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
Two weeks ago we discussed Vanda Pharmaceuticals’ ambitious cert petition asking the Supreme Court to discontinue the “reasonable expectation of success” standard for patent obviousness that for decades has been a mainstay of...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
8 Puma Biotechnology is the latest victim of standing requirements in patent cases that continue to wreak havoc on plaintiffs’ ability to recover a full measure of damages. In Puma Biotechnology, Inc. v. AstraZeneca...more
3/27/2024
/ Article III ,
AstraZeneca ,
Biotechnology ,
Damages ,
Injury-in-Fact ,
Intellectual Property Litigation ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Royalties ,
Settlement Agreements
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