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.

Recent Blog Posts

  • Four Years of IPRs: Lessons from Proceedings for the Cabilly II Patent It has been four years since the first inter partes review proceedings were filed in the United States.  The first IPR petition, filed on September 16, 2012 (the first day IPRs became available), made it all the way to the Supreme Court, and the number of IPR filings has greatly exceeded expectations, making the Patent Trial and Appeal Board one of the most important and busiest forums for patent validity litigation in the US.  IPRs were intended to help high-tech... More
  • Amgen’s Federal Circuit Appeal: the Importance of Manufacturing Information to Biosimilar Litigation Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction.  The appeal presents an important question for biosimilar litigation:  where biosimilar applicants fail to provide manufacturing information in the pre-litigation information exchanges of the Biologics Price Competition and Innovation Act (BPCIA), are they required to provide that information in litigation even if it is irrelevant to the asserted patents?  The question is particularly important... More
  • CIMZIA Does Not Infringe Yeda’s Monoclonal Antibody Patent In UCB, Inc. v. Yeda Research and Development Co., the Federal Circuit affirmed the determination by the District Court for the Eastern District of Virginia that UCB, Inc.’s  Cimzia® (certolizumab pegol), a biologic medicine that treats inflammatory conditions such as rheumatoid arthritis and Crohn’s disease, does not infringe a monoclonal antibody patent owned by Yeda Research and Development Co., Ltd..  (Fed. Cir. Appeal No. 2015-1957, September 8, 2016).  UCB sued Yeda requesting a declaration that Cimzia did not infringe Yeda’s patent. ... More
  • Amgen’s Federal Circuit Appeal to Address Important BPCIA Disclosure Issue The Federal Circuit has now issued two decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  In Amgen v. Sandoz, the first decision to interpret the BPCIA, the majority held that biosimilar makers could opt out of the first step of the BPCIA pre-litigation procedures, the provision requiring biosimilar makers to provide their abbreviated Biologics License Application (aBLA) and other manufacturing information describing the processes used to make the biosimilar twenty days after the FDA accepts the... More
  • US Biosimilar Pathway Update Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US.  Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved.  Zarxio, a relatively simple biologic, was approved in March 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  Zarxio has now has been on the market for a year (since September 2015).  This year, FDA approved two complex biologics, Celltrion and Pfizer’s Inflectra,... More
  • Enbrel Biosimilar Approved in US But Enjoined For Now On August 30 FDA approved Sandoz Inc.’s biosimilar of Enbrel (etanercept), Amgen Inc.’s blockbuster biologic for treatment of moderate to severe rheumatoid arthritis and a number of other autoimmune conditions.  The biosimilar, Erelzi (etanercept-szzs), is the third biosimilar approved for marketing in the US under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  Erelzi has been approved for all of Enbrel’s indications and is the first U.S. biosimilar of etanercept.  In its announcement FDA noted that “Erelzi has... More
  • The Ripple Effect of the Federal Circuit’s Decision in Amgen v. Apotex on Biosimilar Litigation In July, the Federal Circuit decided Amgen v. Apotex, No. 2016-1308 (Fed, Cir. July 5, 2016), its second decision interpreting the U.S. biosimilar statute, the Biologics Price Competition and Innovation of Act of 2009 (BPCIA).  The Federal Circuit affirmed the district court’s preliminary injunction barring Apotex from selling its proposed biosimilar until 180 days after post-licensure notice of first commercial marketing.  The Federal Circuit held that 180 days’ notice was mandatory regardless of whether the biosimilar maker provided its regulatory... More
  • Judge Dismisses Amgen’s BPCIA Declaratory Judgment Action Against Sandoz Judge Chesler of the U.S. District Court for the District of New Jersey has dismissed one of Amgen’s pending lawsuits against Sandoz under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (“BPCIA”).  Amgen and Sandoz are involved in a web of biosimilar litigation regarding Sandoz’s proposed biosimilar versions of Amgen’s related drugs Neupogen (filgrastim) and Neulasta (pegfilgrastim).  In March of this year, Amgen filed a lawsuit seeking a declaratory judgment that Sandoz violated the BPCIA by attempting... More
  • Federal Circuit’s Application of Mayo Revives Biotech Patent In Rapid Litig. Mgmt. Ltd v. CellzDirect, Inc., the Federal Circuit reversed a ruling of patent invalidity under Section 101, reviving a biotech patent to a method of preserving hepatocytes, liver cells, for medical use.  The Federal Circuit reversed the district court at both steps of the Supreme Court’s framework for patent eligibility set out in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).  In the wake of the Supreme Court’s recent denial of certiorari in Sequenom... More
  • Amgen and Hospira Square Off Over BPCIA Private Right of Action After Amgen v. Apotex Ruling Amgen and Hospira have fired off dueling letters to the court in their litigation over Amgen’s Epogen biosimilar, debating whether the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA), contains a private right of action.  The letters come in the wake of the Federal Circuit’s Amgen v. Apotex decision, which held that the BPCIA’s 180-day notice of commercial marketing provision is mandatory and enforceable by an injunction. Last fall, Amgen sued Hospira in the U.S. District Court for Delaware in an effort to prevent the sale of... More