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

  • USPTO Adopts Amgen v. Sanofi, Excises “Newly Characterized Antigen” Test from its Written Description Guidance for Antibody Claims Last month, the USPTO issued a memorandum to its patent examining corps clarifying its guidance concerning the written description requirement for claims drawn to antibodies.  In the memorandum, the USPTO adopts the Federal Circuit’s recent decision Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The Federal Circuit recently denied Amgen’s petition for rehearing and... More
  • PTAB Holds Indian Tribes Don’t Offer an Out from IPR In a highly anticipated decision on the Saint Regis Mohawk Tribe’s motion to terminate inter partes review proceedings, the Patent Trial and Appeal Board rejected tribal sovereign immunity to IPRs.  The PTAB’s decision also raised doubts about the effectiveness of assignments even in cases where the sovereign assignee has immunity but the assignor effectively still... More
  • Hepatitis C Patent Falls for Non-Enablement, Wiping Out $2.5 Billion Infringement Verdict In a hard-fought patent battle involving “groundbreaking” work by both parties, Chief Judge Stark of the U.S. District Court for the District of Delaware ruled that plaintiff Idenix’s patent for treating Hepatitis C virus (HCV) infection was invalid as a matter of law for lack of enablement.  The decision overturns a $2.5 billion award to... More
  • 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