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

  • Part I: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017.  Innovators, biosimilar makers, patients, healthcare providers and other stakeholders have weighed in on the long-awaited guidance.  Interchangeable biosimilars, unlike other biosimilars, may be substituted for the innovator product without the intervention of the healthcare... More
  • Update on Biosimilar Approvals and Pending Applications in Europe and the U.S. Approvals of biosimilar products in Europe continue to outpace those in the United States.  28 biosimilars are currently approved in Europe and five in the U.S.  In 2017, the European Medical Agency has approved six biosimilar applications, including applications for biosimilars to two of the best-selling complex biologics, Humira (adalimumab) and MabThera (rituximab).  EMA is... More
  • The Federal Circuit’s First Application of the AIA’s On-Sale Bar: Implications for Bio/Pharma When a small pharmaceutical company discovers a new medicine, it’s not uncommon for the company – which may not itself have the resources or infrastructure to get that medicine to patients – to seek a distribution partner early in development.  If the partners make a deal – say the distributor pays for the right to... More
  • 100 Days Plus Under Trump: What They Mean for Biologics President Donald J. Trump has now been in office for just over one hundred days.  Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like immigration and foreign policy. Amidst the hubbub, however, few have commented on how President Trump’s opening moves could affect the multi-billion-dollar... More
  • 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