India dismissed U.S. allegations about its intellectual property rights regime Tuesday and said that all its IPR laws are compliant with international agreements, according to local news reports.
The U.S. had claimed that India’s IPR norms discriminate against U.S. companies, especially in the pharmaceuticals sector, and had expressed concerns over issuing a compulsory license, or CL, to Hyderabad-based Natco Pharma (BOM:524816) to manufacture and produce cancer drug Nexavar at a price 30 times lower than that charged by patent-holder Bayer (BOM:506285). In turn, Indian Commerce and Industry Minister Anand Sharma reportedly 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.
Sharma said that the issuance of a CL, which India has done only once, is an option open to all countries and India followed “due process” before issuing the license, unlike the U.S., which has issued such licenses through executive authority several times, Press Trust of India reported.
"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.
Under the Indian Patents Act, if the government considers a drug to be unaffordable by the nation's general population, it can issue a CL and grant permission to companies to manufacture a generic version at a fraction of the cost of the original drug. And, according to norms set by the WTO, if it is in the public interest, such a license can be awarded by a national government without the consent of the patent owner.
Bayer's Nexavar reportedly costs about 280,000 rupees (about $4,500) a month for 120 pills while Natco's generic version costs less than 9,000 rupees (about $145) for a month's dose.