On July 14, 2025, Fresenius Kabi filed IPR2025-01268 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”) and IPR2025-01269 against U.S. Patent No. 10,828,345 (“the ’345 patent”), both relating to EYLEA®...more
8/4/2025
/ Biologics ,
Biosimilars ,
BPCIA ,
Fresenius ,
Inter Partes Review (IPR) Proceeding ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regeneron
On July 18, 2025, after a five-day trial, the jury in Allergan v. Revance Case No. 1:21-cv-01411 (D. Del.) entered a verdict finding claim 8 of Allergan’s U.S. Patent No. 7,354,740 (“the ’740 patent”), claim 6 of U.S. Patent...more
8/4/2025
/ Allergan Inc ,
Damages ,
Intellectual Property Litigation ,
Jury Trial ,
Nonobvious ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Validity ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Royalties
On July 16, 2025, Amgen and Accord settled Case No. 1:25-cv-01305 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) alleging infringement of 34 of Amgen’s patents by Accord’s proposed Prolia® / Xgeva® (denosumab) biosimilar INTP23...more
On July 1, 2025, Fresenius Kabi announced the U.S. launch of Conexxence™ / Bomyntra™ (denosumab-bnht), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab), pursuant to a settlement agreement between the parties ending BPCIA...more
Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more
Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
7/15/2025
/ Biosimilars ,
Drug Pricing ,
FDA Approval ,
Generic Drugs ,
Inter Partes Review (IPR) Proceeding ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more
7/15/2025
/ Biosimilars ,
FDA Approval ,
Inter Partes Review (IPR) Proceeding ,
Litigation Strategies ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Requirements
Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
On June 25, 2025, Amgen filed its sixth and seventh BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-12152 (D.N.J.) against Hikma and Gedeon Richter’s RGB-14 and Case No....more
On June 9, 2025, the Patent Trial and Appeal Board (“Board”) issued a Final Written Decision (“FWD”) in Merck’s IPR2024-00240 against The Johns Hopkins University’s (“JHU”) U.S. Patent No. 11,591,393 (“the ’393 patent”),...more
7/3/2025
/ Claim Construction ,
Inter Partes Review (IPR) Proceeding ,
Johns Hopkins ,
Litigation Strategies ,
Obviousness ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art
On June 26, 2025, Sarepta Therapeutics filed IPR2025-01194, challenging as obvious claims 3-6 of Genzyme’s U.S. Patent No. 9,051,542 (“the ’542 patent), and IPR2025-01195 challenging claims 1-4, 6-7 and 11 of U.S. Patent No....more
On June 2, 2025, the Patent Trial and Appeal Board (“Board”) issued decisions denying institution of Samsung Bioepis’s IPR2025-00176 and Formycon’s IPR2025-00233 against claims 1–12, 14–17, 19, 20, 22–36, 39–42, 44, 45, and...more
Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more
Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more
Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
On June 2, 2025, Sandoz announced the launch of Jubbonti® / Wyost® (denosumab-bbdz), the first Prolia® / Xgeva® (denosumab) interchangeable biosimilars to launch in the U.S....more
6/12/2025
/ Amgen ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Interchangeability ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Sandoz ,
Settlement Agreements