Modern pharmaceutical and biotechnology products typically require lengthy, costly, and resource-intensive development periods before they reach the marketplace. BIO members devote many years and millions of dollars in direct investment and sweat equity to develop innovative new products that cure diseases, improve food security and/or create alternative energy sources, among other things. The ability to maintain and enforce strong patents covering these innovations provides critical incentive to justify this investment. Increasingly, BIO members, large and small, engage third party contract resources to perform research and manufacturing services to reduce development costs, streamline resources, and enhance efficiency. BIO members therefore are especially vulnerable to the misapplication and inconsistent application of standards that lead to the invalidation of patents.The Panel Decision needlessly expands the on-sale bar to discriminate against pharmaceutical manufacturers who choose to take advantage of the economic efficiencies of outsourcing clinical manufacturing or other aspects of the drug development process. Applying the on-sale bar to a contract between a patent holder and a contract manufacturer who confidentially provides manufacturing services conflicts with established precedent and Congressional intent. The decision has wide-ranging economic implications for the pharmaceutical and biotechnology industry as a whole and risks chilling investment in research, development, and commercialization of new products that heal, feed, and fuel the world. BIO and its members have a substantial interest in the Court’s resolution of the questions raised by the Panel Decision.

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.