The Biotechnology Industry Organization (“BIO”) is the country’s largest biotechnology trade association, representing over 1100 companies, academic institutions, and biotechnology centers in all 50 states and in countries around the world. BIO members research and develop biotechnological healthcare, agricultural, environmental, and industrial products. These members are a diverse group that range from start-up businesses and university spin-offs to Fortune 500 corporations.
The Pharmaceutical Research and Manufacturers of America (“PhRMA”) is an association dedicated to representing the Nation’s leading pharmaceutical and biotechnology companies. PhRMA members’ research and development efforts produce the innovative medicines, treatments, and vaccines that save and improve the lives of countless individuals around the world every day. Over the past decade, PhRMA’s members have invested over $500 billion in the research and development of new drugs, with roughly $51.1 billion invested in 2013 alone.
Both BIO and PhRMA regularly participate as amici in cases raising important issues concerning the consistency and predictability of this Court’s decisions, including on questions of claim construction. BIO’s and PhRMA’s members rely heavily on patents to protect their substantial investments of time, resources, and capital necessary to produce new innovations. Uncertainty in claim scope devalues patent assets, which in turn leads to reduced incentives for companies to research, develop, and commercialize new products that heal, feed, and fuel the world. To ensure enforceable patent rights, patent owners need clarity regarding the meaning of claim terms and how courts will interpret them. The panel majority’s decision in this case conflicts with prior decisions of this Court and disrupts the consistency and predictability that BIO’s and PhRMA’s members need to conduct their businesses efficiently and in the public interest.