The questions presented in this case implicate two of the foundational legal conclusions that have allowed the PTAB, even in a relatively short time, to cut a remarkable swath through the ranks of issued patents with barely a light tap on the brakes by the Federal Circuit. First, the Federal Circuit has held that the Patent Trial and Appeal Board (PTAB) may invalidate patents by construing their claims in a way that would never be used in an infringement case in district court, and then finding that artificially broad interpretation too broad to be patentable. Second, the Federal Circuit has held that the PTAB may invalidate patents in an IPR without any court ever being permitted to review whether the PTAB has violated the procedural limitations on its cancellation authority that Congress wrote into the America Invents Act. BIO, AUTM, and their members have a substantial interest in the Court’s resolution of those questions.

BIO as Amicus Curiae supporting en banc reconsideration in Prolitec, Inc. v. ScentAir Technologies, Inc. (US Court of Appeals for the Federal Circuit)   STATEMENT OF INTEREST OF AMICUS CURIAE The Biotechnology Innovation Organization (“BIO”) (formerly: Biotechnology Industry Organization) is the principal trade association representing the biotechnology industry domestically and abroad. BIO’s members depend on robust patent rights and a fair system for adjudicating their validity, including the ability to amend claims in inter partes review (IPR). Accordingly, the question of who has the burden of proof, and what must be proved, before a claim amendment can be entered in IPR is of great importance to BIO’s membership.

Brief of Amicus Curiae Biotechnology Innovation Organization in Support of Plaintiffs-Appellees in Amgen Inc. v. Apotex Inc. (U.S. Court of Appeals for the Federal Circuit) INTEREST OF AMICUS CURIAE   The Biotechnology Innovation Organization (“BIO”) is the world’s largest biotechnology trade organization, representing more than 1,000 member companies and research organizations—from startups to Fortune 500 companies— who research and develop biotechnological products including lifesaving medicines. Biological medicines are now used to treat previously untreatable diseases and have prolonged and improved the lives of countless patients. But, development of a biological medicine generally requires a decade or more of research, as well as a fully capitalized investment that on average exceeds $2 billion.   BIO played a leading role in the effort to establish a statutory pathway for abbreviated approval of biosimilars that would lower costs through increased competition and expand access to lifesaving medicines while protecting patient safety and promoting further biomedical innovation. The aptly named Biologics Price Competition and Innovation Act (“BPCIA” or “the Act”) aims to achieve those goals. Many of BIO’s members are global leaders in the development and commercialization of both innovative biologics and biosimilars. Accordingly, BIO and its members have a strong interest in the proper interpretation of the critical provision of the BPCIA at issue in this case.