On Thursday, the Federal Circuit affirmed the dismissal of a § 271(e)(2) patent infringement action based on method-of-use claims because the ANDA filer was only seeking FDA approval for non-patented uses.  In AstraZeneca Pharms. LP v. Apotex Corp., the Court held that alleging infringement under 35 U.S.C. § 271(e)(2) was sufficient to confer subject-matter jurisdiction on a federal district court regardless of the merits of the claim, and therefore dismissal under Rule 12(b)(1) is inappropriate in such circumstances.  However, to survive a motion to dismiss for failure to state a claim upon which relief can be granted, pursuant to Rule 12(b)(6), a holder of method-of-use patents must allege that an ANDA filer is seeking approval to market its generic drug for a claimed use.  If, instead, the ANDA filer is seeking approval for only non-patented indications, even if the reference listed drug is additionally approved for a claimed use, the patent holder cannot support an infringement claim pursuant to 35 U.S.C. § 271(e)(2).

The brand-name drug at issue in this case was CRESTOR®, which has as its active ingredient the cholesterol-lowering statin rosuvastatin calcium.  Statins work by competitively inhibiting 3-hydroxy-3-methylglutaryl-CoA ("HMG-CoA") reductase, a key enzyme for cholesterol biosynthesis, thereby reducing circulating cholesterol.  The patents-at-issue all claimed methods of using rosuvastatin calcium:  U.S. Patent 6,858,618 ("the '618 patent") for the treatment of heterozygous familial hypercholesterolemia, "a genetic condition characterized by impaired cholesterol metabolism and clinically elevated blood cholesterol," and U.S. Patent 7,030,152 ("the '152 patent") with claims to using rosuvastatin calcium to lower the risk of cardiovascular disease in individuals with normal cholesterol levels but with elevated levels of circulating C-reactive protein.  CRESTOR® is also approved for the unpatented treatment of homozygous familial hypercholesterolemia and hypertriglyceridemia.  In order to skirt AstraZeneca's method-of-use patents, the ANDA filers in this case "carved out" the patented indications from their proposed label, only seeking approval to market the generic version for treating homozygous familial hypercholesterolemia and hypertriglyceridemia.  After the conclusion of a separate ANDA litigation involving composition-of-matter patents (which expire in 2016), AstraZeneca sued the ANDA filers pursuant to 35 U.S.C. § 271(e)(2), claiming infringement of the claims of the '618 and '152 patents.  The U.S. District Court for the District of Delaware dismissed the action for lack of subject matter jurisdiction and because AstraZeneca's claims were not ripe, even if the FDA may require the ANDA filers to amend their proposed label to include the patented indications at some future date.

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