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BIO 2016 Special 301 Submission

February 8, 2016

Executive Summary: 

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to participate in the Special 301 process and is hopeful that our contribution will assist the United States Trade Representative’s (USTR) efforts in preserving strong intellectual property protections for United States’ companies internationally. BIO appreciates the opportunity to comment on 2016 Special 301 Review: Identification of Countries Under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public Hearing.


BIO is a non-profit organization with a membership of more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations in almost all of the 50 States and a number of foreign countries. BIO’s members research and develop health care, agricultural, industrial, and environmental biotechnology products. The U.S. life sciences industry, fueled by the strength of the U.S. patent system, supports more than 7.5 million jobs in the United States, and has generated hundreds of drug products, medical diagnostic tests, biotech crops, and other environmentally-beneficial products such as renewable fuels and bio-based plastics.


The vast majority of BIO’s members are small and medium sized enterprises that currently do not have products on the market. As such BIO’s members rely heavily on the strength and scope of their intellectual property (IP) to generate investment to take their technologies to commercialization. More and more, BIO’s members are looking abroad as they expand their markets and R&D and commercialization efforts.


While IP reforms in foreign countries would greatly improve export of biotech products from the United States, improvements in IP would benefit foreign countries as well. Studies show that even developing countries obtain economic benefits from increasing their IP protection.1 Like in other trade areas, increased standards in IP provide a win-win situation for the United States and other nations around the world.


To help in assessing the IP challenges abroad that may hinder our companies’ activities, BIO has surveyed our members asking them to identify relevant IPR barriers in the identified nation’s law, courts, enforcement regime, regulatory regime, import/export regime, etc. Our members have provided the information found in this submission and we have compiled the information in aggregate form. BIO has chosen to aggregate the issues to help identify roadblocks affecting U.S. biotechnology companies and to maintain the confidentiality of our member’s responses.


To this end, BIO has identified the following countries of interest and recommends the following for our 2016 Special 301 submission. 


Priority Watch List: BIO requests USTR to place Argentina, Brazil, Canada, Chile, China, Colombia, Ecuador, India, Indonesia, South Korea, Russia, Thailand, Turkey, and Venezuela on the Priority Watch List.

Watch List: BIO requests USTR to place Australia, Egypt, the Eurasian Economic Union, European Union, Mexico, New Zealand, Peru, Romania, and Vietnam on the Watch List.

Jurisdictions to Monitor: BIO requests USTR to continue monitoring developments South East Asia.

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 administrative, legal, and judicial standards for patentability, compulsory licensing, inadequate protection of regulatory and test data, 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, double patent review systems, genetic resource access and benefit regimes, and technology transfer issues that involve intellectual property. Furthermore, BIO members face issues in many countries surrounding the adoption of the International Union for the Protection of New Varieties of Plants (UPOV) 1991 provisions and the extension of Plant Variety Protection (PVP). This submission will address these issues as they apply in each country.


BIO hopes this submission informs U.S. Government officials and the public about the IPR challenges U.S. biotechnology companies face around the world. Finally, we hope our submission helps the U.S. government identify IPR roadblocks and potential solutions that will help increase U.S. exports and create jobs in the United States.


Download Full Comments Below
2016 BIO Submission
BIO 2016 301 Submission
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