How Do Public Health Safeguards in Indian Patent Law Affect Pharmaceutical Patenting in Practice?

The article examines the degree to which India’s section 3(d) impacts patent grant rates compared to Europe, a jurisdiction without 3(d) provisions.

The 1995 Trade Related Intellectual Property Rights (TRIPS) agreement requires developing countries to grant product patents in pharmaceuticals. Developing countries have explored additional measures to address potential negative effects of the law on public health. This article examines India’s section 3(d), which restricts patents on incremental pharmaceutical innovations, and the degree to which Indian patent laws on the books impact patent grant rates when compared to Europe, a jurisdiction without 3(d) provisions.

Looking at 2,803 applications for patents filed in both India and in Europe, the researchers examined whether the patents triggering 3(d) considerations were less likely to be granted in India as compared to Europe.

Key Findings:

  • 3(d) applications had a lower grant rate and higher rejection rate than other applications in both India and Europe.
  • The Indian Patent Office granted 57 percent of the applications granted by the European Patent Office.
  • The European Patent Office granted 65 percent of the applications granted by the Indian Patent Office.

Patents for innovation and diffusion in pharmaceuticals play an important role in public health globally. This study addresses the question of section 3(d)’s influence on patents in India, showing that the section 3(d) provision does not make Indian patent law very different from other jurisdictions.