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10 Years of Novartis vs. Union of India

April 1st, 2023 marked a decade of one the most important and highly debated judgement of Supreme Court of India: Novartis Ag vs. Union of India in the context of Indian patent law. On 10th anniversary of the judgement, DPIIT IPR Chair and Centre for Innovation, Intellectual Property and Competition at National Law University, Delhi organized a symposium on ‘10 Years of Novartis v. Union of India’. The event brought together legal experts, industry representatives, and academics to discuss the impact of the Novartis case on Indian patent law and the pharmaceutical industry.

The inaugural session began with a welcome address by Prof. (Dr.) G. S. Bajpai, Vice-Chancellor, National Law University, Delhi. This was followed by a keynote address by Hon’ble Justice S. Ravindra Bhatt, a judge of the Supreme Court of India, who provided insights into the legal and policy implications of the Novartis case. Dr. Yogesh Pai, Associate Professor at NLU, Delhi then provided an introduction and background to the Novartis case, outlining the key issues involved in the case.

The panel discussion that followed was moderated by Ms. Jayashree Watal, Visting Professor, NLU Delhi and featured a distinguished panel of experts, including Mr. Hemant Singh, Founder and Managing Partner, INTTL ADVOCARE, Mr. Guruswamy Natraj, Founder LCGN Advocates, Dr. Malathi Lakshmikumaran, Executive Director and Practice Head, Lakshmikumaran & Sridharan Attorneys and Prof. Bryan Mercurio, Professor of Law, Chinese University of Hong Kong. The panelists provided diverse perspectives on the implications of the Novartis case for Indian patent law and the pharmaceutical industry. Mr. Singh and Mr. Nataraj focused on the litigation aspects of the Novartis case and subsequent legal developments related to Section 3(d) of the Indian Patent Act. They discussed the open-ended interpretation of the term “efficacy” by the Supreme Court in the Novartis case and whether the court could have decided differently on the question of efficacy. They also examined subsequent litigation related to Section 3(d) and its impact on the interpretation of the Novartis decision in the context of exclusion of new forms. They also analyzed how the decisions of the erstwhile IPAB and other courts have narrowed or broadened the Supreme Court’s interpretation of the Novartis decision. Mr. Singh pointed that if section 3(d) sets the norm that physiochemical properties are not considered for patent grant, then there are no incentives for inventors to bring better drugs/solutions in India. Mr. Natraj expressed that Section 3(d) and the Novartis judgement have not been a barrier to investment in pharmaceutical industry in India and section 3(d) is recognition of what social and economic conditions of developing country like India demands. Dr. Lakshmikumaran focused on IPO practice in the post-Novartis era, particularly the evidentiary burden that applicants need to discharge before the patent office in proving therapeutic efficacy. She discussed her experience with post-Novartis cases and the guidance provided by the patent office regarding the submission of efficacy data. She also raised questions about the type of data that should be submitted, the stage at which it should be submitted, and whether patent examiners have the necessary qualifications to evaluate efficacy data.  Dr. Lakshmikumaran also suggested that Indian government should open patenting of improvements in pharmaceutical industry at least for new use or new property. Prof. Mercurio focused on the international IP aspects of the Novartis case and its consistency with WTO Members’ obligations under the TRIPs Agreement. He discussed the potential violation of WTO Members’ obligations under the TRIPs Agreement due to Section 3(d) and the Novartis decision. Although no WTO Member has ever approached the WTO dispute settlement on this issue, there are scholarly works on how both violation and non-violation complaints may be successfully litigated at the WTO on this issue. Prof. Mercurio also discussed how the Novartis decision has panned out in the context of international and comparative IP, particularly in the context of TRIPS-plus FTAs and IIAs. He conluded that improvements leading to better access to solutions should not be considered as evergreening such as reduction in dosages etc. Section 3(d) has been narrowly focused only on one aspect which has resulted into missing the point of having the safeguard.

Overall, the event provided a valuable platform for experts to examine the Novartis decision from different perspectives and shed light on its implications in various contexts.

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