Innovation and Regulation: The Dynamics of Patent Evergreening in India

Introduction:

Evergreening is a method where efforts are made to overextend patent monopolies by obtaining patents for minor or insignificant modifications to the original invention. Patent evergreening is a prevalent strategy primarily observed in industries like pharmaceuticals. The mechanism involves filing additional patents to the original one, thereby shielding the invention and impeding any potential competitors from entering the market for a considerable period of time. However, the strategy has its share of benefits and drawbacks. On the positive side, patent evergreening fosters continued innovation and incentivises research and development. Conversely, critics argue that it can stifle competition, limit access to affordable alternatives, and raise concerns about the true spirit of patent protection.

Legal Framework and Challenges:

The cornerstone principle of our nation’s patent law is grounded in the requirement that a patent can only be granted for an invention demonstrating both novelty and utility. This dual criterion ensures that only genuinely innovative and beneficial creations are eligible for patent protection. In line with this ethos, India’s patent legislation explicitly addresses the issue of incremental advances, colloquially termed “evergreening,” through the Indian Patent Act of 1970, Chapter II, Section 3(d). Section 3(d) of The Patents Act, 1970, stands out as a pivotal element in Indian patent law, introduced in 2005 with the intent of discerning substantive innovation from minor modifications. This provision gained significant prominence during the rejection of Novartis’ patent application for the drug Glivec. Despite legal challenges to its constitutional validity, the Madras High Court upheld Section 3(d). The rejection of Glivec’s patent was subsequently affirmed by the Intellectual Property Appellate Board (IPAB) and later endorsed by the Supreme Court in 2013.

The Novartis case serves as a testament to this changing paradigm, highlighting a more proactive stance in the legal landscape to thwart attempts at extending patent monopolies through evergreening practices. This shift not only reinforces the commitment to protecting genuine innovation but also positions India as a robust participant in the global intellectual property arena. However, despite the clarity provided by court decisions affirming the anti-evergreening stance, there have been concerns about the inconsistent application of Section 3(d) by the Indian Patent Office (IPO). This discrepancy highlights the ongoing challenges in ensuring consistent and robust enforcement of anti-evergreening measures to safeguard the integrity of the patent system and promote genuine innovation in India.

The Novartis case:

Evergreening has surged to the forefront of discussions, particularly following a landmark ruling by the Supreme Court of India in Novartis v Union of India that rejected a patent application by the Swiss pharmaceutical giant Novartis. The company sought a patent for an updated version of its cancer drug Gleevec (imatinib mesylate), contending that the new formulation exhibited improved absorption into the bloodstream, a critical factor in treating leukemia. In the Novartis case, the denial of a patent for Glivec under Section 3(d) of the Patents Act highlighted the stringent criteria set forth in India's patent legislation. This decision was grounded in the requirement outlined in Section 2(1)(ja), which mandates that a product must exhibit a technical improvement over its predecessor that is not apparent to a person of ordinary skill. Glivec, being essentially a modified version of imatinib, failed to meet this criterion.

Additionally, Section 3(e) of the Patents Act sets clear guidelines for the patenting of mixtures of well-known compounds, permitting such patents only if a synergistic effect is demonstrated. In the context of Glivec, this provision played a pivotal role in the rejection of the patent application. Furthermore, Section 3(i) reinforces the principle that exclusivity over treatment modalities cannot be claimed, emphasising the legislative intent to prevent the granting of patents for methods of treatment and ensuring that advancements in healthcare remain accessible and available for the greater good. These provisions collectively underscore the careful balance between encouraging innovation and safeguarding public interest within the Indian patent system. This legal stance exemplifies India's proactive approach to addressing concerns related to pharmaceutical evergreening practices.

Challenges of Patent Evergreening:

The intricacies of India’s patent law, particularly evident in Sections 3(d) and 3(e), reflect the delicate balance between encouraging innovation and preventing the granting of patents for incremental advancements. While Section 3(d) establishes a high threshold for secondary patents, necessitating the submission of clinical evidence, Section 3(e) introduces a less precisely defined criterion related to demonstrating synergy in cases of known substances. Patent applicants, particularly in fields like pharmaceuticals, have adeptly navigated these legal nuances. Applicants often have sidestepped the stringent evidential requirements of Section 3(d). Instead, they redirect attention to Section 3(e), asserting the need to demonstrate synergy in mixtures of known substances. This strategic manoeuvring highlights the need for ongoing scrutiny and refinement of patent laws to maintain a balance that incentivizes genuine innovation while preventing the dilution of patent criteria through legal manoeuvring.

Criticism of Evergreening:

Evergreening has faced criticism for its potential to stifle innovation and impede progress in various fields. By seeking patents for incremental advances or marginal modifications to existing technologies, evergreening can create barriers that hinder other creators from building upon and advancing established innovations. By extending patent protection for minor changes, such as in the pharmaceutical industry, evergreening can lead to increased prices for medications and other copyrighted goods. This rise in costs can limit accessibility, particularly for those in need of essential medical treatments, thereby raising ethical questions about the balance between commercial interests and public welfare. Evergreening, in essence, allows patent holders to extract more financial gains from society than what may be considered fair or just, raising concerns about equitable access to advancements that could benefit humanity at large. Addressing these issues is crucial to fostering a balance between incentivising innovation and ensuring widespread access to critical technologies and medications.

Conclusion:

In conclusion, evergreening allows for the prolongation of patent protection beyond the standard time period, delaying the entry of innovations into the public domain. This practice has, however, sparked debates about striking a balance between incentivising innovation and preventing monopolistic control, prompting ethical considerations within the realm of intellectual property protection. Generic manufacturers find themselves in a challenging position, compelled to either wait for the protracted patent period to expire or engage in negotiations with innovator companies to access the patented subject matter on commercial terms. If evergreening practices were to be permitted, pharmaceutical companies might be incentivised to focus on making marginal modifications to their products solely for the purpose of obtaining patents, potentially diverting resources away from genuine innovation and undercutting the competitive dynamics of the market.

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