Kerfuffle around section 3(d) of Patents Act refuses to die down

Section 3(d) of the Patents Act, 1970, by far, has been one of the most controversial provisions of India’s intellectual property (IP) regime. While India’s domestic pharmaceutical industry vouches for its role in establishing India as the “pharmacy of the world”, foreign multinational companies (MNCs) often denounce it as a restrictive and protectionist measure meant to boost the domestic industry in complete disregard of the international Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). With the Indian Patent Office (IPO) rejecting patent to Gilead’s hepatitis C drug on grounds of being on the wrong side of section 3(d), the provision is once again in sharp focus.

Background of section 3(d)

After India expanded the scope of patent protection, particularly for the pharmaceutical sector, in 2005, and introduced product patents for the same so as to make its patent regime TRIPS-compliant, there were widespread concerns that this would not only increase the prices of important life-saving drugs but would also rupture the business of the home-grown generic drug industry of the country. The Indian parliament had the onerous responsibility of coming up with legislation that was not only TRIPS-compliant, but also flexible enough to take into account public health considerations and the interests of the indigenous pharmaceutical industry.

Section 3(d) was thus an attempt of the Indian legislature to restrict the scope of subject matter eligible for patentability and consequently it specifically disallowed patents for the mere discovery of a new form of a known substance, unless such form demonstrated significant efficacy over the original substance.

Manisha Singh Nair is a partner and Priya Anuragini is an associate.at LexOrbis.