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Title: Section 3(d) and Pharmaceutical Patents in India
Authors: Sohrabji, Niloufer
Maloney, Kaitlyn
Keywords: Evergreening;Section 3(d);WTO;TRIPS Agreement;The Patents Act, 1970;US-India Business Council;Probit estimation;Logit estimation;Active pharmaceutical ingredients
Issue Date: May-2020
Publisher: NISCAIR-CSIR, India
Abstract: In 2005, India amended its Patent Law to bring the country into compliance with the WTO TRIPS Agreement. Criticisms have arisen over a flexibility in the law, Section 3(d), which attempts to reduce evergreening by granting patents to only those inventions that enhance the drug’s known efficacy. The lack of a clear definition in the law has raised worldwide concerns over its misuse which was exacerbated by the 2013 Supreme Court denial of Novartis’s Appeal of Section 3(d)-based patent rejection for the cancer treatment drug, Glivec. To analyze the importance of Section 3(d) and this ruling on patent decisions in India, a database of 500 pharmaceutical patent cases between 2005 and 2016 was created. The determinants of patent decisions were estimated using a binomial logit regression and conducted a statistical analysis to identify their confounding factors. The results show that if a patent application has Section 3(d) objection, the odds of the case being rejected and/or abandoned more than double. Also, although the odds of patent rejections have fallen since the 2013 Supreme Court ruling, this result is driven by non-Section 3(d) cases. Thus, it was concluded that Section 3(d) will play an increasingly important role in patent rejections.
Page(s): 65-73
ISSN: 0975-1076 (Online); 0971-7544 (Print)
Appears in Collections:JIPR Vol.25(3-4) [May-July 2020]

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