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

  • U.S., European Biosimilar Approval Activity in 2017 2017 was a record-setting year for biosimilar approvals in the U.S. and Europe. In the U.S., five complex antibody products were approved, two of which are in new therapeutic areas for U.S. biosimilars. In Europe, 16 biosimilars were approved. The number of approved biosimilars in Europe has doubled in the past two years. These approvals... More
  • Patent dance remains on point The Federal Circuit’s recent decision in Amgen v Sandoz provides a measure of clarity for innovator companies and biosimilar makers eyeing patent litigation. While the Supreme Court of the US held in June that initiating the pre-litigation information exchanges set out in the Biologics Price Competition and Innovation Act (BPCIA) – colloquially referred to as the “patent... More
  • FDA Approves the First Gene Therapy to Treat an Inherited Disease On December 19, 2017, FDA approved the gene therapy Luxturna (voretigene neparvovec-rzyl), developed by Spark Therapeutics, to treat children and adults with biallelic RPE65 mutation-associated retinal dystrophy, an inherited disease of the eye.  Luxturna is the United States’ first approved gene therapy for treatment of an inherited disease, and its approval comes ahead of the... More
  • 2017 Biosimilar Approvals in Europe The European biosimilar market has expanded at record pace in 2017.  The EMA approved marketing of sixteen biosimilar products referencing seven different innovator biologic products.  For five of the innovator products – AbbVie’s Humira, Biogen/Genentech’s Rituxan, Genentech’s Herceptin, Eli Lilly’s Humalog, and Eli Lilly’s Forsteo – no biosimilar was previously approved in Europe.  Biosimilars Approved... More
  • US Biosimilar Approvals Soar in 2017 Marketing approval for US biosimilars has taken off in 2017.  FDA has approved five biosimilar products this year, increasing the number of approved biosimilars from four to nine.  In addition to new biosimilars of AbbVie’s Humira and Janssen’s Remicade, FDA has approved the first two biosimilars for the treatment of cancer.  All five of the... More
  • 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