On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court ruling that claims of a patent directed to the Velcade® cancer treatment drug compound were invalid as obvious. The Court held that the District of Delaware clearly erred by finding U.S. Patent No. 6,713,446 (the ‘446 patent) prima facie obvious to one of skill in the art, and by misapplying the secondary indicia of unexpected success and long-unmet need.
In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195 (U.S. June 12, 2017). The Court’s decision grants more flexibility to biosimilar companies and filers of abbreviated Biologics License Applications (“aBLAs”), holding that (1) a reference product sponsor is not entitled to injunctive relief under federal law for an applicant’s refusal to provide a copy of its aBLA and manufacturing information during the information exchange period contemplated by the BPCIA, and (2) an applicant may provide statutory 180-day pre-launch notice of commercial marketing before its proposed biosimilar product is licensed by FDA. An overview of the parties’ oral arguments before the Court on these issues can be found here.