Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...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
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
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
The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug sponsor did not preclude a finding of...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
A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...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
Third Circuit has previously ruled that non-cash payments to settle patent litigation may violate antitrust laws. On November 7, 2016, the Supreme Court of the United States declined to hear the petition of...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
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Par Pharmaceutical, Inc. v. Glaxosmithkline LLC et al. 2:14-cv-06627; filed November 19, 2014 in the Eastern District of...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. GlaxoSmithKline LLC et al. v. Glenmark Generics Inc. USA 1:14-cv-00877; filed July 3, 2014 in the District Court of...more
Case Name: In re Lamictal Direct Purchaser Antitrust Litigation, Case No. 12-cv-995 (WHW), 2014 U.S. Dist. LEXIS 9257 (D.N.J. Jan. 24, 2014) (Walls, J.) - Drug Product and Patent(s)-in-Suit: Lamictal® (lamotrigine);...more