Nexavar compulsory licence (India, 2012)

India, quasi-judicial ruling under the Patents Act 1970. On 9 March 2012 the Controller General of Patents granted Natco Pharma India's first compulsory licence, under section 84 of the Patents Act, over Bayer's patent on sorafenib tosylate (Nexavar), for the treatment of advanced kidney and liver cancer. The Intellectual Property Appellate Board upheld the licence in March 2013 and raised the royalty from 6 to 7 percent of sales, the Bombay High Court upheld it in 2014, and the Supreme Court declined to hear Bayer's appeal in December 2014. Primary text: the Controller's order is published on the Indian patent office site; the Wikipedia articles on compulsory licensing and sorafenib summarise the case.

What the Controller found: Bayer's price of about 280,000 rupees for a month's treatment meant the drug was not available to the public at a reasonably affordable price, the reasonable requirements of the public were not met (Bayer supplied a small fraction of eligible patients), and the patent was not 'worked' in India since the drug was imported. Natco was licensed to sell at 8,800 rupees a month, to supply the drug free to a number of patients a year, and to pay royalties; Cipla, separately, sold a generic while fighting the patent.

Why it matters and the arguments: the case was the first use by a large developing country of the TRIPS flexibilities confirmed by the Doha Declaration for a non-communicable disease, and it prompted companies to launch differential pricing and patient assistance programmes in India; industry groups and the United States Trade Representative criticised it as expropriation and placed India on the priority watch list, and no further compulsory licence has been granted in India since. The Novartis Glivec ruling a year later reinforced India's distinctive approach to pharmaceutical patents.