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

  • Senator Hatch’s New Legislation Would Eliminate IPR Challenges by Generics and Biosimilar Makers Generics and biosimilar makers have increasingly used inter partes reviews (“IPRs”), proceedings made possible by the America Invents Act, to challenge patents protecting innovator small-molecule drugs and biologic medicines.  Senator Orrin Hatch, co-author of the Hatch-Waxman Act, has introduced an amendment that would require these manufacturers either to take advantage of the abbreviated regulatory approval... More
  • First Decision on Label Carve-Outs for Biosimilars Expected in Enbrel Litigation As biosimilar litigation between Amgen, the maker of Enbrel® (etanercept), and Sandoz, the maker of biosimilar ErelziTM (etanercept-szzs) heads toward trial before Judge Claire Cecchi in the District of New Jersey, Sandoz is seeking to stave off Amgen’s infringement claims for three of the patents in suit by pointing to its recent amendment to the... More
  • Federal Circuit Issues Two Decisions Impacting Standing to Challenge Validity of Pharma Patents Two recent Federal Circuit decisions address when a party has standing to challenge the validity of a patent. Though the cases arose in different contexts, they both center on the question of what it means for a party to be facing an imminent and cognizable injury. In Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., 17-1487,... More
  • Fourth Circuit Rules that Maryland’s Anti-Price Gouging Act for Off-Patent or Generic Drugs is Unconstitutional The U.S. Court of Appeals for the Fourth Circuit last month handed manufacturers and wholesalers of off-patent drugs a victory by ruling that Maryland’s anti-price gouging act violates the U.S. Constitution’s dormant commerce clause.  The legislation, like many others, was enacted in the wake of the Martin Shkreli case, where the former Turing Pharmaceutical CEO... More
  • FDA Approves Pfizer’s EPO Biosimilar Yesterday, Pfizer announced that FDA had approved Retacrit® (epoetin alfa-epbx), a biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa).  Epoetin alfa (EPO) is a blockbuster treatment for anemia.  Retacrit is the first EPO biosimilar approved in the United States. EPO biosimilars have been marketed in the EU for over a decade.  ... More
  • PTAB and Bar Prepare for Aftermath of Supreme Court’s SAS Decision In last week’s Oil States decision, the Supreme Court upheld the constitutionality of inter partes review (IPR) under the Leahy-Smith America Invents Act (AIA), as expected by most observers.    However, it was the Court’s decision in a second IPR-related case that will have an immediate impact on patent practitioners.  In SAS Institute Inc. v. Iancu,... More
  • Supreme Court Holds IPRs Are Constitutional In a highly anticipated ruling, the Supreme Court upheld the constitutionality of inter partes review proceedings.  Justice Thomas, writing for the seven-member majority in Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, held that the Patent Trial and Appeal Board could reconsider and cancel patent claims through inter partes review without violating Article... More
  • In WesternGeco v. ION Geophysical Corp., the Supreme Court Weighs the Availability of Foreign Damages for U.S. Patent Infringement On Monday, April 16, 2018, the Supreme Court heard oral argument in WesternGeco LLC, v. ION Geophysical Corporation, No. 16-1011, a case with broad implications for patent holders that sell products abroad.  The case addresses whether lost profits accrued outside of the United States can be recovered for patent infringement occurring domestically.  In the decision... More
  • Amgen v. Adello: A Blind Biosimilar Infringement Lawsuit Last month, Amgen sued Adello Biologics, a US-based biosimilar maker, for patent infringement under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in connection with Adello’s proposed biosimilar of Amgen’s Neupogen (filgrastim).  Adello elected to bypass the pre-suit procedures of the BPCIA and did not provide any information to Amgen regarding its biosimilar... More
  • Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar Marketing Application Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal Board (PTAB), many of them preceding the filing of a marketing application.  Such early IPRs are attractive to biosimilar makers, because they provide a chance to challenge innovator patents years before the biosimilar... More