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
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
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
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
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
5/13/2025
/ Biosimilars ,
Claim Construction ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art
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
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
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
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
2/18/2025
/ Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art
Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more
1/15/2025
/ Biologics ,
Biosimilars ,
Compliance ,
Data Privacy ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Medical Devices ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Requirements
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
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
Earlier this year, Merck Sharp & Dohme, LLC (“Merck”) requested inter partes review (“IPR”) of a number of patents owned by the Johns Hopkins University (“JHU”). ...more
Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more
7/10/2024
/ Biologics ,
Biosimilars ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Inter Partes Review (IPR) Proceeding ,
Interchangeability ,
Life Sciences ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
Prescription Drugs ,
Purple Book
On June 14, 2024, the PTAB issued a Final Written Decision (FWD) in Samsung Bioepis’s IPR2023-00442 (“the -00442 IPR) determining that the challenged claims of Regeneron’s U.S. Patent No. 10,130,681 (the ’681 patent) that...more
On April 22, 2024, the PTAB issued Final Written Decisions in two related inter partes reviews, IPR2023-00070 and IPR2023-00074, upholding two patents that cover Zynteglo® (betibeglogene autotemcel), a gene therapy treatment...more
On March 13, 2024, Regeneron appealed the PTAB Board’s (“the Board”) recent Final Written Decisions (“FWDs”) that found claims of two Regeneron patents related to EYLEA® (aflibercept) unpatentable....more
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche (Roche) filed a motion to voluntarily dismiss CAFC Appeals 24-1111 and 24-1115, appealing the Final Written Decisions (FWDs) in IPR2022-00578 and IPR2022-00579,...more
The new year has brought a wave of activity for EYLEA® (aflibercept) biosimilars. Following up on our previous report (EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates, December 31, 2023), in...more
The Act’s Objectives -
USPTO data indicate that as many as 80% of instituted Patent Trial and Appeal Board (PTAB) proceedings that reach a final written decision (FWD) result in the invalidation of at least one challenged...more