Clarus Therapeutics, Inc. v. Lipocine Inc., C.A. No. 15-1004 – RGA-MPT, June 17, 2016.

Thynge, C. M. J. Report and recommendation recommending defendant’s motion to dismiss for lack of subject matter jurisdiction under FED. R. CIV. P. 12(b)(1) on the basis of no actual controversy and lack of ripeness be denied.

The disputed technology relates to testosterone undecanoate. Defendant has not been given FDA approval nor has it commercialized its product. It does have several patents pending and an Interference proceeding is pending in which defendant is the senior party. Thus the PTAB will determine the priority of the patent claims and questions of patentability for the patent-in-suit that could result in the cancellation of claims in the patent-in-suit. It has engaged in activity connected to the preparation and launch. The court recommends not dismissing this declaratory judgment action because it has found subject matter jurisdiction exists, the Interference will not decide the infringement issues raised by plaintiff, and it is in the interest of justice for it to proceed.