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 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
  • FDA Approves First Avastin Biosimilar FDA announced Thursday that it has approved Mvasi (bevacizumab-awwb), Amgen and Allergan’s biosimilar of Genentech’s Avastin (bevacizumab), a monoclonal antibody used in the treatment of a number of different cancers. Mvasi is the seventh biosimilar approved in the United States under the BPCIA and the first biosimilar approved by FDA for cancer treatment. Mvasi was... More
  • Humira Biosimilar Approved As Litigation Gets Going The FDA on Friday approved the first U.S. biosimilar of Humira (adalimumab), AbbVie’s best-selling biologic for treatment of inflammatory conditions.  The biosimilar, Amgen’s Amjevita (adalimumab-atto), received approval for all of the indications requested by Amgen:  in adults, moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn’s disease, moderately to severely active... More