On November 20, 2020, the U.S. Food & Drug Administration (“FDA”) released a Q&A-format draft guidance to address four questions regarding the submission of biologics license applications (BLAs) and labeling for interchangeable biosimilar products. 85 FR 74345 (“Draft Guidance”). The
Continue Reading FDA’s New Draft Guidance Regarding Biosimilarity and Interchangeability
On November 18, 2020, companies Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the United States Food and Drug Administration (“FDA”) accepted for review the Biologics License Application for SB11, a proposed biosimilar referencing Genentech, Inc. product Lucentis® (ranibizumab).
Continue Reading FDA Accepts Review of Samsung Bioepis and Biogen’s Ranibizumab Biosimilar
Mark your calendars – on December 9th, the Federal Circuit is slated to hear oral arguments as to whether two Amgen patents claiming a genus of antibodies meet the enablement requirement of 35 U.S.C. § 112. The court’s decision may
Continue Reading Big Pharma to Face Off at Federal Circuit Oral Arguments Over Antibody Genus Patentability
In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., No. 2019-2402 (Fed. Cir. Nov. 5, 2020), the Federal Circuit clarified the venue analysis of 28 U.S.C. § 1400(b), which controls venue for patent infringement cases. Section 1400(b) provides that
Continue Reading Venue Considerations for Hatch-Waxman and BPCIA Litigation
The world-wide market share of biologic drugs is advancing at a staggering pace, with some estimates ranging from $ 300 billion to $452 billion in revenue within the next five years.[1],[2],[3] The treatment costs for
Continue Reading Patent Thickets and Regulatory Challenges Cited as Major Factors Limiting Price Reductions in the Biologic Drug Space
In the context of Immunex’s patent on IL-4 antibodies, the Federal Circuit says yes.
On October 13, 2020, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (the “Board”) final written decision in IPR2017-01884, holding invalid all claims of
Continue Reading Does the Term “Human Antibody” Include Humanized Antibodies?
The Federal Circuit recently held[1] in a 2-1 decision that there was substantial evidence supporting a jury finding that Teva was liable for induced infringement for an indication carved out of its skinny label for its generic version of
Continue Reading Federal Circuit Decision Raises Concern over Whether Skinny Labels are Sufficient to Avoid Induced Infringement
Updated October 12, 2020
As pharmaceutical
Continue Reading How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
Last week, the Federal Circuit denied Sandoz’s petition for an en banc rehearing of its precedential July 1st panel decision upholding two of Immunex’s patents covering Enbrel®.
As explained in the petition, Immunex was the first to make etanercept, the
Continue Reading Federal Circuit Refuses to Reconsider Its Panel Decision Finding No Common Ownership of Immunex’s Enbrel Patents
Pharmaceutical companies Biocon Biologics and Mylan announced at the end of last month the U.S. launch of their long-acting insulin glargine product Semglee. Semglee was approved in June as an equivalent to Sanofi’s reference product insulin glargine, Lantus.
The companies
Continue Reading Biocon Biologics and Mylan Announce U.S. Launch of Insulin Glargine Product Semglee
