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

  • Federal Circuit Upholds Jury Award, Weighs in on Willfulness Standard, in Adynovate® Dispute According to the Federal Circuit, $173 million was the right damages award for almost three years of patent infringement resulting from Baxalta’s sale of its biologic product Adynovate® (Antihemophilic Factor (Recombinant), PEGylated).  In Bayer Healthcare LLC v. Baxalta Inc., et al., Nos. 2019-2418, 2020-1017 (Fed. Cir. 2021), the circuit court upheld an award to Bayer... More
  • Sandoz Petitions the Supreme Court for Review of Enbrel® Patent License The fight over proposed Enbrel® (etanercept) biosimilar Erelzi® continues. Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (“Sandoz”) recently filed a petition for certiorari requesting review of the judgement of the Federal Circuit on whether: [a] patent owner [may] avoid the rule against double patenting by buying all of the substantial rights to a second,... More
  • Federal Circuit Axes Amgen Antibody Patents, Finding Lack of Enablement The Federal Circuit considered its 35 U.S.C. § 112 enablement case law and found that “the enablement inquiry for claims that include functional requirements”—in this case, claims to antibodies defined by their function—“can be particularly focused on the breadth of those requirements, especially where predictability and guidance fall short.”  Dkt. 132 at 10.  In Amgen... More
  • FDA Approves Breyanzi®—A New Biologic for Treating Large B-Cell Lymphoma On February 5, 2021, the FDA approved Juno Therapeutics, Inc.’s Breyanzi® (lisocabtagene maraleucel) for “treatment of adult patients with relapsed or refractory large B-cell lymphoma.”  Juno, a Bristol-Myers Squibb Company, was authorized to manufacture Breyanzi at its Bothell, Washington facility and provide it to patients under a risk evaluation and mitigation strategy (REMS).  Breyanzi was designated... More
  • 2021 Biosimilar Approval and Litigation Update The last two years saw the launch of several biosimilars.  Looking ahead to 2021, several others may be on the horizon.  In 2019-2020, the FDA approved thirteen biosimilars directed to seven reference products.  Eight of the approved biosimilars have launched, while five are either embroiled in litigation or awaiting agreed-upon launch dates.  Over the last... More
  • Rehearing Denied in Federal Circuit Hatch-Waxman Venue Case The Federal Circuit has spoken.  In a per curiam opinion, it denied Valeant’s petition for rehearing by the panel and rehearing en banc.  A case watched closely by the biotechnology and pharmaceutical industries, the Federal Circuit held in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc. that venue in Hatch-Waxman cases brought under 35 U.S.C.... More
  • Opposition to Rehearing Filed in Major Federal Circuit Case Narrowing Hatch-Waxman Venue Last week, Mylan filed a brief in opposition to Valeant’s petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402. In November, a Federal Circuit panel held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of... More
  • WTO to Discuss Member Proposal to Waive IP Rights for COVID-19 Technologies On October 2, 2020, India and South Africa urged the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council to temporarily waive the obligation of member states under the TRIPS Agreement to protect intellectual property rights for technologies related to the “prevention, containment or treatment” of COVID-19. Kenya, Eswatini, Pakistan, Mozambique, and Bolivia... More
  • Rehearing Requested in Major Federal Circuit Case Narrowing Venue in Hatch-Waxman Cases Earlier this month, Valeant Pharmaceuticals North America LLC (“Valeant”) filed a petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, arguing that the Federal Circuit panel’s decision limiting venue in Hatch-Waxman cases conflicts with precedent regarding “what the act of infringement is” and “where the act of infringement... More
  • FDA’s Draft Guidance for Industry Seeks to Answer Questions on Biosimilar Interchangeability FDA has published new draft guidance for industry titled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.”  The draft guidance supplements two prior documents concerning biosimilar interchangeability published in December 2018.[1]  This new guidance, in particular, has some useful information for prospective applicants who seek licensure of an “interchangeable” biosimilar... More