US and India have been sparring over IPR and trade practices. To begin with US claimed that India’s IPR regime discriminated against U.S. companies, especially in the pharmaceuticals sector, and had expressed concerns over issuing a compulsory license (CL), to Hyderabad-based Natco Pharma to manufacture and produce cancer drug Nexavar at a price 30 times lower than that charged by patent-holder Bayer. Replying to the allegation, Indian Commerce and Industry Minister Anand Sharma reportedly noted and accused the U.S. of trade protectionism and obstructing temporary work visas for skilled Indians.
“When it comes to intellectual property rights (IPR), I must firmly put on record that India is signatory to Trade Related Aspects of Intellectual Property Rights (TRIPS) and our laws are fully compliant with the agreement of the WTO (World Trade Organisation). India has never deviated, never diluted (its law),” Sharma reportedly said.
According to Sharma, issuing compulsory licenses is an option open to all countries. He also noted that while India issued a compulsory license through executive order only once, the US has issued such licenses several times.
“India has never invoked (this facility) through an executive authority which India can. And in this (Nexavar) case also it was not the executive decision. The US has invoked executive decisions for CLs,” Sharma reportedly said.
In India, the government can issue a compulsory license and grant permission to companies to manufacture a generic version of any patent protected drug at a fraction of the cost of the original drug, if the government feels that the drug is not accessible to the general public due to high costs. Such a license can be awarded without the consent of the patent owner.
In this case, Bayer’s Nexavar reportedly costs about INR 280,000 a month for 120 pills while Natco’s generic version costs less than INR 9,000 rupees for a month’s dose.