U.S. pharma hits out at Gilead decision

January 20, 2015 12:12 am | Updated April 20, 2016 04:57 am IST - Washington

The decision to deny U.S. biotechnology firm Gilead Sciences a patent for its anti-Hepatitis C drug sofosbuvir shows that India continues to have a “deteriorating climate for innovation,” according to a leading trade group here.

Mark Grayson, a spokesman for PhRMA, which represents the pharmaceutical research and biopharmaceutical companies, said to The Hindu that if India wanted to attract foreign investment “It needs to have a policy that recognises the importance of innovation.”

PhRMA’s comments come days after the Indian Patent Office rejected an application for sofosbuvir, and less than a week before U.S. President Barack Obama lands in New Delhi to join the country’s Republica Day celebrations as Chief Guest.

Although senior State Department officials including Assistant Secretary of State for Economic and Business Affairs Charles Rivkin have in recent days alluded to the need for bilateral alignment on Intellectual Property Rights (IPR) protections, Mr. Grayson said, “Right now it looks like nothing has changed even though Modi government has said they will be looking at IPR policy.”

However PhRMA continues to be “hopeful” that the Indian government will understand their perspective, Mr. Grayson added.

The U.S. private sector and government concerns over India’s “philosophical” differences on IPR issues has a long history and is likely to feature prominently in the summit discussions next week between Mr. Modi and Mr. Obama.

A variety of federal agencies here, including the U.S. Trade Representative and the U.S. International Trade Commission have argued that there are growing concerns with respect to the environment for IPR protection and enforcement in India.

Last year the USITC launched an investigation into whether India’s IPR policies, which denied patents to anti-cancer drugs such as Novartis’ Glivec and Bayer’s Nexavar while granting compulsory licenses to domestic producers of generic versions of certain drugs, “were harming the U.S. economy by discriminating against American firms.”

This week industry insiders criticised some reports in Indian media that compared India’s IPR decisions to the U.S. Food and Drug Administration’s crackdown on Indian generic drug manufacturers over quality control issues, saying “There is nothing further from the truth.”

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