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Thursday, April 25, 2013
FDA Blog Court Rules in Novel False Claims Act Case Where One Pharmaceutical Company Sues Another By Delia A. Stubbs –
The U.S. District Court for the Central District of California issued a ruling last week in an unusual, if not unprecedented, case arising from alleged federal False Claims Act (“FCA”) violations where one drug manufacture has sued its competitor. InAmphastar Pharm., Inc. v. Aventis Pharma SA, No. 09-0023 (C.D. Cal.), Amphastar, on behalf of the United States, alleged in its amended qui tam complaint that Aventis had “fraudulently inflated the price of enoxaparin” thus overcharging the federal and various state governments in violation of the FCA. Interestingly, Amphastar’s claims are predicated on allegations that Aventis fraudulently sold Lovenox®, that was “in essence, non-patented enoxaparin,” thereby charging inflated prices. Slip Op. at *7, n. 9. In an earlier decision, the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s ruling that Aventis engaged in “inequitable conduct” and thus held its patents regarding Lovenox® unenforceable. Id. at *2, n. 4.