Intellectual property strategies for bioproducts

CHAL 31

Mark Stewart, stewart_mark@lilly.com, Associate General Patent Counsel, Eli Lilly and Company, Lilly Corporate Ctr, Indianapolis, IN 46285
While the number of bioproducts will continue to grow over the next several years, whether the public receives the benefit of any particular product may depend on the balance the patent law strikes between rewarding the initial discovery and promoting subsequent innovation. Biotechnology inventions are unique due to redundancy of the genetic code, the ability to easily manipulate DNA and protein sequences, the ability to easily make large populations of antibodies which can be studied for subsequent therapeutic development, as well as the rapid advancement of technology to allow the creation of diverse populations of peptides and proteins that bind the same target. Courts and the United States Patent & Trademark Office have struggled with applying traditional legal principles related to obviousness, enablement, and written description to biotechnology inventions. This presentation will explore the relationship between obviousness and the written description requirement in the context of biotechnology inventions, discuss whether courts and the USPTO are striking the right balance between rewarding the initial discovery without discouraging competition and subsequent innovation, and suggest exclusivity and freedom-to-operate strategies in the context of the evolving law in the United States.