In AstraZeneca Pharmaceuticals LP v. Apotex Corp., the Federal Circuit held that the district court had jurisdiction over AstraZeneca’s ANDA complaint, but also held that the complaint should be dismissed for failing to state a viable claim for relief because the ANDAs included Section viii statements that carved out the methods claimed in the patents at issue.

The Product At Issue

The litigation relates to AstraZeneca’s CRESTOR® product (rosuvastatin calcium) and three patents:

  1. U.S. Patent RE37,314, which claims rosuvastatin compounds and compositions.
  2. U.S. Patent 6,858,618, which claims methods of using rosuvastatin compounds “to treat heterozygous familial hypercholesterolemia (‘HeFH’).”
  3. U.S. Patent 7,030,152, which claims methods of using rosuvastatin compounds “to lower the cardiovascular disease risk for individuals who have normal cholesterol levels but demonstrate elevated circulating C-reactive protein (“CRP”), another risk factor associated with various cardiovascular disorders.”

As noted in the Federal Circuit opinion, “the FDA also approved rosuvastatin calcium for treating homozygous familial hypercholesterolemia (“HoFH”) and hypertriglyceridemia—uses not claimed by either of the ’618 or ’152 patents.”

The ANDAs At Issue

The appellees are generic companies who filed Abbreviated New Drug Applications (“ANDAs”) to obtain FDA approval to market generic rosuvastatin calcium products. The ANDAs carved out the methods encompassed by the ‘618 and ‘152 patents, and sought approval for use in “treating only HoFH and hyper-triglyceridemia.”

The appellees thus filed statements under 21 U.S.C. § 355(j)(2)(A)(viii) (“Section viii statements”), averring that their ANDAs exclude all uses claimed in the ‘618 and ‘152 patents. (The appellees made Paragraph IV certifications against the ‘314 patent, which is being addressed in separate litigation.)

AstraZeneca brought suit under 35 USC § 271(e)(2), alleging that the ANDAs “would cause infringement of the ’618 and ’152 method patents,” because, for example, they will result in rosuvastatin calcium being prescribed for infringing uses.

The District Court’s Jurisdiction

Under 35 USC § 271(e)(2), filing an ANDA with a Paragraph IV certification constitutes an act of infringement, but no similar provision pertains to a Section viii statement. The appellees cited this distinction when they moved to dismiss AstraZeneca’s suit for lack of subject matter jurisdiction.

However, the Federal Circuit took a broad of jurisdiction:

“The district courts have original jurisdiction over any civil action arising under any Act of Congress relating to patents. 28 U.S.C. § 1338(a). . . . AstraZeneca alleged that the Appellees’ ANDA filings infringed its listed patents under § 271(e)(2), and nothing more was required to establish the district court’s subject matter jurisdiction pursuant to § 1338(a).”

Failure To State A Claim

The appellees also moved to dismiss AstraZeneca’s suit for failure to state a claim for which relief could be granted under 35 USC § 271(e)(2) “because AstraZeneca had not alleged and could not allege that Appellees’ ANDAs included Paragraph IV certifications or sought approval to market rosuvastatin calcium for uses claimed in the ’618 or ’152 patents.”

The Federal Circuit agreed with appellees on this issue, relying primarily on the plain language of § 271(e)(2):

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 Federal Circuit cited its 2003 decision in Warner-Lambert Co. v. Apotex Corp., which held that “infringement of method claims under § 271(e)(2) requires filing an ANDA wherein at least one ‘use’ listed in the ANDA is claimed in a patent.” The court noted

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. . . . Thus, an ANDA seeking to market a drug . . . for unpatented methods of treatment cannot infringe under § 271(e)(2).

Off-Label Uses

AstraZeneca argued that Section viii statements “ignore market realities because even if a generic drug is formally approved only for unpatented uses, pharmacists and doctors will nonetheless substitute the generic for all indications once it becomes available.” The Federal Circuit was not persuaded by this policy argument, however.

The court first noted that AstraZeneca’s position would “vitiate § 355(j)(2)(A)(viii) by enabling § 271(e)(2) infringement claims” even when the ANDA statements and proposed labeling “explicitly and undisputedly carve out all patented indications.” The court also noted that, under such a broad reading of § 271(e)(2), “[g]eneric manufacturers would effectively be barred altogether from entering the market” by “serial patents for approved methods of using the compound.”

If an off-patent drug is being used for an unpatented use, that is activity beyond the scope of § 271(a). So is filing an ANDA seeking to market an unpatented drug for an unpatented use beyond the scope of § 271(e)(2).

The Federal Circuit therefore held that AstraZeneca had not stated a claim for infringement of the ’618 or ’152 patents under § 271(e)(2).