Astra v. Apotex: CAFC Affirms Non-infringement of Method of Use Claims

In AstraZeneca Pharms. LP. v. Apotex Corp., the Federal Circuit ruled that an Abbreviated New Drug Application (“ANDA”), filed under § 355(j)(2)(B)(ii) and limited to FDA approved, but unpatented uses of a medication, is not an act of infringement of Orange Book-listed patents covering approved but different uses of the same medication. The Court did find that Plaintiff’s allegation that its listed patents are infringed was sufficient to establish subject matter jurisdiction over the generic Defendants.

As we previously wrote, AstraZeneca and its co-plaintiffs (“AstraZeneca”) had sued ten generic drug companies alleging patent infringement under the Hatch-Waxman Act, relating to methods of treatment using Crestor®. The lower court had dismissed the infringement claims, ruling that it lacked subject matter jurisdiction because AstraZeneca had not presented a valid § 271(e)(2) claim based on the ANDA filings alone. The court also dismissed AstraZeneca’s other 271(e)(2) infringement claims as premature. That claim alleged that because the FDA will require the defendants to amend their ANDAs at some point in the future to include all FDA-approved indications, including those covered by the patents-in-suit, infringement under § 271(e)(2) would occur.

On appeal, the Federal Circuit reversed the subject matter jurisdiction decision, finding that jurisdictional requirements are met once a patent owner alleges that another’s filing of an ANDA infringes its patent under § 271(e)(2). Also, the court held that this threshold determination does not depend on the ultimate merits of the claims.

However, the court affirmed the ruling as to the lack of ripeness of the infringement claim, citing its holding in Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003) that Section 271(e)(2) does not encompass “speculative” claims for infringement. Importantly, the Federal Circuit noted that regardless of a possible future occurrence, the infringement analysis under § 271(e)(2) is limited to whether the accused infringer’s ANDA seeks approval for activities that would constitute infringement of the asserted patents. Accordingly, it could not conclude that the FDA would require the ANDA filers to amend their applications in the future, in part because the statutory framework of the Hatch-Waxman Act provides for the affirmative carving out of patented indications under 21 U.S.C. § 355(j)(2)(A)(viii).

This decision is significant for generic drug manufacturers who seek such a carve out of non-patented, approved indications. Industry — and perhaps legislative — reaction will be closely watched.