BIO Submits Amicus Brief to Federal Circuit Court of Appeals in GILEAD SCIENCES, INC., HOFFMANN-LA ROCHE, INC., F. HOFFMANN-LA ROCHE, LTD., and GENENTECH, INC. v. NATCO PHARMA LIMITED and NATCO PHARMA, INC.

Biotechnology Industry Organization (“BIO”) is the world’s largest trade association, representing over 1100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO members research and develop biotechnological healthcare, agricultural, environmental, and industrial products. BIO members range from startup entities and university spinoffs to Fortune 500 multinational corporations, though the majority of BIO members are small companies that have yet to bring products to market or attain profitability, and thus depend on venture capital and other private investment for their growth.

The Pharmaceutical Research and Manufacturers of America (“PhRMA”) is a voluntary, nonprofit association representing the nation’s leading research-based pharmaceutical and biotechnology companies. PhRMA’s member companies are dedicated to discovering medicines that enable patients to lead longer, healthier, and more productive lives. During 2013 alone, PhRMA members invested an estimated $51.1 billion to research and develop new medicines. PhRMA’s mission is to advocate public policies that encourage the discovery of life-saving and lifeenhancing medicines by its members.

Pharmaceutical and biotechnology products typically require long development times and enormous investments before they reach the marketplace. Companies rely heavily on patents to protect such substantial investments of time, resources, and capital. The panel’s decision here needlessly adds uncertainty to the prospective term of pharmaceutical and biotechnology patents and thereby risks chilling investment in research, development, and commercialization of new products that heal, feed, and fuel the world.

BIO and PhRMA thus appear as amici out of concern that the Gilead majority has expanded the judicially-created doctrine of obviousness-type double patenting in ways that impair the settled expectations of the industry and of the public, and that conflict with established precedent and Congressional intent. The plaintiffs-appellees to this appeal are members of BIO. No party to this appeal has contributed financially or substantively to the preparation of this brief.