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 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]
- 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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