FDA recently doubled down on its approach of allowing new language in an ANDA label as the result of a section viii statement – a so-called “carve-in.” Section viii statements assert that an ANDA does not seek approval for...more
FTC recently placed improper Orange Book patent listings squarely in its crosshairs. In its September 2023 policy statement, FTC announced that it would “scrutinize improper Orange Book listings” and “use its full legal...more
Yesterday, the Supreme Court denied certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, locking in the Federal Circuit’s second panel decision (hereafter “GSK v. Teva”), which held that Teva’s attempted...more
5/16/2023
/ Denial of Certiorari ,
Equitable Estoppel ,
Food and Drug Administration (FDA) ,
GlaxoSmithKline ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
SCOTUS ,
Teva Pharmaceuticals ,
Teva Pharms USA Inc v GlaxoSmithKline LLC