On Monday the United States Supreme Court issued a decision in Sandoz, Inc. v. Amgen, Inc., relating to the Biologics Price Competition and Innovation Act of 2009. BIO issued the following statement regarding the outcome:
“BIO is disappointed with the Supreme Court’s decision today regarding Sandoz v. Amgen, which has effectively gutted a statute that had been carefully designed to facilitate timely resolution of patent disputes in order to avoid delaying market entry of biosimilar products. Importantly, it will do nothing to expedite the delivery of biosimilars to market. To the contrary, it is likely to delay patient access to biosimilars.
“As stated in our legal brief, this outcome will only encourage more confusion, more litigation, and more gamesmanship by biosimilar applicants, negatively impacting patients and the innovators who invested billions of dollars to develop innovative medical breakthroughs.
“The Biologics Price Competition and Innovation Act of 2009 (BPCIA) properly reflects the delicate balance of interests between promoting innovation and lower-cost generic entry. Unlike the BPCIA, today’s Sandoz v. Amgen is a disservice to patients awaiting lower-cost medical therapies.”