Novartis v. Union of India (Glivec, 2013)

India, court ruling. Novartis AG v. Union of India and Others was decided by the Supreme Court of India on 1 April 2013, ending a legal fight that began when the Indian patent office rejected Novartis's application for the beta crystalline form of imatinib mesylate in 2006. Primary text: the judgment is published by the Supreme Court; the Wikipedia article gives the history.

What the court decided: section 3(d) of the Patents Act 1970, added in the 2005 amendment that brought India into compliance with TRIPS, provides that a new form of a known substance is not an invention unless it differs significantly in properties with regard to efficacy. The court held that efficacy means therapeutic efficacy, that improved bioavailability alone does not qualify without evidence that it improves the treatment, and that Novartis had not shown it. The court stressed it was not ruling against incremental innovation as such, and that the 2005 amendment was designed to prevent 'evergreening' of pharmaceutical patents.

Why it matters and the arguments: Glivec cost around 120,000 rupees a month in India against about 8,000 for generics, and the ruling preserved supply from Indian manufacturers to India and to other developing countries, while Novartis's patient assistance programme continued. Industry argued the standard was unique to India and would deter investment; access campaigners called it a template, and provisions modelled on section 3(d) have been discussed in Brazil, South Africa and elsewhere. Together with the Nexavar compulsory licence of 2012, the case defines India's position that TRIPS leaves room for national judgement on what deserves a patent and at what price.