Wednesday, April 9, 2014

Hatch-Waxman Bars Declaratory Relief Claim Against ANDA Applicant's Prospective Supplier

The court granted defendant's motion to dismiss for lack of subject matter jurisdiction with respect to plaintiff's claim that a drug manufacturer defendant would infringe plaintiff's drug patent if another defendant's ANDA was approved. "[W]hether [movant] actually manufactures the generic [drug product] is speculative because the FDA has not approved the ANDA product; and secondly, the Court may rule in [plaintiff's] favor in this case. Both outcomes are unknown at this time, and it is premature to speculate as to [movant's] future role. . . . While the safe harbor provision protects [movant] from being sued, the Declaratory Judgment Act, if one accepts [plaintiff's] argument, would allow suit. When interpreting two conflicting statutes, the 'more specific statute controls over the more general one'; hence the Hatch-Waxman provision controls."

United Therapeutics Corporation v. Sandoz, Inc., 3-12-cv-01617 (NJD March 31, 2014, Order) (Sheridan, J.)

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