Source: Financial Times
13 Dec 2014
Bayer has lost its bid to block a cheap version of the German company’s Nexavar cancer
drug from the Indian market in a landmark ruling that will ensure access to a life-extending medicine. But the decision will also reinforce industry concerns over threats to intellectual property in the world’s second-most populous nation.
The Indian Supreme Court rejected Bayer’s appeal against a decision by the country’s patent controller in 2012 to override the company’s monopoly on Nexavar, which treats kidney and liver cancers.
The case has been closely watched as a test of India’s willingness to challenge drug patents and the associated high prices that keep many medicines out of reach of all
but the wealthiest members of society.
Bayer has been fighting against the issuing of a compulsory licence that allowed Natco, an Indian generic drugmaker, to sell Nexavar for just $173 a month compared with the $5,500 a month charged by the German company.
On Friday, Bayer said it was “disappointed” by the Supreme Court decision. “We are analysing the order and will determine any future course of action afterwards.”
The Lawyers Collective, an Indian human rights group, described it as a “momentous decision that would have wide-ranging implications for access to medicines”. Médecins Sans Frontières, the medical charity, praised “the independence of the Indian judiciary” in the face of industry lobbying Indian courts have recently rejected patent applications on drugs from Novartis and Roche, fuelling tensions with the industry as well as with western governments. The US has kept India on a “watchlist” of intellectual property violators.
However, Nexavar is the only case so far in which India has issued a compulsory licence under rules that allow the government and companies to seek permission to overturn drug patents in the interests of public health.
India’s government in New Delhi had no involvement in the application by Hyderabad-based Natco to apply for a Nexavar licence nor in the patent controller’s decision to grant it.
Activists complain that few Indian generics producers are willing to pursue such licences because many have manufacturing, marketing or distribution tie-ups with the big innovative drug companies.
“There is a huge amount of pressure from multinational companies discouraging their Indian partners from filing these applications,” said Leena Menghaney, who works for the MSF campaign on access to affordable medicines.
Activists had previously appealed to the Indian government to issue compulsory licences for the breast cancer drug Herceptin, but Roche subsequently decided to withdraw its patents on the medicine in India. The drug is now widely available to Indian patients at a fraction of its previous price.
Nearly 70 per cent of Indian healthcare expenses are paid out of pocket by patients or their families.
Western drugmakers often accuse India of using public health as a pretext for boosting the country’s big generic pharmaceuticals industry. They worry that cheap copies of patent-protected medicines will be exported to other markets and that India’s approach risks undermining global drug development.
Shamnad Basheer, an intellectual property rights lawyer, and founder of SpicyIP, a blog focused on intellectual property rights issues, said big pharma’s biggest fear was that India would set a precedent for other emerging economies such as Brazil and South Africa. “They think other countries will pick up the Indian standard.”