Section 8 Compliance in India: Disclosure Obligations and Prosecution Risk for PCT Applications

For foreign patent attorneys entering India through the PCT route, Section 8 of the Patents Act, 1970 is often underestimated. It is frequently viewed as a procedural filing requirement to be completed at the time of national phase entry. In practice, it is a continuing statutory obligation that can influence examination, opposition, and even post-grant validity. Non-compliance is routinely raised in First Examination Reports and is regularly invoked in contentious proceedings.

Section 8(1) requires an applicant to furnish details of corresponding foreign applications relating to the same or substantially the same invention. This disclosure is typically made through Form 3 at the time of filing or within the prescribed period. However, the obligation does not end there. Section 8(2) empowers the Controller to require submission of additional details concerning the processing of such foreign applications, including examination reports and the status of claims. The statutory language makes it clear that this is a continuing responsibility throughout prosecution.

In the context of PCT national phase applications, a common misconception is that the international search report and written opinion available in the public domain sufficiently address disclosure concerns. That assumption is misplaced. Once the application enters India, the applicant must independently comply with Section 8 requirements. If there are parallel national phase entries, continuation filings, divisionals, or significant claim amendments in other jurisdictions, these developments may fall within the scope of disclosure. Failure to update the record when required can trigger objections and, in adversarial settings, become a strategic ground of challenge.

The phrase “same or substantially the same invention” is interpreted broadly. It can extend to parent applications, divisionals, continuations, and related family members depending on the degree of claim overlap. From a risk management perspective, incomplete disclosure presents greater exposure than comprehensive disclosure. At the same time, indiscriminate reporting without monitoring consistency across jurisdictions can create complications if positions taken abroad differ from those advanced in India. The disclosure must therefore be accurate, timely, and coordinated with global prosecution strategy.

Section 8 has been used as a ground in both pre-grant and post-grant opposition proceedings, as well as in revocation actions. Although judicial interpretation has evolved and courts have emphasized materiality rather than automatic invalidation, Section 8 remains a litigation-sensitive provision. Opponents routinely review foreign prosecution histories and compare them with Indian disclosures. In high-value sectors such as pharmaceuticals, chemicals, and technology-driven portfolios, allegations of incomplete or inconsistent disclosure are frequently raised alongside novelty and inventive step challenges.

In practical terms, exposure often arises not from deliberate omission but from portfolio complexity. Large patent families with multiple continuations, divisionals, and jurisdiction-specific claim amendments increase the likelihood of gaps in disclosure. Office actions from major jurisdictions that are not furnished when requested, or inconsistencies in claim scope that are not reconciled in the Indian record, can become focal points during opposition. Coordination failures between global prosecution teams and Indian counsel are a common source of difficulty.

During examination, Controllers may raise objections where Form 3 appears outdated or inconsistent with publicly available information. Requests under Section 8(2) must be handled with care and within the stipulated timelines. Delayed or incomplete responses can weaken the applicant’s position and extend prosecution unnecessarily. India should not be treated as a passive jurisdiction within a large global portfolio. Disclosure management requires active monitoring throughout the lifecycle of the application.

At the national phase entry stage, it is prudent to conduct a structured review of the global filing landscape for the invention. This includes identifying related family members, understanding the status of foreign prosecution, and anticipating potential future filings such as divisionals. Establishing an internal mechanism to track developments in key jurisdictions and update Indian disclosures accordingly reduces procedural vulnerability. In commercially significant matters, disciplined Section 8 compliance is as important as substantive patentability arguments.

Section 8 is not a clerical requirement. It is a statutory obligation with procedural and strategic consequences. For PCT national phase applications entering India, particularly those forming part of complex international portfolios, proactive disclosure management is essential to reduce examination delays and opposition risk.

For coordinated Section 8 compliance strategy and prosecution support in India PCT national phase matters, please contact us at https://origiin.com/contact-us/. To understand the India national phase procedure and compliance framework in detail, please visit https://origiin.com/pct-national-phase-entry-india/.

Pre-Grant Opposition in India: Risk Assessment for PCT National Phase Applications

For foreign patent attorneys managing PCT portfolios, India introduces a procedural element that requires deliberate risk assessment: the pre-grant opposition mechanism. Unlike many jurisdictions where third-party challenges arise only after grant, Indian patent law permits opposition at any time after publication and before the patent is granted. For commercially relevant technologies, this creates a real and measurable exposure during prosecution.

Pre-grant opposition is governed by Section 25(1) of the Patents Act, 1970. Any person may file a representation opposing the grant of a patent after the application is published and before it is granted. The breadth of this provision is significant. The opponent does not need to demonstrate commercial harm or standing in the traditional sense. Competitors, industry participants, or even public interest groups may initiate proceedings.

In the context of PCT national phase applications, timing becomes important. Once the international application enters India and is published in the Indian Patent Office database, the window for pre-grant opposition opens and remains active until grant. This means that even after a favorable response to a First Examination Report, and even when the application appears close to allowance, a third-party intervention may alter the prosecution trajectory.

The statutory grounds for pre-grant opposition broadly reflect invalidity grounds familiar in other jurisdictions. These include lack of novelty, lack of inventive step, non-patentable subject matter, insufficient disclosure, wrongful obtaining, and failure to comply with disclosure requirements such as those under Section 8. In practice, certain grounds are more frequently invoked in national phase matters. Inventive step challenges supported by multiple prior art combinations are common. In pharmaceutical and chemical cases, objections under Section 3(d) are routinely raised. In software and AI-related applications, subject matter exclusions under Section 3(k) often form part of the opposition strategy. Procedural lapses, particularly incomplete disclosure of foreign filings, are also used tactically.

The practical impact of a pre-grant opposition can be substantial. The proceedings introduce an adversarial dimension into what would otherwise be routine examination. Written submissions become more detailed. Hearings are frequently required. Technical arguments must be supported with clarity and consistency across the specification and claims. The timeline to grant may extend, and prosecution costs inevitably increase.

Not all applications carry the same exposure. The likelihood of opposition tends to correlate with commercial visibility and competitive sensitivity. Applications covering pharmaceutical compounds, medical devices, telecom standards, or high-value platform technologies are more likely to attract scrutiny. A crowded prior art landscape or unusually broad claim scope relative to the disclosure may further increase vulnerability. Where a product is already launched or publicly discussed in the Indian market, the risk profile rises.

For foreign associates considering India at the national phase stage, pre-grant opposition should be part of the initial evaluation. It is prudent to assess whether the specification contains sufficient technical depth to withstand inventive step attacks, whether subject matter exclusions have been adequately addressed in the drafting, and whether procedural compliance has been meticulously maintained. If the original PCT disclosure is thin or heavily functional, strategic claim calibration at the time of entry may reduce exposure.

Pre-grant opposition does not automatically suspend examination. The Controller considers the representation alongside the examination record. In practice, this often results in consolidated hearings where both the applicant and the opponent present arguments. The quality of written advocacy becomes critical. Arguments must address not only statutory objections raised in the First Examination Report but also the technical and legal positions advanced by the opponent.

From a portfolio management perspective, opposition exposure should be weighed against commercial objectives. In some cases, a narrower but defensible claim set may offer greater long-term value than pursuing maximal scope at the risk of prolonged challenge. In others, the commercial importance of the invention may justify a more assertive prosecution strategy despite anticipated opposition.

Pre-grant opposition in India is neither exceptional nor unpredictable. It is an established component of the patent system. For PCT national phase applications of strategic significance, it should be treated as a foreseeable procedural risk. Early technical evaluation, careful claim structuring, and strict procedural compliance materially strengthen defensibility before the Indian Patent Office.

Origiin IP Solutions LLP regularly advises foreign patent attorneys and law firms on opposition risk assessment for India PCT national phase applications and represents applicants in pre-grant opposition proceedings. A structured review at the entry stage can significantly influence prosecution strategy and overall portfolio strength in India.

For strategic assessment of pre-grant opposition exposure and prosecution support for India PCT national phase applications:
https://origiin.com/contact-us/

To understand the India PCT national phase procedure, timelines, and compliance framework in detail:
https://origiin.com/pct-national-phase-entry-india/

Central Government’s power to revoke a patent under Section 66

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.

  1. The Agracetus Case- 1994[3]

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]

  1. The Avesthagen Case- 2012[6]

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.

Author: Manya Manohar, Symbiosis Law School, Pune

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Patent Opposition: Before and after the patent grant

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

  1. 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.

  1. 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.

  1. 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.

  1. 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.

  1. 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.

Author: Yashwi Singh, K.L.E Society’s Law College, Bengaluru

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