Drug makers concerned over compulsory licensing [India]

Local units of multinational drug makers — who make billions of dollars of revenues from drugs protected by patents — say they are increasingly worried over a vigorous push by Indian peers to revoke such protection through what are called compulsory licences, and questioned such efforts in the absence of a national emergency.

Local drug makers, who make most of their revenues from sales of non-patented or generic drugs, are exploring the use of a controversial public health provision in global trade laws called compulsory licence that allows the World Trade Organization’s member-nations to override patents and permit cheaper versions of patented drugs. This provision can be invoked if a drug maker is willing to make and supply copies of patented drugs in a medical emergency or to export to least developed countries, which are yet to be covered by the TRIPS, or the Trade-Related aspects of Intellectual Property Rights, regime and entitles the patent holder to an “adequate remuneration”.

It was reported on 29 January that Hyderabad-based Natco Pharma Ltd’s request for compulsory licences on two patented cancer drugs could emerge as a larger trend. Natco Pharma is seeking licences for Sutent, a renal cancer drug of Pfizer Inc. and Swiss F. Hoffmann-La Roche Ltd’s lung cancer medication, Tarceva, which costs Rs1.5 lakh for a month’s treatment—nearly four times the Indian per capita annual income. Sutent, awaiting a patent grant in India, is likely to be priced at $4,000 (Rs1.57 lakh) for a six-week treatment.

Expressing concern that patent provisions could be misused to make products available illegally in the Indian market, Pfizer Ltd’s managing director Kewal Handa said in an email response, “This would be a clear disregard of Indian patent laws.” He added that if continued, this would take the country back “to the pre-product patent era.” He expects the judiciary and the Indian government to “uphold the spirit of innovation.”

The top executive at Novartis India Ltd said the move was unjustified in the absence of a national emergency for which compulsory licensing is designed. “Generic drug makers talk of evergreening of patents but this is (cutting short) patents. What signals are we giving to the global drug makers?” asked Ranjit Shahani, managing director of the Novartis unit. Makers of patented drugs are often accused of trying to extend the life of patents beyond 20 years, a tactic commonly called patent evergreening.

Roche Scientific Co. (India) Pvt. Ltd’s managing director Girish Telang declined comment.
Cipla Ltd, one of country’s largest drug makers, is fighting Roche over the latter’s patent in India for Tarceva in the Delhi high court, though the Indian firm is not asking for a compulsory licence on it.

Foreign drug makers also point out that they run patient access programmes to deliver their patented drugs to those who can’t afford it, though patient groups argue the reach of such initiatives is limited. Pfizer, for instance, has recently put together a Sutent Patient Access Programme that will partly or fully subsidize treatment options for patients in India and expects to extend it to Nepal.

Novartis’ Glivec International Patient Assistance Programme helps some 7,000 patients of myeloid leukaemia, the company says on its website. Novartis is fighting in court and at an appeals tribunal the rejection of a patent for the cancer drug by Indian authorities.