Novartis' Challenge to Indian Patent Legislation Fails

Earlier this month the High Court of Chennai rejected Swiss drug manufacturer Novartis's claim that section 3(d) of the Indian Patents Act was non-compliant with the World Trade Organization's (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The Chennai Patent Office had previously rejected a patent on the crystalline form of Novartis's cancer drug imatinib mesylate (Gleevec), based on section 3(d). Section 3(d) raises the patentability threshold, by excluding from patentability:

[T]he mere discovery of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Novartis felt that the section inappropriately raised the patentability standard, commenting that "India should not establish additional requirements for patentability beyond novelty, commercial applicability and non-obviousness." The Court dismissed Novartis's challenge on the ground that it lacked jurisdiction to decide the matter. It held that an Indian court was not the suitable forum to determine the validity of a domestic law that allegedly violates an international treaty obligation, when the international treaty has a dispute settlement mechanism. International medical humanitarian organisation Médecins Sans Frontières (MSF) praised the decision, calling for international drug companies and wealthy nations to stop pressing developing countries to develop stricter patent regimes. The dispute has likely reached its end, as Novartis has commented that it is unlikely to appeal the decision. For a news report on the ruling, see: http://tinyurl.com/22u9y2 For commentary, visit: http://tinyurl.com/yrr3lv And for commentary from MSF, see: http://www.msf.ca/en/news/newsreleases/2007/080607_novartis.html Summary by: Michael Migus