The Swiss drug company Novartis challenged India's status as the "Pharmacy of the Developing World" when it initiated a lawsuit against the Indian government on February 15, 2007. In 2005, India updated its Patents Act to comply with the World Trade Organization's (WTO) intellectual property requirements. Before 2005, India only granted patents to processes, not products, which facilitated the development of the country's booming generic drug industry. On January 25, 2006, India's Office of the Controller General of Patents, Designs and Trademarks denied Novartis's patent application for its cancer-fighting drug Glivec on the grounds that it was not substantially different from an earlier, unpatented version of the drug. Novartis challenged both the constitutionality of the Indian Patents Act and its compliance with the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). While the Indian High Court asserted that it lacked jurisdiction to rule on the Indian Patents Act's compliance with TRIPS, it determined that the Act was constitutional and did not require further amendments.
The Novartis decision has had important implications for both developed countries that house the pharmaceutical industry and developing countries that cannot afford patented versions of essential medications. Had Novartis won its case against the Indian government, the practice of granting patents for inventions that resulted from "evergreening" would not only have been tolerated but protected, thus striking a serious blow to developing countries that rely on generic drugs from India.
This note analyzes the controversial section of India's Patents Act by comparing its language to the TRIPS Agreement, the Doha Declaration on the TRIPS Agreement and Public Health, and similar laws of India's fellow WTO members. In conclusion, the note asserts that although India's Patents Act is TRIPS compliant, the Indian government should more clearly define the relevant criteria for determining whether a particular modified drug has sufficiently enhanced its efficacy in order to qualify for patent protection. Finally, the note argues that India's decision to protect its pharmaceutical industry and the health of the developing world through section 3(d) of its Patents Act, rather than by relying on compulsory licenses, is a solution that should be employed by other developing countries concerned with TRIPS compliance.
Sara B. Myers,
A Healthy Solution for Patients and Patents: How India's Legal Victory Against a Pharmaceutical Giant Reconciles Human Rights with Intellectual Property Rights,
10 Vanderbilt Journal of Entertainment and Technology Law
Available at: https://scholarship.law.vanderbilt.edu/jetlaw/vol10/iss3/9