Magistrate Judge Thynge has issued a Report and Recommendation addressing whether there is an actual case or controversy within the meaning of the Declaratory Judgment Act over a suit in which the plaintiff seeks judgment of a defendant’s willful infringement based on the defendant’s filing of a New Drug Application with the FDA. Both the plaintiff and the defendant in this case filed NDAs with the FDA and neither party’s NDA has been approved. The parties in the case are also parties to an interference in the PTO in which the defendant is the senior party. Clarus Therapeutics, Inc. v. Lipocine Inc., C.A. No. 15-1004-RGA-MPT, Report and Recommendation at 1-5 (D. Del. June 23, 2016).
Given these facts, Judge Thynge found “significant, concrete steps to conduct infringing activity” as well as ripeness for judicial resolution: “Defendant not only has a working product, but also has an NDA before the FDA for review. Additionally, plaintiff notes defendant’s market research, hiring of new sales and marketing personnel, saving for manufacture of commercial quantities of its product, manufacture of launch supplies, and anticipation of the manufacturing agreements. Defendant contends the prerequisite FDA approval for commercialization and entry into the market is uncertain and, if approval is eventually given, commercial launch will not be immediate. While this may be accurate, defendant’s conduct is still indicative of meaningful preparation for the making, launch, and use of [its drug product] that satisfies the immediacy requirement for declaratory judgment jurisdiction.” Id. at 8-11.
Moreover, “the PTAB’s decision in the upcoming Interference will not determine the issue of infringement central to plaintiff’s complaint. Due to the lack of further factual development needed and the PTAB’s inability to hear plaintiff’s infringement claim in the forthcoming Interference, the issue is fit for judicial decision.” Id. at 11. Judge Thynge therefore recommended that the defendant’s motion to dismiss be denied.
Clarus Therapeutics, Inc. v. Lipocine Inc., C.A. No. 15-1004-RGA-MPT (D. Del. June 23, 2016).