In AstraZeneca UK Limited, et al. v. Watson Laboratories, Inc., C.A. No. 10-915-LPS (D. Del. Mar. 13, 2012), Judge Stark recently granted Watson Laboratories, Inc.’s and EGIS Pharmaceuticals PLC’s motions to dismiss AstraZeneca’s claims of infringement of its ‘618 and ‘152 Patents under Section 271(e)(2). In a previous suit brought by AstraZeneca against different generic drug manufacturers, the Federal Circuit affirmed the district court’s dismissal of similar claims because the defendants “had not sought FDA approval for the method of use indications covered by the ‘618 and ‘152 patents.” Id. at 6. Judge Stark found that Watson had done the same thing here, i.e., “filed a Section 505(b)(2)(B) Statement certifying that it is not seeking FDA approval for the indications covered by the ‘618 and ‘152 patents.” Id.
Judge Stark also granted EGIS’s motion to dismiss AstraZeneca’s declaratory judgment claims that EGIS will induce infringement of the patents-in-suit upon FDA approval of Watson’s NDA. Id. at 10. Judge Stark found that the there was no substantial controversy of sufficient reality to warrant a declaratory judgment. Specifically, the “potentially infringing subject,” i.e., Watson’s proposed NDA label, “has not remained substantially fixed over time.” Id. at 11. Thus, “Watson’s label . . . does not provide the basis for a justiciable Article III controversy of sufficient ‘reality.’” Id.