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

  • Republican Healthcare Bill Would Leave BPCIA Untouched In public debates over the Affordable Care Act (ACA), also known as Obamacare, biosimilars are rarely, if ever, mentioned.  But the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (BPCIA), was in fact enacted as part of Obamacare — specifically, as Title VII to the ACA.  Although the BPCIA is no longer politically... More
  • District Court Rules that BPCIA Does Not Limit Innovator’s Remedy If Patent Dance Not Followed In a memorandum and order published last Friday in the Janssen v. Celltrion litigation pending in the federal district court in Massachusetts, Judge Mark L. Wolf provided “guidance” that the Biologics Price Competition and Innovation Act (BPCIA) does not limit an innovator’s remedy to a reasonable royalty unless a biosimilar applicant initiates and follows all... More
  • Genentech’s BPCIA Complaint Against Amgen Dismissed Today, Judge Gregory Sleet of the U.S. District Court of Delaware orally dismissed Genentech’s lawsuit against Amgen alleging violations of the BPCIA.  Judge Sleet did not issue a written opinion, but his order states that the case is dismissed without prejudice for lack of subject matter jurisdiction in light of Amgen v. Sandoz, 794 F.3d... More
  • Supreme Court Reverses § 271(f)(1) Ruling in Biotech Case In Life Technologies Corp. v. Promega, the Supreme Court reversed the Federal Circuit’s interpretation of 35 U.S.C. § 271(f)(1), and held that a single component does not constitute a “substantial portion of the components of a patented invention” under the statute. The Court, however, declined to address how many components are needed to trigger liability.... More
  • PTAB Ruling on CRISPR: No Interference On Wednesday, February 15, 2017, the Patent Trial and Appeal Board (“PTAB”) ruled in favor of the Broad Institute of MIT and Harvard in a closely watched patent fight with UC Berkeley over the breakthrough CRISPR genome-editing technology.  The PTAB concluded that the Broad Institute’s later-filed patents for using CRISPR in eukaryotic cells did not... More
  • Hurdles for Neulasta Biosimilars A number of biosimilar makers have tried to obtain approval for proposed biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a long-acting version of Amgen’s Neupogen (filgrastim), but have encountered hurdles so far both in the U.S. and Europe. Amgen’s Neulasta is a treatment that is used to help cancer patients on chemotherapy fight off infections. It... More
  • 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... 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... 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... 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... More