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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