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

Apr 24, 2024 | Patent

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]

2. 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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Examining Refusal of Patents Based on Public Policy and Morality in Legal Practice

Apr 15, 2024 | Patent

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.

Harvard Oncomouse Case[14]:

Facts

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

1. Upon meeting the essential patentability requirements, should parents be granted regarding living animals and their varieties, specifically for higher stature animals such as mammals?
2. 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.

Author: Hardik Manwani, UPES Dehradun

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Minimising Patent Infringement Risk

Mar 27, 2024 | Patent

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:

1. Identification of components of the product to be launched and listing out nomenclature of the components, as generally used in the industry.
2. 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.
3. 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.
4. 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.
5. 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”.
6. 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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

Author: Bindu Sharma, CEO, Origiin IP Solutions LLP

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