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Defective Pricing & the False Claims Act

Client Alert | 1 min read | 05.21.19

The enactments of the False Claim Act (FCA) and the Truth in Negotiations Act (TINA) were separated by nearly 100 years, yet the two statutes have become kissing cousins, with many defective pricing cases turning into fraud actions. In Defective Pricing & the False Claims Act, published in the April 2019 issue of Thomson Reuters’s Briefing Papers, Crowell & Moring attorneys discuss: (1) the historical factors and practical warning signs linking defective pricing and FCA actions; (2) the burdens and elements of proof in TINA and FCA litigations and how certain elements may overlap and even bolster defenses to both defective pricing and fraud actions; and (3) the procedural elements of TINA and FCA actions—such as stays of proceedings, evidentiary standards, and statutes of limitation—and where these factors may determine the outcomes in both defective pricing and fraud proceedings.

Insights

Client Alert | 3 min read | 05.26.26

pH, Prosecution History Estoppel, and Patent Scope: Three Lessons from the Federal Circuit's Latest Hatch-Waxman Ruling

On May 13, 2026, the U.S. Court of Appeals for the Federal Circuit affirmed a district court judgment of no infringement in Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 24-1641. The decision offers important guidance for patent holders and generic manufacturers on the role of industry standards in interpreting scientific terminology during claim construction, prosecution history estoppel, and the disclosure-dedication rule....