In a precedential ruling, the U.S. Court of Appeals for the Federal Circuit in Jazz Pharma. v. Avadel CNS Pharma., 2025 WL 1298920, — F.4th — (Fed. Cir. May 6, 2025), addressed the scope of the 35 U.S.C. § 271(e)(1) “safe...more
5/13/2025
/ Biologics ,
Clinical Trials ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Injunctions ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Safe Harbors
On January 29, 2025, the Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with...more
1/31/2025
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Foreign Corporations ,
Generic Drugs ,
Hatch-Waxman ,
Life Sciences ,
Marketing ,
Patent Litigation ,
Personal Jurisdiction ,
Pharmaceutical Patents ,
Preliminary Injunctions
The Federal Circuit recently reversed a District of Delaware decision that invalidated claims of Novartis’s Orange Book listed patent, U.S. Patent No. 8,101,659 (the “’659 patent”), for its blockbuster drug Entresto®, a...more
1/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Intellectual Property Litigation ,
Life Sciences ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents