FCPA Compliance and Ethics Report-Episode 121-FCPA Year in Review, Part II
FCPA Compliance and Ethics Report-Episode 82, continued fallout from GSK in China
FCPA Compliance and Ethics Report-Episode 15-GSK in China: a Game Changer in Compliance
Late last week, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC filed suit in the District of Delaware alleging that Pfizer, Pharmacia & Upjohn, BioNtech SE, BioNtech Manufacturing GMBH, and BioNTech US, Inc....more
On May 15, 2023, the Supreme Court of the United States denied Teva Pharmaceuticals USA, Inc.’s (“Teva”) petition for certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, LLC, ending a nearly nine-year court...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
On May 15, 2023, the Supreme Court denied certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC et al., a case some argued had enormous implications for so-called “skinny labeling” practices amongst generic drug...more
In one of the first district court opinions applying the Federal Circuit’s recent GSK decision on induced infringement in the context of label carve-outs, Judge Richard Andrews in the District of Delaware held that plaintiff...more
Background - On August 5, 2021, the Federal Circuit issued an opinion in GlaxoSmithKline v. Teva Pharmaceuticals, Case No. 18-1976, in favor of GSK, finding that Teva was liable for inducing infringement of GSK's patent....more
On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding...more
GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. [OPINION] – PRECEDENTIAL - Before Moore, Newman, Prost (dissent). Panel rehearing of an appeal from the U.S. District Court for the District of Delaware - Summary:...more
Coreg® (carvedilol) - Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., No. 2018-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Circuit Judges Prost, Newman, and Moore presiding; Opinion by Newman, J.; Dissent by Prost, C.J.)...more
2020 has been referred to as an unprecedented year for the world in so many ways—the pandemic, the California and Washington fires, the racial justice protests and calls to action—but that didn’t stop the Federal Circuit from...more
Case Name: GlaxoSmithKline LLC v. Teva Pharma. USA, Inc., No. 14-878, 2018 U.S. Dist. LEXIS 51169 (D. Del. Mar. 28, 2018) (Stark, J.). Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S. Patent No. RE40,000 (“the...more
Case Name: GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA, 2017 U.S. Dist. LEXIS 82534 (D. Del. May 23, 2017) (Burke, M.J.)....more
District Court Overrules Defendants' Objections to Magistrate's Report on Lost Profits - Earlier this month, in GlaxoSmithKline LLC v. Glenmark Pharmaceuticals Inc., U.S. District Judge Leonard P. Stark of the U.S....more
Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Civ. No. 14-878-LPS-CJB, 2016 U.S. Dist. LEXIS 94438 (D. Del. July 20, 2016) (Burke, M.J.) - Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S....more
This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
Case Name: GlaxoSmithKline LLC. v. Glenmark Generics Inc., USA, Civ. Nos. 14-877-LPS-CJB; 14-878-LPS-CJB, 2015 U.S. Dist. LEXIS 52525 (D. Del. Apr. 22, 2015) (Burke, J.) - Drug Product and Patent(s)-in-Suit: Coreg®...more
Case Name: GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., Nos. 2013-1593, -1594, -1595, -1598, 2014 U.S. App. LEXIS 3356 (Fed. Cir. Feb. 24, 2014) (Circuit Judges Taranto, O’Malley, and Wallach presiding; Opinion by Taranto,...more
The U.S. Court of Appeals for the Federal Circuit affirmed a district court rejection of a written description challenge to patentability, concluding that under either parties’ construction of a disputed claim term the...more
The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more