United States: 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 that: (1) Appellees' ANDAs, as filed, violated § 271(e)(2) as 'application[s] for a drug the use of which is claimed' in the '618 and '152 patents; (2) if approved by the FDA, Appellees' proposed activities will induce infringement of the '618 and '152 patents; and (3) the FDA will require Appellees to make labeling amendments explicitly incorporating the indications covered by the '618 and '152 patents." AstraZeneca Decision, at 10. Appellees moved to dismiss on a few grounds including that (1) the district court lacked subject matter jurisdiction because Appellees' ANDAs did not contain Paragraph IV certifications relating to the Patents-in Suit and (2) the complaints failed to state a claim because Appellees' ANDAs were not seeking approval for a method of use claimed in a patent. The district court dismissed AstraZeneca's claims under Fed R. Civ. P. 12(b)(1) and 12(b)(6), holding that it lacked subject matter jurisdiction because the ANDAs excluded all methods of use claimed in the Patents-in-Suit and thus no claim existed under Section 271(e)(2), and, even if the court did have subject matter jurisdiction, AstraZeneca could not state a claim.

On appeal, the Federal Circuit held that the district court did have subject matter jurisdiction because AstraZeneca alleged that Appellees' ANDAs infringed under Section 271(e)(2). As the Federal Circuit noted, 28 U.S.C. § 1338(a) provides that district courts have original jurisdiction over any civil action arising under an Act of Congress relating to patents. AstraZeneca Decision, at 12. When Congress enacted Section 271(e)(2), it created a new "'highly artificial act of infringement' ... so that court could promptly resolve infringement and validity disputes before the ANDA applicant had engaged in the traditional statutorily defined acts of infringement." AstraZeneca Decision, at pp. 12-13 (quoting Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 678 (1990); and citing Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed. Cir. 1997)). Accordingly, and consistent with its decision in Allergan, Inc. v. Alcon Labs, Inc., 324 F.3d 1322 (Fed. Cir. 2003), the Federal Circuit held that once a patent holder alleges that an ANDA infringes its patents listed in the Orange Book under Section 271(e)(2), district courts have subject matter jurisdiction over the action. AstraZeneca Decision, at 13-14.

The Federal Circuit held, however, that AstraZeneca failed to state a claim under Section 271(e)(2). The Federal Circuit's holding was based on the language of Section 271(e)(2) and its decision in Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003). The Federal Circuit began by setting forth the language contained in Section 271(e)(2), which provides, in pertinent part, that:

It shall be an act of infringement to submit - (A) an application [i.e., an ANDA] under section 505(j) of the Federal Food, Drug, and Cosmetic Act [codified at 21 U.S.C. § 355(j)] for a drug claimed in a patent or the use of which is claimed in a patent ... if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug ... claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.

AstraZeneca Decision, at 14-15 (quoting 35 U.S.C. § 271(e)(2)) (alterations and emphasis added in original). The Federal Circuit then explained that it has previously "construed the term 'the use' as used in § 271(e)(2)(A) to mean 'the use listed in the ANDA.'" AstraZeneca Decision, at 15 (quoting Warner-Lambert, 316 F.3d at 1356-60).

The Federal Circuit rejected AstraZeneca's attempts to condense the language of Section 271(e)(2). AstraZeneca argued that a viable claim under Section 271(e)(2) only requires that the ANDA be for "a drug ... the use of which is claimed in a patent...." The Federal Circuit "rejected this parsing of the statute because it 'eviscerated an important part of the statutory provision by conflating the first and second clauses of § 271(e)(2)(A),'" and, therefore, also rejected the contention that filing an ANDA for any drug claiming any patented use constitutes infringement. AstraZeneca Decision, at 15-16 (quoting Warner-Lambert, 316 F.3d at 1355). The Federal Circuit then stated:

As we held in Warner-Lambert, a patented method of using a drug can only be infringed under § 271(e)(2) by filing an ANDA that seeks approval to market the drug for that use. [316 F.3d] at 1358–59. Thus, an ANDA seeking to market a drug not covered by a composition patent for unpatented methods of treatment cannot infringe under § 271(e)(2). AstraZeneca has not alleged, nor could it allege, that Appellees' ANDAs seek FDA approval for uses of rosuvastatin calcium covered by the '618 or '152 patents as would be required to state a viable § 271(e)(2) claim.

AstraZeneca Decision, at 17.

AstraZeneca attempted to distinguish Warner Lambert on the grounds that the patent asserted in that case claimed a use that had not been approved by the FDA whereas the Patents-in-Suit contained uses that were approved by the FDA. The Federal Circuit rejected that argument because Section 271(e)(2) requires courts to analyze the scope of approval sought in the ANDA, and the statute defines infringement as filing an ANDA for "a drug claimed in a patent or the use of which is claimed in a patent." 35 U.S.C. § 271(e)(2)(A).

As the Federal Circuit noted, Congress permitted generic manufacturers to limit the scope of ANDAs by excluding patented methods of use and, therefore, permitted generic manufacturers to avoid filing Paragraph IV certifications and a Section 271(e)(2) claim. To hold otherwise would have reduced the import of seeking approval of a generic based on a Section viii statement.

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