2012 Special 301 Report: Biotech's International IP Issues

BIO has identified the following countries of interest and recommends the following for our 2011 Special 301 submission.

Priority Foreign Country: BIO requests USTR to elevate Turkey to a Priority Foreign Country due to new alarming issues pertaining to IPR.

Priority Watch List: BIO requests USTR to keep Argentina, Brazil, Canada, Chile, China, India, Indonesia, Israel, Thailand and Venezuela on the Priority Watch List. BIO requests USTR to elevate the Philippines to Priority Watch List status.

Watch List: BIO requests USTR to keep Colombia, Egypt, Mexico, Peru, Russia and Ukraine on the Watch List.

Section 306 Monitoring: BIO requests USTR to continue monitoring Paraguay under Section 306.

Countries/Organizations of Concern: BIO requests USTR to observe developments in Japan, Taiwan, and the European Patent Office to ensure IPR is properly protected.

For each of the countries identified in this submission, BIO has identified numerous issues as important to our members. While the biotechnology industry faces international IPR challenges that are common across industries, it also faces challenges that are unique to the biotechnology sector. Those issues common across industry sectors include counterfeiting, large backlogs and patent office inefficiency, differing judicial standards for enforcement, compulsory licensing, in adequate data protection, and a need for harmonization of substantive standards and processes across patent offices around the world. Issues unique to biotechnology include patentability of biotechnology inventions, genetic resource access and benefit regimes, and technology transfer issues that involve intellectual property. This submission will address these issues as they apply in each country.