Precedential and Key Federal Circuit Opinions - BETEIRO, LLC v. DRAFTKINGS INC. [OPINION] (2022-2275, 06/21/2024) (Dyk, Prost, Stark) - Stark, J. The Court affirmed the district court’s dismissal of multiple, related...more
The Ninth Circuit Court of Appeals recently issued three noteworthy decisions holding that courts may consider information on the back or side of consumer product labels to clarify any ambiguous language on the front labels...more
On November 5, 2021, the U.S. Court of Appeals for the Federal Circuit in Celgene Corp. v. Mylan Pharmaceuticals Inc., Case No. 21-1154, affirmed a decision from the District Court of New Jersey dismissing a suit brought by...more
The Hatch-Waxman Act provides a cause of action for infringement based on the submission of an abbreviated new drug application (ANDA) to FDA. 35 U.S.C. § 271(e)(2). Following the Supreme Court’s ruling in TC Heartland LLC v....more
Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more
The debate over the meaning of “100% Natural” remains unsettled. On May 7, 2020, the United States Court of Appeals for the First Circuit reversed a district court’s October 2017 decision to dismiss a consumer’s complaint...more
Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more
On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that...more