Tuesday, December 21, 2010

Question of Whether to Incur "Substantial Expenses" for Testing and Clinical Trials does not Create Substantial Controversy Sufficient

to Assert Declaratory Relief Claim
Defendant's motion to dismiss plaintiff's declaratory relief claims of noninfringement and invalidity for lack of subject matter jurisdiction was granted because plaintiff's device was still in early development. "[Plaintiff] argues that the present controversy satisfies the immediacy prong of [MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 (2007)] because '[plaintiff] has reached a point where it would incur substantial expenses in conducting bench, animal and clinical testing.' However, in light of Plaintiff’s own allegations that '[p]rior to being introduced for commercial sale, [plaintiff's] medical devices undergo rigorous and intensive laboratory testing, in vitro and in vivo studies, and clinical trials,' and that '[t]ypically, a product may undergo many years of testing and clinical trials . . . before being ready for commercial sale,' it remains uncertain when, if ever, the declaratory plaintiff would engage in potentially infringing activity. While Plaintiff contends that it 'has completed the design of its products,' it has not yet submitted them for approval by the [FDA], which suggests, consistent with its own factual allegations, that it has yet to initiate the 'many years' of testing and clinical trials required prior to commercialization. That Plaintiff has reached a point where it would 'incur substantial expenses' by embarking on bench, animal, and clinical testing is also insufficient to satisfy the immediacy requirement where the potentially infringing activity could still be 'many years' away."

W.L. Gore and Associates Inc. v. GI Dynamics, 3-10-cv-08088 (AZD December 15, 2010, Order) (Snow, J.)

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