Section VIII Statements -- Still A Viable Route To Generic Approval Where The Application Is Not Claimed In An Orange Book Patent

In its recent decision in AstraZeneca Pharmaceuticals LP v. Apotex Corp., Nos. 2011-1182 – 2011-1190 (Fed. Cir. Feb. 9, 2012) (hereinafter the "AstraZeneca Decision") (Rader*, Bryson & Linn), the Federal Circuit affirmed a District of Delaware decision dismissing an infringement case for failure to state a claim, pursuant to Fed. R. Civ. P. 12(b)(6). Defendants/appellees (collectively, "Appellees") each filed an Abbreviated New Drug Application ("ANDA") with Section viii statements, seeking approval for methods of use not claimed in a patent listed in the Orange Book. Plaintiffs/Appellants AstraZeneca Pharmaceuticals LP, AstraZeneca AB, IPR Pharmaceuticals, Inc., and The Brigham and Women's Hospital, Inc. (collectively, "AstraZeneca") hold certain patents relating to the cholesterol-lowering drug rosuvastatin calcium, which AstraZeneca marketed under the name CRESTOR®. Two of those patents were in suit — U.S. Patent 6,858,618 ("the '618 Patent") claims methods of use to treat heterozygous familial hypercholesterolemia ("HeFH"), and U.S. Patent 7,030,152 ("the '152 Patent" and, together with the '618 Patent, the "Patents-in-Suit") claims methods of use to lower the cardiovascular disease risk for individuals who have elevated circulating C-reactive protein ("CRP"). When the FDA approved AstraZeneca's New Drug Application ("NDA") to treat HeFH and elevated CRP, the FDA also approved rosuvastatin calcium to treat homozygous familial hypercholesterolemia ("HoFH") and hypertriglyceridemia.

When Appellees filed their respective ANDAs with the FDA seeking to market generic rosuvastatin calcium, Appellees limited the claimed methods of use to those seeking to treat HoFH and hypertriglyceridemia, neither of which was the subject of a claim in either of the Patents-in-Suit. Pursuant to 21 U.S.C. § 355(j)(2)(A)(viii), an applicant filing an ANDA is permitted to file a statement (a "Section viii statement") that the ANDA excludes all methods of use claimed in a patent contained in the Orange Book. Since Appellees limited their respective ANDAs to methods of use that were not claimed in a patent by AstraZeneca, Appellees each filed Section viii statements.

After commencing an action against Appellees relating to another patent relating to rosuvastatin calcium owned by AstraZeneca, AstraZeneca commenced another action against Appellees alleging infringement of the Patents-in-Suit pursuant to 35 U.S.C. § 271(e)(2). In particular, "AstraZeneca alleged...