On December 9, 2020, the Federal Circuit heard oral arguments on the validity of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741) on cholesterol-lowering drug Repatha. Specifically, the question came down to whether the patents, claiming a genus of antibodies by their functional properties, are enabled under 35 U.S.C § 112. The panel consisted of

As previously reported, the FDA had yet to approve any biosimilars in 2020 as of June 9, despite a growing pipeline. Since then, the FDA has approved two biosimilar products.

On June 11, Pfizer Inc. announced the FDA’s approval of Nyvepria™ (pegfilgrastim-apgf), a biosimilar of Amgen’s Neulasta™. Nyvepria is indicated “to decrease the incidence of

Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for treatment of high cholesterol.[1]  The case reached an important milestone recently as a jury entered a verdict largely upholding the validity of Amgen’s asserted patents, to the disappointment of Sanofi and Regeneron.  A similar

On February 14, 2019, the PTAB issued final written decisions in two separate IPRs filed by Sanofi-Aventis, Genzyme Corp., and Regeneron Pharmaceuticals (collectively “Sanofi”) against U.S. Patent No. 8,679,487 (“the ʼ487 patent”) assigned to Immunex Corporation (“Immunex”). Claim 1 of the ʼ487 patent is the only independent claim, and it is directed to “an isolated

Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee™, received marketing approval from both the European Commission (which applies to all 28 European Union member states) and the European Economic Area member states of Norway, Iceland, and Liechtenstein.[1] Additionally, the Therapeutic Goods Administration approved the biosimilar for use

Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. recently scored a victory in their ongoing dispute over a patent that Immunex Corporation claims covers Dupixent®, Sanofi and Regeneron’s anti-IL-4 antibody marketed for treatment of moderate-to-severe eczema. In February, the Patent Trial and Appeal Board (“the Board”) instituted two petitions for inter partes

On December 20, 2017, Bristol Myers Squibb Company, Bavarian Nordic, and Enzo Biochem, Inc. filed an amicus brief in support of Amgen’s petition for rehearing en banc. We reported previously that on November 6, 2017, Amgen filed a petition for rehearing en banc of a Federal Circuit panel’s decision vacating a permanent injunction against