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 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 February 14, 2024, Seagen requested director review of the PTAB’s January 16th Final Written Decision (“FWD”) in PGR2021-00030 finding antibody-drug conjugate claims in U.S. Patent No. 10,808,039 (the “’039 patent”)...more
On January 16, 2024, the PTAB issued a Final Written Decision in a post-grant review (“PGR”) of claims in U.S. Patent No. 10,808,039 (the “’039 patent”) owned by Seagen Inc. (“Seagen”). PGR2021-00030 was filed by Daiichi...more