AstraZeneca Pharmaceuticals, L.P. v Apotex Corp., No. 11-1182 (Fed. Cir. 2012)
Annotate this CasePlaintiff markets, under the name CRESTOR, a cholesterol-lowering drug, rosuvastatin calcium, a member of a class of drugs known as statins, and holds related patents, 314, 618, and 152. After filing its 2003 New Drug Application and obtaining FDA approval, the company complied with the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), notifying the FDA that those patents were among those it believed could be infringed by the unlicensed manufacture, use, or sale of rosuvastatin calcium to be published in the FDA's "Orange Book," 21 U.S.C. 355(b)(1). Defendants are generic pharmaceutical manufacturers that filed Abbreviated New Drug Applications with the FDA seeking to market generic rosuvastatin calcium. The district court ruled in favor of plaintiff in a case claiming infringement of the 314 patent. Plaintiff brought a second action, claiming that defendants' ANDA filings infringed the other patents. The district court dismissed. The Federal Circuit affirmed. Plaintiff failed to state a 35 U.S.C. 271(e)(2) claim based on defendants' existing ANDA filings, and claims premised on presumed future labeling amendments were not ripe for adjudication.
The court issued a subsequent related opinion or order on February 24, 2012.
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