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
Among the most established standards in patent law is that obviousness requires a motivation to combine the prior art with “a reasonable expectation of success.” The Federal Circuit alone has employed the “reasonable...more
On August 22, 2023, the Federal Circuit affirmed an IPR Final Written Decision holding claims to deuterated derivatives of ruxolitinib unpatentable as obvious and rejected the patentee’s argument that a skilled artisan would...more
In the first decision to issue following the Supreme Court’s denial of certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, Magistrate Judge Sherry R. Fallon of the United States District Court for the...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