Pharmaceutical patent law in India

This project examines the factors that impact pharmaceutical patent approval in India after the passage of the 2005 Patent Act Amendment. The 2005 amendment brought India into compliance with the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (WTO TRIPS) agreement. This amendment changed the intellectual property rights regime for pharmaceuticals from process patents (based on the 1970 Patent Act) to product patents. Process patents allowed the pharmaceutical sector to flourish through reverse engineering (where a different process could be used to produce an existing drug) and made India a leader in generic drug production.

The 2005 amendment was expected to provide stricter protections for intellectual property rights. However, there have been complications associated with the interpretation of the law, such as the inclusion of Section 3(d) in the 2005 amendment. This clause prohibits the granting of a patent to inventions involving new forms of a known substance unless it enhances the known efficacy. This is designed to restrict the process of "evergreening" product patents (extending their life by slight modifications). This unique clause allows the Indian Controller of Patents to interpret the law without a firm definition of demonstrated “enhanced efficacy.” This has stirred worldwide debate starting with the landmark patent case, Novartis v. The Union of India & Others, which resulted in patent rejection for the cancer drug, Glivec under violation of Section 3(d).

Our research seeks to answer three questions: Is Section 3(d) a significant determinant of patent rejections? How is Section 3(d) connected with other parts of the law? What are the confounding factors that affect the likelihood of a patent case being rejected based on Section 3(d)? To address these questions, we created a database and examined various characteristics of approximately 500 patent case rulings in India between 2005 and 2016. Data is drawn from the Intellectual Property India website: http://ipindiaservices.gov.in/patentdecisionsearch/patentsearch.aspx. The database of cases includes patent applications from the ten largest international and ten largest Indian pharmaceutical companies such as Pfizer, Merck, Sun Pharmaceuticals, Novartis, and Lupin Ltd. We use descriptive statistics, basic correlation tests, binomial logit regression, and case study approaches to answer our questions. We find that Section 3(d) is an important determinant of case rulings and that the region of the patent application and company characteristics are important factors. Also, objections regarding Section 3(d) are positively correlated with objections raised about inventiveness and correct specification of the patent application.