Thursday, February 09, 2012

AstraZeneca loses appeal in CRESTOR case

The final paragraph of the decision body states:

In view of the foregoing requirements, AstraZeneca’s claims based on presumed future labeling amendments are unripe. As we have noted, the Act permits generic manufacturers to file ANDAs directed to a subset of FDA- approved indications and even provides a mechanism for ANDA applicants to affirmatively carve out patented indications by submitting Section viii statements. In this case, Appellees have limited their ANDAs to unpatented methods for using rosuvastatin calcium, nothing in the record indicates that the FDA has required Appellees to add further indications, and we see no reason to presume that the FDA will do so in the future. In fact, as Appellees point out, the FDA has tentatively approved several of their ANDAs without issuing any such requirements. E.g., J.A. 206–10. Accordingly, the district court correctly dismissed AstraZeneca’s claims as unripe to the extent that they rely on prospective labeling amendments for Appellees’ generic rosuvastatin calcium because these claims rest on contingent future events that may never occur.

As to ripeness:

Among the requirements for establishing a justiciable case or controversy under Article III, a dispute must present issues that are ripe for judicial resolution. “A claim is not ripe for adjudication if it rests on contingent future events that may not occur as anticipated, or indeed may not occur at all.” Texas v. United States, 523 U.S. 296, 300 (1998) (internal quotations omitted). In the context of patent infringement actions under § 271(e)(2), we have held that “Section 271(e)(2) does not encompass ‘speculative’ claims for infringement.” Warner-Lambert, 316 F.3d at 1364. Regardless what may or may not occur in the future, 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. Id. at 1364–65.


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