Compulsory licensing a recognised instrument, says WIPO chief Francis Gurry

NEW DELHI: Francis Gurry, director general of the World Intellectual Property Organisation, has said that the compulsory licensing and drug pricing issue will remain a point of tension in the global system, but he acknowledged that compulsory licensing is a recognised instrument. “Compulsory licensing (CL) is a recognised instrument in an international system.
Terms and conditions are set up for its exercise but it is a recognized part of the international system,” Gurry said on Wednesday. “However it is not for me to decide whether it is effective or not,” he added, talking at the sidelines of an intellectual property conference by Ficci. The World Intellectual Property Organization (WIPO) is a United Nations agency working to promote protection of intellectual property.

The US has been sharply critical of India’s judicial and subsequent policy interpretation of the controversial Section 3(d) provision in the Indian Patents Act that deals with the so-called evergreening of patents, and compulsory licensing. It is now bilaterally discussing the matter with India.

New Delhi has so far maintained its regulation was compliant with the relevant international agreement, the TRIPS. Indian patents office issued the first CL to Hyderabad-based Natco Pharma for a generic version of Bayer’s liver cancer drug Nexavar in 2012.

The Indian government is currently examining the proposal to issue compulsory license for a generic version of cancer drug Dasatinib sold by US innovator Bristol-Myers Squibb. Indian patent law allows the government to give license to generic drug firms to make cheaper version of patented drugs in case of national emergencies, extreme urgency or public noncommercial uses.

WTO laws provide flexibility to individual governments to formulate their own patent laws within the multilateral framework. “Flexibilities is a large part of an international system,” said Gurry. On the US picking holes in India’s WTO-compliant IPR regime Gurry said it was simply to do with economic interests.

“This is an area that is at the heart of an economy now and gives competitive advantage, so, naturally, different countries are going to promote their own interests in the area. You expect the dialogue that takes place between India and its trading partners is also taking place between most other countries and their trading partners. The dialogue will continue as different partners push their area of interest,” he said.