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Judge Sleet: Motion to Dismiss Counterclaims in ANDA case Denied in Part and Granted in Part

Judge Sleet recently granted in part and denied in part plaintiffs’ motion to dismiss defendant’s counterclaims in an ANDA case. Bone Care International LLC v. Sandoz Inc., C.A. No. 09-524-GMS (D. Del. Sep. 30, 2010. One patent in suit had expired and another was disclaimed. Plaintiffs also requested the FDA delist it from its Orange Book. Defendant’s asserted injury “[was] that if the FDA’s current interpretation and application of the delisting rule . . . is overruled on appeal, approval of its ANDA could be delayed.” Id. Judge Sleet granted the motion to dismiss as to these two patents, however, because “the highly speculative nature of [defendant’s] alleged injuries-in-fact renders their claims non-justiciable[.]” Id. at 1 n.1. Judge Sleet denied plaintiffs’ motion to dismiss as to the third patent-in-suit, however. Although plaintiffs offered defendant a covenant not to sue, “offering a covenant not to sue does not remove declaratory judgment jurisdiction when a party lists patents in the Orange Book and then later refuses to enforce them, since non-first filers still face delayed approval of their ANDAs even with a CNS.” Id. at 2 n.2.

Bone Care International LLC v. Sandoz Inc., C.A. No. 09-524-GMS (D. Del. Sep. 30, 2010

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