AstraZeneca Pharmaceuticals LP et al. v. Apotex Corp. et al.


Docket No. 2011-1182, -1183, -1184, -1185, -1186, -1187, -1188, -1189, -1190

RADER, LOURIE, MOOORE

February 9, 2012

Subject matter: Generics, ANDA

Brief Summary: Filing an ANDA for a drug having any patented use does not automatically constitutes infringement under § 271(e)(2). An “ANDA seeking to market a drug not covered by a composition patent for unpatented methods of treatment cannot infringe under § 271(e)(2).”

Summary: AstraZeneca (AZ) appealed USDC DE dismissal of their 271(e)(2) patent infringement claims against Apotex et al. (“Apotex”). The patents relate to the cholesterol-lowering drug rosuvastatin calcium (e.g., CRESTOR®; RE37,314) and methods for using the same (US 6,858,618 and 7,030,152). Apotex restricted their ANDAs to formulations for treating only homozygous familial hypercholesterolemia (HoFH) and hyper-triglyceridemia, omitting (“carving out”) patented indications directed toward HeFH (‘618 patent) and elevated CRP (‘152 patent). Apotex filed a Paragraph IV certification for the ‘314 composition patent and Section viii statements regarding the ‘618 and ‘152 patents. AZ sued for infringement of the ‘314 composition patent and the DC found in its favor. This appeal relates to a second suit alleging that the Apotex ANDAs “infringed and would cause infringement of the ’618 and ’152 method patents, even though Appellees had not requested approval for any patented indications and had filed Section viii statements to that effect”. Apotex alleged that the patented drug “will be prescribed and administered to human patients to treat HeFH, which uses will constitute direct infringement of the ’618 patent” (e.g., “off-label” use). The DC dismissed the second suit, deciding it lacked jurisdiction. The FC concluded that the DC did in fact have jurisdiction under 271(e)(2) (Allergan, FC 2003) but agreed “with the district court’s underlying determination that AstraZeneca failed to state a viable claim for relief” (citing “271(e)(2) itself” and Warner-Lambert, FC 2003 (construing “the term ‘the use’ as used in § 271(e)(2)(A) to mean ‘the use listed in the ANDA'”)). The panel wrote that it “again reject[s] the contention that filing an ANDA for a drug having any patented use automatically constitutes infringement under § 271(e)(2)” and that “an ANDA seeking to market a drug not covered by a composition patent for unpatented methods of treatment cannot infringe under § 271(e)(2)”. Thus, the DC decision was affirmed.

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