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 24, 2025, the PTO Acting Director Coke Morgan Stewart discretionarily denied Amgen’s IPR2025-00601 and IPR2025-00602 challenging Bristol-Myers Squibb’s (“BMS”) U.S. Patent Nos. 9,856,320 (“the ’320 patent”) and...more
8/1/2025
/ Amgen ,
Biosimilars ,
BPCIA ,
Bristol-Myers Squibb ,
Denial of Institution ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
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 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 May 16, 2025, the Court in Case No. 1:21-cv-01478 (D. Del.) granted bluebird bio’s motion for summary judgment, finding that its gene therapy Zynteglo® (betibeglogene autotemcel) does not infringe San Rocco Therapeutics‘...more
6/9/2025
/ Appeals ,
Biotechnology ,
Claim Construction ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Summary Judgment
On May 22, 2025, the CAFC affirmed the PTAB’s (Board) Final Written Decisions in Pfizer’s IPR2021-00925 and IPR2021-00926 finding all challenged claims of uniQure’s U.S. Patent No. 9,982,248 (“the ’248 patent”) unpatentable...more
6/6/2025
/ Anticipation ,
Appeals ,
Court of Federal Claims ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art
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
5/13/2025
/ Biosimilars ,
Generic Drugs ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs