Generic drug makers get a boost from SC ruling

In a significant development for the pharmaceutical industry, the Supreme Court has rejected multinational Bayer’s appeal to block production and sales of the low cost version of its kidney cancer drug, sorafenib tosylate (branded as Nexavar), by Natco Pharmaceuticals.

Hyderabad-based Natco was granted the first and to date only compulsory licence (CL) by the government in 2012 to make and sell a patented drug at a fraction of the price at which it was sold by the patent holder, Bayer.

Since 2012, Natco has been selling the drug at Rs.8,880 a pack of 120 against Bayer’s selling price of Rs.2.84 lakh. Natco pays Bayer a royalty fee. Bayer has challenged the order before the Intellectual Property Appellate Board (IPAB) and then the Bombay High Court unsuccessfully.

“It is a landmark decision in the patent history of India,’’ was how a senior industry source described the decision.

“It vindicates the stand taken by us keeping in mind the low per capita income levels in the country. The intention is to have wide reach, accessibility and affordability for medicines,’’ a spokesperson from Natco told this correspondent.

Since 2012, Natco treated more than 20,000 cancer patients with the drug, of which 2,000 were treated free of cost, the spokesperson said.

Leena Menghaney, Regional Head (South Asia), MSF Access Campaign, said, “MSF is encouraged by this particularly strategic win for public health and access to medicines, whereby the Supreme Court has worked to ensure continued patient access to affordable versions of this lifesaving cancer drug, in spite of a multi-year campaign by Bayer to reverse the decision.’’

“Today, we applaud this heartening news, which reaffirms India’s critical role in forging a new and progressive path in balancing intellectual property and public health,’’ she said.

“The development will act as a fillip for generic manufacturers and encourage manufacture of affordable drugs to increase accessibility. Being the first and only CL granted by the government to date, it is definitely a positive development for Indian generic drug manufacturers,’’ S. V. Veeramani, President, Indian Drug Manufacturers’ Association (IDMA), said.