Novartis AG v. Union of India, (2007)

Nature of the Case

High Court decision regarding the constitutionality of Section 3(d) of the 2005 Amendment to India’s Patent Law concerning the requirement for an invention to show an “enhanced efficacy” if based on a known substance. A pharmaceutical company’s modification of an existing drug was denied a patent in India for not meeting Section 3(d) requirements, and they subsequently  petitioned the Madras High Court arguing that Section 3(d) was unclear, arbitrary, and discriminatory so as to be unconstitutional. The Court upheld Section 3(d).

Enforcement of the Decision and Outcomes

The denial of Novartis’ patent application for its leukemia drug was upheld for not meeting Section 3(d) requirements.  Novartis subsequently appealed to the Indian Supreme Court in Delhi.  On April 1, 2013, the Indian Supreme Court upheld Section 3(d) in India’s Patent Law as constitutional.

Significance of the Case

This case, and the subsequent ruling by the Indian Supreme Court, shows the divide between pharmaceutical companies and the Indian state’s position on affordable drugs. Had Novartis been successful in eliminating Section 3(d) from India’s Patent Law, the price of medicine in India would increase exponentially, eliminating access to medication for a large proportion of the second most populated country on the planet.  Although India had to amend its patent laws to comply with WTO requirements, the Indian legislature inserted Section 3(d) in order to protect access to medicine, and the Supreme Court judgment consolidates Section 3(d).

For their contributions, special thanks to ESCR-Net member: the Program on Human Rights and the Global Economy (PHRGE) at Northeastern University.