A large number of Indian health groups have welcomed the announcement of the first compulsory license (CL) issued by the Controller of Patents on March 12. The CL was granted in response to an application filed by generic manufacturer Natco Pharma nine months ago requesting authorization to manufacture and market generic versions of the kidney and liver cancer medicine, sorefanib tosylate.

“The unthinkable pricing of medicines has been a reality for cancer patients for some years now. Bayer’s price for sorefenib for which it obtained a patent in 2008 is over US$ 60,000 per patient per year. Not just sorefanib, several patented cancer medicines are being sold at exorbitant prices in India,” said Dr YK Sapru of the Cancer Patients Aid Association (CPAA).

Terming the development as a game changer, AIDAN's S Srinivasan said that this is a turning point for India’s generic manufacturers. “The next step will be for the government to take the initiative in issuing CLs for government use,” he added.

“Such a compulsory license is an extremely important step that can be a precedent towards the grant of many such licenses in the future to address public health goals,” says Dr Amit Sengupta of the Peoples Health Movement.

Welcoming the decision, Anand Grover of Lawyers Collective said that the idea of an exceptional compulsory licensing system limited only to emergencies or to epidemics is a myth that has been promoted by multinational companies. “In 2001, all WTO members including the US and EU signed the Doha Declaration on TRIPS and Public Health that recognises, “the right to grant CLs and the freedom to determine the grounds upon which such licenses are granted” of all governments. This compulsory license which has been issued on an anti-cancer medicine reflects that compulsory licensing provisions in the Indian law can be used to promote access to medicines, even for non-communicable diseases,” he added

“The health safeguards in Indian Patent law are exceptionally important for us who depend on affordable generics,” said Loon Gangte of the Delhi Network of Positive People (DNP+).

Meanwhile, Centad's Santhosh MR has cautioned that India is likely to face exceptional pressure from developed countries and multinational pharmaceutical companies in the coming weeks.