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Critical Evaluation of ‘Glivec’ drug case in India

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Background

Two judges delivered a judgement that impacted the national and worldwide discourse concerning patents and patients on April 1, 2013, in a packed room within India’s Supreme Court.In a major decision, India’s apex court denied Novartis AG’s patent appeal for its life-saving cancer medicine Glivec, which is marketed under the brand name Glivec in most areas of the world.

The Novartis case sparked a divisive debate around the world over a crucial aspect of India’s patent system.Novartis had fought a long and difficult battle for a patent on imatinib mesylate (Glivec), which treats chronic myloid leukemia, for several years, paying some of India’s most prominent lawyers, but in the end, India’s Supreme Court rejected the company’s final petition for a patent on the drug (CML).

Facts of this case

In 2005, the Madras Patent Office considered Novartis’ patent application for the medicine Glivec, which was refused on the grounds that the drug had been anticipated by earlier publication and did not meet the requirements of innovation and non-obviousness, furthermore, the asserted invention is not patentable under section 3(d) of the Patent Act, 1970, because the medicament did not show any significant differences in therapeutic efficacy over its pre-existing form, i.e. the Zimmermann patent.

After getting two appeals rejected and another appeal to IPAB resulting fruitless, in 2009, Novartis filed an SLP (Special Leave Petition) with the Supreme Court of India, challenging the IPAB’s order under Article 136 of the Indian Constitution.

Judgment in the current case

In April 2013, a two-judge bench of the Supreme Court of India dismissed Novartis’ appeal, ruling that the beta crystalline form of Imatinib Mesylate is a new version of the well-known chemical Imatinib Mesylate, with well-established efficacy.The Supreme Court made it plain that “Efficacy” in section-3(d) solely refers to “Therapeutic Efficacy” in the case of medicine, and that all other features of the drug are irrelevant; the properties that directly pertain to efficacy in the case of medicine are its therapeutic efficacy.In the third issue, the Supreme Court ruled that, if evidence is supplied, a 30 percent improvement in bioavailability qualifies as an increase in therapeutic efficacy under section-3(d) of the Patent Act, 1970.

The Supreme Court compared the efficacy of “Beta Crystalline form of Imatinib Mesylate” to “Imatinib Mesylate” in terms of flow properties, thermodynamic stability, and hygroscopicity, and concluded that none of these properties contribute to an increase in therapeutic efficacy under section-3(d) of the Patent Act of 1970, and also Novartis has not given any documentation demonstrating that the efficacy of “Beta Crystalline version of “Imatinib Mesylate” is superior to “Imatinib Mesylate.”

The impact of this judgement

Two major studies have been published in the recent years on the question of how India’s patent office grants and rejects patents.Based on the Supreme Court’s precedent in dealing with Section 3(d) of the Indian Patent Act in the Novartis case, the first study, which looked at patents denied by the IPO, found a surge in rejections.The IPO used Section 3(d) as a policy tool in denying applications that came within the exceptions in 69 percent of the situations where the exceptions to patentability were highlighted, according to the report released in December 2017.

“The increased application of Section 3(d) by the IPO soon after the Novartis case could be due to the legal certainty provided by the Supreme Court’s decision upholding the rejection of a patent application rejected under that section,” according to the report by Dr. Feroz Ali, Dr. Sudarsan Rajagopal, Mohamed Mustafa, and Chinnasamy Prabhu.

Challenges that remain

However, a subsequent study of the patents awarded by the IPO by the same set of writers concluded that Section 3(d) has not been used effectively in prohibiting secondary patents from being granted.The study examines the problems that have led to Section 3(d) being under-utilized despite the Supreme Court’s landmark verdict in an April 2018 report titled, Pharmaceutical Patent Grants in India: How our safeguards against ever greening have failed, and why the system must be overhauled.

Feroz Ali, IPR chair professor at the Indian Institute of Technology, Madras, and a practicing lawyer who worked on both investigations, emphasizes that the Indian Patent Office has dealt with the ‘Novartis standard’ inconsistently.

International impact of this case

The impact of the Indian Supreme Court’s 2013 decision can be seen in the report of the UN Secretary-High-Level General’s Panel on Access to Medicines.The report, published in September 2016, recommends that members of the World Trade Organization make full use of the policy space provided by Article 27 of the TRIPS agreement by adopting and applying strict definitions of invention and patentability that prevent “ever greening” and ensure that patents are only granted when genuine innovation occurs.

South Africa’s draught intellectual property rights policy, which is based on India’s model, proposes tighter patent standards and patent oppositions.

Civil society organizations in Thailand are utilizing Section 3(d) as a model to lobby their government for stricter patentability criteria.

Conclusion

The Novartis case, by bringing the pharmaceutical industry into the purview of patent law, may set a significant precedent for access to medications. The Supreme Court of India’s decision could serve as a precedent for how other developing countries interpret and execute the TRIPS Agreement in the future.This case exemplifies how India is adhering to its international duties regarding intellectual property laws while also ensuring that domestic demands are met by interpreting its legal obligations in a manner that is consistent with home preferences and needs. The decision prioritizes social justice over commercial interests while simultaneously benefiting India’s local industries.This is the first time an Indian law has been implemented to ban drug patents with only minimal modifications to an existing one. Patenting will henceforth be used to protect only truly unique and inventive drugs that have a real therapeutic impact. In the case of India, we are witnessing a sophisticated game that has resulted in a conflict between global trade commitments and domestic public health concerns.In this scenario, the latter has definitely taken primacy.

Contributed by:– Nidhi Jha, Legal intern at LLL

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