Section 3(d) and Pharmaceutical Patents in India

Sohrabji, Niloufer ; Maloney, Kaitlyn

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.

Keyword(s)

Evergreening; Section 3(d); WTO; TRIPS Agreement; The Patents Act, 1970; US-India Business Council; Probit estimation; Logit estimation; Active pharmaceutical ingredients

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