Amidst intense US pressure on behalf of its pharmaceutical industry to undermine the use of public health safeguards in India’s patent law, the decision of the Indian Supreme Court brings cheer.
Yesterday (12 December 2014) the Supreme Court of India refused to entertain Bayer’s appeal to set aside the compulsory license (CL) on the anti-cancer drug sorafenib.
The Supreme Court’s decision – upholding the legal validity of the CL and dismissal of Bayer’s Special Leave Petition – concludes the legal proceedings on the first ever CL issued in India. The CL granted by the Indian Patent Controller in March 2012 to a generic manufacturer for the kidney and liver cancer drug sorafenib tosylate, was unsuccessfully
challenged by Bayer before the Intellectual Property Appellate Board (IPAB), Bombay High Court and later before the Supreme Court. The SLP filed by Bayer challenging the order of the Bombay High Court was listed before Justice Ranjan Gogoi and Justice Rohington Nariman.
In the Supreme Court proceedings, Justice Nariman enquired why Bayer had not made available the research and development (R&D) expenses to develop the drug which would have been the best evidence to arrive at a reasonable rate of royalty. Bayer argued that 98% costs accrue from failed drugs, making it impossible to provide a precise account. Unimpressed, the Bench opined that in absence of any evidence supplied by Bayer, the affidavit of James (“Jamie”) Packard Love – the director of Knowledge Ecology International – providing information that R&D costs have been recouped within the first year itself, can be taken into account. The affidavit can be found here
The Bench also noted that the Bayer failed to supply the drug to a significant number of cancer patients who require it despite the existence of its patient access programme.
The compulsory licence was granted in March 2012 by India’s Controller of Patents to the generic company Natco, allowing it to market the generic version for the eight years the cancer drug sorafenib tosylate will remain patented in India (until 2020), and against the payment of a royalty (6% which was later revised to 7%).
The reasoning behind the decision: Bayer had made the drug available to only a small percentage of eligible patients (approximately slightly above 2 percent), which did not meet the requirements of the public. The price of Rs 280,000 per month (approximately US$5,500) was not “reasonably affordable.”
Natco was required to make the drug available within India at a price of not more than Rs 8,800 (approximately US$175) for one month’s treatment.
The order of the compulsory licence can be found here
The IPAB decision by Justice (Ms) Sridevan upholding the compulsory licence can be read here
The decision of the Supreme Court is still to be published on its official website.