On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more
5/12/2025
/ aBLA ,
Biosimilars ,
BPCIA ,
Celltrion ,
Drug Pricing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Fresenius ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Interchangeability ,
Legislative Agendas ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Proposed Legislation
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 13, 2024, the PTAB granted institution of IPR2024-00240 that Merck Sharp & Dohme, LLC (“Merck”) filed in November 2023 challenging claims 1-42 of The Johns Hopkins University’s (“JHU”) U.S. Patent No. 11,591,393 (“the...more
On April 16, 2024, the PTAB proposed new rules (“proposed rules”) governing the Director Review process, which would remain consistent with the Interim review process currently in place, and codify those procedures....more
On March 4, 2024, the PTAB granted Biocon and Janssen’s joint motion to terminate IPR2023-01444 due to a settlement reached prior to an institution decision. The parties announced in a press release that their settlement and...more
On January 3, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a BPCIA litigation in the District of Delaware (Case No. 1-24-cv-00005 (D. Del.)) against...more
On November 22, 2023, Biocon Biologics Inc. (“Biocon”) submitted a Petition for Inter Partes Review of claims 1-34 of U.S. Patent No. 10,961,307 (“the ’307 patent”), assigned to Janssen Biotech, Inc. (“Janssen”), requesting...more