Writing in Science, LSE’s Kenneth Shadlen, Bhaven Sampat (Columbia) and Tahir Amin (Harvard) debate the implications of an upcoming Indian Supreme Court decision on pharmaceutical patents for variants of existing compounds and its impact on the accessibility of affordable drugs

Amin, Tahir M.

Sampat, Bhaven N.

Shadlen, Kenneth C.

LSE Research Online

2012-7-23Balancing innovation and access: India’s pharmaceuticalpatent lawsblogs.lse.ac.uk /southasia/2012/07/23/balancing-innovation-and-access-indias-pharmaceutical-patent-laws/Writing in Science, LSE’s Kenneth Shadlen, Bhaven Sampat (Columbia) and Tahir Amin (Harvard) debatethe implications of an upcoming Indian Supreme Court decision on pharmaceutical patents for variants of existingcompounds and its impact on the accessibility of affordable drugs.The Indian Supreme Court will soon hear final arguments in a challenge by the pharmaceutical company Novartisagainst the Indian Patent Office’s (IPO) rejection of a patent for the leukemia drug, Glivec. The outcome of the caseis likely to affect patent terms and access to drugs in the developing world.The World Trade Organisation’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights(TRIPS), in effect since 1995, requires all WTO countries to allow patenting of pharmaceutical products andprocesses. Global extension of pharmaceutical patents, which will be the effect of TRIPS when fully implemented,has fuelled concerns about drug prices and, subsequently, access to lifesaving medications.The introduction of pharmaceutical patents in India has been particularly controversial. Indian producers have longbeen suppliers of low-cost medicines domestically and also to other low- and middle- income countries. In amendingits patent law to meet new international obligations, India, like many developing countries, attempted to takeadvantage of flexibilities in TRIPS to ameliorate potentially negative effects that pharmaceutical patents might haveon the supply of medicines. India used its full transition period, waiting to introduce pharmaceutical product patentsuntil 2005 (pharmaceutical process patents were already available, prior to TRIPS). Applications dating from 1995onwards were received, but not examined until 2005.India also introduced a clause designed to restrict the number and type of pharmaceutical patents granted: Section3(d) of the Patent Act prohibits patents on variants of existing compounds that do not show enhanced efficacy.Section 3(d) has been extremely contentious since its introduction in 2005. The transnational pharmaceuticalindustry regards it as establishing an unacceptably high barrier to patenting, as do many foreign governments. Butmany observers, including the United Nations Programme on HIV/AIDS and civil society groups, defend 3(d) andpoint to India as a model for developing countries attempting to use TRIPS flexibilities to promote public health.In 2006, the IPO, citing 3(d), rejected Novartis’s application for a patent on a crystalline form of Glivec’s basiccompound, imatinib mesylate. Glivec is widely recognised as having revolutionised treatment of chronic myeloidleukaemia and demonstrated the potential for targeted drug development. As a result of the IPO’s decision, Glivec isnot protected by a patent in India.Novartis appealed against the rejection, and the case has worked its way to the Supreme Court. Though the case ismeant to determine whether the rejection was appropriate, the broader issues of how the IPO interprets and applies3(d) are likely to be considered by the Court, making the case a referendum on 3(d). Novartis, making its casebefore the court of public opinion, has emphasised that the drug has received patents in over 40 other countries,implying that if even Glivec cannot be patented in India, 3(d) must be setting unreasonable standards. Meanwhile,civil society groups have called on Novartis to drop the suit, emphasising the crucial role that section 3(d) has inIndia’s ability to supply low-cost generic pharmaceuticals.The Supreme Court is scheduled to resume hearings in August. The Court’s ruling will have profound implicationsfor the questions of whether and how countries with newly introduced pharmaceutical patent regimes limit“evergreening” of existing molecules and patent portfolios. Evergreening is a term used to describe the sequentialaccumulation of secondary patents on drugs, including alternative forms of active ingredients, new formulations,1/2dosages and uses.For more information on this topic and the debate around secondary patents, see the complete version of thisarticle, with references, in Science Express or the 27 July issue of Science. The article reviews alternativeapproaches to combatting evergreening and analyses the Indian approach.Dr Kenneth Shadlen is a Reader in Development Studies at LSE’s Department of International Development.  Copyright © 2016 London School of Economics2/2

Balancing innovation and access: India’s pharmaceutical patent laws

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