IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
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
The Hatch-Waxman Act provides a cause of action for infringement based on the submission of an abbreviated new drug application (ANDA) to FDA. 35 U.S.C. § 271(e)(2). Following the Supreme Court’s ruling in TC Heartland LLC v....more
Precedential Federal Circuit Opinions - CELGENE CORPORATION v. MYLAN PHARMACEUTICALS INC. [OPINION] (2021-1154, 11/05/2021) (PROST, CHEN, and HUGHES) - Prost, J. This is a case about venue and pleading under the...more
A Complaint Identifying Infringing Products and the Patents Allegedly Infringed, Accompanied by Statements that the Products Meet All Elements of at Least One Claim of the Asserted Patents, May be Sufficient to Meet the...more