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
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
Venable’s BiologicsHQ Monthly Injection – June 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
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
As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more
5/23/2024
/ AstraZeneca ,
Biologics ,
Biosimilars ,
Celltrion ,
EU ,
European Patent Office ,
Genentech ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Novartis ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Samsung Bioepis ,
Unified Patent Court
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
Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary...more
5/14/2024
/ Amgen ,
Amgen v Sandoz ,
Biosimilars ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Interchangeability ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Settlement
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
Latest News...more
5/1/2024
/ Biden Administration ,
Biologics ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and...more
3/15/2024
/ Biosimilars ,
BPCIA ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Sandoz ,
Sandoz v Amgen
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
There has been a flurry of activity relating to proposed EYLEA® (aflibercept) biosimilars in November, starting with a BPCIA litigation against Celltrion’s proposed biosimilar CT-P42 filed on November 8, 2023, Case No....more
On November 8, 2023, Regeneron Pharmaceuticals Inc. filed a BPCIA Complaint against Celltrion Inc. in the district court for the northern district of West Virginia, asking the Court to block Celltrion’s biosimilar product...more
11/27/2023
/ Biosimilars ,
BPCIA ,
Celltrion ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regeneron