Biologics Blog

Biologics Blog is a source of insights, information and analysis related to biologics, including the legal developments, trends and changing regulation that impact the biotechnology industry. Patterson Belknap represents biotechnology, pharmaceutical and healthcare companies in a broad range of patent litigation matters, including patent infringement cases, PTO trial proceedings, patent licensing and other contractual disputes.

Recent Blog Posts

  • Federal Circuit: BPCIA Preempts State Law In Biosimilar Litigation The Federal Circuit on Thursday issued an opinion in Amgen v. Sandoz holding that that the Biologics Price Competition and Innovation Act (BPCIA) preempts state-law claims that are based on a biosimilar applicant’s failure to participate in the BPCIA’s patent dispute resolution procedures, a/k/a the “patent dance.”  In light of the Supreme Court’s earlier ruling that... More
  • Mixed Results as IPR Petitions for Biosimilars Soar Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More... More
  • Federal Circuit Affirms Apotex Bench Trial Win in Neulasta Biosimilar Suit On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein patent in its abbreviated Biologics License Applications referencing Amgen’s Neulasta and Neupogen.  Judge James Cohn of the Southern District of Florida ruled in Apotex’s favor in September 2016 after a bench trial.  On... More
  • All-or-Nothing Damages Strategy Leaves Promega with Nothing The Federal Circuit’s recent decision in Promega Corp. v. Life Technologies Corp. is a cautionary tale that failure to present evidence of damages closely tied to each alternative basis of liability may result in a hollow victory – infringement with no corresponding damages.  The Federal Circuit, on remand from the Supreme Court, affirmed the district... More
  • Fed. Circ. Clarifies Law For Functional Antibody Claims On Oct. 5, the Federal Circuit issued a decision in Amgen Inc. v. Sanofi (No. 2017-1480), a closely watched case involving functional antibody claims, claims that define antibodies not by their sequence or structure but by their function, such as the ability to bind a biological target. The Federal Circuit held that although written description and enablement of... More
  • A New Strain Of Inequitable Conduct Litigation In July, a split panel of the Federal Circuit upheld the district court’s use of an adverse inference from litigation misconduct to hold a patent unenforceable for inequitable conduct. The Federal Circuit’s decision in the case, Regeneron Pharmaceuticals Inc. v. Merus NV, raises interesting questions about the relationship between attorney misconduct during litigation (which is not... More
  • The Supreme Court’s interpretation of the biosimilars statute and the value of certainty In Sandoz v. Amgen, the Supreme Court interpreted the U.S. biosimilars statute, the Biologics Price Competition and Innovation Act (BPCIA), for the first time. The Court held unanimously that provisions of the BPCIA requiring disclosure allowing innovator companies to assess whether their patents are infringed cannot be enforced under federal law. The ruling also allows... More
  • Amgen and Genentech Break New Ground in Avastin Biosimilar Dispute Amgen and Genentech have become embroiled in a novel procedural dispute relating to Mvasi, Amgen’s biosimilar of Genentech’s Avastin (bevacizumab).  On October 6, in a complaint filed in the Central District of California, Amgen brought an action seeking a declaratory judgment that 27 of Genentech’s patents are not infringed, invalid, and unenforceable.  Amgen’s suit appears... More
  • Amgen Files Infringement Suit Against Mylan Over Neulasta Biosimilar Amgen has filed patent infringement claims against Mylan and its subsidiaries over Mylan’s proposed biosimilar version of Neulasta (pegfilgrastim).  Neulasta, a long-acting version of Amgen’s Neupogen (filgrastim), is a blockbuster biologic medicine used by cancer patients on chemotherapy to fight off infections.  Amgen alleges that Mylan infringes two of its patents, U.S. Patent Nos. 8,273,707... More
  • Following Biosimilar Trial, Jury Awards Amgen $70 Million for Pfizer’s Pre-Approval Infringement of Now-Expired EPO Patent In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents protecting Epogen®.  Notably, the damages relate to product that Pfizer is not yet approved to sell in the United States. ... More