison of prior art with novel elements of the invention
Comparison of prior art with novel elements of the invention shall be done for each novel element and finally the invention shall be assessed for patentability.
Step 6: The invention shall also be assessed to check if it falls under category of inventions not patentable in a specific jurisdiction.
In addition to meeting 3 conditions of patentability such as novelty, inventive step and industrial application, the invention shall not fall into any of the category of inventions not patentable. In Indian patent law, section 3 and 4 talk about the inventions that are not patentable in India. For example, the inventions that relate to computer software, traditional knowledge, atomic energy or the inventions that are injurious to human, plant animal life or environment are not patentable in India even though such inventions fulfil criteria of patentability. In step 7, invention shall also be assessed to check if it falls under category of inventions not patentable in a specific jurisdiction.
Step 7: Assessment of patentability of the invention in terms of novelty, inventive step and industrial application
In order to assess patentability of the invention and write opinion on patentability of the invention, the searcher shall be thorough with that different provisions of patent law. Based on finding of above 6 steps, opinion on novelty and patentability of the invention shall be written.
Novelty search is important to be performed before taking final decision on filing for a patent. If this search reveals similar or identical prior art, which is very close to the invention, inventor has a chance to improve upon the invention to minimise the objections to the grant of the patent during examination of the patent application.
Origiin, with a skilled team of patent agents is one of the best patent companies in India offering patent services such as, patent searching and patent filing, in India and foreign countries.
Deliverables: Patentability search report is written in word document with opinion on patentability considering statutory provisions along with PDF copies of all prior arts listed
Buying patent (s) is a very effective way for the companies to increase size of their patent portfolio and get access to the new and latest innovations without spending much time and money on R&D. In today’s highly competitive world, acquiring intellectual property, is increasingly becoming an important business strategy to increase companies’ offerings or differentiating itself with respect to competition.
By in licensing a patent, companies get permission from the patent holder to use the patented invention for a specific period of time in a given jurisdiction and therefore, buying a patent may also help companies overcome risk of patent infringement.
The sole difference between buying and in-licensing of patent is that in case of buying patent, ownership of the patent gets transferred to the buyer and when patent is licensed, there is no transfer of patent ownership from patent holder to the buyer but it’s only permission granted by the patent holder to the buyer to use the patented invention for a specific period of time.
In this article, we will discuss advantages of buying patents and important considerations before taking decision to buy patents.
Why should companies buy patents?
Innovation is key to success of any business today and in order to obtain a competitive edge in the market, innovative products, processes or services shall be created. Acquiring innovative patents or technologies could be one of the most effective ways to create innovative products. When the patent is granted to patent holder by the Patent office, the patent holder is granted specific rights in a specific jurisdiction which he/she can license or sell it to other in lieu of royalty or an upfront payment. Therefore, if both patent holder and buyer are interested, the ownership of patent may be transferred to the buyer by patent holder.
In 2017, InVisage was acquired by Apple Inc, along with its patent portfolio of more than 100 patents on Quantum Dot Technology for Advanced Cameras along with other technologies. This is how Apple got access to Quantum Dot Technology and thereby it helped enhance size of its patent portfolio and use the acquired technology in their latest cell phones.
In 2014, flash array vendor Pure Storage acquired 100 patents from IBM, which were related to storage technology to prevent litigation. This way, Pure Storage could not only build a robust patent portfolio but also got freedom to operate in a wider range by minimising patent infringement risk. Further, acquiring patents also improved valuation of the company.
There are various advantages of buying patents, such as:
Obtaining access to new/latest technologies and markets
Reduce R&D cycle, thereby reducing time to market
Remain “ahead of the curve” vis-à-vis competition
Minimise patent infringement risk
Increase size of patent portfolio
It may help in branding or marketing
Important considerations while acquiring or licencing a patent
Buying of patent is a cost to the company. Hence it becomes important that only useful and relevant patents are bought. Following points shall be taken into consideration before taking final decision to buy a patent:
a. Area of Technology: In order to buy patents, first of all, areas of technology in which patents are to be bought shall be identified. Reading through the entire patent specifications, especially the claims will be immensely useful to find out subject matter claimed in the patent. Further, the patent to be acquired should complement or enhance the current technology offerings.
b. Jurisdiction: The buyer should be clear about the jurisdiction where the patented invention is to be used. For example, if the business of a company is only confined to India and US, then, patents filed/granted in these two jurisdictions shall be searched. However, there is a possibility of existence of good and relevant patents in other jurisdiction where there may be opportunity for companies to use such patents without a need to buy them or in-license them. For example, if an Indian automobile company finds a good, patented invention in Brazil for which Indian patent is either not filed or timeline to file in India has expired, the Indian company may use such patent in the countries other than Brazil. Patent rights are territorial in nature and patent granted in Brazil is valid only in Brazil. Using such patent outside Brazil generally does not deem to be infringement of patent rights. However, thorough due diligence is needed in such cases to ensure that there is no patent infringement risk involved.
c. Searching right patents: There are free and paid patent databases from where list of published patent applications or granted patents may be extracted using various search strategies. You may shortlist the relevant documents, read through the abstract and if need be, full patent document may be downloaded and read to understand which is the right patent to be bought.
d. Legal status of patents: It is very important to check legal status of the identified patents so that you know if they are “in-force”, “abandoned” or “expired” patents. It is good idea to segregate the identified patents into various categories depending upon their legal status. It is important to note here that you must buy only “in-force” patents because expired patents anyways are available for you to be used for free. As far as abandoned patents are concerned, they may have a possibility to be restored. So, if you are interested in abandoned patent, you must watch it carefully and periodically to understand if it comes into force again or gets expired. So, your strategy to buy such abandoned patent will change accordingly.
e. Making offer to the patent holder: After you have identified the patents of interest and confirmed their legal status, the next step could be to extract name and contact details of the patent holders to contact them to show your interest in buying the patents. Discussion may be initiated with patent holders regarding buying of the patents. At the time of buying patents, before making an offer to the patent holder, one of the important action points you should be focussing at, is valuation of the patent to understand how much you are going to pay for buying the patent. There are various well-tested methods to assess value of a patent, however, lots of things depend upon how the parties want to proceed.
f. Check prosecution history of the patent and it’s renewal fee: After patent application is filed, there are various prosecution stages through which a patent application passes to get a patent granted. This prosecution history may give you very vital information on quality of patent, kind of objections the examiner raised before grant of patent. This information may be of great use at the time of negotiation the patent holder. Further, after a patent is granted, there is an annual renewal fee which is to be paid by the patent holder to respective patent office to keep the patent in force. Failure to pay this fee may result in expiry of the patent. Once you buy the patent, you will be responsible for paying this renewal fee. So, depending upon the term of patent left, you must estimate the amount of fee payable by you to keep the patent in force.
g. PatentAssignment: Patent assignment is the term used with respect to transfer of patent rights and ownership from patent holder to buyer of patent. Here the buyer becomes owner of the patent and patent assignment is completed by executing assignment deed between patent holder and the buyer. Copy of such Assignment Deed is submitted to the respective patent office and then Controller of patent makes changes in the official records.
h. Patent Infringement Risk: It is worth noting here that even if you buy a patent and own it legitimately, before implementing or using such patent, it is important to ensure that usage of such patent does not infringe any third party’s patent rights. Hence Freedom to operate search or infringement analysis is important to be performed before acquisition of the patent.
Conclusion
Buying a patent is an effective and powerful way to increase size of IP portfolio and own patents without spending much on R&D. However, like owning tangible property, IP ownership also comes with obligations and responsibilities. With proper due diligence and expert advice, this process can be made really effective and useful for the organization.
Indian patent law allows more than one person to come together and apply jointly for a patent. Upon grant of such patent, these applicants become joint/co-owners of the granted patent. Co-ownership of a patent might be unavoidable in certain scenarios when more than two parties have jointly invested or have common interests with respect to commercialisation of the patented product. Applicants who have joint ownership of a patent should be aware of the risks & legal ramifications involved because joint ownerships involve a great deal of shared investment and experience, both of which may be wasted if the applicants are not aware of risks and legal implications.
Co-ownership of a patent is dealt under sections 50 and 51 of the Indian Patents Act, 1970. Section 50 [Rights of co-owners of patents] lists out the rights of the joint owners as below:
Each co-owner is entitled to an equal and undivided share in the patent, unless there is an agreement to the contrary. Co-owners may be two or more and they shall own equal share in the patent, by default. However, this equal share in the patent may be changed by executing an agreement where there is a clear mention of share each co-owner holds.
Each co-owner is entitled to equal patent rights, as mentioned Section-48 [right of patentee], for his own benefit without accounting to the other person or persons. Each co-owner can independently commercialise the patent without seeking permission of other co-owner (s).
If a patented article is sold by one of the co-owners, the purchaser and any person claiming through him shall be entitled to deal with the article in the same manner as if the article had been sold by a sole patentee.
As stated above, when a patent is jointly owned, all joint owners can commercialise the patent independently without consulting the other co-owners; however, a license for such patent shall not be granted to any third party by any of the co-owners without consent of the other co-owners. Further, a share in the patent shall not be assigned by one of the owners without consent of the other co-owners or joint owners. If proper care is not taken with respect to this clause while entering into a joint ownership of a patent, this may lead to dispute amongst the co-owners. Further, when a patented technology is sold by any one of the co-owners of the patent, the right that the buyer of the property acquires in the technology will be the same rights he would have acquired if the patent were not jointly held.
A patent shall be treated as a movable property (property that can be moved from one place to another) and rules of law applicable to the ownership and devolution of movable property generally shall apply in relation to patents. Movable property includes personal items such as clothing, jewellery, household goods such as furniture, decorative items and appliances and so on. For better understanding, let us take the following example.
Let us consider a situation where a patent has two joint owners: A and B. According to Indian Patents Act, 1970 both of them have an equal and undivided share in the patent and both of them can exercise the rights granted to them under section 48 of the Act on their own without accounting or waiting for the other’s consent. Here, the patent should be handled like a movable property for the purposes of ownership and devolution of patent rights.
Though co-owners can enjoy equal patent rights and privileges, the problem starts when one of them wishes to assign or license the patent. If a patent has to be licensed in India, it has to be written, duly executed and registered. If A wants to license the patent to someone, A must obtain B’s permission. If B is not willing to consent to such licensing, the situation becomes complicated. In such circumstances A is left with only one option. A has to approach the Controller, seeking his power to direct B to agree to the licensing under Section 51 (1) of the Indian Patents Act 1970. This section empowers the Controller to give directions to joint owners regarding the sale or lease of the patent, grant of licenses etc. Powers of the Controller to give directions to co-owner in case of sale or lease or execution of instrument are as follows:
If a patent is co-owned, the Controller may give directions for the sale or lease of the patent or any interest therein or the exercise of any right under Section-50 to any of the co-owners. Such direction is given by the Controller only when application is made to him in the prescribed manner by any of the co-owners.
If any person registered as grantee or proprietor of a patent fails to execute any instrument or to do any other thing required for carrying out of any direction given under this section within 14 days after being requested in writing so to do by any of the other persons so registered, the Controller may, upon application made to him in the prescribed manner by any such other person, give directions empowering any person to execute that instrument or to do that thing in the name and on behalf of the person in default.
Illustration
Maya is registered as grantee of a patent and she fails to execute the instrument (license agreement) with 14 days after being requested by the co-owner of the patent. If the co-owner makes an application to the Controller, any other person can execute the instrument in the name and on behalf of Maya.
Before giving any directions under this section, the Controller shall give an opportunity for the following to be heard:
In the case of an application under sub-section (1) to the other person or persons registered as grantee or proprietor of the patent;
In the case of an application under sub-section (2), to the person in default.
No direction shall be given under this section so as to affect the mutual rights or obligations of trustees or of the legal representatives of a deceased person or of their rights or obligations as such, or which is inconsistent with the terms of any agreement between persons registered as grantee or proprietor of the patent.
Approaching the Controller for directions might turn out to be a time-consuming process. Also, it may lead to uncertainty as it will be the Controller who then will decide about the directions to be given. No directions will be given under this section so as to affect the mutual rights or obligations of trustees or of the legal representatives of a deceased person or of their rights or obligations as such, or which is inconsistent with the terms of any agreement between persons registered as grantee or proprietor of the patent. This situation may get further complicated if the ownership of the patent itself is in question. These possibilities make it imperative for the parties to take utmost care while entering into a joint ownership of a patent.
This whole complexity can be taken care of if both A and B enter into an agreement about how they would exercise the licensing rights each of them have in order to avoid such complexities later. So, a lot of hardships may be prevented if a little precaution is taken at the time of entering a joint ownership of a patent, specifically at the time of entering into an agreement about the licensing of the patent.
Patent Cooperation Treaty or PCT is an important treaty, concluded in 1970. The uniqueness of PCT stems from the fact that it provides a unified procedure for filing patent applications in its contracting states, earning it the title of “International Application”. As on 1st September 2020, 153 countries are contracting states of PCT (details may be viewed here: https://www.wipo.int/export/sites/www/pct/en/list_states.pdf). PCT is administered by the World Intellectual Property Organization (WIPO), primarily created to promote and protect intellectual property (IP) across the world by cooperating with countries as well as international organizations. Headquartered in Geneva, Switzerland, WIPO began operations on 26th April 1970 when the convention came into force. Key responsibilities of WIPO include extending technical & legal assistance in the area of intellectual property, conducting research on various areas of IPR and ensuring the proper facilitation of international IP protection.
Steps to file PCT Application
PCT is one of the most preferred ways to file patent application in multiple counties. Steps to file PCT application are as below:
Applicant is required to file patent application (provisional or complete application) in his home country first to claim date of priority.
Within 12 months from the date of priority, PCT application shall be filed.
PCT application may be filed directly with International Bureau of WIPO (online) or via a Receiving Office (RO), which ultimately transmits PCT application to International Bureau.
As soon as the PCT application is filed, international phase starts. The application is searched by International Search Authority or ISA at a later point in time and international search report and written opinion is generated. This report is very important as it gives detailed patentability analyses of the invention. The inventor can consider this report and can take a decision regarding the number of countries in which the application must be filed.
Before International Phase ends, i.e., within 30 or 31 months from the date of priority, PCT national phase application, in PCT-contracting states shall be filed. The applicant may chose any number of countries out of 153 contracting states of PCT. The deadline to enter national phase is 30 months in majority of the countries but some countries like India follow a deadline of 31 months from the date of priority.
Advantages of PCT application filing
The main advantages of filing PCT application are as below:
PCT is a unified platform that enables applicants to file their patent application in multiple countries claiming priority from the application filed in their home country’s national office. Please note that the applicant can file patent application via PCT route only in the countries that are member states or contracting states of PCT.
The process of filing PCT application is completely hassle-free. The application may be filed online, requiring the filing of only a single application.
Unlike convention application filing where international application has to be filed within 12 months from the date of priority, PCT allows the applicant a time window of 30 or 31 months from the date of priority to file application in individual countries that are PCT contracting states.
International Search Authority (ISA) gives written opinion on patentability of invention which helps applicant to take right decision with respect to national phase filing.
Myths and facts
Even though PCT is a popular and a convenient way to file patent application in multiple countries, there are a lot of myths surrounding PCT filing, as listed below:
Myth 1: PCT grants patent
Fact: PCT is a patent filing platform and does not grant patents. Patents are granted only by national offices when PCT-national phase application is filed and prosecuted as per national laws of the given country (ies). PCT does not have any authority to grant patents.
Myth 2: PCT filing ensures grant of patent globally
Fact: Filing PCT application does not mean that you have an automatic protection in all contracting states of PCT. Instead, you get protection in the contracting states of PCT only if you file national phase application there and your patent is granted by such national offices.
Myth 3: Foreign attorney files PCT application
Fact: The patent agent of your country is authorised to file PCT application, which means you don’t need a foreign attorney to file PCT application. However, a local attorney belonging to the country in which the PCT is being filed will be required for filing PCT National Phase application in that specific country.
Myth 4: PCT filing fee takes care of all expenses
Fact: Applicants often ask whether they are required to file separate fees at the time of filing PCT national phase application as they have already paid PCT filing fees. The fact is that PCT national phase filing fees is independent of PCT filing fees. The fee that the applicant paid to PCT is only for PCT filing and for generating the search report. When a national phase application is to be filed, applicant needs to pay fees for each country for filing and prosecution of the application.
Myth 5: With PCT, National Phase application may be filed in any country
Fact: By filing PCT application, national phase application can only be filed in PCT contracting states. Before considering PCT filing, it is highly recommended to look into list of PCT contracting states on the official website of WIPO to ensure that the countries where you desire to file application is a contracting state of PCT.
Even though PCT is a popular and convenient way to file international application, all pros and cons shall be weighed carefully before opting for PCT route.
A Patent agent as defined under Section 2(n) of the India Patent Act, 1970 is a person who has passed Indian Patent Agent Examination and is registered under section 126 of the Indian Patent Act as a patent agent. Patent agent is involved in drafting filing, and prosecution of the patent application before the controller on behalf of the person who wish to file a patent. Patent agent has to be authorized by the inventor to act on his behalf by executing power of attorney in his name. Patent agent is person who has written and passed patent agent exam and registered himself as a patent agent. Doing this, his name is entered in the Register of Patent Agents by the Controller.
Who can be a patent agent?
The qualifications to become a Patent agent are as follows:
He should be a citizen of India;
He have completed the age of 21;
He should have completed a degree in either Science, Engineering or Technology from any university established under law for the time being in force in the territory of India or should possess such other equivalent qualifications as specified by the Central Government; In this regard, final year students can also apply as long as they can produce their degree certificate with all the marks card within 2 months from the date of announcement of patent agent examination results;
He should have either passed the qualifying examination prescribed for the purpose or should have functioned either as an examiner or discharged the functions of the Controller under section 73 or both, for a total period not less than 10 years provided that, at time of making the application for registration he has ceased to hold any such capacity; &
He should have paid the prescribed fees.
Indian Patent Agent Examination
Only a person meeting the qualification provided under Section 126 of the Act shall apply for the Indian patent agent examination. The applicant should select the center of his convenience to write the exam which is usually conducted in 5 cities that is, Mumbai, Delhi, Nagpur, Chennai and Kolkata. The Indian patent agent examination, generally, is conducted once every year and the examination consist of:
Written Exam: The written exam, conducted by the office of the Controller of patents comprises of:
Paper I (100 marks)
Paper II (100 marks)
The Paper I will have both Objective and Descriptive type questions and is based on the Patent Act and Rules.
Paper II will have questions related to drafting, interpretation of patent specifications and other descriptive questions from Patent Act and PCT.
A candidate is required to score a minimum of 50 marks in each paper to pass the examination. Therefore, to qualify, the person should be thorough with the acts, rules, practice and procedures of patenting.
Viva voce: Candidates who pass in Paper I and II are called for Viva and it is conducted for 50 marks. The questions that are generally asked are based on IPR and more specifically patent law provisions related to the technical field of the candidate. For a person to qualify as a patent agent, he should secure an overall 60% aggregate of the total marks. The amendment in relation to the scores requires to be qualified were made after 2012, Delhi High court decision in the case of, Anvitha Singh v. Union of India wherein the rule prescribing a minimum 50 per cent marks in the viva-voce part of the patent agent examination was struck down thereby giving less weight to it.
The result of the examination is usually announced after two months of conducting the examination. The results are announced on the official website of Office of Controller General of Patents.
Rights of a Patent Agent
Rights of a Patent agents are described under section 127 of The Patents Act 1970. These rights are as follows:
(a) to practice before the Controller; and
(b) to prepare all documents, transact all business and discharge such other functions as may be prescribed in connection with any proceeding before the Controller under this Act.
Indian Patent Agent is authorized to draft, file, prosecute patent and design application in India and PCT.
How to prepare for Indian Patent Agent Exam
In order to prepare for the exam, you need following:
Indian Patent Act 1970. You must be thorough with all sections, rules, fee and forms of Indian Patent Act 1970. The manual of patent office practice and procedure is very useful to understand various provisions of the Act.
A patent agent, being atleast gradate in science is a perfect candidate to work in research and innovation-based industries. Based on his scientific degree, he can work in pharmaceutical, biotechnology, manufacturing, automobile, automotive industry as a patent engineer or patent analyst. A patent agent can work in following areas:
Different types of Patent searches like novelty search, technology landscape, invalidation search, EOU (Evidence of use) search etc.
Patent specification drafting, file, prosecution in India and PCT
Handling patent opposition, revocation etc
Being a registered patent agent is helpful for those who want to have long term career in the area of patents. It opens up many more areas to work in, especially patent specification drafting, filing and prosecution.
Origiin has been successfully conducting training sessions to help aspiring candidates qualify the Indian Patent Agent Examination since the year 2009.
Our in-house IP experts have been instrumental in developing a comprehensive study material for the Online Course to prepare for Indian Patent Agent Examination.
Course advantages:
Learn at your own pace and convenience
Illustrations and examples provided for easy learning
Assessment and practice questions at the end of every module
Link to register for the course: https://www.origiin.com/indian-patent-agent-examination/
Some important links:
Official website of Indian Patent Office
https://ipindia.gov.in
Guidelines to apply for exam (forms, fee and procedure)
Evidence of Use search (EOU) Search is performed to help patent owners identify potentially infringing products in the marketplace. The purpose of EOU search is to identify products or processes in the market which are likely to infringe the patent holder’s patent or even patent application. In order to perform EOU search, thorough understanding of patent infringement and jurisdiction specific laws is important as it is a very sensitive search and any negligence in the process of performing search and analysis of the findings may prove to be dangerous for the organization.
Understanding of rights of patent holder as well as patent infringement is also critical for EOU search. In simple words patent infringement means violation of rights of the patent holder i.e., to prevent third parties from making, using, offering for sale, selling and importing patented product or product made using patented process in a given jurisdiction.
Advantage of EOU search is that the patent holder can get to know about the existing products in the market that may infringe upon his patent (s) and patent holder can take necessary action against the infringer by enforcing his patent rights.
The steps to be followed in order to perform EOU search are as below:
Step 1: Subject matter of patent shall be understood thoroughly, especially the claims. Claims is a part of patent document that seeks legal protection. Further patent claims shall be interpreted in best possible manner with help of case laws pertaining to the particular jurisdiction.
Step 2: Assessment of strength of the patent based upon the corresponding forward and backward citations of the patent document is important because this step determines strategy to be adopted to handle the infringing products found in the EOU search. Further, it is advisable to check legal status, expected expiry date of the patent as well along with chances of it getting invalidated in case any opposition or revocation is filed.
Step 3: A secondary research shall be performed to identity products available in the market that are likely to infringe claims of said patent of the patent holder. A very vital part of the investigation is to assess size and strength of the companies that are manufacturing the infringing products because this helps patent holder to have right strategies in place.
Step 4: Claim maps or claim charts shall be prepared in order to analyse the extent of the overlap of the identified product with said patent claims.
Step 5: Opinion on EOU shall be written based on jurisdiction specific laws. EOU report will typically have list of infringing products found, mapping of product components of features with patent claims, opinion on patent infringement, strength of the patent, strategies to be adopted to enforce patent rights etc.
Evidence of Use search (EOU) Search is an important search for the patent owners to identify potentially infringing products in the market sothat they can take necessary steps to address it.
Origiin, with a skilled team of patent agents is one of the best patent companies in India offers patent services such as patent searching, and patent filingin India and foreign countries. Origiin also provides value added search services such as Evidence of Use. Origiin, with in-house patent attorney can also help you in drafting and sending patent infringement notices based upon the derived EOU opinion.
Deliverables: EOU report, claim charts along with PDF copy of all prior arts listed in the report
A patent is one of the most complex legal documents that is techno-legal in nature. Drafting and prosecution of patent needs technical skills as well as thorough knowledge of patent law. There is a provision in the Patents Act for appointment of a Patent Agent by the inventor/applicant to assist him in filing and other modalities in the Patent Office.
A Patent Agent or a patent attorney is person who has the specialized qualifications necessary for representing clients in obtaining patents and acting in all matters and procedures relating to patent law and practice. A Patent Agent may be appointed by the inventor/ applicant to perform various actions before the patent office on behalf of the applicant and in consultation with him.
The term Patent Agent is used differently in different countries. In some jurisdictions, the terms Patent Agent and patent attorney are interchangeable and used as synonym but in others, the latter is generally used only if the person is qualified as a lawyer and additionally is registered as Patent Agent. This means that a patent attorney can not only practice before Indian Patent Office but also is eligible to practice in the Courts. Some jurisdictions also use the term “patent attorney” to include attorneys, who are not admitted to practice before the Patent Office, but who represent parties in patent litigation and other legal matters. Such attorneys may or may not have technical backgrounds.
Registration as a Patent Agent in the register of Patent Agents
An attorney, who is not a Patent Agent, is not admitted to practice before the Patent Office but he may represent parties in patent litigation before Court of law. On the other hand, a Patent Agent may prosecute patent applications but may not be qualified to represent parties in patent litigation. Indian Patent Act, 1970 (Section-132) does not stop an advocate, not being a Patent Agent, from taking part in any hearing before the Controller on behalf of a party who is taking part in any proceeding under the Act.
In India, a person registered to practice before Indian Patent Office (IPO) is called as “Registered Patent Agent” or a “Patent Agent”. Indian Patent Office conducts a qualifying examination for Patent Agent registration twice a year and the candidates qualifying the examination are registered as Patent Agents and are authorized to practice before IPO.
According to the Indian Patents Act, 1970, a Patent Agent is a person who has passed Indian Patent Exam and is registered as a Patent Agent. He is authorized to represent applicants before the Controller of Patents in the preparation, filing, and prosecution of patent applications. In order to become a registered Patent Agent in India, an individual must pass the Patent Agent Examination conducted by the Indian Patent Office and register himself/herself as a Patent Agent. Patent Agents in India play an important role in helping inventors, companies, and organizations register patents in India.
The Indian Patent Agent Examination is a written examination conducted by the Indian Patent Office to test the knowledge of individuals who wish to become registered Patent Agents in India. The examination is designed to test evaluate the candidate’s knowledge of on Indian Patents Act, 1970 and the rules / regulations related to patent practice and procedure in India. Additionally, patent specification drafting and prosecution skills of the candidates are also evaluated.
Refer the guidelines thoroughly: http://ipindiaonline.gov.in/AgentExam2020/Documents/Guidelines2023.pdf
Click on “Registration for Patent/Trade Marks Agent Examination 2023”. The online
application filing system will be available from 03/01/2023 (12:00 noon) to 31/01/2023
(05:30 PM).
Registration (New Applicant): http://ipindiaonline.gov.in/AgentExam2020/User/frmLogin.aspx
After successful registration, sign in to your account and fill Application Form. Upload scanned copy of coloured photograph, signature in prescribed format, documents of proof of age, citizenship and degree certificate.
Ensure to have correctly entered all the details before clicking on Final submit.
Complete the application by paying the fee online through Make Payment.
Submitted application form and payment details can be viewed any time using Pre-View and Print CBR
The Indian Patent Office does not conduct the exam at fixed regular intervals. The last two exams were conducted in May 2022 and October 2018. However, notification of the exam comes atleast 2 months prior to the date of the examination.
There is minimum qualification, age and nationality prescribed for the candidates, who can write the Indian Patent Agent examination. Eligible candidate shall write and pass the Indian Patent Agent Examination and request the Controller to register him as a registered Patent Agent and finally the Controller adds his name in the Register of Patent Agents.
A person shall be qualified to have his name entered in the register of Patent Agents if he fulfils the following conditions:
He is a citizen of India;
He has completed the age of 21 years;
He has obtained a degree in science, engineering or technology from any university established under law for the time being in force in the territory of India or possesses such other equivalent qualifications as the Central Government may specify in this behalf, and, in addition:
Omitted by Act 15 of 2005.
Has passed the qualifying examination prescribed for the purpose; or
Has for a total period of not less than ten years, functioned either as an examiner or discharged the functions of the Controller under section 73 or both, but ceased to hold any such capacity at the time of making the application for registration.
The exam structure shall consist of the following papers and marks, namely: –
Paper I (Two Hours) – Patent Act and Rules-100 marks, (Nature: Objective type; Multiple Choice Questions)
Paper II (Three Hours) – Drafting and interpretation of Patent specification and other documents (Nature: Descriptive and Viva-Voce) – 100 marks
Viva-Voce: 50 marks
Total: 250 Marks.
Schedule for Viva-Voce examination is announced after the completion of the written exam. Only those candidates who have scored a minimum of 50% marks in each paper will be allowed to appear for Viva-Voce.
Candidates who are eligible for Viva-Voce shall appear at the designated Patent Office (Delhi/Mumbai/Kolkata/Chennai) opted. Candidates who score an aggregate of 60% from Paper-I, Paper-II and Viva-Voce shall be qualified as Patent Agents.
A candidate shall be required to secure a minimum of fifty 50 marks in Paper-I and Paper-II and shall be declared to have passed the examination only if he obtains an aggregate of sixty per cent of the total marks (Aggregate of Paper-I, Paper-II and Viva-Voce)
Examination centre will fall in the city which you selected while filling the form to write exam. Exam will be conducted in some college, about which you will be informed when a hall ticket is issued to you.
After passing the Patent Agent Examination, the successful candidate shall request the Controller to register him as Patent Agent in the Register of Patent Agents.
Every person who desires to be registered as a Patent Agent shall make an application in Form-22 [Application for registration of Patent Agent under rule 109 (i) or 112]. This form is required to be filled and sent only after the Patent Agent examination result has been declared and the person is declared as successful (pass).
The applicant shall furnish the additional information required by the Controller such as attested copy of degree certificate or character certificate. A person desirous to appear in the qualifying examination [Rule 110, Particulars of the qualifying examination for Patent Agents], shall make a request to the Controller along with the fee of 1600 INR after the announcement of Patent Agent examination within the period specified in the announcement.
A Patent Agent in India is authorized to represent individuals and organizations in matters related to obtaining and enforcing patents. Every Patent Agent whose name is entered in the register shall be entitled:
(a) To practice before the Controller during prosecution process such as at the time of opposition to the grant of patent, he can practice before the Controller; and
(b) To prepare all documents, transact all business and discharge such other functions [such as filing of patent, sending request for early publication or examination, reply to examination report, paying renewal fee etc.] as may be prescribed in connection with any proceeding before the Controller under this Act.
Yes, an advocate is eligible to write the Indian Patent Agent Exam if he/she has graduation degree in science. Advocates with BA, LLB or BCom LLB degree are not eligible to write exam. However an advocate, without being a Patent Agent can represent clients in the Court of law in patent litigations.
The Controller shall maintain a register, called “Register of Patent Agents” in which the names, addresses, phone number, fax number, email id and other relevant particulars of all persons qualified to be registered as Patent Agent shall be entered under Section-126 [Qualifications for registration as Patent Agents]. Controller may keep the register of Patent Agents in computer floppies, diskettes or any other electronic form and safeguards appropriately. The names and addresses of persons registered as Patent Agents shall from time to time be published.
The Controller may remove of any person from the register of Patent Agent under certain circumstances.
The Controller may remove the name of any person from the register when he is satisfied, after giving that person a reasonable opportunity of being heard and further inquiry:
That his name has been entered in the register by error on account of misrepresentation or suppression of material fact;
That he has been convicted of any offence and sentenced to a term of imprisonment or has been guilty of misconduct in his professional capacity which in the opinion of the Controller renders him unfit to be kept in the register.
The Controller may on application and on sufficient cause being shown, restore to the register the name of any person removed.
The Controller may, on application and on sufficient cause being shown, restore the name in the register of Patent Agent.
An application for the restoration of the name in the register of Patent Agents shall be made in Form-23[1] [On application for restoration of the name of a person in the register of Patent Agents under rule 117 (1)] within 2 months from the date of such removal.
If the name of a person is restored to the register of Patent Agents, his name shall be continued for a period of one year from the date on which his last annual fee became due.
The restoration of a name to the register of Patent Agents shall be communicated to the Patent Agent and also published on the official website.
In connection with the patent application (s) filed by the Patent Agent, there may be several communications between the Patent Agent and the Controller. However, the Controller may refuse to deal with certain Patent Agents under specific circumstances.
The Controller may refuse to recognize as agent in respect of any business:
Any individual whose name has been removed from the register and not restored.
Any person who has been convicted of an offence under Section-123 [Practice by non-registered Patent Agents].
Any person who is not registered as a Patent Agent but is engaged wholly or mainly in acting as agent in applying for patents in India or elsewhere in the name or for the benefit of the person by whom he is employed.
any company or firm, if any person whom the Controller could refuse to recognize as agent in respect of any business under this Act, is acting as a director or manager of the company or is a partner in the firm.
The Controller shall refuse to recognize as agent in respect of any business, any person who neither resides nor has a place of business in India.
No person shall practice as a Patent Agent or call himself a registered Patent Agent, if he is not registered in the Register of Patent Agent.
No person either alone or in partnership with any other person, shall practice, describe or hold himself out as a Patent Agent, or permit himself to be so described or held out, unless he is registered as a Patent Agent or he and all his partners are registered.
No company or other body corporate shall practice, describe itself or hold itself out as Patent Agents or permit itself to be so described or held out.
Practice as a Patent Agent includes any of the following acts, namely:
Applying for or obtaining patents in India or elsewhere;
Preparing specifications or other documents for the purposes of this Act or of the patent law of any other country;
Giving advice other than of a scientific or technical nature as to the validity of patents or their infringement.
It is not necessary under the patent law to engage a registered Patent Agent for filing an application for patent. The applicant is free to file an application by himself or through the Patent Agent. However, an applicant who is not a resident of India is required to file either through the registered Patent Agent or must give an address for service in India.
No, Patent Office does not make any recommendations regarding selection of a Patent Agent. However, a list of Patent Agents is maintained by the office. This list can also be viewed at Patent Office website. The applicant is free to appoint any Patent Agent from the said list.
No. This is a discussion between the Patent Agent and the applicant. The fee a Patent Agent charges is not determined by the Patent Office. However, the Patent Office has engaged the facilitators to help start-ups submit patent applications and has set a cap on the amount of fee reimbursement that can be paid to the facilitators under the SIPP scheme. You can view the specifics of the programme at https://ipindia.gov.in/.
The term patent agent is used differently in different countries. In some jurisdictions, the terms patent agent and patent attorney are interchangeable and used as synonym but in others, the latter is generally used only if the person is qualified as a lawyer and additionally is registered as patent agent. This means that a patent attorney can not only practice before Indian Patent Office but also is eligible to practice in the Courts. Some jurisdictions also use the term “patent attorney” to include attorneys, who are not admitted to practice before the Patent Office, but who represent parties in patent litigation and other legal matters. Such attorneys may or may not have technical backgrounds.
A Patent Agent can not file trademark application on behalf of his clients. However, an Advocate or a registered trademark agent is authorised to file trademark applications. A Patent Agent is authorised to represent his client to file and prosecute Design applications in India.
Origiin is a Bangalore based legal and IP firm handling work in the area of Patent, Trademark, Copyright, Design, Contracts & Policies, IP Licensing and mergers/acqusition of the companies. Origiin has been training candidates to clear Indian Patent Agent Exam since 2009 and we have brillint content prepared by practicing patent agents and attorneys.
Printed Study material (Edition 8.0)
Module 1: Complete interpretation of Indian patent act, each and every section/rule
Module 2: How to start preparations, PCT, IP conventions, patent drafting, tips to viva question, FAQ
Online course in Udemy
Module 1: Patent Act and Rules, https://www.udemy.com/course/patent-specification-drafting/
As per the Indian Patent Law, one patent application shall relate to a single invention. However, if more than one invention is to be claimed in a single application, it is necessary to establish that the inventions so claimed in a single patent application have unity and they form a single inventive concept. The golden rule is that the claim (s) of a complete specification shall relate to a single invention, i.e. the concept of unity of invention shall be there.
According to Section 10 of the Patents Act 1970, if claims refer to a group of inventions, such inventions shall form a single inventive concept. The claims shall be clear and succinct and shall be fairly based on the subject-matter disclosed in the specification and moreover, a single inventive concept may be recognized between independent claims of different categories.
The invention comprising a polymer, process to prepare polymer and commercial utility of polymer can be claimed in the single patent application because even though the invention has three main components, all of them relate to a single invention and have unity. On the other hand, the invention relating to two independent formulations used to treat cancer and HIV/AIDS shall not be claimed in a single patent application as both formulations are independent of each other and hence lack unity of invention.
The purpose of this requirement of unity of invention is administrative, as well as financial. That is, the requirement serves to prevent the option of filing one patent application for several inventions, while paying only one set of fees, such as, fee for filing application, examination, early publication or annual renewal etc. Moreover, the concept of unity of invention also makes the technical classification easier.
Under Section 16 of the Indian Patents Act, 1970, if a single patent application has been filed with more than one invention and inventions so claimed lacks unity, the applicant shall be required to divide main application into divisional application (s). However, the further application (divisional application) and the complete specification accompanying it shall be deemed to have been filed on the date on which the first mentioned application had been filed, and the further application shall be proceeded with as a substantive application and be examined when the request for examination is filed within the prescribed period.
However, during the process of examination of the patent application, the examiner may also ask the applicant to divide the application into two or more applications and file divisional application. It is interesting to note that both parent application and divisional application will have the same priority date though divisional application is often filed later than parent application. For example:
Date of filing provisional application and priority date: 15th November 2006
Date of filing complete specification: 13th November 2007
Publication and examination of the patent application takes place and the Controller raises the objection that the invention lacks unity of invention and hence the application shall be split into two applications i.e., main parent application and divisional application. Here, the date of filing divisional application will be 10th Jan 2009.
In such a case, both parent application and divisional application will have priority date of 15th November 2006 even though the divisional application was filed 10th Jan 2009, which also mean that both parent application and divisional application expire on the same date irrespective of the date of filing.
A specification in respect of a divisional application under section 16 shall contain specific reference to the number of the original application from which the divisional application is made. The request for examination in case of divisional application shall be filed within 48 months from the date of filing or priority of the parent application or within six months from the date of filing the divisional application, whichever expires later. Request for divisional application shall be filed only after filing request for the parent application to ensure the requirement of section 16(3).
Moreover, the complete specification of a divisional application should not include any matter not in substance disclosed in the complete specification of the first application. The reference of parent application should be made in the body of the specification. A divisional application has to be filed before the grant for a parent application.
Though it sounds economical to club multiple inventions together and file for a single application, it is logical to follow the concept of unity of the invention and ensure that separate applications are filed for each invention.
United States Patent and Trademark Office (USPTO) is considered to be one of the most lucrative destinations for the applicants to file for a patent for various reasons. Business opportunities in US are better than any other jurisdictions; enforcement of patent rights is effective; time taken for patent grant is less; US market is mature for buying or selling of patents; & US patent is valued more by the investors. For all these reasons, when the applicant wants to file patent application both in India and US, the biggest dilemma he has is where to file for a patent first, in India or US? Problem becomes bigger if the applicant does not want to file for a patent in India at all and directly wants to file in the US without pursing Indian filing.
In this article, we will explore the advantages of filing for a patent in India first, and consequences of filing directly in US first if the applicant is a resident of India.
Filing in India first makes sense (U/S 39)
Before taking a decision on where to file first, it is essential to understand what Indian Patent Laws say about foreign filing of a patent. The issue is sensitive as well as critical and lack of expert legal advice on the same may have fatal consequences.
The first option is to file a patent application in India first, wait for 6 weeks and then go for foreign filing or PCT (Patent Cooperation Treaty) application filing, as the case may be. After filing the patent application in India, if the applicant does not get any objections from Indian Patent Office within 6 weeks from the date of filing, this indicates that the Controller does not have any objections with respect to foreign filing and applicant can file application outside India.
The second option is to take Foreign Filing Permission (FFP) on Form-25 [Request for permission for making patent application outside India] from the Controller of patents, if the applicant does not want to file patent application in India and wishes to go for foreign filing directly. Prescribed fee to be paid along with Form 25 is 1600 INR for natural person/start-up/small entity and 8000 INR for others except natural person/start-up/small entity for e-filing and ten per cent additional respectively in case of filing by physical mode. This permission is usually granted by the Controller within 21 days from the date of request. So, if the applicant wants to file patent application in any foreign country without Indian filing, this Foreign Filing Permission (FFP) or Foreign Filing License (FFL) is required.
If the invention is relevant for defence purpose or atomic energy, the Controller shall not grant permission to file patent in foreign country without the prior consent of the Central Government. This section shall not apply in relation to an invention for which an application for protection has first been filed in a country outside India by a person resident outside India.
Who is “Resident of India”?
The term “Resident of India” has not been defined in the Patents Act, 1970 but according to Income Tax Act, an individual can be termed as a ‘Resident of India’ if he stays for the prescribed period during a fiscal year i.e. 1st April to 31st March, either for:
182 days or more; or
Has been in India in aggregate for 365 days or more in the previous four years.
Any person who does not satisfy these norms is termed as a ‘Non-Resident’. A resident individual is considered to be ‘ordinarily resident’ in any fiscal year if he has been residing in India for nine out of the previous ten years and, in addition, has been in India for a total of 730 days or more in the previous seven years. Residents who do not satisfy these conditions are called individuals ‘not ordinarily resident’.
Rational behind filing in India first
Main rational behind having Section 39 is to safeguard national defence and security. If the invention is relevant for defence purpose or atomic energy, the Controller shall not grant permission for foreign filing without the prior consent of the Central Government. Secrecy Directions may be imposed on such application and the Controller may give direction for prohibiting or restricting the publication of such application if it appears to him that the invention in question falls in one of the classes notified to him by Central Government as relevant for defence purposes or the Controller himself considers it to be so. However, this section shall not apply in relation to an invention for which an application for protection has first been filed in a country outside India by a person resident outside India.
Do you lose anything by filing in India first?
It is a myth that by filing a patent application in India first and US later, one loses on the date and filing and patent filing in the US gets delayed. The fact is that even if you file for a patent in India first, you can file the same application in US (as convention application) immediately after expiry of 6 weeks from the date of Indian filing. Kindly note that patent application may be filed anytime before expiry of 12 months from the date of Indian filing to claim priority from the Indian application. At the time of filing in US, you can claim priority date from your Indian filing as both India and US are convention countries as per the Paris Convention. Effectively, this means that even though you file in India first and US later, the same date of priority can be maintained in USPTO as well. In-fact when priority is claimed from Indian filing, the applicant has to submit to USPTO, the priority document obtained from the Indian Patent Office.
Therefore, it actually does not matter where you filed first, but yes, it certainly is a better and a safe choice to either file for a patent in India first or take permission from the Controller for foreign filing.
Consequences of violating section 39
If a person makes or causes to be made an application for the grant of a patent in contravention of section 39, he shall be punishable with imprisonment for a term which may extend to two years, or with fine, or with both. Hence, it is important to either file application in India first or take FFP from the Controller of Patents.
Conclusion
In the instances where the applicant or inventor is a resident of India, it is important to consider filing for a patent in India or taking permission for foreign filing from the Controller, before filing for a patent in foreign country or PCT for the reason that violation of this provision can lead to fatal consequences.
Cross border trade refers to trading of goods and services between two commercial entities or consumers and commercial entities across state borders. This gives consumers a huge range of commodities to choose from and provides commercial entities with a plethora of opportunities and new markets to exploit. Cross border trading and outsourcing to meet necessary requirements has been an important part of civilizations since the inception of the barter system. The motivations of cross border trade and expansion of markets lies at the very foundation of international relations. While cross border trade is not new by any means, the role that it plays today in markets across the globe is unprecedented. This is a boon of modern technology and the internet marketplace.
It is estimated that by 2022, cross border shopping will take up about one-fifth of the e-commerce space along with sales recording a whopping 627 billion dollars. The Indian market, ranked ninth in cross-border growth, is showing growth projections of upto 4% of the total retail trade by 2025.
While the scope for profit and promotion has increased manifold with the popularization of cross border trading, additionally has spiked the risk of infringement of Intellectual Property Rights (IPR), duplication and counterfeit of the products.
The protection of intellectual property on a global scale can be a complex issue, a tight rope to walk while balancing national autonomy at the same time as to drive further into global existing markets. The risk of IPR infringement exists at multiple areas in the transit of goods. The many working aspects of the supply chains further complicate the issue.
Protection for IPR exists at various levels, internationally which simply implies that the said protection of property extends across numerous regions and nationally. The World Intellectual Property Organization (WIPO) founded in 1967 is the foremost intergovernmental organization working towards ensuring protection of intellectual property rights across borders. International conventions such as the Paris Convention and the Hague Agreement for Industrial property and designs, and the Madrid Agreement regarding deceptive indication and false goods date back to the 19th century, India is party to most of these agreements except The Hague Agreement. However, the protection these treaties offer extends only to the territories of member countries; this magnifies the risks that exist in the countries that are not signatories to the treaty. Though this protection includes goods being exported, imported and also those in transit i.e only passing through these member states, it is not adequate.
While international conventions grant rights, aid in easing the application procedure across member states and in some cases even outline procedural aspects they do not provide for mechanisms to enforce these rights. Territorial or national enforcements of these rights leave space for multiple interpretations, some of which can be unjust and ill motivated. This also happens due to IP rights registered and enforced in bad faith, as is the case with Chinese patents, copyrights and designs.
In recent times ecommerce giants such as Amazon and popular clothing sites like Shein have faced slander for copying designs from small time designers, a piece of clothing designed in interior North America might very well gain immense popularity in cities far away without the designers ever getting any deserved (or even legal) recognition. This speaks to the potential and scope of IPR infringements and the impact it carries.
As of today six BIPOC have been awarded copyrights, for choreographies they created that went viral during the first set of lockdowns imposed world-wide and are highly used and recognised amongst young adults. These copyrights now ensure credit is given to them in case these are used in games or movies. Though considering the multiple languages and regions that produce cinema and e-games the scope of infringement is wide and questions of justness and ease of the process of redressal in such cases arise. This copyright in a global sense would be granted under the WIPO Performances and Phonograms Treaty of 1996, the issue of justice in case of violation remains open ended so far.
The latin maxim Ubi jus ibi remedium est used in various areas of law, including contract law, supports the idea that the existence of right also implies the need for a remedy, rights that are not justiciable are no rights at all. Like most practices of international law, the conventions and agreements under the WIPO and IPR protection purview is not by nature applied in its whole essence, the application and adoption lie with the member states as sovereignty of nations is priority.
But sovereignty cannot take precedence in the face of blatant violation of rights of individuals. It is also important to note that WIPO does have an Arbitration and Mediation Center, traditional methods of recourse and redress are still lacking.
Simply put, there is a need for an intergovernmental organisation, a neutral adjudicator. This could be in the form of an appellate dispute resolution body on an international level, exercising the powers of review and recall, or in terms of separate councils for different continents consisting of members elected by various states exercising the powers of regulation.
While many approaches can be thought of, to solve this problem, the root of all such approaches must be with the intention of maximum utility and enforcement of all intellectual property rights across the world.
Intellectual property rights (IPR) are elemental in modern-day business strategy. Technology transfer transactions provide income to several companies operating in countries all across the globe. These countries immensely benefit from the taxation of IP related transactions leading to the growth of their economies. Thus, to promote more of such ventures, willing countries pledge to follow international treaties such as the Trade-Related Aspects of Intellectual Property Rights (TRIPS), which contain several provisions to govern trade-related matters between countries in respect of IPR. Certain tax exemptions and deductions are also provided to native companies in other member states to provide an incentive to enhance their business income. In the Indian context, it has been observed that an efficient IP taxation regime and royalty policy would persuade creators to produce more original and artistic work and expand the number of technology or know-how transfers into the country.
The following article provides a basic understanding of how income derived from IPR transactions are taxed under the Income Tax regime in India.
Taxation Policy in India w.r.t. Intellectual Property Rights
The taxation structure in India provides that income from intellectual property rights (IPR) are segregated according to the nature of the transaction. If an individual authors a book, creates music or is the sole inventor of a medicinal cure, then in those situations, the Income Tax Act of 1956 (the ‘Act’) provides for certain tax deductions which will promote tax planning. Once the nature of the transaction is determined, it is easy to identify whether the amount paid is taxable or would be allowed as a deduction. The categories under which IP can be taxed are –
Deductions – In the pre-existing stage of an IP, the cost which is incurred on analysis, manufacturing, i.e., capital spent on research and development is treated as an expense and is to be deducted from the gross income received for the calculation of income tax.
Income – Income from an IPR either by assignment or licensing is treated as Capital gains or income received from royalties under the Income Tax Act, 1961.
Goods and Sales Tax – Tax on the sale of IP, transfer of IP, licensing of IP and assignment of IP are covered under the GST Act.
What is intellectual property according to tax law?
As per the definition of ‘capital asset’ in Section 2(14)[1], a capital asset has an all-embracing connotation except if it expressly excludes a certain item. It includes ‘property of any kind,’ which undoubtedly incorporates intellectual property. The Act does not define intellectual property as such but the difference between tangible and intangible assets is examined in Section 2(11)[2]. Intangible assets, as per the definition, include ‘know-how, patents, copyrights, trademarks, licenses, franchises or any other business or commercial rights of a similar nature.
Royalty
Section 9(1)(vi)[3] of the Income Tax Act elaborates the definition of royalty. Royalties are taxable as income or as a business expense. It is to be noted that regardless of the conditions mentioned in Section 9(1)(vi)[4], if the IP is located in India, then the consideration for its use or disposal will arise in India and will be taxed according to Section 5(2)[5] of the Income Tax Act. Income by way of royalty is taxable under the Income Tax Act for a resident except in respect of:
any right, property or information used or services utilized outside India or
To make or earn any income from any source outside India.
Royalty income is taxable for a non-resident in respect of –
any right, property or information used or services utilized in India or
To make or earn any income from any source in India.
If such income is payable due to an agreement made before the 1st day of April 1976, and the agreement is approved by the Central Government, such income cannot be taxed.
In CIT Vs. Koyo Seiko Co. Ltd[1999 233 ITR 421 AP] it was held that royalty excludes any consideration which would be chargeable under the head of ‘Capital Gains’ and is assessable to capital gains tax at the rates applicable. Thus, royalty is any consideration, including lump-sum amounts but excluding those which would be the income of the recipient chargeable under the head capital gains, for:
The transfer of all or any rights (including the granting of a licence) in respect of an invention, patent, secret formula or process, model, design, trademark or similar property;
The imparting of any information concerning the working of or the use of an invention, patent, secret formula or process, model, design, trademark or similar property;
The use of any invention, patent, secret formula or process, model, design, trademark or similar property;
The imparting of any information or the use or right to use concerning technical industrial, commercial or scientific knowledge, experience or skill; (but not including the amount referred to in Section 44BB[6].)
The transfer of all or any rights (including the granting of licence) in respect of any copyright, scientific, artistic or literary work including films or videotapes for use in connection with television or tapes for use in connection with radio broadcasting, but consideration for the sale, distribution or exhibition of cinematographer films.
The render in of any other service about the activities mentioned above.
Expenditure and Deductions
While determining tax liability, the aim and object of the expenditure should be kept in mind to decided whether it is a capital expenditure or revenue expenditure. A revenue expense is deductable from the chargeable income of a business, while the expenditure incurred on capital is not. The Supreme Court in the case of Assam Bengal Cement Companies Ltd. v. CIT [1955 SCR (1) 876], observed that if the expenditure is made for acquiring or bringing into existence an asset or advantage for the benefit of the business it is attributable to capital expenditure. On the other hand, if it is made for running the business or using it to produce profits, it is a revenue expenditure.
Section 32 (1)(ii) – Depreciation of an intellectual property asset as an expenditure [7].
Depreciation of an asset is considered to be a business expense and the section accounts for such depreciation of IP to be an expenditure for computation of Income Tax.
Section 35A – Expenditure on the acquisition of patents and copyrights [8]
When the consideration is paid in a lump sum, the depreciation over the acquired patent and copyrights shall be claimed over a period;
When the consideration is paid periodically, the depreciation can be claimed as an expenditure fully incurred for business.
Any expense undergone after 28th February 1966 but before 1st April 1998 on the acquisition of patent rights or copyright for a business committed actions will be allowed for each of the previous years on an amount equal to the appropriate fraction of the amount spread over fourteen years.
Section 35AB – An assessee who has paid any lump sum consideration to acquire any know-how for the use of his business, the expenditure for the same shall be deductable in six equal instalments for six years in the following manner [9]–
1/6th of the amount paid shall be deducted while calculating the profits and gains of the business for the previous year;
the balance amount shall be deducted in equal portions for each immediately succeeding the previous five years.
Section 80 GGA – deduction in respect of certain donations for scientific research or rural development [10].
The research work for the development of intellectual property such as a patent comes under the category of scientific research. Under present laws, expensed deductions and additional weighted deductions are permitted to everyone for research and developmental expenditure. For the tax years 2017-2018 to 2019-2020, the weighted deduction is limited to 150% after which it will be reduced to 100% of the expenditure.
Section 80 O – no deduction in respect of royalties from certain foreign enterprises [11]
40% for the assessment year beginning on the 1st April 2001,
30% for the assessment year beginning on the 1st April 2002,
20% for the assessment year beginning on the 1st April 2003,
10% for the assessment year beginning on the 1st April 2004,
No deduction from 1st April 2005 onwards.
Section 80 QQA – Specific provision for copyright products [12]
A deduction of 25% shall be allowed from any income obtained by an author in the exercise of his profession on account of any lump sum consideration for the assignment or grant of right in the copyright of any of his works, except for the following –
Dictionary
Thesaurus
Encyclopedia,
Any book that has been added as a textbook in the curriculum by any university for the degree of graduate or postgraduate course of the university, or
Book which is written in any language specified in the 8th schedule of the constitution or any other language as the Central Government by notification in the official gazette specifies for the promotional need of the language.
Section 80QQB – deductions made in respect of royalty income of authors of certain books other than text-books [13]
Section 88 RRB – Specific provision for patented goods and services [14]
In some cases, the total income earned on a patent can be divided into royalty and additional income other than royalty. The income received as royalty is only eligible for tax deductions. When income is received as a royalty, the whole income or Rs. 3 lakhs (the lesser amount) shall be deducted. If a compulsory license is being granted for a patent, the terms and conditions of the license agreement shall decide the status of the income to allow deduction under this section which shall not exceed the amount of royalty.
Basic qualification criteria for an inventor under this section-
The individual must be an Indian resident.
Original patent holders are only eligible to tax benefits.
The patent under this section should be registered under the Patent Act of 1970, either on or after April 1, 2003.
Section 115BBF – concessional tax rate on the exploitation of patents [15]
10% concessional rate of taxation is applicable on royalty income from the exploitation of patents granted under the Patents Act, 1970. The following criteria must be satisfied –
The patentee should be an eligible Indian taxpayer,
The total income of the patentee must include income by way of royalty in respect of the patent developed and registered in India,
At least 75% of the expenditure is incurred in India for the invention, and
No other expenditure is allowed under the tax provisions if the concessional tax rate under this section is availed.
The benefit of Section 115BBF can be used in any year but the patentee is required to continue to avail of the benefit for the next 5 years. If the option is not exercised in any of the next 5 years, the benefit under the section for the next 5 years following such year in which option is not exercised, shall cease the exist.
Startups and SME’s
A Startup is an industry that has been in existence for not more than seven years and has a turnover not exceeding twenty-five crores whereas an SME is an enterprise with an investment of up to one crore in Plant and Machinery. A startup primarily focuses on the innovation and development of products and processes. Startup-India is an initiative of the government which intends to catalyze the startup culture in India to build a strong and inclusive ecosystem for innovation and entrepreneurship in the country and to provide IPR facilitation, better tax benefits and easier compliance procedures. The special tax exemptions to promote such startups are –
Section 80 IAC: Income tax exemption for recognized startups [16]
After getting recognition as a startup, this section provides that for any three consecutive years out of a block of 7 years (10 years for startups from the Bio-Technology Sector) from the date of its incorporation, tax exemptions can be availed. The eligibility criteria for the same is –
The entity should be a recognized startup,
Only private limited companies or limited liability partnerships are eligible,
The startup should have been incorporated after the 1st of April 2016.
After getting recognition, a startup may apply for Angel Tax Exemption. Eligibility Criteria for this section is –
The entity should be a DPIIT recognized startup
The aggregate amount of paid-up share capital and share premium of the startup after the proposed issue of shares, if any, does not exceed INR 25 Crore.
Other Benefits for Startups regarding IPR:
Patent applications and facilitation helpline will be speedily available.
The entire fees of the facilitators for any number of patents, trademarks or designs that a startup may file shall be taken up by the Central government and the cost of the statutory fees shall be paid by the startup.
Startups shall be provided with an 80% rebate in the filing of patents.
Government Scheme for MSMEs– Support for International Patent Protection in E&IT (SIP-EIT) Scheme
This scheme of the Government of India provides financial support to MSMEs and technology startups for international patent filing. The reimbursement limit provided in it has been set to a maximum of INR 15 lakhs per invention or 50% of the total charges incurred in filing and processing a patent application, (the lesser of the two). This scheme can be availed at any stage of international patent filing by the applicant. The reimbursement, however, will only apply to expenditures incurred from the date of acceptance of a complete application by DeiTY which has to be approved by a competent authority.
Conclusion
Today, several entities derive most of their income from their IP assets and thus enforce the importance of IP and the need for a more enabling taxing regimen. In India, the current economy is witnessing rapid growth in micro and small sector enterprises with great abilities to compete at a global level. Most of these enterprises do not protect their intellectual property due to several reasons such as lack of awareness, lack of funds, exhaustive procedures etc. and are not well equipped to take their businesses to the next level. Awareness of tax planning and a supplementing taxing regimen is the way forward to make a win-win situation for both the Government and the competing parties.
For various reasons, every inventor wants to file for a patent internationally after filing it in his/her home country. Sometimes it’s about the status that is associated with having a patent filed in the US or Europe, but having an international patent may also enhance the valuation of the technology which ultimately may impress investors and fetch better value to the inventor. Oftentimes, inventors drop the idea of filing for patent internationally because it is expensive, complicated, and long procedure. Laws across the countries are also not unified in terms of procedures, fee and timelines leading to more and more confusions at every stage,
It is firstly of crucial importance to understand the term “International Patent”. In reality, there is nothing called international patent or global patent. Despite there being ways to file for a patent internationally, there is no single authority to grant international patents with validity across the globe. Patents are required to be filed in and granted by each country where the inventor wishes to seek protection.
Few things are required to be focused on, when filing a patent outside India. For a resident of India, Section 39 [Residents not to apply for patents outside India without prior permission] of Indian Patents Act 1970 states that the patent must be filed in India first and can be filed in any foreign country within a period of 12 months. Once this 12-month period expires, the inventor loses the chance of filing outside India.
Two ways to file patent application internationally
There are 2 ways to file a patent in foreign countries. These are:
A. Patent Cooperation Treaty (PCT) Route
An inventor may file a single patent cooperation treaty (PCT) application or international application within 12 months from the date of filing a patent application in India. PCT is an international patent law treaty that provides a unified system for filing patent applications in each of its contracting states. It is a convenient platform to assist inventors that are seeking patent protection internationally (in the contracting states of PCT) for their inventions. It also helps patent offices with their patent granting decisions by providing comprehensive search reports for the patent application along with opinion on patentability. PCT publishes the patent application filed with it and maintains an online database called Patentscope which facilitates patent searches as well as gives public access to a wealth of technical information in the form of patents.
PCT examines the application, issues examination report and enables inventors to file their application within 30/31 months from the date of priority in any of the member states of PCT. After this, the patent is processed and granted by the national offices of the countries where patent protection is sought, based on the procedures and requirements of the respective offices. PCT enables patent filing in its member states & gives extra time to the inventor to decide about the countries they want to file their application in.
B. Convention Route
The countries which are members of the Paris Convention are called convention countries and an application filed in a convention country is called a convention application. Unlike PCT, convention application is required to be filed in the convention country within 12 months from the priority date.
Reasons to file international application
Filing international application without clarity on the reason to file is not a good idea. It does not help inventors in long run and may actually lead to a very stressful situation if the prosecution is left midway, further making the overall process financially cumbersome. Following parameters should be considered when deciding about the countries to file patent application in:
Your future business plans
Patents must be filed in the countries where the inventor wishes to expand the business in the future. It must be remembered that there is a specific time period within which inventors must file the patent application in specific countries. Once this period has lapsed, it is not possible to file an application at a later stage. Therefore, if it is desired by the inventor to expand the business in countries like the US or Japan 5 years later, it would make sense to file patents in these countries within the required time frame.
Potential of technology in given jurisdiction
Sometimes, it makes sense for an inventor to file for patent in some countries even if the inventor does not have business there. Countries like the US have a mature system of buying, selling and enforcing patents. If technology has good potential in a specific country, a patent should be filed in that country. Further, licensing and selling options may also be explored to facilitate easier transition of the patented technology to the market.
Your budget
Filing and prosecution of a patent is a long process and strictly regulated by several timelines. A patent may be lost if the inventor does not respond to the office in time or fails to pay the necessary fees. Further, there are standard expenses for each country and renewal fees to be paid post grant of the patent. This leaves a very small window for postponing expenses and timelines, making the overall process of getting a foreign patent extremely time consuming, complex and expensive. The tentative costs of filing, prosecution and maintenance must be assessed in advance and only then should a decision about foreign filing be taken.
Keeping in mind budget, type of invention and area of business, the decision to file patent internationally shall be taken.
Video Link: https://www.youtube.com/watch?v=vdBEv1F_vk4
The term “Convention application” refers to any patent application which is filed in the convention countries.
According to Section 133 [Convention countries] of Indian Patents Act 1970, convention country is any country, which is a signatory or party or a group of countries, union of countries or intergovernmental organizations which are signatories or parties to an international, regional or bi-lateral treaty, convention or arrangement to which India is also a signatory or party and which affords to the applicants for patents in India or to citizens of India similar privileges as are granted to their own citizens or citizens to their member countries in respect of the grant of patents and protection of patent rights shall be a convention country or convention countries for the purposes of this Act. Convention country accords the same rights in respect of the grant of patents and protection of patent rights to citizens of India, as it accords to its own nationals.
For example:
India and US, both are members of Paris convention and hence both are convention countries.
Applicant from US can file patent application in India within 12 months from the date, he filed application in US and vice versa
The members of convention countries shall grant similar privileges to citizen of India as granted to its own citizens in respect of the grant of patents and the protection of patent rights.
Section 135 of Indian Patents Act defines the term Convention Application. According to Section 135, the applicant usually files patent application for the first time in his/her national office and claims priority. This application is called as “Basic Application”. Within 12 months of filing basic application, he/she can file application in one or more convention countries. Where applications for protection have been made in one or more convention countries in respect of two or more inventions which are cognate [similar] or of which one is a modification of another, a single convention application may [subject to the provisions contained in section 10, Contents of specifications] be made in respect of those inventions at any time within 12 months from the date of the earliest of the said applications for protection.
For example:
Robert files a patent application: 15th July 2005
Basic Application and 15th July 2005 is Priority Date
Robert has 12 months’ time from 15th July 2005 to file application in any of the convention countries.
Applications filed in other convention countries are called Convention Applications
Priority date of all application in such a case shall be 15th July 2005.
The term Anti dating refers to assign a date to an event that is earlier than its previously assigned date. This term is mostly used in Indian Patent law with respect to the divisional application.
Generally, a divisional application is filed when a patent application contains more than one invention. Section 16 of the Indian Patents Act defines the provisions related to divisional application.
According to Section 16 [Power of the Controller to make orders respecting division of application], when an application made by applicant claims more than one invention, the applicant on his own or to meet the official objection during examination of patent application by the examiner, may divide the application and file two or more applications, as applicable for each of the inventions. This type of application, divided out of the parent one, is called a Divisional Application. The priority date for all the divisional applications will be same as that claimed by the Parent Application and this concept of claiming priority from the earlier filed application is called as Ante-dating.
For Example:
Date of filing provisional application and priority date: 15th November 2006
Date of filing complete specification: 13th November 2007
Upon examination of the application, the Controller raises the objection that the invention lacks unity of invention and hence, the application should be split into 2 applications i.e., main or parent application and divisional application.
Applicant again files the divisional application on 10th Jan 2009
In such a case, both parent application and divisional application will have priority date of 15th November 2006 even though the divisional application was filed 10th Jan 2009.
So, this assignment of earlier date to the divisional application is called as Ante-dating.
Section 16[Power of Controller to make orders respecting division of application], also says that an applicant, at any time [before the grant of the patent], if he so desires, or with a view to remedy the objection raised by the Controller on the ground that the claims of the complete specification relate to more than one invention, file a further application in respect of an invention disclosed in the provisional or complete specification already filed in respect of the first mentioned application.
One patent application shall have one invention but if the applicant has filed more than one invention in one patent, the Controller may ask the application to divide the application and file separate application for each invention. Such application, which has been divided from the main application, is called as divisional application [Section-16]. In such a case priority date of the divisional application is same as priority date of the main application.
Competition takes numerous forms in commerce, but in the pharmaceutical industry there is one market segment of specific characteristics and interests. This market incorporates community pharmacies providing legend medications based on physician prescriptions, and brand name distinction is the basis for competitiveness. The leading pharmaceutical houses license patents to one another and not to the remaining enterprises in the industry. Each licensee markets the replicated product under a distinct trademarked name, as is a customary practice.
An over- simplification of licensing is monetizing an intellectual property of the invention by allowing third parties the right to exploit the patented invention in exchange of royalty. Along with the patent rights, often, there is also transfer of know-how, experience, methodology, processes etc. Subject to the provisions of the licensing agreement, when an invention is given for licensing to a licensee, the organization is empowered with the ability to manufacture, distribute and sell in specific jurisdiction and for a specific period of time. The inventor is given royalties by the licensee as a consideration for the said patent license agreement.
Patents are designed to encourage private sector companies to spend in research and development (R&D). There are disparities in how different industries rely on the patent system. Because of two factors, the pharmaceutical sector is particularly reliant on the patent system. One, the technology is uncomplicated to reverse engineer, and two, the industry has no entrance hurdles. This is why the pharmaceutical industry has been at the center of the argument about patents.
In India, there was a remarkably extensive debate on the relationship between patents, and development, which emerged shortly after independence. Attempts to develop a distinct patent system began in 1948 and indicated in the Patents Act of 1970. There was a debate about whether India should join the Paris Convention until around 1986. Another round of discussion was sparked by the inclusion of so-called Trade Related Aspects of Intellectual Property Rights (TRIPS) as a negotiating subject during the Uruguay Round of multilateral transborder trade related negotiations of the General Agreement on Tariffs and Trade (GATT). The implementation of the TRIPS agreement in India has been a source of contention since 1994.
Patent Law in India
Patent rights were initially introduced in India in 1856, and the Patent Act 1970 (“the Patents Act”) was passed in 1970, abolishing all earlier laws. India is also a signatory to the Paris Convention for the Protection of Industrial Property, which was established in 1883, as well as the Patent Cooperation Treaty, which was established in 1970. Any invention that meets the criteria of novelty, non-obviousness, and industrial utility can be the subject of a patent, according to the Patents Act. Some of the non-patentable inventions under the Patents Act encompass techniques of agriculture or horticulture, mechanisms for the medicinal, surgical, curative, prophylactic or other treatment of human beings, animals or plants or substances acquired by a simple admixture, culminating only within the agglomeration of the properties of the components, etc. With respect to pharmaceuticals, in the particular instance of substances deliberately designed for use or capable of being utilized as food, drugs or medicines or substances developed by chemical processes, patents are only issued for the manufacturing techniques of such compounds, not for the substances themselves. As a result, pharmaceutical products are now unprotected under Indian law.
The Patents and Designs Act 1911 established a product patent regime for all inventions in India. In 1970, however, the government passed the new Patents Act, which made pharmaceuticals and agrochemical products ineligible for patent protection.
“Thereby, under our established patent laws, molecules, which are products of chemical processes, are as such non-patentable in India,” the exclusion was initiated to break India’s ’s dependency on imports for drugs in bulk, formulations and to provide for the development of a self-reliant indigenous pharmaceutical industry. This restriction, combined with the prohibition on admixtures that result in the aggregation of qualities in which the components have no synergistic effect, significantly limits what can be patented in India. Although chemically manufactured “activities” have functional properties, they are not patentable in India. In India, typical pharmaceutical compositions in which the ingredients operate as admixtures are equally ineligible for patents. Only the process, i.e. the method of generating the product, is patentable in such instances.”[1]
The paucity of protection for product patents in pharmaceuticals and agrochemicals has had a considerable impact on the Indian pharmaceutical industry, leading to the development of remarkable expertise in reverse engineering of drugs that are patentable as products throughout the industrialized world but are unprotected in India.[2]
As a result, the Indian pharmaceutical sector flourished quickly by manufacturing less expensive versions of a number of patented pharmaceuticals for the home market, and then aggressively expanding into the global market with generic drugs once the international patents expired. Furthermore, the Patents Act establishes a number of measures to avoid patent infringement and improve medicine accessibility.
The legal recourses of bringing the patented product in the markets: Once patent is granted, in order to generate revenue, the commercialization of the patent becomes essential. For a patent holder there are three recourses established in order to make money from his property (i.e. patent). The first option involves patent licensing wherein the patent holder transfers patent rights to the third party for a specific period of time without transferring the ownership of the patent in exchange of royalty. Second course of action is the patent assignment wherein patent holder permanently transfers the ownership of his/her patent to the third party and such third party then becomes owner of the patent. The third is to bring patented product in the market via a Joint Venture (JV) wherein both patent holder and third party join hands to build and establish new venture in collaboration. All these modes may be explored by both patent holder and third parties to find out the most effective way of collaborating.
Compulsory licensing is a license granted by the Government under certain specific circumstances. On the expiration of three years from the date of securing the patent, any individual engaged in working the patented innovation may apply for a compulsory license with respect to the invention. The mandate of the controller of patents being satisfied that the reasonable requirements of the public with regard to the patented invention have not been met or that the patented invention is not accessible to the public at a reasonable price may direct the patent-holder to grant such a license on the conformity with the terms and conditions.
In addition to compulsory licensing, the Patents Act includes a provision for “right licenses,” under which the central government can apply for an order that the patent be endorsed with the words “right licenses” after three years from the date of the patent’s sealing, on the grounds that the reasonable requirements of the public with respect to the patent have not been met.
Patents for certain compounds that are not food items or drugs as such but that are capable of being used as food items or medications are presumed to be endorsed with the words “license of right” instantaneously on fulfillment of three years from the date of the sealing of the patent. Endorsing a patent with the terms “licensing of right” has the effect of allowing anyone interested in working on the patented innovation in India to obtain a license from the patentee. Even if he or she currently has a license under the patent, the grant of a license would be on mutually agreed-upon terms. If the parties are unable to reach an agreement on the terms of the license, they can apply to the patent controller for a settlement.
As mentioned earlier, a simplification is that by granting a license, a patentee allows others to create, use, or exercise an invention that would otherwise be prohibited. The licensing of a patent transfers a set of rights that are time, geographical, and scope of use limited. A patent license might be voluntary or compulsory.
Voluntary licensing: A voluntary license is the one where patentee, at his or her discretion, grants another person permission to create, use, or exercise the patented invention through a written agreement. In such a license, neither the Indian patent office nor the central government plays any part.
–Exclusive License Agreement: A license that is confined to a specific field or subject, such as a market, territory, time period, or context, is covered by an exclusive license agreement. A technology application, a manufacturing method of the products, a geographical area, or the production of a certain product could all be covered by the agreement.
Exclusive does not imply that the license is “one and only license” but rather that the licensor agrees not to grant any additional licenses with the same rights that fall within the field or scope of the agreement. The licensor has the authority to issue an unlimited number of licenses with different rights within the same field or licenses with the same rights in a different field.
Anyone who infringes on any licensed rights within the field or extent of the agreement is subject to legal action by the holder of an exclusive license. In this case, the licensee becomes almost owner of the patent
Non-Exclusive License Agreement: On the contrary, the non-exclusive license is the one wherein patent holder may grant such license to more than one party.
ii. Involuntary licensing: An involuntary license is granted by patent holder to the company under specific circumstances where the company infringes patent rights of the patent holder and wants to continue using the patented invention. This is the kind of license which is granted only when there is likelihood of patent holder filing law suit against company for patent infringement, and to avoid it, company undertakes the license or permission to use the patent from the patent holder.
iii. Compulsory license u/s 84: A compulsory license is a statutory license that the Controller of Patents can award to a third party under specified conditions. A compulsory license under the Patent system is an involuntary contract imposed and enforced by the government between a willing buyer and an unwilling seller. Compulsory licenses allow someone else to manufacture a patented product or process without the patent owner’s permission. Under section 84 of the Patents Act, 1970, a compulsory license may be granted on the following grounds:
(i) The public’s reasonable requirements for the patented innovation have not been met, or
(ii) The patented invention is not available to the public at a reasonable price, or
(iii) The patented invention is not used in the Indian territory. Compulsory licenses, on the other hand, can only be awarded after a three-year period has passed since the patent was granted.
A compulsory license to manufacture and sell a product is granted under Section 92 to any company that applies for one, and a license U/S 92 is granted in the event of extreme urgency or a national emergency.
In certain exceptional circumstances, compulsory license U/S 92A is granted for the export of patented pharmaceutical products.
The World Trade Organization’s Impact on Pharmaceutical Patents
As briefly mentioned earlier the World Trade Organization (WTO) was established in 1995, and it has since ushered in a massive paradigm shift in global trade. The agreement on Trade-Related (Aspects of) Intellectual Property Rights (TRIPS) was negotiated during the Uruguay round trade negotiations of the General Agreement on Tariffs and Trade (GATT), and “the pharmaceutical industry was one of the primary reasons for incorporating intellectual property issues into the GATT framework.” India signed the GATT on April 15, 1994, making it mandatory to comply with the agreement.
Consequently, India must comply with the TRIPS Agreement’s patent and pharmaceutical industry minimum standards. The availability of patents for both pharmaceutical substances and process inventions must now be included in India’s patent legislation. Any invention of a pharmaceutical product or technique that meets established requirements will be given a patent for a minimum term of 20 years.
Patent licensing’s significance in the pharmaceutical industry
Licensing is often regarded as one of the most essential means of transferring technology to developing nations. It usually includes the acquisition of production rights for innovative goods or services, as well as distribution rights, as well as the sale of basic technical information and know-how contained in the corresponding good, i.e. service. Licensing entails the transfer of intellectual property associated with an innovative product, such as a service, that is the subject of the license agreement[3].
The relationship between licensing, technology diffusion, and intellectual property protection is more complex and multidimensional than in other technology transfer channels. According to Maskus[4], one of the most important reasons is the diversity of license agreements. License agreements can be established between companies in the same joint venture or between companies that are completely unrelated. These contracts typically cover a wide range of topics, including technical assistance, the transfer of codified knowledge, the transfer of knowledge and skills, and the transfer of intellectual property rights.
Today, every country seeking a highly wealthy economy implements its growth strategy through a channel of increasing degrees of implementation mechanisms for the exercise of rights to industrial property protection. The pharmaceutical industry’s need for patents to safeguard inventions plays a prominent role in society’s progression and is one of the determinants of economic growth. Building a reliable and efficient system in the research process is associated with the costs that occur during the creation of new chemical supsatncii suspatnici as active in order to treat is associated with the costs that occur during the creation of new chemical supsatncii suspatnici as active in order to treat. Due to various unpredictable occurrences (such as a worldwide pandemic), the length and duration of the research stages are challenging to anticipate. Therefore, it’s not uncommon for it to take several years from baseline to first patent registration. To ensure stringent patent rights and to safeguard other parties, the first patent application should be filed as soon as possible, usually following the first detection of a successful operation. Patents are intended to create exceptions, but firms are not accustomed to doing so. The patent owner has the right to sell his or her patent. Some experts suggest that the existence of positive powers is justified by the right of disposal, particularly the right to derogate from the patent’s use by granting a license.
The monetary value of a patent or its licensing might vary substantially, making it difficult to determine.
Case Studies involving Patent Licensing of drugs
1. Celgene Corporation for Cancer drug Revlimid: Sun Pharma negotiated an agreement with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, to resolve patent litigation in the United States involving the generic version of Revlimid (lenalidomide capsules). Revlimid is a drug that is used to treat cancer.
Celgene will provide Sun Pharma a license to Celgene’s patents required to manufacture and sell a limited amount of generic lenalidomide capsules in the United States commencing on a confidential date after March 2022, pursuant to the conditions of the settlement. This will mandatorily be subjected to USFDA approval.
Sun Pharma will also be able to manufacture and sell an unlimited number of generic lenalidomide capsules in the United States starting January 31, 2026, under the terms of the license. Before this case between Celgene and Sun Pharma, other Indian companies, Cipla Ltd., Natco Pharma Ltd., Cadila Healthcare Limited and Dr Reddy’s Laboratories Ltd. and the U.S.-based Alvogen had settled patent litigations with Celgene. Celgene granted a patent license to all these companies, required to manufacture and sell an unlimited quantity of generic drug in the United States beginning after January 31, 2026.
Merck for Molnupiravir: Merck entered into non-exclusive voluntary licensing agreements for molnupiravir with five Indian generics manufacturers namely Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals, Hetero Labs Limited and Sun Pharmaceutical Industries
The purpose of this license agreement was to expand access to Molnupiravir, an experimental oral antiviral Covid-19 therapy. Molnupiravir is an oral antiviral agent being studied in a Phase 3 trial for the treatment of non-hospitalized patients who have been tested positive with COVID-19 virus. Merck has been developing molnupiravir in collaboration with Ridgeback Biotherapeutics.
MSD Pharmaceuticals which is a trade name of Merck & Co. entered into these agreements to accelerate the production and availability of the antiviral molnupiravir in India along with in other low and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.
Compulsory licensing: P.H. Kurian, India’s Controller General of Patents, Design and Trademarks, marked his last day in office on March 9, 2012, by issuing a landmark judgment granting the first-ever compulsory license to an Indian generic pharmaceutical company, Natco Pharma, to manufacture and sell a generic version of Bayer Corporation’s patent-protected anti-cancer drug ‘Sorafenib Tosyalte’ (NEXAVAR).
This significant development is prone to alter the complexion of India’s pharmaceutical industry. Many contentious issues are raised by this decision, including whether “local manufacture” of a protected innovation is required in India, and what drug price is “reasonable” under the current patent framework.
Trastuzumab is a type of antibody that is used to treat breast cancer. It is manufactured by Roche Pharmaceuticals and sold under the trade name Herceptin®. In India, this medicine was patented.[5] Each year, around 25000 Indian women are diagnosed with breast cancer. Only 5-6 percent of Indian patients have access to the medicine, according to research.[6] The underlying issue was the drug’s expensive cost. A month of therapy costs roughly INR one lakh. In 2013, the Indian government took a step forward in addressing this issue by initiating the process of giving Herceptin® compulsory licenses.[7] However, Roche chose not to pursue the patent in India later in 2013.[8] The company took this decision since there were no biosimilars of Herceptin available in India at the time, forcing patients to purchase Roche’s products. At the same time, the company may be spared from having to get a compulsory license.[9]
However, it has undoubtedly opened the market for the generic version of the drug. Many large Indian pharmaceutical companies have been working on biosimilars to Herceptin®. Compulsory licensing, if implemented, may make this feasible. Biocon Ltd., based in India, and Biocon Inc., based in the United States, collaborated in 2014. Mylan Inc. suggested selling Herceptin under the brand name CanmabTM. They proposed that it be sold in two dosage sizes. The MRP for a 440 mg vial is INR 57,500, whereas a 150 mg vial is INR 19,500.
Furthermore, this price is only 25% less than Roche’s original drug pricing.[10] In 2014, the High Court ordered Biocon to establish that their product had undergone adequate testing, after Roche claimed that the drug makers could not have completed acceptable clinical trials in such a short time. Biocon, on the other hand, disputed the allegations.[11] It is a tremendous hope that a cheaper version of the life-saving Herceptin will be available in the Indian market. All of this may be conceivable as a result of the threat and consequence of mandatory licensing.
Novartis & Cipla License deal: Novartis has a patent on indacaterol, which is commercialized under the brand name Onbrez® in India. This medication is used to treat chronic obstructive pulmonary disease (COPD). In the late 2014, Cipla, an Indian generic pharmaceutical manufacturer, introduced a petition with the DIPP, asserting that COPD had reached epidemic proportions in India. It further asserted that the demand for Onbrez® imported in India by licensee Lupin was only 0.03 percent of the population, which was insufficient. Furthermore, the drug’s cost is excessive. As a result, Cipla requested that DIPP issue a compulsory license for Onbrez® under Sections 92 and 66[12]. Cipla introduced a generic version of Indacaterol, promising to sell it for over 42% less than Novartis. However, the Health Ministry determined that this application lacked a solid foundation and advised Cipla to make a new application under Section 84[13].
Taking into account the recent events the imposition of world-wide pandemic, Israel issued compulsory license to allow the government to import generic versions of Kaletra: For the sole purpose of medicinal treatment of COVID-19 patients.
This authorization is the first time Israel invoked Section 104 and Section 105 of the Israeli Patents Law, 1967 for public non-commercial use. Israel issued compulsory license to allow the government to import generic versions of Kaletra.
Royalty Rates
In pharmaceutical licensing agreements, an initial payment was historically acknowledged to protect any one or a combination of the following: a fee for disclosure of know-how, an advance payment for patentable improvements to be granted within the agreement period, and settlement for a patent dispute. Royalties, which the licensor considers the “rent”—which includes a profit for the drug’s sales are linked to the initial payment. The initial payment has recently become an integral component of contracts of ever-increasing complexity and magnitude. A single licensing deal for an innovative drug might incorporate an initial payment generally ranging from a few millions to several tens of millions of dollars. Royalties of up to 20% on net sales may also be included in a transaction. In the pharmaceutical industry, initial payments and royalty rates have tended to rise.
This pattern can be attributed by the considerable factors mentioned below:
The task of discovering new drugs has gotten increasingly complex.
Pharmaceutical companies must constantly discover and/or get new compounds that show promise of becoming innovative development pharmaceuticals because it takes more than ten years and at least a few hundred million dollars to introduce a new drug to market.
Internal R&D efforts at pharmaceutical corporations have not been entirely successful, resulting in a pipeline of new drugs that is insufficient.
Licensing operations must be used to supplement pharmaceutical companies’ R&D deficits. These variables have combined to produce fierce competition for crucial licensing possibilities.
Therefore, it’s no coincidence that initial payments and royalties have increased dramatically in pharmaceutical licensing transactions. Nonetheless, the magnitude and correlation between initial payments and royalty rates in the agreement should be determined on a rational and objective basis.
Negotiating mutually appropriate royalty rates is always fascinating and demanding for the licensing professional. Royalty rates on sales in the pharmaceutical sector have ranged from a few percent to over ten percent. In terms of determining the rates, one theory is that the minimum royalty should be set at a rate that covers the cost of licensing the patent and know-how. At research-oriented pharmaceutical companies, the most typically seen research and development expenditures to sales ratio is between 7% and 15%.
Conclusion
During the last two to three decades, the conventional chemical-centered pharmaceutical industry appears to have reached a plateau, with new inventions becoming a rarity. One of the reasons why developing new pharmaceuticals is becoming more expensive is as a result of this. The liberalization process, which began in 1991, has aided in the development of policies aimed at attracting overseas investment and establishing India as a transnational manufacturing base. Inflows of foreign direct investment and technology transfers have resulted in an atmosphere conducive to India’s industry’s dynamic growth and greater competitiveness.
India is gradually making inroads into global markets, competing with international quality standards and pricing criteria. Although R&D is critical for maintaining a competitive edge in the global marketplace, the Indian pharmaceutical industry’s future is highly reliant on patent protection. While economic analysis does not offer the rationale for value judgments, it is an economic reality that the extremely low volume pharmacy must pass on its higher average expenses to the consumer. The duplication of patent-licensed pharmaceutical products on the shelves of community pharmacies has a finite cost to the consumer.
Furthermore, TRIPS and the Doha Declaration viewed compulsory licensing as a crucial measure for providing health benefits to people without regard to race, caste, creed, or even country. These regulations allow for flexibility because each country’s and disease’s requirements change. These laws, as well as the flexibility they provide, should not be subjected to political pressure and should be used to serve the public as well as the patent holder.
Thus, this article tries to provide for a better understanding of the patent licensing regime in the pharmaceutical industry and the direct ripple of effects on the economic standings of the corporations alongwith implications on macroeconomics of the country at large.
[1] Pradubuddha Ganguli, Gearing up for patents: The Indian scenario, p. 47
[2]“TRIPs and Pharmaceuticals: Implications for India”, http://www.cuts-india.org/1997-8.htm#Pharmaceutical
The provision of Section 3(k) of Indian Patent Law, that says computer software per se is not patentable till it has technical applications, puts most of the inventors down. Knowing the fact that software patent in India is tough; the next question from the inventor is that, if not patent, can we at least get a copyright?
The fact of the matter is that the statutory right that one gets in the case of patent cannot be substituted by a copyright and it is important to understand difference between the two. Copyright and patents fall under separate legal regimes and for one single product, one may file for patent as well as copyright.
Prime difference between copyright and patent is that copyright protects only expression of the idea but not the idea itself, whereas, patent protects the concept as well. For example, if there is a product, meant for administration of a hospital, the idea or concept is administration of a hospital, which does not get protection under copyright law. However, the way code has been written is the expression of the idea and the author who has written the code has copyright over it. If any other person writes another code (without copying code from first author), he also has his copyright on the product. On the other hand, if there is a patent for the product, the patent holder can prevent everyone else from making, using, selling, offering for sale or even importing the patented product in the jurisdiction (s) where he has valid patent rights.
Independent creation of copyright is not an infringement whereas the same is not true for a patent. This means that if the work is not directly copied from the copyright holder, and created independently, it is not deemed to be copyright infringement. On the other hand, independent creation of patented product is deemed to be infringement.
As soon as patent application is filed, the applicant may write ‘patent applied for’ or ‘patent pending’ on the product, whereas copyright notice, such as ‘(c) copyright, Origiin IP Solutions LLP’ can be written without registration as well. Though copyright is an inherent right and needs no formal registration as such, but registration becomes important and registration certificate serves as a proof of ownership in case of copyright infringement or even in case of merging/acquisition or to obtain funding/loan from bank or venture capital.
Novelty-Critical Requirement
Novelty is the most critical requirement for a patent which means that before the date of filing a patent application, there shall not be any disclosure of the invention. Whereas copyright, though requires originality in the work, does not have novelty as a critical requirement that enables one to file backdated application as well. Term of a patent is 20 years from the date of filing whereas term of copyright is 50-70 years from the date of death of last author.
It is interesting to note that copyright registered in any country which is a member of Berne Convention hold good in all countries which are members of Berne Convention. In order to get patent rights in multiple countries application shall be filed separately in each country. Though we have single patent application filing platform like PCT, patent rights are granted only by national offices.
Case study
In order to understand difference between copyright and patent, lets have a look at Stac vs Microsoft, an interesting court case in the USA, which Microsoft lost and was required to pay $120 mn for its willful infringement of #4,701,745 (a compression software patent). Stac had a software patent on the algorithm for its PC hard disc data compression software product. Microsoft expressed interest in working with Stac and in the process copied the compressed algorithm of the Stac product. Microsoft then wrote its own code to execute the Stac algorithm and used the code in MS DOS 6.2 product. Stac sued Microsoft for patent, trade secret, and copyright infringement.
A permanent injunction was given against Microsoft and was ordered to pay Stac $120 mn. Calculation of the damage was calculated on basis that Microsoft had included the infringed code which prevented Stac from marketing millions of copies of its separate data compression software. After litigation, for about a week, a lobotomized version of DOS was shipped with the compression feature disabled. DOS manuals were shipped with stickers on the cover warning to ignore the chapter on compression. MS finally got license to use the algorithm in DOS and agreed to pay $1 mn per month for 43 months and to purchase about $40 mn of Stac convertible preferred stock.
Since Microsoft did not copy the source code and wrote a new code for same algorithm, Stac could only prove patent infringement in the Court but not copyright infringement as independent creation of the work is not copyright infringement. Patents can protect the basic concept of a software product, regardless of the actual source code but copyright only protects source code.
Before you decide between copyright and patent protection for the software product, it is essential to understand the difference between the two so that you are clear about what rights you are getting. Though both patent and copyright have their own pros and cons, it makes a lot of sense to consider registration process based on requirements.
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A patent gives exclusive rights to the patentee to prevent other from making, using, selling, offering for sale and importing the patented product into the country where the patent is granted. Any violation to these rights without the permission from the patentee would generally cause patent infringement. However, there are certain exceptional Acts where the use of patented invention without consent of the patentee doesn’t constitute infringement. Section 107 of Indian Patents Act details such exceptions.
In certain countries including India, the generic drug makers are allowed to use the patented invention without the consent of the patentee for development and submission of information required under law. This provision is called Bolar-like provision or Regulatory provision. This provision came into existence from the case of Roche Products v. Bolar Pharmaceuticals. Roche is a discovery based pharmaceutical whereas Bolar is a generic drug maker. Roche holds a patent over the drug Valium. Bolar intended to submit an Abbreviated New Drug Application (ANDA) to the FDA for a similar drug containing the same active ingredient as to Valium. Hence Bolar used the patented chemical in its experiments, before its patent expiry in order to determine if the generic version is bioequivalent to Valium. Roche responded to this by filing a suit for patent infringement. The District Court of Eastern District of New York declined Roche’s appeal saying that no infringement had taken place owing to the experimental nature of Bolar’s work. The Court of Appeal for the Federal Circuit however disagreed with Bolar’s argument as it intended to sell its generic product in competition with Roche’s Valium, soon after its patent expiry and stated that the exemption does not apply to experiments which have commercial objective. Bolar argued that such violation of exemption would extend the monopoly of Roche over Valium even after its patent expiry. Thus in 1984, in response to Roche v Bolar judgement, and in an attempt to promote competition by simplifying authorisation for generics while maintaining appropriate protection for the interests of research-based pharmaceutical manufacturers, the US Congress passed the Drug Price Competition and Patent term Act (known as Hatch-Waxman Act). This law permits the use of patented products in experiments for the purpose of obtaining FDA approval and it established the modern system for FDA approval of generic drugs.
Another instance where an exception made for infringement is in the case of Parallel import. A parallel import is said to occur when a product sold by a patent holder in one country is exported by a buyer to another country with the price for the same patented product being higher. The purpose of the parallel import is to check the abuse of patent rights and to control the price of the patented product. Pharmaceutical companies follow the practice of differential pricing of drugs according to the purchasing capacity of the prospective consumer in a target country. As a result, the same drug may be expensive in a developed country and relatively cheap in developing countries. This principle of differential pricing forms the basis of parallel trade. It enables countries in which drugs are expensive to import them from cheaper markets.
On March 23, 1995, a decision regarding parallel imports was delivered by the Tokyo High Court. BBS Kraftfahrzeug Technik A.G. (“BBS”) of Germany held both German and Japanese patents for certain aluminum automobile hubcaps. The hubcaps were legitimately purchased in Germany by a Japanese company which was engaged in the export of the relevant goods to Japan where an affiliated Japanese company was engaged in the sale of the goods. These two companies were virtually under the same management when the goods were imported into Japan for sale at a price lower than that charged by BBS dealerships in Japan. Subsequently, BBS filed suit for patent infringement in Tokyo District Court in June of 1994. The district court found that the two companies had infringed the BBS Japanese patent. However, on appeal the judgment in favor of BBS was reversed. In reversing the district court, the High Court held that the patentee’s right to enforce its Japanese patent against the imported goods had been exhausted since the patentee had legally transferred title to a rightful purchaser of the patented product.
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Law regarding patents in India is governed by The Patents Act, 1970. A patent is a monopoly right given for a limited period of time to a person who have invented a novel product or process through his skills, judgement, and knowledge. Unlike Copyright, trademark and other intellectual property rights, the protection granted is for a shorter period. But then, the protection so granted is very extensive and prevents all kinds of misuse of the same. The core object of this patent system is to encourage scientific research and new technological progresses. According to Section 2(1)(m), a patent is granted for inventions and Section 3 of the Act deals with the subject matter for patent in India. It describes in detail what not are inventions for the purpose of granting the monopoly right. A monopoly of the Patent is the reward of the inventor.[1] Section 2(1)(j) of the Act defines what an invention is. It says, a new product or process involving an inventive step and capable of industrial application. [2] Therefore, for obtaining patent for a product or process should be novel, involve an inventive step and be capable of industrial application. According to Section 2(1)(ja) of the Act, an inventive step is when there is a technical advancement from the existing knowledge or there is an economic significance to it or both. It is also important to note that, the technical advancement and/ or the economic significance should not be obvious to a person skilled in the art. The capability of an invention to be made or used in an industry is what constitutes the requirement of capable to industrial application.[3] By novelty, the law demands that the invention should not have been anticipated or used in the country or anywhere in the world before the date of filing of the application for patent.[4]
Agreement on Trade Related aspects of Intellectual Property Rights
TRIPS Agreement or Agreement on Trade Related aspects of Intellectual Property Rights is the extensive multilateral agreement that deals with Intellectual property rights and have recognised Intellectual Property rights as private rights. TRIPS agreement was born out of a need for a multilateral framework for rules and disciplines dealing with international trade in counterfeit goods.[5] Section 5 of the TRIPS Agreement deals with Patent and Article 27 under the same comprises of patentable subject matter. According to Article 27(1) of TRIPS, any inventions, be it product or process, if it fulfils the conditions of being novel, involving an inventive step and capability of industrial application, patents shall be granted. This is applicable to inventions in all fields of technology. Article 27(2) and (3) of the TRIPS agreement lists out the category of things that may be excluded from patentability. This includes preventing patenting of inventions to protect the public morality, human, animal or plant life and health. Any therapeutic, diagnostic, and surgical methods which are essentially for the treatment of humans or animals may be exempted from granting of patents. Plants and animals and essentially biological processes for production of the same is exempted as well. But Micro-organisms are exception to this clause. The non-biological process and microbiological processes are also an exception to the said clause. For the members to apply this clause, they shall provide through patents or any such law the protection for the plant varieties.[6]
Impact of TRIPS Agreement on The Patent Act, 1970.
The TRIPS Agreement came into force on January 1, 1995. Prior to that The Patent Act, 1970 satisfied the international norms of patentability covering novelty, inventive step, and industrial application. Post TRIPS, for the ease of trade sanctions, all the members were ought to fulfil the obligations under TRIPS to which they are signatory of. To fulfil the same, The Patent Act, 1970 was first amended in the year 1999 retrospectively with effect from January 1, 1995. After that the Act was amended twice in 2002 and 2005 respectively.
The Patent Act prior to the amendments had its subject matters mentioned under Section 3 of the Act. It was a list of categories that were not considered as an invention. The following are the same:
An invention which is frivolous in nature or is contrary to well established natural laws;[7]
An invention of which primary or intended use would be contrary to law, morality or injurious to public health;[8]
An invention where a scientific principle is merely discovered or an abstract theory is formulated;[9]
An invention which is a mere discovery of new property or new use of a known substance or process respectively; [10]
An invention which is just an admixture resulting in aggregation of properties or process;[11]
An invention which is a mere arrangement or re-arrangement of a known aspect;[12]
A method or process of testing which is applicable during the procedure of manufacture;[13]
Any medical, surgical, curative, or prophylactic or other procedure for treatment of human beings or animals and plants to free them from disease or increase the economic value of the same.[15]
The above mentioned nine clauses were the subject matter to which patentability was tested prior to the amendments. The Act listed out certain exceptions to which an invention can be defined or narrowed down to.
In 1999, an amendment was passed to fulfil the TRIPS obligation but no changes were made to the subject matter part in the Act. Hence, the same was followed by the authorities to decide the question of patentability of an invention. In 2002, the next amendment was passed and had major changes in the Section 3 which deals with subject matter. The following are the changes made with respect to Section 3:
In clause (b), the commercial exploitation of the invention was added which was previously just the primary and intended use of the invention. Further excluded those inventions which caused serious prejudice to human, animal or plant life or health or to the environment.[16] Prior to the amendment, only those inventions which were contrary to law or morality and the ones injurious to public health were excluded.[17] This can clearly be concluded as a step to comply with clause 2 of Article 27 of TRIPS Agreement.
In clause (c), “discovery of any living thing or non-living substance occurring in nature”, this was added towards the end denoting the invention those are merely discovery of living things or non-living things which is essentially already found in the nature shall not be patented.
Clause (g) was omitted from the Act.
In Clause (i), the terms “Diagnostic and therapeutic” was added to include these along with the other types of processes in medical arena. Clause 3(a) of Article 27 of the TRIPS Agreement is incorporated here.
Clause (j), (k), (l), (m), (n), (o), (p) was inserted. Clause (j) dealt with non-patenting of plants and animals except micro-organisms. But it excluded seeds or varieties and species and essentially biological processes for production or propagation of plants and animals.[18] The provision under Article 27 Clause 3(b) is reflected in this particular clause. Clause (k) excluded mathematical methods, business methods, computer programmes from getting a patent. Clause (l) excluded the plethora of things which are capable of getting a copyright for like literary, dramatic, artistic works etc. Clause(m) eliminated mere scheme, rule, or method of performing a mental act or playing games from patenting. [19]Presentation of information and topography of integrated circuits were decided to be an ineligible invention under clause (n) and (o) respectively. Traditional knowledge became non-patentable through clause (p).
After this major amendment in 2002, in the year 2005 another amendment was made. Only a minor change was bought in the Subject matter that is an explanation clause was added to Section 3(d) was added for a better clarity and understanding.
Conclusion
Section 3 of the Act delas with what not are inventions and is considered as the subject matter of patentability. Article 27 of the TRIPS Agreement deals with provisions related to patent and gives out the standard as well as the subject matter in it. The current legislation that gives out the subject matter for patentability is result of many amendments to keep up with various international obligations like TRIPS Agreement. The changes so made have reflected in a positive way and have bought perfect clarity to confusions surrounding this area of law. The makers of law have given such a makeover to the legislation so as to have a strong patent system in our country and maximum people can be benefitted from the same. The category of things that are protected either by a different law or through different provisions are excluded by the Patent law.
Author: Akhila Sridharan
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Innovation is the key to sustainable growth for any business today and patents play a vital role by securing innovations and obtaining competitive edge in the market. Patent filing is increasing globally and hence keeping yourself updated with the latest trends and progress of technology is important for any business.
Patents are excellent source of technical information, primarily for the reason that inventions are not only disclosed systematically in the patent specification but also the best mode is disclosed to meet statutory requirements in most of the jurisdiction. Therefore, the patent databases contain valuable information that can be used to add value to an invention.
Staying ahead of your competitors in the world where innovation is happening in every area of technology is not easy. In order to improve quality of innovation, avoid duplication of work, filing quality patents and giving right direction to R&D, it is essential for the companies to be updated with latest inventions for which patents are being filed for/published/granted/expired.
However, keeping track of the kind and number of patent applications published, granted, abandoned or expired is a big challenge today. On one hand, knowing latest happenings in the area of patents helps business in multiple ways, on the other hand, with growing data & increasing number of patent filing, extracting desirable information is extremely tough.
Generating periodic (weekly, monthly or half yearly) patent alerts is one of the most effective tools to track the latest happenings in the area of patents. Published/granted and even abandoned/expired patents can be monitored on regular basis in the technical area of interest to get valuable information on:
New products/processes for which patent applications have been filed and build up own products to ensure that the same invention is not replicated and also to assess likelihood of patent infringement. In addition to this, since the patents technically disclose the invention, thorough review of the same might be extremely useful to assess chances of getting patent for your core technologies or new idea by knowing novelty, non-obviousness and industrial applicability of the invention.
By knowing published applications, one might want to oppose the applications, which may not be subject matter of a patent or grant of which might affect the business adversely, though there are several other reasons to oppose a patent application or a granted patent.
New markets or new technologies that your competitors are focusing at. This might give you overview of the kind of products they are planning to launch in given markets.
Patent watch can be done primarily in two ways:
Technical Patent Watch: Here you may list out core technology (ies) of interest and monitor newly published patent applications or granted patents in a technical area of interest as soon as they are published. One may also monitor latest prosecution status of pending patent applications. This way it will be easier to keep in touch with latest happenings in the industry and one may also come across interesting patents that may be used and implemented to add value to existing products or technologies.
Such patents may be considered for licensing or if they are not filed in the jurisdiction of interest or they don’t have a chance to be filed in the jurisdiction of interest, it may be used without any fear of infringement. However, it is highly recommended to take opinion of an expert on the legal status of such patent (s) before implementing it.
Competitor Patent Watch: Knowing patent portfolio and watching patent activity of the competitors may be of great business value. Competitor companies may be listed out and their newly published patent applications or granted patents may be monitored on periodic basis. However, one may also monitor latest prosecution status of pending patent applications or latest legal status/continuation applications of granted patents of competitor companies.
This information obtained by observing periodic patent alerts may prove to be a game changing strategy for any company.
Staying ahead of your competitors is critical for sustainability today. With increasing focus on innovation, it becomes important to know about the recent trends in the area of patent filings. It is not only interesting to watch what your competitors are doing or the latest technologies for which patents are being filed or granted in given jurisdiction, but also, it gives you platform which you can use to fine tune your existing products and assess chances of infringement.
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Innovation and growth have always been synonymous to each other, ultimately leading to development. Business ecosystems are largely dependent on these innovations and diffusion of technology plays a crucial role in shaping the future of these organizations. The term ‘technology transfer’ indicates the movement of knowledge, skills, know-hows and other valuable assets of the organization which is driven by profit. The concept of technology transfer is age old and has been rightly referred by Mansfield as, “One of the fundamental processes that influence the economic performance of nations and firms is technology transfer”.
Economists have long recognized that transfer of technology is at the heart of process of economic growth, and that the progress of both developed and developing countries depends on the extent and efficiency of such transfers. In recent years, economists have also come to realize (or rediscover) the important effects of international technology transfer on the size and patterns of world trade.
Meaning of Technology Transfer
The process of disseminating knowledge, skills and other know-how that manifests in the form of technology from its owner (individual or an organization) to another person or organization is known as technology transfer. It is also popularly known as Transfer of Technology. Various stakeholders amongst whom technology transfer takes place includes universities, business organizations, research and innovation societies and others. Such transfer takes place with the motive to share skills, knowledge, technologies, methods of manufacturing and other related profit motives. The transfer is further done with an intention to provide improved accessibility to a wide range of users who can then further develop and exploit the technology to develop new products, processes, applications, materials or services.
Types of Technology Transfer
Technology transfer can be broadly classified into vertical and horizontal technology transfer.
Vertical Technology Transfer- This chain of transfer includes basic research to applied research, applied research to development and from development to production. It is also known as internal technology transfer. This type of transfer is mostly carried out between research associations, universities, and governments, among others.
Horizontal Technology Transfer- When technology which has already been put in place or use within one organization is further transferred and used in another place, the transfer is known as horizontal technology transfer. It is also known as external technology transfer. This type of transfer takes place between private companies, small and large business organizations, among others.
Methods of Technology Transfer
Technology transfer can take place using the following instruments.
Licensing- An agreement between the owner of the technology (Licensor) and the receiver (Licensee) which gives the right to use the technology developed or owned by the transferring individual or company for a specified time period is known as licensing. The two broad categories of licensing include the one which grants exclusive rights to use the technology and another which grants non-exclusive rights wherein the owner reserves the right to further transfer the technology to other company apart from the receiver. It may also include the right to sub-license, permitting the licensee to grant someone else the right to use the technology.
Joint Venture Agreement- The company executes a joint venture agreement with respect to technology transfer for a particular business with a vision to incorporate long-term cooperation between the parties, motivation of all participants in the successful transfer and to incur lower costs as compared to working independently.
Franchising- It is one of the most preferred methods of transferring technology. The companies generally transfer technical know-how or skill involved under this type of agreement.
Original Equipment Manufacturer- It is a kind of sub-contracting agreement wherein a foreign company transfers a relevant portion of its technologies and a local company manufactures according to the specifications in the agreement. Such agreement enables local companies and firms to absorb technologies and restructure their production mechanism.
Buy-Back Contracts- It is a form of agreement between stakeholders from developing countries and large foreign companies, wherein a foreign company supplies industrial equipment in exchange for profits derived from the sale of raw materials or goods produced. This kind of technology transfer is often used in the construction of new plants and other related business.
It is interesting to note that a considerable amount of knowledge and technology exists today that enables the development of approaches and can effectively plan and implement business processes. What needs to see the light of day is a well-funded and potent mechanism for executing technology transfer between the stakeholders in order to ensure uninterrupted economic advancement.
The role of a patent agent has been a source of curiosity since enactment of the Patents Act 1970 (the Act). The provisions relating the patent agents have been comprehensively amended in 2002 amendment enforced from 20th May 2003. One of the most commonly asked questions is whether it is important to be patent agent especially when there is huge scope for people who are expert in patent searches, who may or may not be patent agent. In this article, lets analysis, who can be a patent agent, what are advantages of the same and how are the job prospects better if one is a patent agent?
Patent specification required to filed for obtaining a patent is invariable termed as a techno-legal document as it is a combination of technical description and the claim, which are purely legal in nature. The patent specification discloses technical details of the invention and defines scope of the invention by restricting legal rights to the claims. Since by nature, a patent is a technical document, in order to draft patent specifications, one needs excellent writing skills and expertise as well we deep understanding of the subject matter and knowledge about the patent law. For a person to work in the area of patent law, he has to have cocktail of all these attributes.
Who is a patent agent?
Technically/legally speaking the patent agent is a person so registered under the Patent Act. However, in practice the Patent Agent is a person, which is the link between the inventor and the patent authorities, such as, the Controller, who facilitates the work of grant of patent by assisting the inventor, the Controller or his subordinate officials. He has exclusive right to do certain acts in the process for obtaining a patent and has exclusive right to practice before the Controller. The Patent Agent is also allowed to appear before patent office of other PCT member country in respect of national phase of the corresponding application.
The patent agent should have thorough knowledge of the Patent Act and rules, Patent Co-operation Treaty provision and prosecution therein and also comparative knowledge of procedures in other important countries such as US, EP, Japan and China.
Who can become a patent agent?
A person for being eligible to register himself in the register of the Patent Agents under the Act must have qualification prescribed under section 126. These qualifications are as follows:
The person shall be a Citizen of India;
He must have completed 21 years of age;
He shall possess a Degree in Science, engineering or technology from recognized university or other equivalent qualification as prescribed by the Government; and
Should have passed the qualifying examination conducted by the Patent Office or Should have worked as examiner or discharged functions of Controller for not less than ten years.
Additionally, he also must have paid such fee as prescribed. The Act does not define the degree in science, technology or engineering, hence, these terms are open to interpretation. The equivalence of qualification should be as per notification made by the Government in this regard. For example there are graduations awarded by Universities in certain subjects like Mathematics, Statistics, Geography in both Science and Arts. The Diploma Holders in engineering or Bachelors’ degree in engineering from a foreign university, who are equally knowledgeable as graduates are not allowed to appear. Their case needs to be considered sympathetically by the Government. Prior to 2002 amendment, there was no such restriction. The restriction though well intended must also take into consideration of various diploma holders in science, technology and engineering who may be equally learned in science, technology and engineering but might not get opportunity to be a bachelor for various socio-economic reasons.
“However, one must understand that being a patent agent is not everything. There are several proceedings under the Act which take place in the courts and being an Advocate is always of great advantage. Even if one does not wish to practice in courts, in addition to patent law, sound knowledge of law of interpretation, contracts, Indian Constitution is of great value to attain better hold on the subject”.
Those Agents who are already registered before the amendment shall subject to payment of renewal fees continue to be registered so irrespective of their qualifications. Before 2002 amendment came into force any Advocate under the Advocate’s Act could register himself as a patent agent, without appearing for examination, however after the amendment came in to force on 20th May 2003, even an Advocate also needs to be a science, and engineering or technology graduate and is required to appear for the patent agent examination conducted by the Patent Office.
What are the advantages of becoming patent agent?
There are many advantages of being a patent agent, more so after the 2002 amendment to the Act. Prior to 2002 amendment, Section 132(a), nothing in the chapter XXI relating Patent Agents prohibited any person not being a Patent Agent who was duly authorised by the applicant from drafting any specification or appearing before the Controller and an Advocate from taking part in any proceeding under the Act except drafting specification. The situation has dramatically changed after the 2002 amendment. Now the Patent Agents only have exclusive right to practice before the Controller as spelt out in Section 129(2). Except the applicant himself, even advocate cannot appear in general but can appear on behalf of the party in proceeding under the Act only if the party is also taking part in the said proceedings. Thus the role of the patent agent in the patent prosecution has been significantly enhanced by the said amendment in 2002. Only patent agents can prepare all documents, transact all business and discharge such other function as prescribed under the Act and the role of other authorised persons and advocates has been considerably limited.
A registered patent agent also gets added weightage and advantage over others in securing jobs if he/she does not want to practice independently. The Advocate firms will employ them as they only can appear before the controller for prosecuting the patent applications filed by the firm. The registered patent can also practice before the IPAB even if he is not an Advocate. It is interesting to note that a registered patent agent can also act as an agent for design registration under the Designs Act 2000.
However, one must understand that being a patent agent is not everything. There are several proceeding under the Act which take place in the courts and being an Advocate is always of great advantage. Even if one does not wish to practice in courts, in addition to patent law, sound knowledge of law of interpretation, contracts, Indian Constitution is of great value to attain better hold on the subject.
Patent Agent Examination
The qualifying patent agent examination is conducted by the office of the Controller. The particulars of the examination, the curriculum and qualifying marks are given in Rule 110. Upon passing the examination, the successful candidates are required to follow a registration process as provided in chapter XV of Patent Rules.
The examination consists of two written exams and viva. Paper 1 relates to Patent Act and Rules, Paper II relates to drafting and interpretation of patent specifications and other documents. Each written paper carries maximum 100 marks. The Viva carries 50 marks.
The Rule 110 (3) regarding qualifying marks has been amended after the decision of the Delhi High Court in Anvita Singh V/s Union of India and Others in 2012 and Renu Bala case. The amended rule 110(3) reads as follows:
110(3) A candidate shall be required to secure a minimum of fifty marks in paper I and paper II and shall be declared to have passed the examination only if he obtains an aggregate of sixty percent of total marks.
The amended rule has practically reduced the viva redundant as one need to only have compulsory appearance in the viva. If a candidate secures 150 marks in both the written papers and only appears for viva.
The detailed nature of the paper I and paper II is as follows:
Paper 1: Total 100 Marks
It is divided into part A1, A2 and B.
Part A1 (30 Marks)
15 multiple choice questions Each question carries two marks;
Candidate to answer all the questions in this section; and
To choose the right answers from maximum six choices and maximum two correct choices.
Part A2 (10 marks)
True or false, 10 questions one mark each.
Part B (60 Marks)
8 Subjective type questions. Candidate to answer any 6 questions.
Paper 2: Total 100 Marks
It is divided into part A, B1 and B2.
Part A (40 Marks)
Consist of 6 questions of 10 marks each and the candidate to attempt any 4 questions. The questions will relate to drafting and interpretation of patent specifications and other documents
Part B (60 marks)
It consist of parts B1 and B2.
Part B1 is compulsory and will consist of 1 question relating to drafting of claims and abstract from a given description of an invention.
Part B2 consists of 2 questions and the candidates will be required to attempt any 1 question. Out of the two questions, one question will relate to general engineering and the other question will relate to field of chemistry/life sciences.
The prospecting patent agents may refer to old papers available on the patent office website to understand nature of questions asked in the examination.
Job opportunities for a patent agent
A patent agent, being an expert in patent law as well as technology shall have good opportunities not only in IP department of any R&D oriented firm but also the law firm. Areas of work could be patent specification drafting, filing, prosecution and performing patent searches of various kinds. However, clearing the patent agent exam and registration as a patent agent alone is no more than a certification. In the super specialized area like patents, one need to work really hard and acquire skills and expertise for long term and sustainable career growth. Career of a patent agent can always extend to more specialized areas, such as, patent valuation, technology commercialization, IP management etc.
After working hard on the new idea, investing money, resources, it’s time to fulfil the dreams, set-up new business, bring new product in the market. IP protection is an important step to secure innovation to prevent others from copying it. Is there anything else that is required to be done much before it? Following are the most crucial issues to be considered by an inventor to help him in enhancing quality of research and file the patent application in a cost-effective manner:
Prior art search: Get a thorough prior art search done right in the beginning when you conceive a new idea. The scope of the search should not be limited to the granted patents, but the published patent applications and paper publication should also be searched. The search shall be done globally using various paid or unpaid databases to identify the closest and the most relevant patents/patent application that would help you to assess the novelty of the invention. Prior art search also is helpful in drafting of the patent specification. Prior art search is an essential and crucial step to give shape to your idea and hence it’s a good idea to take professional help to get the search done.
Maintain confidentiality: Inventors often are extremely passionate and enthusiastic about their invention. Having invented something feels great and one feels like disclosing it to the world. But stop! It is strictly essential to maintain strict confidentiality of the invention till the patent application is filed. One of the critical requirements of getting a patent is that invention shall be novel on the date of filing. Hence, never disclose, publish or make your invention available to public till you file a patent application for the same. Additionally, do have an NDA (Non-Disclosure Agreement) with your attorney as well for the same before initiating discussion on filing patent application. A classic example is when Archimedes solved the problem of checking the purity of a gold crown without damaging the crown. While taking a bath, he noticed that the level of the water in the tub rose as he got in and realized that this effect could be used to determine the volume of the crown. Archimedes then ran in the street naked, so excited by his discovery that he had forgotten to dress, crying “Eureka!”.
Documentation: Documentation of an invention is extremely critical. Stepwise documentations shall be done and the novel features of the invention, existing technical problem which your invention overcomes, how your invention works shall be highlighted. Explain the process or the product with drawing and\or flow diagrams. Thorough understanding of the invention by your attorney is necessary. Don’t get lazy to fill the invention disclosure form if given by your attorney in order to describe the invention systematically. Consider the cost: Understand why and in which county (ies) or jurisdiction (s) you want to file a patent application. Choosing to file provisional or complete application, PCT application or convention application or filing in India based on your requirements can really help you to manage your finances and to identify the timelines. Spend some time with your attorney to understand the procedure to work on the most cost-effective package.
Explore options other than patent: Depending upon kind of product, it is advisable to explore other option for protection of the innovation in the form of copyrights, design or trademark. Being an inventor requires tremendous amount of effort and taking invention in right direction, in right manner is imperative to protect it appropriately and to reap the benefits.
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In order to file a patent application outside India, for Indian residents, it is required to seek permission from Indian Patent Office and this permission is called as Foreign Filing Permission or Foreign Filing License. According to Section 39 of the Indian Patent Act, 1970, if an applicant is a resident of India but is interested in filing a patent application in a foreign country, the applicant has the below-mentioned options:
Option 1: Filing an application at the Indian Patent Office under section 7 and wait for 6 weeks before filing in the foreign county of their choice including PCT. If there are any issues regarding the invention or its subject matter, the Controller is expected to provide necessary directions, including secrecy directions, within 6 weeks. In the absence of any such directions within this timeframe, the applicant is free to file applications outside India.
Option 2: Obtain permission from Indian Patent Office to file patent application directly in the foreign country without filing an application in India.
This permission is known as foreign filing permission and is required to be submitted by the applicant to the Indian patent office on Form 25, “On application for permission for applying patent outside India under section 39 and rule 71(1)”. The fee for submitting Form 25 is INR 1600 for natural persons, start-ups, small entities or educational institutions and INR 8000 for large entities. There is a 10% additional fee which is applicable for filing in physical mode. The details required for such a form include applicant details, inventor details, and the reason for which the applicant is seeking the foreign filing license. Along with the Form 25, the applicant is required to submit the details of the invention in the form of a complete specification and the drawings enabling the Controller to review the invention in light of subject matter relevant to defence purpose or atomic energy, if any, which the applicant is planning to file in the foreign country.
The Controller usually takes approximately 21 days of time to examine and provide his approval for the request. However, if the invention is relevant for defence purposes or related to atomic energy, the Controller will not grant permission to file patent in a foreign country without the prior consent of the Central Government of India. In case of inventions relating to defence or atomic energy, a period of 21 days shall be counted from the date of the receipt of clarification/consent from the central government.
It is interesting to note that if the invention is relevant for defence purpose or atomic energy, the Controller shall not grant permission to file patent in foreign country without the prior consent of the Central Government. This section shall not apply in relation to an invention for which an application for protection has first been filed in a country outside India by a person resident outside India.
Non-compliance with provision of Section 39
As per section 40 of The Patents Act, an application shall be deemed abandoned if contravention of section 39 is found.
Further, as per section 118, violation of directions given under section 35 or contravention of section 39 may result in imprisonment for 2 years or payment of a fine or both.
Conclusion
If the applicant is a resident of India and wishes to file an application in a foreign country, the applicant can either file the application in India and wait for 6 weeks to subsequently file in the required foreign country or the applicant can take a Foreign Filing permission from Indian Patent Office and file directly at the respective foreign country without filing in India.
Author: Dharini Dinesh
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In this case, Medley Laboratories (P) Ltd. (hereinafter referred to as Medley) filed a suit of trademark infringement against Alkem Laboratories for usage of mark “SUPAXIN” which is deceptively similar to registered trademark of Medley, “SPOXIN”. Brief facts of the case are as follows:
Medley is registered proprietor of the trademark “SPOXIN” in respect of Pharmaceutical and Medicinal Preparations in Class 5 vide Registration number 420835. They applied for registration in year 1984 and have been using the mark since 1999, for medicinal preparations containing the generic drug SPARFLOXACIN.
Alkem, India’s 10th largest Pharmaceutical Company (at the time of suit), started using the mark “SUPAXIN” and for the same registration application had been sent to Registrar of Trademark as ‘proposed to be used’.
Suit for infringement and notice of motion was taken out by plaintiff to restrain Alkem from using infringing mark, initially an ex-parte injunction was passed in favour of Medley, but on another notice of motion by Alkem, parties were heard afresh and it was held by a single judge that the marks in question are not similar and therefore injunction is bound to be said aside. On such order by the Single Judge, appeal was preferred by Medley, which was the subject matter of present case.
Arguments
By Medley i.e., Appellant
That medley is the registered proprietor of the trademark “SPOXIN” vide registration number 420835 and by virtue of registration they are entitled to exclusively use the mark and protect it.
That Single judge has committed error of law by not granting injunction in favour of Medley, decision of Hon’ble Supreme Court in case of Cadila Healthcare Ltd. v. Cadila Pharmaceuticals Ltd.; {[2001]2SCR743}, was relied upon, wherein Supreme Court decided upon similar question with respect to marks being used in medical preparation. Medley contented that Apex Court held that in medical products and drugs public interest should be considered and a stricter approach has to be adopted because confusion as to medicinal product can have disastrous effect on health and in some cases on life as well.
That balance of convenience was in favour of Medley as their mark “SPOXIN” is a registered mark and irreparable loss and injury would also be caused to them if injunction is refused, as the suit will take a long time and in spite of registered trade mark, the defendant will continue to use ‘deceptively similar’ mark SUPAXIN.
By Alkem i.e., Defendant
That Alkem is honest user of the mark “SUPAXIN”, it has coined the term by taking into consideration two words i.e., “SUPA” which means superior and “XIN” which is a common suffix for antibiotics. That prior to applying for registration, they made an application to Registrar under rule 24 of Trade and Merchandise Marks Rules, 1959, requesting him to conduct a search and issue a search for similar marks and on basis of such search report they started using the mark “SUPAXIN”.
That there was no dishonest intention in applying the mark and the mark is neither deceptively similar nor it would create any confusion to customers.
That a discretionary order has been passed by Single Judge and under ordinary circumstances such orders are not interfered with by Appellate Court.
That balance of convenience was not in favour of Medley because as per the findings of Trial Court Medley and Alkem started using the mark at around same time. That Alkem has established its bona fide usage by making search request to Registrar.
That no evidence is produced before the court of Medley regarding the confusion, on the contrary affidavits were produced by Alkem to support that there was no likelihood of deception or confusion to doctors, or to chemists, or to patients.
Issue
The primary issue before the court was, whether the mark of Medley i.e., “SPOXIN” is deceptively similar to mark of Alkem i.e., “SPUAXIN”.
Judgement
Hon’ble Delhi High court observed that by virtue of registration Medley got the right to exclusively use the mark “SPOXIN” and the right to prevent others from using deceptively similar mark. Further court observed that the marks “SPOXIN” and “SPUAXIN” are deceptively similar and that once the mark is proved “to be identical or deceptively similar, the other factors, viz., the packing being different, number of tablets contained in the competing package is not the same, prices are not identical and/or the goods being sold on doctor’s prescription are altogether irrelevant and immaterial.”
Decision of Single Judge was overruled, as he failed to promptly apply the principles laid out of Apex Court in the case of Cadila Health Care (supra). It was held by court that:
“In our opinion, however, when the test is ”possibility’ of confusion in medicinal preparations, as held by the Supreme Court in Cadila Health Care Ltd., and the Courts have been asked by the Apex Court to take special care, in such cases, since confusion may harm and result in unpleasant consequences, if not disastrous results, the learned Single Judge ought to have granted injunction as prayed by the plaintiffs (Medley).”
As to the issue of discretionary matter it was held that when an adjudication has been made, may be prima facie, and in doing so, correct test has not been applied, it is open to the Appellate Court to interfere with the discretionary order made by the trial Court.
Thus, the appeals were allowed and Alkem’s mark was found to be deceptively similar with the mark of Medley.
In this technologically progressive era, huge amount of knowledge gets generated and added in the prior art every day. Where on one hand keeping pace with technical progress in present times is a challenge, on the other hand, innovation has to happen to ensure sustainable growth. Till the time, you foresee the innovation in a given area of technology, it is impossible to create significantly creative and valuable products. Another issue in technologies such as electronics or software is that innovation cycle is too short, meaning that in no time after you market or commercialize the product, you may see next versions of the product floating around. Considering the high cost of R&D and resources, output often is not that meaningful and sustainable.
In most of the companies, before designing R&D in a given area of technology, one important parameter is often missed out, i.e. assessment of “state of the art”. Even though by means of product surveys, competitors’ products or otherwise, the products available in the market are often watched carefully but the wealth of technical information lying in the form of patents is largely ignored. It is important to note that few of the patented technologies actually come in the market, meaning that, there is a huge amount of knowledge, in the form of patents, which is not seen in the market. However, assessment of this wealth may help in various ways, such as:
It helps you to assess quality of your product and after knowing state of the art, you may further fine tune your product or add more value to it.
‘State-of-the-Art’ may reveal many interesting ways of performing a process or a method or manufacturing a product, which you would have never thought about and this actually can add lots of value to the existing product/process.
Assessment of patentability of the invention compared to state of the art becomes clear and easy.
The best thing about a patent is that the best mode of performing an invention known to the inventor is disclosed. In most of the countries, patent law expects inventor to disclose the best mode of working the inventions. Thus, most of the times the patent documents provide complete technical working of the inventions with illustrations, drawings and examples.
Based upon State-of-the-Art, if you feel that your invention is significantly better than existing patents, you might consider filing for a patent for your invention.
Infringement of patent happens when one makes, sells, offers to sale, import patented product or a product made from a patented process without permission of a patent holder. As a result of state-of-the-art search, you might come across a few patents or patent application (not been granted), that are very close to your invention. In such a case, it is worth looking at such patents in detail and check for their validity (whether they are legally enforceable or not) or to see if they have been filed or granted in the country (ies), where you intend to market your product. If there are any such patents, you need to be careful as there are chances that you might be infringing such patents.
State of art data can be represented in various forms and interpretation of such data into various graphs can provide you valuable information in terms of key players, active areas of technology, patent filing, publication and grant trends, favorable jurisdictions, international classification etc. This data may play a vital role in formulating patent strategies for the organization.
State-of-the-art is a wealth of knowledge, in fact a powerful tool that is important not only to prepare a strong base to formulate your R&D strategies but also assists in multiple ways. It is worth investing time to unfold state-of-art to create innovative, commercially viable and meaningful products to obtain a competitive edge in the market.
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In simple words, patent infringement is the violation of patent rights of a patentee in the country or jurisdiction where the patent has been granted. This violation happens when any third party, makes, uses, sells, offer for sale, a product or process claimed in the patent, granted to the patentee without his/her authorization or license. When a patent is granted, the patentee gets the right to prevent third party (ies) from making, using, selling, offering for sale or importing the patented product in the country where there is patent protection.
A business owner may violate rights of a patent with or without knowledge and therefore, it is highly recommended for business owners to examine existing patents before launching their new products to ensure that no patent rights are violated in the territory where their product is going to be launched. This investigation to assess patent infringement risk is called as Freedom to Operate (FTO) analysis or clearance search.
How is FTO performed?
Purpose of FTO search is to assess the likelihood of patent infringement upon launch of new product in a specific market. The best time to perform FTO search is at the time of designing the new product because its is easier to make changes in the product specifications and the infringement risk can be minimised or nullified easily at early stage of product development. FTO is a very specialised investigation and analysis of patent documents, done by a skilled attorney, who possesses a good working knowledge of technology as well as law. The final opinion on infringement shall always be rendered by an advocate according to the laws of the jurisdiction. Generally, following steps are taken up to perform FTO analysis:
Identification of components of the product to be launched and listing out nomenclature of the components, as generally used in the industry.
Performing a patent search with all possible synonyms of the product component names and other search techniques to pull all relevant patents. Patent search here may be global or country-specific depending on the countries in which the product is going to be launched or sold. The business owner must be very focussed and specific with respect to patent search strategies to ensure that the appropriate data is extracted.
Depending on the requirements, a history dating 20 to 22 years prior to the date of performing the search may be set as the scope of patent search because the term of a patent is 20 years and only “in-force” or live patents get infringed. Therefore, considering very old and expired patents may not be of much use for FTO search. However, expired patents may be extremely helpful to find out technologies or products for which patents have expired. Even though expired patents may not impose any infringement risk but they can certainly provide valuable information otherwise.
After the relevant patent documents are extracted, it is important to segregate them into “expired”, “abandoned” or “in-force” patents. Further, there may be a need to separate out patent applications and granted patents. If there are any risky patent applications, it is highly recommended to monitor them periodically to find out the kind of objections that the examiner raises during prosecution and to know if patent application gets granted as a patent or not.
Further, during performing FTO search, if there are any “lapsed patents”, there may be chance of restoring such lapsed patent. Therefore, the legal status of lapsed patent shall be checked periodically and the risk it imposed shall be completely ruled out only after the timeline to restore has lapsed and its legal status reflects as “Expired”.
Patents so extracted shall be studied in detail by comparing claims of the patents with product features. Generally, patent practitioners prepare claim maps where the portions of the claims with match or overlap with product components are highlighted. Based on the extend of overlap between patent claims and the product components, the patent documents may further be considered as low, moderate or high-risk patents.
How to handle high-risk patents?
In case the FTO analysis reveals high risk patents, using such patents may be detrimental for the business. Following points may be taken into consideration before using such patents:
Check expiry date of the patent. If the patent is going to expire soon, it is worth to wait for the patent to expire before using it.
Carefully read and analyse patent claims and try to understand what is claimed. Often the language used in the claims is very complex and expert advice must be sought.
Perform invalidation search to understand how strong the patent is. This search is performed to identify the grounds on the basis of which a patent may be invalidated. Generally patent search is performed to reveal closest prior art and novelty/inventive step is assessed.
Based on the outcome of invalidation search, opposition to the grant of patent, if patent is not yet granted; or post-grant opposition or even revocation may be filed. The opposition petition shall have all possible statutory grounds of opposition, which help the Controller of Patents to give decision on invalidating or revoking the patent.
In case there is no other way out, obtaining license to use the patent may be obtained from the patentee. This option may not be feasible in most of the cases as granting license is at sole discretion of the patentee.
Above listed are few ways to handle a situation where there is a high risk of patent infringement. If none of the steps work, it is advisable not to use the patent because if patentee takes a legal action, it may be detrimental for the reputation and good will of the business. In Merck vs. Glenmark case, the Delhi High Court passed an injunction against Glenmark for manufacturing the generic drug Sitagliptin and using patented product of Merck as there was prima facie infringement of patent rights of Merck. Delhi High court passed injunction order against Glenmark from manufacturing and selling of Zita and Zitamet. Thereby, patent rights of Merck were protected and enforced.
Patent infringement risk assessment and mitigation shall be integral part of steps to be followed before new product launch. FTO search can be extremely helpful to understand extent of infringement risk and to take right measure to minimise it.
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Patents are recognized as a valuable source of technology and competitive information due to the disclosure of technical and scientific information in it. Study and analysis of patent literature provides good understanding of current technological and competitive environment of any technology domain. A better insight of the patenting activity reveals a more objective approach in determining how to prioritize research and development. Research-based firms continuously seek to discover new ideas and new technologies and to translate these into unique products that can be protected from competition by patents or other intellectual property rights such as design or copyright.
In order to convert ideas into unique product one should possess solid knowledge of the market and trends in the market, also a better understanding of the competitors in the relevant field of technology. This is possible through patent mapping or patent landscaping. Patent landscaping, also known as “patent mapping” or “patent analytics” is a comprehensive state of art search, which gives past and present patent and non-patent activities of the competitors in the given area of technology. It also provides a graphical representation allowing for comprehensive analysis with an ability to link more detailed text when needed. This search is a deeper analysis of a State of Art Search, where State of Art Search is the broadest and most general of all patent searches. It is essentially a market survey that should ideally finds out what technology already exists and then build on it.
The Patent Landscape Search can identify potential patent portfolios for acquisition, existing or potential infringers to be pursued, and potential technology to be exploited. The typical Patent Landscape Analysis, Patent Mapping or Patent Analytics are customized to the client’s needs and are useful for:
Identifying the key players operating in a technology domain. This is critical for any business to know so that activity of competitors can be monitored and based on this own IP strategies can be devised.
Identifying the R&D focus of key industry players by identifying the patents and analyzing the technologies they are working in. Based on this, own R&D can be planned in a better manner.
Identifying the technology curve & trends
Identifying seed patents in a technology domain
Identifying licensing opportunities based on the identification and knowledge of technologies patented by others in particular jurisdiction. The thorough review of the valid patents can also help to minimize patent infringement risk.
Monitoring market interest
Identifying opportunistic technology gaps for licensing, development, or in a geographic area
Visualizing the most densely patented and most sparsely patented technology area
Determining the most prolific inventors
Identification of possible collaboration and acquisition and merger opportunities
Therefore, patent analytics or patent landscape can be useful for to formulate business strategists, market analyst, scientists who make key decisions in new product development, R & D planning and strategic business development in order to gain a competitive edge.
Origiin, with a skilled team of patent agents is one of the best patent companies in India offering patent services such as, patent searching and patent filing, in India and abroad.
Deliverables: Landscape report in PDF and backend data in excel sheet is provided
Timeline: 15 business days
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The most significant aspect of a patent specification is unquestionably the patent claim. A patent claim concisely defines what the invention claims and what is to be protected. In other words, patent claims specify the scope of the invention. Every patent application must have carefully phrased claims, as claims are very important in litigation. Notably, a claim is typically phrased as a codified statement of technical facts indicating the extent of the invention claimed to be protected. A patent claim specifies the novel characteristics in the patent application that the inventor wishes to protect.
Anatomy of a Patent Claim
A patent claim comprises three essential parts: the preamble, transitional phrases, and the body of the claim.
Preamble: This section specifies the type of invention for which the patent is being applied, such as a method, process, apparatus etc. The preamble should always be consistent with the title of the invention. For example, if the applicant wishes to patent a method/assembly/system, the preamble will begin like, “A method for…”
Transitional Phrases: The transitional phrases indicates whether the claim is restricted to the elements stated or whether it may apply to products or processes that have other elements. In other words, they are typically the statements that convey the idea that the claim is either limited to the items specified or encompasses more procedures with additional attributes. Some examples of transitional phrase are, comprising of, wherein, consisting of etc.
Body: This section of the claim includes all constraints and aspects of the claim and illustrates their relationship.
Preamble Transitional Phrase Body of the Claim
A bed sheet tensioning device comprising [a resilient strap with releasable fasteners at each end thereof, each of the releasable fasteners being adapted to fasten the strap to the cloth material of a bed sheet by gripping the cloth material without any part of the fasteners being included on the cloth material]
Different types of patent claims
Types of claims based on drafting
Independent Claims: Due to their ability to precisely define the distinguishing quality, they are also referred to as “primary claims.”. Independent claims are “stand-alone” claims that do not refer to any other claim. Independent claim includes a preamble and all the details required to describe the invention. The first claim, generally stands alone, establishes the level of protection that the invention is claiming. To prevent possible infringers from evading the independent claim in any way, independent claims are often more expansive than dependent claims.
Dependent claims: These claims are so called because they relate back to a prior independent or dependent claim, thereby limiting the applicability of the earlier claims. The scope of dependent claims is generally less than that of the claim upon which they are based such as independent claim. It occasionally might include well-known characteristics, even minor details and optional innovative elements of the invention.
Types of claims based on invention field
Jepson claims: The preamble of a Jepson claim describes a prior art statement, which is followed by claims that represent an improvement over the prior art. In an overview, it elaborates on the point of the invention’s uniqueness in comparison to previous art in a specific domain. Jepson claims are the most common in US patent law.
Markush claims: A Markush claim is a type of claim that is used to prevent the creation of new claims. A Markush claim allows a patent drafter to select a specific element of the invention from a group of features that all share some common characteristics.
Swiss-type claim: This type of claim is used when a previously unknown compound or substance is to be patented for a new medicinal use. In other words, this is a resurrected claim format intended to include the first, second, or subsequent medical utilisation of a well-known composition or substance.
Types of claims based on invention
Product claim: A product or apparatus claim addresses an invention’s structure or functionality. A product claim, for example, can define the components of a new device, the structure of an electrical device, or the functional components of an equipment.
Process claim: A process or method claim describes how you do something, such as perform a task, develop a product, or process the data. For example, the manner you process specific materials to form a product, encode and decode data within a particular context, or perform image recognition using an imaging system are all examples of processes which may be described with a process claim. Software and corporate approaches also fall into the process claim category.
Types of Claims based on structure
Composition claims: These claims are frequently made when an innovation relates to the elemental composition of any component or material.
Mean-plus-function claims: These claims make no reference to the precise design of the invention. Further, the mean plus function claims provides instructions on how to carry out the desired function. In a mean-plus-function claim, the element in the claim can be expressed in terms of the steps necessary to carry out a function. Additionally, the scope of these claims is broad enough to encompass all the components or structures described in the application.
Patent claims are perhaps the most significant aspect of any patent application. As a matter of fact, when drafting a patent claim, the patent drafter should always consider taking extra care and attention. The more precisely the patent claim is documented, the easier it is to defend the invention against potential infringers. The technical aspects of the invention should be stated as thoroughly as possible in the claims. Drafting a patent is a challenging task, and failure to do so properly can arise in a delay in grant, or even rejection. To avoid such disruptions, one should seek the advice/assistance of patent experts to attain a thorough understanding of preparing claims that provide better protection.
By: Dr. Paridhi Malhotra
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Patents are statutory negative rights granted for a limited period of time for 20 years. The patent right conferred is the right to exclude others from making, using, selling or offering for sale the patented invention in any jurisdiction or from importing into the specific jurisdiction. Patents are granted only for the inventions that are novel i.e. new. It is crucial to check the state of art before filing a patent to avoid anticipation.
The state of art includes patent applications, patents and non-patent literature such as publications, articles, books, thesis, conference proceedings etc. Patent databases are the source of patent applications, publications etc. and helps in identifying the relevant state of art.
Patent database is a collection of technical information that is organized so that it can easily be accessed, managed and updated. Across the globe, there are approx. 180 Patent offices in different countries operating in different languages. Thus, it is important for any database to timely cover the documents of all possible jurisdictions.
About 600,000 patents are granted globally each year covering almost every field of technology. As patent applications disclose a new technology, it is important for the innovators to track the development in the field.
Patent databases are classified into free patent databases and commercial patent databases. The free patent databases are further classified into Government databases and Non-Government databases. The Government databases are generally maintained by the respective Intellectual Property Offices. Each patent database may differ in terms of use of keywords, search strategies, use of special operators, collection of patents, time periods, languages etc.
Free Patent Databases
Free patent databases are available for free access without any subscription and can be accessed directly. This include
Government Database
Non-government Database
Government Databases are maintained by the respective patent offices of the country. They include the details of the patent applications only restricted to the respective jurisdiction or globally. Government databases are as follows:
Patentscope
Espacenet
JPO IPDL
PatFT/AppFT
INPASS
The non-government databases include Google Patents, Freepatentsonline, Patent Lens etc.
Google Patents indexes more than 87 million patents and patent applications with full text from 17 patent offices including the USPTO, the EPO and databases from China, Japan and Korea.
Freepatentsonline has search fields similar to PATFT. It allows for searches including U.S., EP, (European), JP (Japanese), and WO (PCT) patents. Alerts, portfolios, and PDF downloading are available with free registration.
Patent Lens, created by CAMBIA, an independent, international non-profit has a structured search and good range of coverage. It provides full text of PCT (1978-present), USPTO (AppFT, and PATFT (1976-present), EPO (1980-present) and IP Australia (applications and patents 1998-present).
Commercial Patent Databases
Commercial Patent databases are available for search analytics only upon subscription. The subscription tariffs vary from one database to the other. The coverage and the provision of search strategies and flexibility of operators also vary from one database to the other. The following are the few commercial patent databases:
TotalPatentOne from LexisNexis
Patbase from minesoft
Dialog from ProQuest
Orbit from Questal
STN
Thomson Innovation from Thomson Reuters
WIPS Global from WIPS
The commercial Patent databases are associated with few advantages such as:
Value added data: Corrected bibliographic data, improved classification or indexing and timely update
Sophisticated search and analysis tools: Chemical formula/Structure, sequence searches, patent topographical tools, citation analysis, machine translation
Integrated access to non-patent literature
Export of data into multiple formats
Cost based on preferential access cost
To summarize, no single patent database may not comprehensively cover all relevant information as required and the search services and databases differ in the features offered by them and a combined search and analysis from of commercial and free patent database may be more beneficial.
Author: Deepa Sai
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A patent is a type of intellectual property right (IPR) that gives its owner, the legal right to exclude others from making, using, or selling, offering for sale or importing the patented invention in the territory where patent is granted. Patent rights are granted for a limited period of time, generally 20 years from the date of filing application. As provided in, Section 2(1)(j), an invention must fulfil certain requirements known as conditions of patentability, such as, novelty, inventive step and industrial applicability.
Section 6 of the Indian Patents Act 1970, prescribes for the person who are entitled to file for patents, any person who is a first and true inventor of an invention, by any person being the assignee of the person claiming to be true and first inventor of the invention, by legal representative of any deceased person who immediately before his death was entitled to make such an application can file for patent.
A. Steps to register a Patent
Filing a Patent Application
In India, the patent registration process starts with filing of patent application in the respective patent office branch. Section 7, dealing with form of application requires every application for a patent to be made for one invention only. In order to obtain a patent, an applicant must fully and particularly describe the invention therein claimed in a patent specification. The Patent Specification, thus, forms a crucial part of the Patent Application. It is mandatory on the part of an applicant to disclose fully and particularly various features constituting the invention. The specification may be filed either as a provisional or as a complete specification.
Publication of Application
Section 11A(1) provides that no application for patents shall ordinarily be open to the public before expiry of eighteen months from the date of filing of the application or the date of priority of the application, whichever is earlier. Every application for patent shall be published on expiry of the period specified in sub-section (1) except those applications in which;
a. secrecy direction is imposed under Section 35;
b. application has been abandoned under section 9(1);
c. application has been withdrawn three months prior as specified under section 11A(3).
The publication of a patent application is an opportunity for the public or any third party to put forward any opposition with respect to the grant of patent. The opposition filed after publication of application and before grant of a patent is called as pre-grant opposition.
Examination of Application
After publication, the application is examined by the examiner of patents and first statement of objections is sent to the applicant, to be replied within 6 months from the date of issuance. There may be a hearing also before patent is granted. After examination, the patent is granted.
Grant of Patent
According to Section 43(1) of the Act, the patent shall be granted as expeditiously as possible to the applicant or, in the case of a joint application, to the applicants jointly, with the seal of the patent office and the date on which the patent is granted shall be entered in the register, where an application for a patent has been found to be in order for grant of the patent and either:
(a) the application has not been refused by the Controller by virtue of any power vested in him by this Act; or
(b) the application has not been found to be in contravention of any of the provisions of this Act,
Further, Section 43(2), specifies that on the grant of patent, controller shall publish the fact that patent has been granted and thereupon it is open for public inspection.
Renewal of the Patent
Under section 53, the term of every patent granted, shall be twenty years from the date of filing of the application for the patent. Rule 80 requires that to keep a patent in force, the renewal fees specified in the First Schedule should be paid at the expiration of the second year from the date of the patent or of any succeeding year and the same should be remitted to the patent office before the expiration of the second or the succeeding year. The annual renewal fees payable in respect of two or more years may be paid in advance.
Opposition to the Patent
The Indian Patents Act 1970 provides two types of opposition, “pre-grant and post-grant” opposition, which allow third parties flexibility to contest the validity of a patent. There are various grounds mentioned in the Act, on the basis of which a patent application may be opposed. Pre-grant opposition is the first opportunity for the opponent to challenge grant of the patent.
Once the application is published, it is kept open for a particular period of time for any opposition. The opposition of a patent that takes place before grant of the patent but after publication is called as “Pre-grant opposition”. There are various grounds mentioned in the Act, on the basis of which a patent application may be opposed. Pre-grant opposition is the first opportunity for the opponent to challenge grant of the patent.
However, even after grant of the patent, the patent is kept open for one year for any opposition called as “post-grant opposition”. The patent may be opposed within 12 months from the date of publication of the grant of the patent. There can be various grounds on the basis of which the application can be opposed. The main purpose of the opposition proceedings is to give opponents the opportunity to challenge the validity before as well as after grant of the patent.
Pre-grant Opposition
Under, Section 25(1), where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent. This opposition is called as Pre-grant opposition and it can be filed under certain grounds, which are as follows:
wrongfully obtained the invention or any part thereof
anticipation by prior publication, anticipation by prior date, prior claiming in India
anticipation by prior claiming in India
public knowledge or public use in India before the priority date
invention is obvious and lack inventive step
subject of any claim of the complete specification is not an invention
specification does not clearly specify the invention, the method of invention
providing materially false information by the applicant
application for patent not filed within 12 months of filing the first application in a convention country
non-disclosure or wrong information about the source of biological matter and
invention anticipated with regard to traditional knowledge of any community, anywhere in the world.
Post Grant Opposition
Post-grant Opposition can be filed by any “person interested” within one year from the date of publication of the grant of a patent, as laid down in Section 25(2) of the aforesaid Act. A post-grant opposition can be filed on a number of grounds as specified under Section 25(2)(a) to (k), such as:
wrongfully obtained the invention or any part thereof
anticipation by prior publication, anticipation by prior date
anticipation by prior claiming in India
public knowledge or public use in India before the priority date
invention is obvious and lack inventive step
subject of any claim of the complete specification is not an invention
specification does not clearly specify the invention, the method of invention
providing materially false information by the applicant
application for patent not filed within 12 months of filing the first application in a convention country
non-disclosure or wrong information about the source of biological matter
invention anticipated with regard to traditional knowledge of any community, anywhere in the world
On receiving the notice of opposition (post-grant opposition), the Controller shall constitute an “Opposition Board” to deal with the opposition proceedings. The board consists of such officers as the Controller may determine and refer such notice of opposition along with the documents to that Board for examination. The board examines the opposition proceedings and submits of its recommendations to the Controller. Every Opposition Board shall conduct the examination in accordance with prescribed procedures as mentioned in the Act.
Technology transfer in simple words means a process wherein owner of the technology transfers its skills, knowledge, and know-how to another party. In return owner of the technology often gets royalty which is determined based on various parameters, such as, market value of the technology, the effort needed to implement technology and initial investment etc. However one of the extremely important parameter that is to be taken into consideration is whether the technology has legal protection in the form of patent or not, though there might be possibility of protection in the form of trademark, copyright, design as well.
If worked out well, technology transfer is an extremely effective way to commercialize the patented invention. It plays an important role as a catalyst for the further development of technology and patents play a very vital role in case of technology transfer because patent is one of the best ways to protect a technology. Technology transferred without even filed for a patent is a very risky affair. At least a patent application for the technology should have been filed before negotiating on technology transfer for the reason that after grant of the patent, the certificate obtained from the patent office serves as a proof of ownership. A Patent also confers certain statutory rights to the patent holder that the technology transfer process.
Technology transfer happens by means of executing an agreement between owner of technology or Patentee and the buyer. Practically speaking, taking a patent to the level of technology transfer is a very big challenge where strength and value of the patent shall be assessed vigilantly and at the same time it is important for the patent holder to examine capacity of the buyer to manufacture, market and sell his patented invention. Technology transfer is beneficial to the patentee because he gets a channel to commercialize his invention and still have ownership of the patent with him. For the buyer, getting access to patented technology can give him cutting edge over his competitors.
Though the process of technology transfer is not as simple as it sounds, there are various success stories. As reported by The Chronicle of Higher Education, in academic research in the 2011 fiscal year, Northwestern University earned the most of any institution reporting, with more than $191-million in licensing income. The revenue mainly came from the invention related to new breeds of wheat, a new drug for the treatment of HIV, and from longstanding arrangements over enduring products like Gatorade.
Having a patent is one of the essential pre-requisites before transfer of technology though there are several other factors that determine fate of the invention to be commercialized by means of technology transfer. Well negotiated agreement between patentee and buyer can lead to a real profitable and symbiotic relationship.
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The word corona represents crown. The term coronavirus was coined in 1968 for the virus which resembled a solar corona, the bright crown-like ring of gasses surrounding the sun that is visible during a solar eclipse.
Corona Virus are a group of RNA virus which affects the mammals and birds. In mammals, the attack and effect the respiratory tract causing infections, that can be mild to severe to lethal. Mild illnesses in humans include some cases of the common cold (which is also caused by other viruses, predominantly rhinoviruses), while more lethal varieties can cause SARS, MERS, and COVID-19. In cows and pigs, they cause diarrhea, while in mice they cause hepatitis and encephalomyelitis. Corona viruses constitute the family of Coronaviridae, order Nidovirales and realm riboviria. Corona Virus have been said to have existed for around 8000 BCE. The Human Corona Virus have their origin in Bats. Coronavirus can have cold with major symptoms, such as fever, cough and sore throat.
In total six species of corona viruses are known till date, in which one strain is divided into two different strains making it a number of seven. Three human coronaviruses produce potentially severe symptoms:
Severe acute respiratory syndrome coronavirus (SARS-CoV), β-CoV (identified in 2003)
Middle East respiratory syndrome-related coronavirus (MERS-CoV), β-CoV (identified in 2012)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), β-CoV (identified in 2019)
These cause the diseases commonly called SARS, MERS, and COVID-19 respectively.
Leading Manufacturers of Corona Virus or Covid-19 vaccines
Vaccine and vaccination are derived from Variolae vaccinae (smallpox of the cow), the term devised by Edward Jenner (who both developed the concept of vaccines and created the first vaccine) to denote cowpox.
Abstract of patent: The present invention provides recombinant adenoviral vectors, immunogenic compositions thereof and their use in medicine, and methods for generating recombinant adenoviral vectors. In particular, the present invention provides an adenovirus vector comprising a capsid derived from chimpanzee adenovirus AdY25, wherein said capsid encapsidates a nucleic acid molecule comprising an exogeneous nucleotide sequence of interest.
Contact Information: University of Oxford, University Offices, Wellington Square, Oxford, OX1 2JD, United Kingdom, Telephone: +44 1865 270000, Fax: +44 1865 270708
Kind of vaccine: A VIRAL VECTOR VACCINE, adenovirus vectors rAd26 and rAd5, which promote the delivery of antigens to the human body, to promote the immune response.
Patent Number: The Russian patent RU2720614C1 has already been internationalized through application WO2021002776A1 and in the future patent protection in other countries should be requested.
Abstract of the patent: FIELD: Biotechnology, immunology, virology. SUBSTANCE: The invention relates to the field of biotechnology, immunology and virology, in particular to an immunobiological agent for the prevention of diseases caused by the severe respiratory syndrome virus SARS-CoV-2. Also, a method is disclosed for inducing specific immunity to the SARS-CoV-2 virus, comprising administering one or more immunobiological agents to the mammalian body for the prevention of diseases caused by the severe respiratory syndrome virus SARS-CoV-2. The invention allows to effectively induce an immune response against SARS-CoV-2 virus. EFFECT: the invention allows to effectively induce an immune response against SARS-CoV-2 virus.
Contact Information: The Russian Direct Investment Fund (RDIF) Capital City, South Tower, 7th 8th floor 8 bid. 1 Prsenenskaya nab, Moscow, Russian 123112, T- +7 495 644 3414, F- +7 495 644 3413
Abstract of the patent: The disclosure relates to respiratory virus ribonucleic acid (RNA) vaccines and combination vaccines, as well as methods of using the vaccines and compositions comprising the vaccines.
Contact Information: Global Headquarters 200 Technology Square Cambridge, MA 02139, T- 617- 714-6500
Name of the vaccine: Janssen COVID-19 Vaccine, JNJ-78436735
Patent’s abstract: The invention relates to the production of coronaviruses. In particular, the invention relates to methods for producing SARS-CoV by using cells expressing a functional SARS-CoV receptor.
Patent Number: The Sputnik Light vaccine is the first component (recombinant human adenovirus 26 serotype (rAd26) of the Sputnik V vaccine. Therefore, has the same characteristics as of Sputnik V.
Contact Information: The Russian Direct Investment Fund (RDIF) Capital City, South Tower, 7th 8th floor 8 bid. 1 Prsenenskaya nab, Moscow, Russian 123112, T- +7 495 644 3414, F- +7 495 644 3413
Patent’s abstract: The invention provides a novel coronavirus vaccine taking human type 5 replication-defective adenovirus as a vector. The vaccine takes replication-defective human type 5 adenovirus with combined deletion of E1 and E3 as a vector, HEK293 cells integrating adenovirus E1 genes as a packaging cell line and carried protective antigen genes are 2019 novel coronavirus (SARS-CoV-2) S protein genes (Ad5-nCoV) which are subjected to optimization design. After the S protein gene is optimized, the expression level in the transfected cells is obviously increased. The vaccine has good immunogenicity on mouse and guinea pig models and can induce organisms to generate strong cellular and humoral immune responses in a short time. The protection effect research on the hACE2 transgenic mouse shows that the virus load in lung tissues can be obviously reduced after a single immunization of Ad5-nCoV14 days, and the vaccine has a good immune protection effect on 2019 novel coronavirus. In addition, the vaccine is fast and simple to prepare, and can be produced in a large scale in a short time to cope with sudden epidemic situations.
Patent’s abstract: The invention discloses a kind of coronavirus vaccine of the receptor binding domain subunit based on dimerization, belong to pharmaceutical technology field.The present invention expresses RBD (E367 Y606) regions of MERS CoV albumen and the RBD (R294 F515) of ARS CoV by baculoviral body in insect cell, so that RBD by the cysteine residues of S protein itself 603 can form dimer or form dimer by the cysteine residues of S protein itself 512, Balb/c mouse are immunized using the RBD albumen dimer and monomer of purifying respectively. The RBD of dimerization of the invention overcomes the not enough shortcoming of RBD monomeric immunogenics, and the neutralizing antibody for substantially increasing mouse for MERS CoV is produced.
Patent number: NO DATA AVAILABLE IN THE PUBLIC DOMAIN
Contact Information:108819, Russian Federation, city of Moscow, settlement Moskovsky, settlement of the Institute of Poliomyelitis, household 8, building 1, T- +7(495) 841-90-02, +7(495) 531-01-70
The concept of Drug Exclusivity can be perceived as a period or duration of time when a drug of a particular brand is protected from other generic drugs competition in the market. The conceptualization of Exclusivity was majorly evolved to induce and bring about a balance between new drug production and competition of generic drugs.
Initially, the concept of “exclusivity” was attributed to the protection of undisclosed data, and information that have highly commercialised value that needs to be protected in accordance with the TRIPS Agreement. Under the common law, these types of date have been protected as Trade Secrets.
Therefore, Data Exclusivity can be perceived as a transformational notion of protecting data by not disclosing the data to the general public which essentially is the protection of data in the form of trade secrets and the basis of principles such as equity and good faith. In addition, the invention whose information is kept protected must confine itself to the essentialities of a patent that is- the invention must be new, should be an inventive step and must be capable of being industrially applied.
Therefore, in specific pertinence to drugs, there arises a need to gauge and assess the existing conditions in the developing countries wherein a generic drug manufacturer might develop drugs at prices that are cheaper by manufacturing a biologically equivalent drug that is similar to the innovator company.
The concept of exclusivity acts as a conflict between the inventing company that has already availed protection under the existing patent laws and that of the public interest.
Extension of Data Exclusivity to Drugs
In India, the Indian Pharmaceutical Alliance was brought notice about a rule change that was proposed by the Central Government to provide a longer duration of protection to drugs that are newly manufactured which would bring about an impact of generic and low cost medicines for the public in India.
This change was suggested in lieu of the United States Trade Representative (USTR), which falls under the United States government that is responsible for the enforcement of intellectual property from the US around the world. The proposed change by the central government was to increase the exclusivity period from the existing four years to that of ten years.
Data Exclusivity in essence includes the exclusion of registration data, and can be established as the period of not disclosing the chemical compositions, pharmaceutical compositions and any other form of agrochemical registration or test data. This is an individual intellectual property right and cannot be included under the protection that is provided by the other rights like the patents.
For Drugs, there are many clinical trials and tests that are conducted, the results of which cannot be disclosed as it is a resultant scientific discovery and the innovating company has invested expenses as well as time. A simple molecular discovery and development generally takes about a decade and is seen to be expending millions of dollars. Within this, the generation of test results takes 50% of the cost. Therefore, the data when publically disclosed might be taken advantage of by third parties.
Data and Drug exclusivity provide the innovating company with the right to secrecy and prevents third parties from utilising the data to obtain any marketing authorization for duration of time. But this right does not prevent any third parties from producing their own data.
Subsequent manufacturers could apply for their formulations and discoveries, but they have to get it sanctioned by the innovating company and prove the equivalence of the product with that of international standards. Otherwise, by simply making reference to the originator’s submitted information, they get an unnecessary benefit, as they have not played out any of the costly and tedious tests or presented any information to show the security and viability of their item. Therefore this process helps in securing and making sure that-
The innovating company obtains exclusivity of the drugs for a specified period which would enable the company to recover the costs that would be incurred while obtaining approvals.
The regulatory authority is not supposed to check the innovating company’s data, without the consent, while reviewing applications put forth by the subsequent manufacturers.
The subsequent generic manufacturers could apply for marketing sanctions if they are in a position to generate their own test results.
Without a drug data exclusivity period, subsequent registrants can bring identical items into the market solely based on bioequivalence tests without leading tedious and costly preliminary tests that are needed to show the effectiveness of the discovery. This would bring about extreme detriment to the innovating company, having made significant speculation and investments to their discoveries.
An Anatomization of Drug Data Exclusivity: A Global Frame of Reference
Data protection of drugs came into effect and gathered international limelight when the issue of unfair competition was undertaken in the Paris Convention and importance was attributed to undisclosed information. The Agreement on Trade-Related Aspects of Intellectual Property Rights, 1994 also advocates the exclusivity of information under Article 39(3).
Accordingly, the concept of drug exclusivity provides that there exists a predefined period where no subsequent manufacturer could demonstrate bioequivalence and stay away from a tests for adequacy, safety and different properties. A trade off is struck where the innovating company is permitted a specific timeframe to recover the costs engaged with the testing in; and the public premium objective of benefiting protected and proficient items in the commercial center, while empowering subsequent participant items to enter the market yet after a characterized period. The subsequent participant may not be permitted during this period to be absolutely or to some extent excluded from recording unique testing information by demonstrating bio-equality. This is a commitment of non-dependence, both by the authorities and that of the third parties.
A Reference to Indian Legal Framework
There has been immense tension on India from the nations like the US and the EU, as international embargoes on the issue of drug data exclusivity, obviously on the grounds that the vast majority of the drug monsters have a place with these nations.
As per The Official Secrets Act, 1923- has been enacted that binds the public servants and government official from using any information that is deemed to be confidential in an unauthorised manner which would ultimately affect the security, integrity and sovereignty of the country. An oppressed party might sue the Government in a Civil Court. Nonetheless, the extent of this enactment is exceptionally restricted as it doesn’t guarantee data protection, however is restricted to security against divulgence of the information which is just one of the components of information protection. There is no arrangement to address against unfair competition brought about by outsider to unlawfully depend on the innovative company’s exclusive information. Albeit, this resolution accurately concedes an oppressed party the option to guarantee harms in a common suit and get damages, it doesn’t proactively guarantee insurance against out of line business utilization of the information. Consequently, the Official Secrets Act, 1923 doesn’t guarantee information security according to TRIPS Article 39.3 principles.
Trade secret protection is a solution to forestall the revelation of information, yet it is a private cure that is untested against administrative experts in India. Moreover, regardless of whether such an apparatus might be utilized to limit the abuse of test information, it again doesn’t keep the regulatory authorities from depending on it themselves to allow endorsements to subsequent manufacturers.
The Indian Patents Act, 1970 is another significant enactment. In any case, the Patent Act is appropriate just to patentable developments and doesn’t secure new utilization of a known substance or definitions by blends. Further, patent security stretches out just to the creation yet not to the information produced by the originator.
Conclusion
The methodology suggested for drugs and pharmaceuticals includes a momentary period for which initial steps will be taken to carry out the process of minimum data protection for example to work on the protection information the board in the Drug Regulatory Authorities and to forestall unapproved revelation of information. This period will can be trailed by a post transition period which will involve a duration of 5 years in which the Drug Regulatory Authority would not depend on the information put together by the innovating company while giving second and ensuing marketing approvals.
Purple Book, brought out on September 9, 2014, by the FDA consolidates list of licensed biological products including biosimilar and their interchangeable biological products. This compendium guides pharmacists in implementing pharmacovigilance in biological products and its biosimilars. Biological products and biosimilars are FDA approved that are primarily governed under Public Health Services Act. For the FDA approval, a Biologics License Application (BLA) can be filed under sub-sections of Section 351(a) and 351(k) of PHSA. An application filed under Section 351(a) for biologics and innovator biologics should submit all requisite information supporting its safety and effectiveness. This section 351(a) application is also referred as a standalone application for its non-reliance placed on other biologic products. A BLA filed under Section 351(k) for biologics license should submit information that confirms the manufacturer’s claim that the biosimilarity of the product is based on data to animal studies, clinical studies and analytical studies. Thus, the primary purpose of the Purple Book is to enable cross-checking as to whether a licensed biological product under Section 351(k) is biosimilar to or interchangeable with the reference product and to provide information pertaining the exclusivity of such reference product. Thus, the Purple Book lists all the biological products licensed under Section 351(a) and lists correspondingly, all the licensed biosimilar and interchangeable products of the reference product.
Purple Book originally accommodated two separate lists:
Biologics approved by FDA’s Centre for Drug Evaluation and Research
Biologics approved by FDA’s Centre of Biologic Evaluation and Research
The aforementioned lists have been replaced and discontinued after FDA releasing a single, searchable, online database, Purple Book Database, storing all the information about FDA approved / licensed biological products. This planned transitioning to online database is a step forward for ensuring improved transparency and accessibility for patients, industry users and other stakeholders. The information of the biologic product listed in Purple Book include:
BLA tracking number
Product Name
Biologic product’s non-proprietary name
If a biological product is a biosimilar or interchangeable one
Application number
Approval date
Biosimilar information
Date of licensure
Date of first licensure- this indicates whether the biological product qualifies for reference product exclusivity and the expiration date to such exclusivity if applicable.
Expiration date of Reference product exclusivity (12 yrs)- This exclusivity period disallows FDA from approving a 351(k) application until the exclusivity period of reference product is expired in 12 years from its first licensure.
Biologics Price Competition and Innovation Act, 2009
BPCI Act of 2009 amended the PHSA Act to create an abbreviated approval pathway for biosimilars or interchangeable biological products, which is comparable to the one created through Hatch-Waxman Amendments for ANDA applications under FD&C Act for the Orange Book. BPCI Act requires the BLA applicant to submit evidences supporting the claim that the biological drug is biosimilar to reference product. Evidences should show that the drug has same dosage, same route of administration and same strength as the reference biological product, and additionally, exhibits no clinically meaningful differences in terms of its purity, safety and potency from the reference product. Now for the designation of interchangeability, the BLA applicant must provide requisite information to demonstrate bisoimilarity as well as to show that the biological product has same clinical result as its correspondent reference drug when administered to the patient. Moreover, it is essential to demonstrate that a biological product when administered to a patient more than once, the risks associated in terms of its safety and diminished efficacy upon alternating or switching the reference product with the biological product, should not be greater than the risks associated when administering the reference product alone.[1] Section 351(i)(3) of the PHS Act implicates that once a biological product has received the designation of interchangeability, it can be in official capacity be substituted for the reference product with no intervention from the public health care provider. [2]
PURPLE BOOK CONTINUITY ACT, 2020
Patent Listing in Purple Book
Since its time of outset, Purple Book limited itself in providing information on a biological product’s labeling of being a biosimilar or its interchangeability to a reference biological product, and accommodated no listing of patents for such biological products. However, with the recent enactment of Purple Book Continuity Act (PBCA), FDA has for the first time imposed the requirement of patent listing of approved biological products as well as FDA regulatory exclusivity information. This transparency of patent information facilitates the biosimilar developers in getting hold of the patent information before the patent dance itself. Patent dance is a procedural concept formulated under the legislation of Biologics Price Competition and Innovation Act, intended to create an opportunistic space for patent dispute resolution between biosimilar applicant and biologic license holder, thus facilitating for a less elaborative approval route for biosimilar applicants. The preliminary step that needed to be furthered for the patent dance is the disclosure of such patent information that could otherwise possibly result in infringement by the biosimilar applicant, as per Section 1(3)(a) of the BPCI Act. As per the new law, a window period of 30 days is provided for the biologic license holders to share the disclosed patent information and its expiry dates to FDA which would later be incorporated in Purple Book.
Section 325 of the Consolidation Appropriations Act has specifically recognized for biological product patent transparency which upon preliminary concordance with the Public Health Service Act, has given FDA a period of 180 days from the date of enactment of the Purple Book Database. Moreover, FDA is required to update the list within 30 days after its first publication to include newly licensed products. In regards to the patent information that has been already subjected to the disclosure during the patent dance, requires the reference product sponsor to submit such list of patents and its corresponding expiry dates before FDA, within 30 days after such disclosure to the biosimilar applicant. [3]When the exclusivity of the biologic product has been duly determined or established by the Secretary of FDA, the product would be accordingly fitted into the Purple Book.
Implications of the Patent Information Requirement in Purple Book
With the new law creating an attic for the incorporation of patent information alongside with other details of the biologic product, it is essential to understand its implications on a biosmilar applicant. As mentioned before, patent information gets incorporated in the Purple Book database only upon following a standardized disclosure of the same by the biologic license holder to the section 351 (k) applicant during patent dance. This implies that only subsequent applicants can have an effective perusal of the patent information mentioned in the Purple Book and little impact on the first applicant. It is imperative to understand that this patent information provided and updated in Purple Book is not holistic at its preliminary view since it is totally dependent on the extent of disclosure engaged in by the license holder during the patent dance. hence, when a subsequent applicant peruse through the provided patent information in Purple Book, the possibility of the applicant getting ambushed by the license holder with its unidentified patent information still lies ahead.
Exclusivity Information
Under the new legislation, FDA is required to codify all the regulatory exclusivities for biological products including any attached pediatric exclusivities.[4] Initially the list did not identify periods of orphan exclusivities of the biological products and their expiration dates, which are usually listed in Orphan Designated and/or Approved Products.[5] However, the revised Purple Book database has listed information on orphan exclusivities as well. [6]
CONCLUSION
Though biosimilar and interchangeable products are not as dominant in market place as the generic drugs in pharmaceutical sector, it is prospectively expected that the marketing of biological products will potentially increase. Even the enactment of Purple Continuity act can be viewed as a step taken towards this potential shift in pharmaceutical market. The confidentiality shield that once protected the patent information of the products are partially lifted with the new listing requirement under the Act. Essentially, this compendium is facilitated for the pharmacists in comprehending the nature of the biological product and its administration in patients, and to implement pharamacovigilance on the biological products.
One of the prime stages in the process of getting a patent is publication of the patent application in official journal of the patent office. Publication of the application, in India, happens after expiry of 18 months from the date of filing patent application or from the priority date, whichever is earlier. The publication of application happens on its own without any specific request made by the applicant. The date of publication is very crucial because on this date, the patent application is published by the patent office and from this date, the invention forms part of the prior art.
If the applicant wants application to be published before expiry of 18 months, he/she must request for publication of the application before expiry of 18 months by making request in a prescribed manner for “Early Publication”. It is important to note here that provisional application is never published, and it is only the complete specification, which gets published. The advantages and disadvantages of early publication of the application are as below:
Withdrawal of application
Upon publication of the application, the invention forms the part of prior art. However, Indian patent law gives a chance to the applicant to withdraw application within 15 months from the date of filing and such withdrawal makes sure that confidentiality of the invention is maintained. In such a case, the inventor can further work on the invention and file the patent application again. If the applicant has opted for early publication, he loses the chance to withdraw the application.
Pre-grant opposition
The pre-grant opposition can be filed by any person, upon publication of the application and anytime before grant of the patent provided examination fee has been paid. Thereby, early publication certainly gives more time for the opponents for pre-grant opposition
Rights and Privileges of the patent holder
On and from the date of publication of application for the patent and until grant of the patent, the applicant has rights and privileges of the patent holder as if the patent for the invention has been granted to him on the date of publication, provided that the applicant shall not be entitled to institute any proceedings for infringement until the patent is granted. Moreover, in case of any infringement, the applicant can claim damages from the date of publication. Here, the applicant gets the advantages if he opts for early publication.
Infringement proceedings
No suit or other proceedings shall be commenced or prosecuted in respect of an infringement committed before date of publication of the application, meaning that publication of the application is critical to initiate any suit or any other proceeding.
Expedited Examination
As per the recent amendments and the provision of the Expedited Examination for certain categories of applicants, the early publication to be filed by the applicant to seek the benefit of Expediated Examination.
The period within which the Controller shall refer the application and specification and other documents to the examiner in respect of the applications where the request for examination has been received shall ordinarily be one month from the date of its publication or one month from the date of the request for examination whichever is later. Hence, it may be conclude that early publication of the application for a patent has certain advantages as well as disadvantages which shall be taken into account depending upon the circumstances and preferences of the applicant.
Author: Bindu Sharma
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The National Dairy Research Institute (NDRI), a deemed university and a flagship institute of the Indian Council of Agricultural Research (IARI), has created low-cholesterol ghee that has been scientifically evaluated and contains up to 85 percent less cholesterol than traditional desi ghee. The unique technology, created by NDRI’s Dairy Chemistry Division, employs processing technology rather than chemicals, ensuring that the quality and taste of the finished product are identical to the original, with no additional manufacturing costs. Importantly, the procedure adheres to FSSAI requirements.
The NDRI has inked a Memorandum of Understanding with Vaishal Patliputra Dugdh Utpadak Sahkari Sangh Ltd Patna, also known as Patna Dairy Project, to launch the product in Bihar. The Patna Dairy Project has been given access to the technology for a low charge of Rs. 6 lakhs, with no time constraints.
This product is likely to appeal to India’s large health-conscious population. As a result, the NDRI is contacting Haryana and Punjab to see if this product can be made available in these states as well. The substance is safe for cardiac patients, but it can also be consumed by healthy people with no negative side effects.
PRODUCT THAT HAS BEEN SCIENTIFICALLY TESTED
This variation, which is a scientifically verified product, had a lot of potential in the cooperative sector.
This was the first time that technology created five years ago, had been transferred to a milk cooperative society.
“NDRI and Vaishal Patliputra Dugdh Utpadak Sahkari Sangh Ltd Patna, also known as Patna Dairy Project, inked a memorandum of understanding. The product will be launched by Bihar dairy officials, and it is a big dairy brand in the state “Srivastava stated.
NDRI is a famous research institute of the Indian Council of Agricultural Research and is a deemed university (ICAR). According to Srivastava, the low-cholesterol technology was given to a private dairy firm in 2011-12 with exclusive rights for five years.
“Following the completion of the contract, NDRI has chosen to make the technology available to the general public. The technology may be obtained for a minimal charge of Rs. 6 lakh, with no time limit”
“It’s a simple technology that adds no further costs to the production,”
GOOD FOR CARDIOVASCULAR PROBLEMS PEOPLE
Even though low-cholesterol ghee is highly advised for persons with cardiovascular problems, he claims that healthy people can consume it without harming their health.
Srivastava said he will meet with Vita authorities in Haryana, Verka officials in Punjab, and other cooperative dairy officials shortly to convince them to embrace the revolutionary method. “The cooperative sector should abandon traditional techniques in order to get into the massive diet-conscious market. For the new ghee to conquer the market, the cooperative should focus on smaller communities as well “he stated Srivastava said that the ghee made with the technique met all of the Food Safety Standards Authority of India’s (FSSAI) criteria and tasted and looked like regular ghee.
Cholesterol is a fatty substance that can lead to heart disease. Although cholesterol is produced in the body, the majority of it comes from the foods we eat. Cholesterol levels are high in fat-containing foods, such as egg yolk, red meat, and high-fat dairy products. High-density lipoproteins (HDL) (“good cholesterol”) and low-density lipoproteins (LDL) (“bad cholesterol”) are the two forms of cholesterol. Because of lipid accumulation in the arteries, too much LDL cholesterol causes obstruction. This is especially problematic when it comes to the heart’s coronary arteries, which can lead to heart attacks. HDL cholesterol is healthy for the heart because it eliminates cholesterol from the blood vessels.
It’s critical to understand the specific quantities of cholesterol in diets so that high-cholesterol foods can be avoided. As a result, the FSSAI has stipulated, in accordance with the Food Safety and Standards (Packaging and Labeling) Regulations, 2011, that complete nutritional information, including cholesterol (in mg) in relevant food items, must be clearly labeled on the packet so that consumers can make an informed decision based on their needs.
Conclusion
The National Dairy Research Institute (NDRI) here has decided to encourage milk cooperative societies in Haryana and Punjab to launch similar products to meet the demand of the health-conscious section of the society, just a day after transferring technology for low-cholesterol ghee to a Bihar-based co-operative dairy.
A patent assignment is an act by the patent owner in which the patent owner permanently transfers the patent’s exclusive rights to third party (Assignee). This transfer of rights is documented in the official patent record. In a patent assignment, the assignee must pay the assignor a consolidated amount and can collect profits from the patented invention subsequently. This qualifies as a consideration.
Patent licensing allows for the creation of value from innovation as well as the advancement of certain other strategic corporate objectives. Bilateral licensing transactions are the hallmark of the ‘traditional’ patent-licensing industry. It is moreover characterized by consequential transaction costs borne by the parties and information asymmetries that threaten to shrink the market over time. An exclusive license encompasses all of the patent’s rights licensee receives except the title. In this instance, the licensee enjoys the same rights as the patent owner, with the exception of the ability to transfer the patent to another individual or company. This restriction exists simply because even though the agreement allows the rights to be transferred; the patent owner retains ownership of the title.
The rights in lieu of the license agreement are predominately granted to the licensee and in accordance to the terms of the said agreement cannot be transferred further. Ergo, patent licensing is only for a limited term, when the license period ends, the owner reclaims his exclusive rights to his invention.
Professor David Teece asserted in an unconventional paper[1] that the ability to construct value from invention was dependent on interrelate assets like marketing, production, and after-sales assistance. Innovators frequently lack direct ownership or control over these assets, forcing them to license out the commercialization process.[2] Licensing can also be used to impact market demand and competitiveness. Patents are licensed out to restrict competitors from further conducting research and development.
This article states the various practices involving the re-assignment clarifying the ownership of the Patent Agreements.
Infringement Litigation
The patentee (licensor) has the sole right to sue for infringement under the Indian patent system.[3] The only statutory exceptions are the exclusive license and the licensee to whom a compulsory license has been granted.[4] A non-exclusive licensee is not allowed to sue for infringement in his or her own name.[5]
Preventing a third party from infringing on the patent, on the other hand, serves the interests of both the licensor and the licensee. Unlicensed usage by a third party will result in ULR fees being charged to the licensor. Similarly, the licensee will be concerned about an infringing competitor who has not been subjected to ULR payments, the expressions of the mutual interest. It may be however become problematic as the expenses of contesting the infringement are more than the patentee’s personal returns, (s)he may not be motivated to file the claim.
Patent buyouts
At least two instances during the early nineteenth century, when both patents and prizes were employed to encourage discovery, Governments integrated the patent and prize systems by purchasing patents. Patent buyouts are appealing because they provide the chance to eliminate monopolistic pricing distortions and duplicate research incentives while increasing rewards for innovative research. It’s crucial to investigate how they implemented the patent buyouts in practice.
Patents scarcely incentivize original research owing to the fact that potential inventors will not consider consumer surplus while deciding whether or not to pursue it. By purchasing the patent for Daguerreotype photography and releasing the technique in the public domain in 1839, the French government blended aspects of the patent system and direct government sponsorship of research. Daguerreotype photography was quickly embraced over the world after the patent was bought out, and it underwent significant technical advances. Patent buyouts like these have the capacity to eradicate monopolistic price distortions and inefficient reverse engineering incentives while further stimulating original research. Determining the price is a major difficulty for any patent buyout mechanism.
The government would propose to buy out patents at this private value times a fixed markup that would roughly cover the gap between the social and private value of inventions. Inventors could have the option of selling or preserving their patents. Government-purchased patents are usually released into the public domain.
However, in order to encourage auction participants to be honest about their appraisals, the government would select a few patents at random and sell them to the highest bidder. Encouragement of invention through such a process would necessitate greater discretion from government officials than the current patent system, but somewhat less discretion than that exercised by the National Institutes of Health.
Patents also restrict research by generating excessive motivation to produce alternatives for patented assets while providing too little incentive to develop complements. Firms can steal rents from existing patent holders by producing replacement inventions. The minimal information available implies that this issue could be intense. Mansfield, Schwartz, and Wagner (1981) discovered that 60 percent of patented discoveries were reproduced within four years, with the average imitation cost being two-thirds of the original cost of development. Potential complementary invention developers, conversely, will have insufficient incentive to create these inventions if they must first invest in developing supplementary inventions before negotiating license arrangements with original patent owners [Green and Scotchmer 1982]. Sometimes, due to asymmetric information, agreements between owners of complementary patents are not achieved, and inventions go underutilized.[6]
Grant Back
Many patent license agreements fail to address licensee improvements, allowing the licensee to file improvement patents of their own, potentially rendering the licensor’s technology obsolete or even preventing the licensor from commercializing its own product with the enhancements. By including “grant back” provisions in license agreements, a licensor can ensure that when licensing out patents covering its technology, any improvements by the licensee are granted back to the licensor. A licensor can ensure that when licensing out patents covering its technology, any enhancements made by the licensee are granted back to the licensor by incorporating “grant back” terms in license agreements.
Literature in relation to Employee-Employer Patent Ownership
By omitting to add a “deemed ownership” provision in the Patents Act of 1970, Indian policymakers missed the mark. Section 39 of the UK Patent Act, Section 132 of the Israeli Patent Act, and Section 6 of the Chinese Patent Act have all codified similar provisions. This deeming theory is founded on the “duty to invent” principle, which states that a person who has a duty to invent cannot have a patent registered in his name. This premise is based on the idea that if an employee has exploited the company’s facilities, technological know-how, or resources, the employer should not be barred from the benefits.
As a corollary, an employee who created the invention during his or her “course and scope of employment” is unable to get a patent in his or her own name. In Darius Rutton Kavasmanek v. Gharda Chemicals, the Bombay High Court was introduced this argument of “duty to invent.” The court, however, refused to evaluate the issue since it was an injunction appeal, and it could not opine on the merits of the case. In addition to the “duty to invent” argument, the “shop-right” principle, which originated in the United States, can be used to address the ownership problem. Regrettably, it has yet to be implemented in India. Even if there is no agreement for royalties, shop-right is a non-exclusive and non-transferable license with the employer to use the innovation without paying royalties. Even if the employee, who is the patent owner, sells his interest in the patent, the employer retains his shop-right in the patent under this doctrine.
When global firms are involved in Research and development activities and their inventors are Indian employees, the above-mentioned flaw in Indian patent law is very troublesome. According to Section 39 of the Patents Act, any resident of India who applies for a patent or causes an application for a patent to be filed in a country outside of India must first obtain authorization from the Controller of Patents.
For instance, a US corporation wishes to submit a patent in the US, but the inventors are Indian employees who live in the country. It might now be argued that the Indian employees, by their patent assignment agreement, have ‘caused’ the patent application to be filed in the United States, necessitating clearance from the Indian Controller of Patents. This is a significant impediment to the employer-company receiving a patent in a timely manner. Such unnecessary delay in an area as dynamic as intellectual property is likely to have an influence on the utilization of resident Indian personnel for invention. Incorporating such a provision that assigns patent ownership to the employer/company, on the other hand, will go a long way toward resolving such issues.
It’s worth noting that the United States Patent Act makes no mention of patent ownership between employers and employees. However, the courts have established a number of precedents that benefit employers“It is feared that if a corporation is denied the advantages of its success, it would cease to subsidize and experiments will go,” the court held in Goodyear Tyres and Rubber Company v. Miller in the United States. In future judgements, Indian courts could take cognizance of this and set better precedents to potentially enable occlude loopholes in the patent law.
With India’s existing patent ownership framework, the employer bears the threat of not owning the invention despite making significant investments. Employers may be hesitant to invest in research possibilities as a result of this. An equivalent approach in India, as in the United States, the United Kingdom, and other nations, would undoubtedly aid in the resolution of patent ownership disputes between employers and employees. If the invention was developed using the employer’s resources and during the course of employment, the employer should be given a say in the patent, even if there is no pre-assignment / assignment agreement for the same involving the abovementioned principles.
There clearly is a dilemma revolving the true ownership of the Patents developed under employment and the legal literature of various countries reflect the very same. The question of ownership, however, in India remains with the employer (with the assignment of intellectual property in the course of employment) development during an employment.
There is a certain exception which that outruns the private benefit and focuses on public good.
Compulsory License
Compulsory license occurs when the government grants authorization to any individual or organization to use, sell, or manufacture a patented design or product for the public good, regardless of the patent owner’s wishes. Compulsory licenses are commonly given in the pharmaceutical industry and in products that meet the standards set forth in Section 84 of the Patent Act 1970. On March 9, 2012, Natco Pharma Ltd. received the first compulsory license in India for making a generic version of Nexavar, a patented Bayer Corporation drug.
Compulsory licensing is provided under Chapter XVI of the Patents Act of 1970 as an essential precaution for defending the public interest. Any interested party can request compulsory license after three years if the invention is not fairly available to the general public. The central government has the authority to file an application with the controller, requesting that the controller endorse a patent with the ‘license of right’.
The provision of the central government was repealed by the amendment. Furthermore, required adjustments were made with regard to whether the public requirements were fulfilled, if the innovation is not manufactured in India or if the patentee refuses to accord a license, by removing a presumption that the public’s requirements are fulfilled based on local manufacture. The amendment also granted the controller the authority to issue a forced license in the event of a national emergency. There is also a provision that allows a third party to apply for a compulsory license even though the invention is not manufactured in India. This shift also allows the controller to revoke the compulsory license if the circumstances that led to it cease to exist.
In simple terms, the choice to assign or license is based on the most profitable commercialization route available to the patent holder. And, while making a decision, the advantages of receiving royalties or alternatively receiving a lump sum price, giving away title, or simply surrendering the rights to commercialize the invention in a certain location for a set length of time must always be evaluated against one another. Assignment may occasionally seem more beneficial than licensing.
Regardless of the fact that the law safeguards a patentee’s interests, the patent holder must prepare an appropriate assignment or license agreement to avoid any potential disputes regarding the ownership. Intellectual property rights have only recently come to the attention of the general public. Where industrial property is adequately protected, which in turn raises the country’s economy, a comprehensive understanding of intellectual property rights is vital. The entire legal infrastructure was furnished by the Government of India. Software, traditional knowledge, plant varieties, and geographical indications have all been accorded specific legal provisions. Among these provisions, certain remedies are only available to the owner of the intellectual property; hence the determination of ownership and proper re-assignment becomes vital.
[1] David J. Teece, “Profiting from Technological Innovation : Implications for Integration, Collaboration, Licensing and Public Policy”, 15 Research Policy 285 (1986).
[5] Pravin Anand, T. Saukshamaya & Aditya Gupta, India, in Patent Litigation : Jurisdictional Comparisons 201, 203 [Massimo Sterpi et al. (eds.), 2011]; Suchita Saigal, Parul Kumar & Aditya Verma, Licensing Intellectual Property Rights’ Use, in The Law of Business Contracts in India 92, 96 (Sairam Bhat edn., 2009).
[6] The Quarterly Journal of Economics , Nov., 1998, Vol. 113, No. 4 (Nov., 1998), pp. 1137-1167
The process of obtaining the grant of a patent begins with drafting of the patent specification and filing in appropriate branch of patent office. After filing, application is published and take up for examination. Examiner performs a patent search or prior art search to assess novelty of the invention before granting a patent. Once examination has taken place and the applicant has replied to all objections raised by the examiner, patent is granted. Even though patent is granted by the patent office, there may be some additional grounds based on which it may be possible to invalidate a patent. In India, if the patent has to be invalidated, it can be done at 3 levels, i.e., pre-grant opposition (before a patent is granted), post-grant opposition (within 12 months from the date of grant) or revocation (after 12 months’ time has expired from the date of the grant).
When in invalidation or validation search done?
Though the steps to perform validation or Invalidation search are same, purpose and outcome may be different. Invalidation search is performed to identify the grounds on the basis of which a patent can be opposed or revoked whereas validation search is primarily performed to find out how strong the patent is compared to prior art and how strong is it to sustain a litigation. In simple words, we can say that when a search is conducted to validate the claims of a given patent, it is called Patent Validity search and when it is used to invalidate the claims of a given patent then it is called Patent Invalidity Search. Other that prior art in the form of patents, this search also includes the non-patent literature.
Some of the scenarios where invalidation or validation search is performed are:
In case of patent infringement, when defendant wants to oppose or revoke a patent, he performs invalidation search to identify statutory grounds on the basis of which patent can be invalidated. Therefore, invalidation report’s finding form part of opposition or revocation petition and helps the defendant to gauge the substance of patent infringement.
In case of Technology Transfer process or at the time of valuating a patent, the patent to be licensed, often needs to be validated to find how strong the patent is. Here, the invention claimed in the patent specification is usually analysed in comparison with the prior art to understand how strong the patent is and this may be a great impact over the royalty fixed between the parties to license the patent.
Sometimes the companies launch their products in the market without performing infringement analysis or FTO (Freedom to operate) search or don’t have knowledge about existing patents which they might be infringing. After they get to know about some existing patents that they might be infringing, it may be too late for them to stop manufacturing the product. In this situation, if there is no other option left and they are willing to take some risk, they usually get invalidation search done to understand the kind of risk they are taking by using third party’s patent (s).
The statutory grounds to invalidate a patent will differ according to the national patent laws of different countries. However, most national laws recognize grounds such as novelty, inventiveness of the invention as grounds to oppose a patent application or a patent. Therefore, an exhaustive prior art search will be directed at each of these separate sources of prior art to identify the prior publication to invalidate the patent.
Steps to perform an invalidation search
The broad steps to perform invalidation search are as below:
Check legal status of the patent and the country wherein it is granted.
Perform a global prior art search, restricted by priority date of the patent to be invalidated. Prior art available, before data of priory of the patent to be invalidated shall be taken into consideration. While performing search, it is highly recommended to perform a search in research papers too.
Claims of all prior art and patent to be invalidated may be mapped to understand clearly the extent of overlap. It helps to understand novelty and inventiveness of the patent to be invalidated.
Further, file wrapper history of the patent to be invalidated shall be checked thoroughly to find out if there is any official requirement which the patent holder has skipped. And this may be a useful piece of information to be added in the report.
Finally, all findings shall be compiled to an Invalidation Report.
We at Origiin have expert team to perform Invalidation/Validation search for Patents. Our deliverables include:
Invalidation report
Claim mapping
All prior arts in PDF format
Please contact us at info@origiin.com to know more about our services (Patent, Trademark, Copyright, Contract, IP Licensing, M&A of companies)
Biosimilars can be perceived as a category of biological product that have been sanctioned and approved by due regulatory authorities in consonance with the fact that these products are highly alike and akin to a biological product that has been approved on a prior basis. This previously approved biological product is known as the biological reference product.
In distinct contrast to the chemically synthesised generic versions of drugs, biosimilars are sanctioned in accordance with the standards of the pharmaceutical standards, effectiveness, efficacy and safety that are in common parlance applied to all biological medicines.
Biosimilars and Generic Medicines- An underlying dissimilarity
A Biosimilar cannot be perceived as a generic biological medicine, in due accordance with the process of manufacture of a Biosimilar. This means that the variability that occurs naturally and the complex process of manufacturing biological medicines does not facilitate the process of exact replication of molecular microheterogeneity.
Biosimilars are seen to be very similar to the reference product that they are manufactured in comparison to, but have certain minute differences in terms of the purity and potency.
An Anatomization of Biosimilars- Legal and Regulatory Framework in India
India refers to Biosimilars as “similar biologics” and has paved its way into the biosimilar industry with the first launch of “similar biologic” for the disease hepatitis B. India has about 95 biosimilars that are duly approved by the regulatory authority.
In India, the Central Drugs Standard Control Organization is the national authority and the regulatory body that has introduced new guidelines for biosimilars that became effective from the 15th of August, 2016. The previous guidelines that were in existence with regards to biosimilars were the “Draft Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India” which was effective from 2012.[i]
The 2012 guidelines seek to address the pre and post-marketing regulatory requirements body which is also known as the comparability exercise. These guidelines direct and address the requirements related to the manufacturing process and quality control.[ii]
India follows the pattern of “sequential approach” with regards to biosimilar products. The guidelines that were released in 2016 focus on the aspect of Post Marketing. The major vital difference underlined between the 2012 and 2016 guidelines is the Reference product. If the reference product cannot be marketed in India, it could be licensed and marketed in any ICH Country (International Council for Harmonization).
Apart from the guidelines as enforced by the Central Drugs Standard Control Organization, biosimilars are also synchronised and balanced by the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, Recombinant DNA Safety, 1990 and the Guidelines and Handbook for Institutional Biosafety Committee, 2011.
Market Authorization for the sale of these biosimilars in India is authorised by the Department of Biotechnology via the Review Committee on Genetic Manipulation. There are three stages that act as a precursor to the marketing authorization of these biosimilars- pre-clinical, clinical and post-clinical trials.
The Pre-Clinical Trial process includes information on the biological reference product, and the corresponding information on the biosimilar. This trial phase also includes the submission of details with regards to the downstream process development like that of fermentation, considerations of molecular biology and other quality based considerations.
The Clinical Phase consists of information in consonance to the pharmacokinetic, pharmacodynamics, immunogenicity and other efficacy studies.
The Post- Clinical Trial process includes the studies carried out on the marketing of the biosimilar, drug safety and reporting of any adverse reactions to the drug.
These trial phases and processes are exhibited in the strict and stringent manner in India. In the case of Roche Products (India) Private Limited v. Drugs Controller General of India[iii], Roche had filed a case against two other pharmaceutical companies in lieu of non-adherence to the guidelines applicable and grossly misrepresenting the generic drugs as biosimilars. The court enforced a restraining order on the pharmaceutical companies.
PatentProtection of Biosimilars in India
It is of immense necessity to conform to the regulations set out for the production and trial process to duly attain the right of marketing the biosimilar in India. The process of patenting biosimilars is subject to the criteria that are applicable to patentable items like that of novelty, involving an inventive step and industrial application of the biosimilar. The nature of biosimilars mandates it to be close in efficacy and nature to the biological reference product.
Therefore, these biologic medicines and biosimilars are subject to and governed by Section 3 of the Patents Act. Any biological product that are not naturally occurring and are synthetically developed by human beings could be patented, but if it contains a living organism that occurs in nature then it would fall under Section 3(c)[iv] which rules out the patentability of a scientific discovery or conception of abstract theories.
Section 3(d)[v] of the Patents Act, lays down the following for which patent protection is prohibited-
The sole discovery of any new forms of a known substance if it does not increase the effectiveness and efficacy of the substance at hand.
The discovery of any new property of a substance that has already been discovered.
Albeit, a few boundaries for deciphering improved viability for drugs have risen up out of court choices, as far as biopharmaceuticals (especially biosimilar innovations) the subtleties stay obscure.
Trends Observable
Albeit Indian organizations are known for delivering conventional and generic biological drugs, many organizations are presently moving into the worldwide biosimilars market. As per the Associated Chambers of Commerce of India’s 2017 Report, biosimilars sum to $2.2 billion of the $32 billion Indian market – and is required to accomplish a development pace of around 30% build yearly development. A phenomenal illustration of the organization of worldwide drug firms in concurrence with an Indian drug organization can be discovered when Swiss-based Roche went into a concurrence with Emcure for Herceptin, a biosimilar utilized for human epidermal development factor and in instances of positive metastatic bosom and gastric disease. The medication was subsequently promoted by Emcure in India under the brand name ‘Biceltis’. In another model, Mylan, a worldwide monster with an enormous generics portfolio, gone into association with Bangalore-based biopharmaceutical organization, Biocon. Trastuzumab, a biosimilar made by the joint endeavors of both the organizations to lessen febrile neutropenia during chemotherapy, was supported by the US Food and Drug Administration in 2018 and was the first biosimilar created by an Indian organization to be endorsed in the United States.
In spite of the fruitful turn of events and showcasing of some biosimilars by Indian companies, innovative work in this space will face difficulties with regards to the improvement biologics and biosimilars. As opposed to generics – which are comparative instead of indistinguishable from the marked medication – biosimilars are substantially more mind boggling and costly to produce. In furtherance, as opposed to the generics business, biosimilars are likewise dependent upon rigid clinical courses of events obviously characterizing administrative methodology for enormous scope, complete clinical projects setting up the security and viability for treatment of demonstrated problems. The oddity of the biologic and biosimilar improvement measure makes it hard for new organizations to enter this space. Considering an illustration of other drug organizations in India, Dr Reddy’s Laboratories, Cipla, Lupin and Aurobindo are additionally producing biosimilars, some of which are endorsed for promoting. It is normal that more Indian drug organizations will have the capacities and assets to create biosimilar items. As need be, steady and clear administrative and authoritative rules are at present expected by the business.
Conclusion and Way Ahead
In layman’s context, pharmaceutical products and biosimilars are a combination of effort and time from the conception of idea to the process of commercialisation and require rigorous endeavours with regards to research and development. There has been a rampant and a pronounced switch in the pharmaceutical industry of India to that of biopharmaceutical products. It has been seen that regardless of the extra time and exertion needed for advancement and foundation for research work, just as the patching up of consolidations and extensions, it is expanding to address the issues of the biologics.
[i] Government of India, Department of Biotechnology, Central Drugs Standard Control Organization. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India; 2012.
[ii] Government of India, Department of Biotechnology, Central Drugs Standard Control Organization. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India; 2016.
[iii] Roche Products (India) Pvt. Ltd. and Others v. Drugs Controller General of India and Others, 2014 SCC OnLine Del 7682.
Under the ambit of Section 66, the seemingly impenetrable shield provided by patents undergoes legal scrutiny, particularly when the public interest is perceived to clash with the exclusive rights granted to patent holders. Section 66 of the Act runs as follows:
In 2005, the Madras Patent Office considered and later (in 2006) rejected the product patent application filed by Novartis AG for Glivec on the basis that it was not novel, that is obvious to a person skilled in the art and was anticipated by the prior publication of Zimmermann patent; Novartis AG had also wrongly claimed date of filing of the application in Switzerland as the priority date in India. Further, Section 3(d)
In India, the law of patents is governed via the Indian Patents Act 1970, with notable amendments in 2002 and 2005. A patent is an exclusive right granted to the true and first inventor of an invention for a period of 20 years from the date of filing. Section 2(1)(j)
Patent licensing is the process by means of which patent owner grants permission to other party or licensee to use the patented invention for a specific period of time in a particular jurisdiction in lieu of royalty. By granting license to use the patent, the patent owner is able to introduce his patented invention into the new markets through the licensee, who, in most of the cases, is a well-established company. By obtaining a license, the licensee gets to exploit the patented invention in terms of building, marketing and selling innovative products.
Invalidation or validation search is a kind of search wherein prior art is compared with the patent to assess the ease or difficulty involved in invalidating the patent. The term ‘Invalidation’ is often used when patent office declares a patent to be invalid as a result of pre/post-grant opposition or revocation of the patent. Before patent is granted and after its publication, there is a chance for third parties to oppose a patent application to prevent it from getting granted on the basis of statutory grounds listed under Section 25 (1) of the Indian patents Act 1970. Likewise, there are statutory grounds for post-grant opposition and revocation of patents also listed under section 25 (2) and Section 64 of the Act, respectively. It is important to note here that the Controller of Patents invalidates the patent only when opposition or revocation petition is filed by the third party (ies). Decision to invalidate the patent is taken by the Controller after reviewing arguments and evidence submitted by both the parties (i.e., opponent and patent owner). The steps and process involved to perform invalidation and validation search are the same but the outcome or opinion may be different. An invalidation search is performed to identify the grounds on the basis of which a patent can be 
The System comprises of the 
The first ever aeroplane was introduced to the world in North Caroline on the 17th of December in the year 1903 by Orville and Wilbur Wright, who are popularly known as the 
There are numerous benefits associated with rainwater harvesting. Firstly, it provides an additional water source, reducing the strain on existing water supplies and alleviating water scarcity concerns. Secondly, rainwater harvesting helps to mitigate the burden on storm water drainage systems, reducing the risk of flooding and soil erosion. It also promotes self-sufficiency and resilience, as individuals and communities rely less on centralized water distribution systems. Rainwater can be utilized for various purposes, such as irrigation, household chores, livestock watering, and even after proper treatment, for drinking. Utilizing rainwater for non-potable purposes helps conserve precious freshwater resources, which can be reserved for essential needs.
In an era of technological advancements, innovations are on a verge of representing the qualitative approach of a changing society. On one hand, innovations have the potential of ameliorating the quality of life by significantly contributing to labor and production. On the other hand, such transitions also demand ground-breaking competitive advancements that can square up to the needs of changing dynamics of developments. The ideology of managing the adoption and flow of knowledge has become a crucial parameter for every country. Therefore, it’s of utmost importance to focus on scientific and technological research methods for fruitful exchange to maintain the aura of competition.
The state of art includes patent applications, patents and non-patent literature such as publications, articles, books, thesis, conference proceedings etc. Patent databases are the source of patent applications, publications etc. and helps in identifying the relevant state of art.
A patent is a type of intellectual property right (IPR) that gives its owner, the legal right to exclude others from making, using, or selling, offering for sale or importing the patented invention in the territory where patent is granted. Patent rights are granted for a limited period of time, generally 20 years from the date of filing application. As provided in, 
If worked out well, technology transfer is an extremely effective way to commercialize the patented invention. It plays an important role as a catalyst for the further development of technology and patents play a very vital role in case of technology transfer because patent is one of the best ways to protect a technology. Technology transferred without even filed for a patent is a very risky affair. At least a patent application for the technology should have been filed before negotiating on technology transfer for the reason that after grant of the patent, the certificate obtained from the patent office serves as a proof of ownership. A Patent also confers certain statutory rights to the patent holder that the technology transfer process.
Corona Virus are a group of RNA virus which affects the mammals and birds. In mammals, the attack and effect the respiratory tract causing infections, that can be mild to severe to lethal. Mild illnesses in humans include some cases of the common cold (which is also caused by other viruses, predominantly rhinoviruses), while more lethal varieties can cause SARS, MERS, and COVID-19. In cows and pigs, they cause diarrhea, while in mice they cause hepatitis and encephalomyelitis. Corona viruses constitute the family of Coronaviridae, order Nidovirales and realm riboviria. Corona Virus have been said to have existed for around 8000 BCE. The Human Corona Virus have their origin in Bats. Coronavirus can have cold with major symptoms, such as fever, cough and sore throat.
Therefore, Data Exclusivity can be perceived as a transformational notion of protecting data by not disclosing the data to the general public which essentially is the protection of data in the form of trade secrets and the basis of principles such as equity and good faith. In addition, the invention whose information is kept protected must confine itself to the essentialities of a patent that is- the invention must be new, should be an inventive step and must be capable of being industrially applied.
Purple Book, brought out on September 9, 2014, by the FDA consolidates list of licensed biological products including biosimilar and their interchangeable biological products. This compendium guides pharmacists in implementing pharmacovigilance in biological products and its biosimilars. Biological products and biosimilars are FDA approved that are primarily governed under Public Health Services Act. For the FDA approval, a Biologics License Application (BLA) can be filed under sub-sections of Section 351(a) and 351(k) of PHSA. An application filed under Section 351(a) for biologics and innovator biologics should submit all requisite information supporting its safety and effectiveness. This section 351(a) application is also referred as a standalone application for its non-reliance placed on other biologic products. A BLA filed under Section 351(k) for biologics license should submit information that confirms the manufacturer’s claim that the biosimilarity of the product is based on data to animal studies, clinical studies and analytical studies. Thus, the primary purpose of the Purple Book is to enable cross-checking as to whether a licensed biological product under Section 351(k) is biosimilar to or interchangeable with the reference product and to provide information pertaining the exclusivity of such reference product. Thus, the Purple Book lists all the biological products licensed under Section 351(a) and lists correspondingly, all the licensed biosimilar and interchangeable products of the reference product.
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Patent licensing allows for the creation of value from innovation as well as the advancement of certain other strategic corporate objectives. Bilateral licensing transactions are the hallmark of the ‘traditional’ patent-licensing industry. It is moreover characterized by consequential transaction costs borne by the parties and information asymmetries that threaten to shrink the market over time. An exclusive license encompasses all of the patent’s rights licensee receives except the title. In this instance, the licensee enjoys the same rights as the patent owner, with the exception of the ability to transfer the patent to another individual or company. This restriction exists simply because even though the agreement allows the rights to be transferred; the patent owner retains ownership of the title.
The process of obtaining the grant of a patent begins with drafting of the patent specification and filing in appropriate branch of patent office. After filing, application is published and take up for examination. Examiner performs a patent search or prior art search to assess novelty of the invention before granting a patent. Once examination has taken place and the applicant has replied to all objections raised by the examiner, patent is granted. Even though patent is granted by the patent office, there may be some additional grounds based on which it may be possible to invalidate a patent. In India, if the patent has to be invalidated, it can be done at 3 levels, i.e., 
A Biosimilar cannot be perceived as a generic biological medicine, in due accordance with the process of manufacture of a Biosimilar. This means that the variability that occurs naturally and the complex process of manufacturing biological medicines does not facilitate the process of exact replication of molecular microheterogeneity.
