Journal of Intellectual Property Rights

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Section 3(d) and Pharmaceutical Patents in India


Affiliations
1 Department of Economics, Simmons University, Boston, MA 02115, United States
 

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.

Keywords

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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  • Section 3(d) and Pharmaceutical Patents in India

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Authors

Niloufer Sohrabji
Department of Economics, Simmons University, Boston, MA 02115, United States
Kaitlyn Maloney
Department of Economics, Simmons University, Boston, MA 02115, United States

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.

Keywords


Evergreening, Section 3(d), WTO, TRIPS Agreement, The Patents Act, 1970, US-India Business Council, Probit Estimation, Logit Estimation, Active Pharmaceutical Ingredients.

References