The House Judiciary Committee conducted a hearing on World IP Day on “International Patent Issues: Promoting a Level Playing Field for American Industry Abroad.” BIO submitted written comments for the record highlighting the unique patenting challenges that biotechnology companies face around the world.
“To fully understand what is needed to level the playing field for the biotechnology sector in international markets, one must understand the intellectual property (IP) needs of the biotechnology sector. Biotechnology innovation requires predictable and effective upstream (early stage) and downstream (product) IP protection. Biotechnology innovation generally starts with an early laboratory discovery, and thus upstream protection helps to generate investment and interest in the further, applied research and development of the invention. Upstream protection includes broad patent eligibility for biotech innovations, consistent patent term, flexible licensing practices, and effective patent enforcement.
Downstream protection is just as important. As mentioned above, the research and development of a biological product can take decades and cost more than a billion dollars to complete. A significant portion of this time and money goes towards developing the regulatory data package that is required by the U.S. FDA, USDA, or similar foreign regulatory offices to approve the biotech product. Therefore, downstream protection for biotech products must include sufficient protection against foreign and domestic competitors relying on the innovator’s data package to secure abbreviated approval of competitive products in such markets. “