Congress authorized the FDA to determine whether a drug is “in shortage in the United States.” The FDA’s determination of a drug shortage triggers mechanisms designed to alleviate the shortage. For example, a determination of...more
Judge Andrews of the District of Delaware recently denied Novartis’s request for a preliminary injunction against MSN Pharmaceuticals. Novartis Pharm. Corp. v. MSN Pharm. Inc., Civil Action No. 20-md-2930-RGA, Dkt. No. 1456...more
JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC.
Before Prost, Dyk, and Hughes. Appeal from the United States District Court for the District of New Jersey. Summary: District court erred by adding...more
On January 9, 2024, the USPTO published guidelines for its patent examiners when evaluating compliance with the enablement requirement in light of the U.S. Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et...more
Elekta Limited v. Zap Surgical Systems, Inc.
Before: Reyna, Stoll, and Stark. Appeal from the Patent Trial and Appeal Board.
Summary: Patentee’s failure during prosecution to distinguish relevant art provided support...more
In Sanofi-Aventis Deutschland GmbH v. Mylan Pharm. Inc., Case No. 2021-1981, the Federal Circuit reversed an obviousness determination by the PTAB. At issue was Sanofi’s reissued U.S. Patent No. RE47,614 (the ’614 patent),...more
6/13/2023
/ Analogous Art ,
Inter Partes Review (IPR) Proceeding ,
Medical Devices ,
Mylan Pharmaceuticals ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Ownership ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
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Sanofi-Aventis
In Re Google LLC -
Before: Moore, Lourie, and Prost. Appeal from the Patent Trial and Appeal Board.
Summary: The PTO’s arguments on appeal did not reflect the record below....more