No country has objected to India issuing compulsory licence or refusing patent for drugs: WTO chief Pascal Lamy

Global pharma majors are unlikely to get any support from the WTO in arm-twisting India to change its patent rules.

No member of the World Trade Organisation has so far raised any concerns either on India issuing compulsory licence for production of Bayer’s anti-renal cancer medicine or on its refusing patent for Novartis’ anti-cancer medicine.

“Recent decisions by the courts in India have led to a lot of protest by pharmaceutical companies. But decisions made by an independent judiciary have to be respected as such,” WTO Director-General Pascal Lamy said.

Patent law adequacy

Lamy’s statement is important as global drug majors and some developed countries, including the US, have been questioning the adequacy of India’s patent laws. New Delhi has maintained that it has not flouted TRIPS (the global intellectual property regime) but has only used the flexibilities the Agreement provides.

The Supreme Court recently ruled against Swiss company Novartis and upheld the Government’s decision not to grant patent to Glivec, a drug for leukaemia, on the basis of Section 3(d) of the Indian Patent Act that prevents ever-greening of patents.

India’s refusal to give Novartis the patent on the ground that it was not new as the original compound Imatinib was disclosed before the TRIPS Agreement of 1995, has irked pharma giants in developed countries.

Drug companies were also upset when India provided its first compulsory licence to Hyderabad-based Natco last year. The patent was provided for renal cancer medicine Nexavar as the German major Bayer’s version, priced at Rs.2.8 lakh (about $5,235) for a month’s treatment, was prohibitive for most patients. Natco is now providing the drug at a fraction of the price — Rs 8,800 or about $165).

But the TRIPS Agreement clearly allows issuing of compulsory licences for life-saving drugs. “TRIPs provides flexibilities that allow countries to issue compulsory licences for patented medicines to address health urgencies,” Lamy said.

NGO lobbying

Although the US and a number of European countries, including Switzerland, had some years ago raised their voice against Section 3(d), alleging that it was violative of TRIPS, public opinion largely favoured generic manufacturers.

“Because of the active NGO lobbying against a stringent patent regime for generics, it has become a sensitive issue at the WTO and nobody is speaking against India,” an Indian Government official told Business Line.

amiti.sen@thehindu.co.in

(This article was published on April 26, 2013)
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