Court rules in novel False Claims Act case where one pharma firm sues another viewed by HP&M lawyer

The US District Court for the Central District of California issued a ruling recently in an unusual, if not unprecedented, case arising from alleged federal False Claims Act (FCA) violations where one drug manufacture has sued its competitor, said Delia Stubbs, writing on Hyman, Phelps & McNamara’s FDA Law Blog.

In Amphastar Pharm Inc v Aventis Pharma SA, No 09-0023 (CD Cal), Amphastar, on behalf of the USA, alleged in its amended qui tam complaint that Aventis (now a part of French drug major Sanofi [Euronext: SAN]) had “fraudulently inflated the price of enoxaparin” thus overcharging the federal and various state governments in violation of the FCA.

Interestingly, says Ms Stubbs, Amphastar’s claims are predicated on allegations that Aventis fraudulently sold Lovenox (enoxaparin sodium injection), that was “in essence, non-patented enoxaparin,” thereby charging inflated prices. In an earlier decision, the US 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.