BIO Shares U.S. Trade Representative's International Patent Concerns

Washington, D.C. (May 2, 2013) The Biotechnology Industry Organization (BIO) today expressed concern over specific foreign government's weak intellectual property (IP) enforcement efforts, following the Office of the U.S. Trade Representative’s (USTR) release of its Special 301 Report.

"The USTR's Special 301 Report illuminates the failings of India, China, Brazil and Canada, among others, to provide adequate IP protection for biotechnology companies creating novel and innovative products,” said Joseph Damond, BIO's Senior Vice President, International Affairs. “We support the USTR's ongoing efforts to encourage IP policies throughout the world which ultimately benefit consumers.”

As laid out in recent Special 301 Submission guidelines, BIO shares many of the USTR's concerns over the decision by India’s Supreme Court to deny patent protection for a novel therapy on the grounds it did not demonstrate "enhanced efficacy.”   At least eight medicines have lost patent protection in India when such protection is granted to these products worldwide. 

Furthermore, China, Brazil and Canada have established additional bureaucratic and burdensome hurdles to patentability. Brazil's unprecedented review of patents by the health regulatory authority, China's increased data requirements and Canada's increased utility requirements all ultimately undermine the process and may delay the delivery of novel medicines to market.

"In our Special 301 Submission, BIO encouraged the USTR to perform out-of-cycle reviews of these country's patent systems, as they are currently undergoing dynamic change. This is as an appropriate means of monitoring and responding to inadequate IP protection for innovative and creative industries," said Damond. "BIO continues to work around the world to champion IP rights as a vital means of creating jobs, saving lives, advancing global economic growth, and generating breakthrough solutions to global challenges."