2011 Special 301: BIO Comments to USTR

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 2011 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 all 50 States and a number of foreign countries. BIO’s members are involved in the research and development of 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 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. 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 2011 Special 301 submission.