Case: Astrazeneca Pharm. LP v. Apotex Corp., No. 2011-1182 (Fed. Cir. Feb. 9, 2012).
AstraZeneca holds the rights to patents claiming methods for using rosuvastatin calcium, a drug used for lowering cholesterol, in patients with heterozygous familial hypercholesterolemia (“HeFH”) and elevated circulating C-reactive protein (“CRP”). AstraZeneca filed a New Drug Application (“NDA”) with the Food and Drug Administration (“FDA”). The FDA's approval of the NDA related to the treatment of HeFH and elevated CRP, as well as two additional uses—relating to the treatment of homozygous familial hypercholesterolemia (“HoFH”) and hypertriglyceridemia—that are not claimed in any of AstraZeneca’s method-of-use patents.
The defendants subsequently submitted Abbreviated New Drug Applications (“ANDAs”) to obtain FDA approval to market generic rosuvastatin calcium for use in patients with HoFH and hypertriglyceridemia. AstraZeneca brought suit under 35 U.S.C. § 271(e)(2), alleging that the defendants’ ANDAs infringe its method-of-use patents. Section 271(e)(2) provides the following:
It shall be an act of infringement to submit—(A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act [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.
35 U.S.C. § 271(e)(2). The defendants moved to dismiss, claiming, among other things, lack of subject matter jurisdiction and failure to state a cognizable § 271(e)(2) claim.
The district court dismissed AstraZeneca’s patent infringement claims under § 271(e)(2) for lack of subject matter jurisdiction. Because the infringing act is the submission of the ANDA, the district court labeled § 271(e)(2) an “artificial cause of action” and reasoned that its jurisdiction depended on the “validity” of AstraZeneca’s § 271(e)(2) claim. The district court concluded that no “valid” § 271(e)(2) claim existed because the defendants’ ANDA did not list any of the uses claimed in AstraZeneca’s method-of-use patents.
The Court of Appeals for the Federal Circuit (“CAFC”) disagreed and concluded that the district court erred in its jurisdictional analysis. The existence of subject matter jurisdiction does not depend on the “validity,” or merit, of AstraZeneca’s § 271(e)(2) claims. Rather, subject matter jurisdiction exists “once a patent owner alleges that another’s filing of an ANDA infringes its patent under § 271(e)(2).” Slip Opinion at 13.
Even though the district court’s jurisdictional analysis was flawed, the CAFC agreed with the ultimate outcome and affirmed the district court’s decision to dismiss the case for failure to state a claim. In support of its position, AstraZeneca argued that it had stated a claim for relief under 271(e)(2) by alleging that the defendants submitted ANDAs for “a drug . . . the use of which is claimed in a patent,” even if the uses claimed in the patent are different from the uses stated in the ANDAs. The CAFC rejected this argument and held 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).” Slip Opinion at 17.