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

  • Supreme Court Grants Cert in Amgen v. Sandoz Today, the Supreme Court granted Sandoz’s petition for certiorari and Amgen’s cross-petition in Amgen v. Sandoz, case nos. 15-1039 and 15-1195.  The two cases were consolidated, and an hour was allotted for oral argument.  This case will be the Supreme Court’s first to interpret the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  The Federal Circuit’s decision on appeal held that a biosimilar maker does not violate the BPCIA by failing to comply with certain information exchange provisions, known... More
  • FDA Issues Final Guidance Requiring Meaningless Suffixes for Biosimilar Names Despite nearly universal opposition from both biosimilar makers and innovator companies, FDA has issued final guidance adopting its controversial August 2015 proposal for naming biologics.  Under the guidance adopted by FDA, the nonproprietary name of a biologic will consist of the core nonproprietary name of the originator product plus a meaningless but distinguishable suffix of four lowercase letters unique to each product. As an illustration, FDA explains that an originator and a biosimilar sharing the core name “replicamab” might be assigned... More
  • Biosimilars in Europe: 2016 Year in Review and What’s Ahead Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA).  22 biosimilars are approved in eight different product classes and 16 biosimilar applications, including applications in four new product classes, are pending as of December 1, 2016.  2017 may see significant expansion of the biosimilars available in Europe. Approved Biosimilar Products The EMA approved four additional biosimilars in 2016, including three biosimilars in two new product classes: a... More
  • Discontent At Fed. Circ. Grows Post Cuozzo The America Invents Act established inter partes review proceedings within the U.S. Patent and Trademark Office for certain challenges to the validity of issued patents.  More than 5,000 IPR petitions have been filed to date, and more often than not the PTO institutes review of the challenged claims. In over 80 percent of IPRs that have reached a final decision, the PTO has invalidated some or all of the instituted claims.  IPR proceedings have impacted patents across technologies, including pharmaceutical and biotech... More
  • Solicitor General Supports Cert in Amgen v. Sandoz, Supreme Court Denies Cert in Amgen v. Apotex Last week, the Solicitor General submitted its brief in Amgen v. Sandoz, arguing that the Supreme Court should review and decide in Sandoz’s favor both questions presented by the parties’ cross-petitions for certiorari.  Two days later, however, the Supreme Court denied cert in Amgen v. Apotex, which raised similar issues.   Amgen v. Sandoz was the Federal Circuit’s first decision interpreting the BPCIA.  The court first addressed the patent dance, the series of back-and-forth pre-suit information exchanges between the biosimilar applicant... More
  • U.S. Biosimilars Pathway Under Trump This week’s election of Donald Trump as the next President of the United States undoubtedly impacts many sectors of the American economy, and the bio/pharmaceutical industry is no exception.  Two of Trump’s stated policies might bear directly on how biologics will be protected and litigated in this country and abroad: the repeal of the Affordable Care Act of 2010 (ACA), also known as Obamacare, and the repudiation of the Trans-Pacific Partnership (TPP). The Biologics Price Competition and Innovation Act (BPCIA)... More
  • FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept any filing or approve any application for a biosimilar version of Humira® (adalimubab), AbbVie’s best-selling biologic, or any other product for which a biologics license application (BLA) was submitted to FDA prior to March 23, 2010, the date on which the Biologics Price Competition and Innovation Act... 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 ulcerative colitis, and moderate to severe plaque psoriasis, and in patients four years of age and older, moderately to severely active polyarticular juvenile idiopathic arthritis.  Amjevita... More
  • Apotex Prevails in Neulasta Biosimilar Litigation, Files for Cert on 180-Day Issue Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen (filgrastim) and Neulasta (pegfilgrastim).  That dispute has resulted in the first final judgment in a BPCIA lawsuit.  Earlier this month, Judge James Cohn of the Southern District of Florida ruled after a consolidated bench trial addressing both products that Apotex’s biosimilar applications did not infringe Amgen’s sole remaining patent,... More
  • FDA Announces Approval of Second U.S. Biosimilar On April 5, the FDA issued its approval for Inflectra, Celltrion and Pfizer’s biosimilar of Johnson & Johnson’s Remicade (infliximab).  Inflectra is now the second biosimilar approved for sale in the United States, after Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen (filgrastim).  The label for Inflectra contains a statement that it has been “approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and... More