German drug major Bayer has lost its long-running battle to get India’s first-ever compulsory licence – for its liver and kidney cancer drug Nexavar (sorafenib tosylate) – overturned.
The compulsory license, which was issued by India’s Controller of Patents in March 2012, has allowed Indian drugmaker Natco to make a generic version of the drug priced at US$175 per patient per month, a 97% reduction on the $5,500 being charged by Bayer in India, in return for payment of a royalty fee.
The multinational has been seeking to get the compulsory license overturned ever since, initially before the Intellectual Property Appellate Court - which upheld the compulsory license but increased the royalty rate from 6% to 7% - and subsequently at the Bombay High Court, through the issue of a Special Leave Petition. However, this month all legal proceedings have been concluded, as the Supreme Court of India backed the Bombay court’s decision to uphold the compulsory license.
Bayer said it was disappointed at the Supreme Court decision. “We are analysing the order and will determine any future course of action afterwards,” said the firm in a statement.
But welcoming the Supreme Court decision, nongovernmental agency Medicines Sans Frontieres (MSF) praised the “independence of the Indian judiciary in upholding India’s right to legislate with public health interests in mind…amidst intense ongoing US government pressure tactics being waged on India on behalf of the US pharmaceutical industry.”
In the order granting the compulsory licence in 2012, the Patent Controller had noted that, while in 2011 8,842 patients were eligible for the drug, Bayer had supplied Nexavar to fewer than 200 patients after the patent began in 2008. Critics also point out that Bayer only set up a patient access programme for Nexavar once the compulsory licence proceedings had been initiated.
Moreover, Anand Grover, senior advocate appearing on behalf of Natco before the Supreme Court, told the judges that currently more than 17,000 patients in India need the drug.
It was clear, said Leena Menghaney, regional head for South Asia in MSF’s Access campaign, that Bayer’s “so-called patient access programme was reaching only around 2% of patients in need and that, furthermore, Bayer’s full R&D costs for development of the drug had been recouped in just one year.”
Indian human rights group The Lawyers Collective also welcomed this “momentous” ruling, which it said will have “wide-ranging implications for access to medicines,” while India’s Cancer Patients Aid Association said it will ensure that cancer patients will continue to get access to Nexavar at an affordable price. Multinational profits “should not be allowed at the cost of patient lives,” said the group.