Médecins Sans Frontières (MSF) has urged other Indian generic companies to come forward to apply for compulsory licenses (CLs), including on HIV medicines, if they can’t get appropriate voluntary licenses from the patent holders, to make these life-saving patented drugs available to the common people of this country.
The MSF's clarion call in this regard comes in the wake of the Indian Patent Office's landmark decision on March 12 in which the Indian controller general of patents P H Kurian granted for the first ever compulsory license to Natco Pharma to manufacture an affordable generic version of German pharma major Bayer's patented kidney and liver cancer drug Nexavar.
“More generic companies should now come forward to apply for compulsory licenses, including on HIV medicines, if they can’t get appropriate voluntary licenses,” said Dr Tido von Schoen-Angerer, director of the MSF's Access Campaign. “This decision marks a precedent that offers hope: it shows that new drugs under patent can also be produced by generic makers at a fraction of the price, while royalties are paid to the patent holder. This compensates patent holders while at the same time ensuring that competition can bring down prices,” he added.
“This decision serves as a warning that when drug companies are price gouging and limiting availability, there is a consequence: the Patent Office can and will end monopoly powers to ensure access to important medicines,” said Michelle Childs, director of Policy/Advocacy at the MSF Access Campaign. “If this precedent is applied to other drugs and expanded to include exports, it would have a direct impact on affordability of medicines used by MSF and give a real boost to accessing the drugs that are critically needed in countries where we work.”
“Behind this action is the idea that the public has a right to access innovative health products and they should not be blocked from benefiting from new products by excessive prices,” said Michelle Childs. “If more compulsory licenses are granted in this vein, the answer to the question of how to ensure affordable access to new medicines could radically shift.”
In July 2011, Natco applied for a CL in the Mumbai patent office to manufacture an affordable generic version of sorafenib tosylate - the anti-cancer drug for which Bayer has obtained a patent IN215758 in India in 2008. The patent expires in 2020.
In its CL application Natco had proposed to market the same drug at Rs.8,800 per patient per month if the patent office grants it a compulsory license. Bayer currently markets the drug at a high price of approximately Rs.2,80,000 per patient per month.