On October 20, 2025, Celltrion and Regeneron announced they reached a settlement agreement, dismissing Case Nos. 1-23-cv-00089 (N.D.W. Va.) and 1-24-cv-00053 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the...more
On October 1, 2025, the PTAB granted Amgen’s request for adverse judgment based on Bristol-Myers Squibb’s (“BMS”) statutory disclaimer of all challenged claims prior to institution of trial....more
10/27/2025
/ Amgen ,
Biosimilars ,
Bristol-Myers Squibb ,
Disclaimers ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Statutory Disclaimers ,
Statutory Interpretation ,
USPTO
On October 9, 2025, Celltrion announced the FDA approved Eydenzelt® (aflibercept-boav), a biosimilar of Regeneron’s EYLEA® (aflibercept). ...more
On September 18, 2025, the Patent Trial and Appeal Board (“Board”) issued a Final Written Decision (“FWD”) in Merck’s IPR2024-00625 against The Johns Hopkins University’s (“JHU”) U.S. Patent No. 11,339,219 B2 (“the ’219...more
On October 1, 2025, the FDA approved Gedeon Richter / Hikma’s Enoby™ / Xtrenbo™ (denosumab-qbde), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
On September 30, 2025, Amgen and Biocon Biologics reached a settlement in Case No. 1:25-cv-13358 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.). The litigation related to Biocon’s Prolia® / Xgeva® (denosumab) provisionally...more
10/8/2025
/ Amgen ,
Biocon ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Settlement
On September 9, 2025, Sandoz announced it reached a settlement agreement with Regeneron, dismissing Case No. 1:24-cv-00085 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the commercialization...more
On September 5, 2025, Amgen and Samsung Bioepis reached a settlement in Case No. 1:24-cv-08417 (D.N.J.) / 1:25-md-3138 (D.N.J.), and the Court entered a consent judgment. The litigation related to Samsung Bioepis’s Prolia® /...more
9/30/2025
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Intellectual Property Litigation ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Samsung ,
Settlement
On August 14, 2025, Genentech filed BPCIA litigation No. 2:25-cv-14648 (D.N.J.) against Shanghai Henlius Biotech (“Henlius”) and Organon alleging infringement of 24 patents by Henlius / Organon’s proposed Perjeta®...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
8/13/2025
/ Amgen ,
Biosimilars ,
Coherus ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Sandoz
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
8/13/2025
/ Biocon ,
Biologics ,
Biosimilars ,
BPCIA ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Teva Pharmaceuticals
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
8/13/2025
/ Biologics ,
Celltrion ,
Fresenius ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Section 102 ,
Section 103
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
8/13/2025
/ Amgen ,
Biologics ,
Biosimilars ,
Coherus ,
Hoffman LaRoche ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz
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
8/12/2025
/ Biosimilars ,
Eli Lilly ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Merck ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sanofi
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
8/12/2025
/ Biogen Idec ,
Biologics ,
Biosimilars ,
Boehringer ,
Celltrion ,
Genentech ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents
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
8/12/2025
/ AbbVie ,
Amgen ,
Biosimilars ,
Boehringer ,
Coherus ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
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
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