Novartis v Union of India and the Person Skilled in the Art: A Missed Opportunity

Abstract

The Indian Supreme Court’s decision in Novartis v Union of India (UOI), decided earlier this year, formalizes a concerted and focused attempt by Indian law-makers to reject trivial secondary pharmaceutical inventions. The SC concluded that S 3(d) of the Indian Patents Act made new forms of known substances ineligible for patents in the absence of ‘enhanced efficacy’, which in this case was defined as ‘therapeutic efficacy’.

This paper argues that the SC wrongly ignored the context of S 3 and Chapter II of the Act, which is a medley of exclusions, exceptions and ineligible subject matter each of which can be differentiated by the need to involve the person skilled in the art standard. In this case a greater appreciation of the flexibility afforded by this notional standard as part of a broader non-obviousness enquiry would have led the SC to a more conventional legal option. Instead the SC’s adoption of the patent eligibility route has paradoxically left it much less room to manoeuver the law around secondary pharmaceutical inventions.

Keywords: pharmaceutical patents, efficacy, person skilled in the art, nonobviousness, patentable invention, S 3(d)