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Supreme Court Denies Cert. in Rule 9(b) Pleading Requirements Case

Client Alert | 1 min read | 04.03.14

The Supreme Court has followed the government's recommendation (discussed in a previous bullet point and blog post) not to hear an appeal challenging the dismissal of relator's complaint in U.S. ex rel. Nathan v. Takeda Pharmaceuticals, 707 F.3d 451 (4th Cir. 2013), for failure to allege specific false claims instead of a false scheme – an issue over which the government admits there is "at least some continuing uncertainty." The Court has invited the government's views on granting cert. in another prominent FCA case, KBR, Inc. v. U.S. ex rel. Carter (addressing the scope of the FCA's first-to-file bar and the Wartime Suspension of Limitations Act) (discussed here), but the Solicitor General has not yet weighed in.


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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....