AstraZeneca Pharma. LP v. Apotex Corp.

April 09, 2012

GENERICally Speaking
Case Name: AstraZeneca Pharma. LP v. Apotex Corp., Case No. 2011-CV-1182-90, 2012 U.S. App. LEXIS 2512 (Fed. Cir. Feb. 9, 2012) (Circuit Judges Rader, Lourie, and Moore presiding; Opinion by Lourie) (Appeal from D. Del., Kugler, J.) (ANDA must list a use that would read on a patentee's claims in order for patentee to file an action pursuant to 271(e)(2).). 

Drug Product and Patent(s)-in-Suit: Crestor® (rosuvastatin calcium); U.S. Pat. Nos. RE37,314 ("the '314 patent"), 6,858,618 ("the '618 patent"), and 7,030,152 ("the '152 patent")

Nature of the Case and Issue(s) Presented: AstraZeneca ("AZ") appealed the dismissal of its § 271(e)(2) claims against Apotex for lack of subject matter jurisdiction.  On appeal, the Federal Circuit considered (i) whether subject matter jurisdiction existed where the patentee brought suit under 35 U.S.C. § 271(e)(2) for the infringement of two method patents (the '618 and '152 patents) against a generic drug manufacturer who submitted a statement under 21 U.S.C. § 355(j)(2)(A)(viii) ("a section viii statement") averring that the ANDA excludes all uses claimed in the patent; and (ii) whether the issue was ripe for adjudication to the extent that AZ relied on presumptive future labeling amendments.  Although the Federal Circuit found that subject matter jurisdiction existed, it affirmed the lower court's dismissal because the complaint failed to state a claim and the claims were not ripe.

Why Apotex Prevailed:  At the outset, the Federal Circuit reiterated that under the Hatch-Waxman Act, Section 271(e)(2) created a new statutory basis for a patent infringement claim.  The court observed that jurisdiction under this section is met when "a patent owner alleges that another's filing of an ANDA infringes its patents under § 271 (e)(2)" regardless of whether the underlying claims are valid.  The court noted that the district court dismissed this action for lack of subject matter jurisdiction under Section 271(e)(2) in error.  Though the district court found the complaint did not allege a "valid" claim, the Federal Circuit concluded that subject matter jurisdiction does not turn on whether the claim is "valid."  Instead, once a party alleges that an ANDA lists a product that infringes another's patents, jurisdiction under Section 271(e)(2) exists for the patentee.

Despite this holding, the Federal Circuit affirmed the dismissal because AZ failed to state a viable claim of relief under Section 272(e)(2).  Section 272(e)(2) provides 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 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."  The Court construed the term "the use" as used in § 271(e)(2)(A) to mean "the use listed in the ANDA."  Thus, the ANDA must list a use that would read on a patentee's claims.  Here, Apotex' ANDA listed only uses that the patents did not cover.  Consequently, the Court found that AZ failed to make a claim under Section 272(e)(2).  The FDA allows generic manufacturers to file ANDAs limiting the use of the proposed drug.  If a generic manufacturer limits the drug's use in a manner that precludes a finding of infringement of a method claim, then under the Federal Circuit's holding, a claim under Section 272(e)(2) does not exist.

Next, the court addressed whether the FDA would require Apotex to label the drug with uses covered by the '618 and '152 patents.  AZ argued that the FDA would require such labeling, and therefore the ANDA would fall within the ambits of Section 272(e)(2).  The district court had rejected this argument under Rule 12(b)(1) due to lack of ripeness, and the Federal Circuit affirmed.  The Court of Appeals reasoned that an issue is not ripe if it rests on contingent future events that may not occur.  Consequently, AZ could not rely on an anticipated ANDA amendment to plead infringement under Section 272(e)(2).  Instead, "the infringement analysis under Section 272(e)(2) is limited to whether the accused infringer's ANDA seeks approval for activities that would constitute infringement of the asserted patents."  Thus, the Court held that AZ's claims based on presumed future labeling amendments was not ripe.

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