BIO submitted a full report to the U.S. Government highlighting intellectual property challenges

Stanford McCoy
Assistant U.S. Trade Representative for Intellectual Property and Innovation
Office of the U.S. Trade Representative
Chair of the Special 301 Committee
Office of the United States Trade Representative
Washington, D.C.





The Biotechnology Industry 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 2014 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 1,100 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 patents 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.

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