IP Law Daily, PATENT—D. Del.: Dismissal granted in congenital adrenal hyperplasia dispute, (Jun 10, 2025)

By Kevin M. Finson, J.D.

Subject matter jurisdiction was lacking for declaratory judgment of patent invalidity when the patent holder had not done any affirmative act to suggest it would attempt to enforce its patent rights.

A pharmaceutical company failed to show subject matter jurisdiction in a declaratory judgment action over the validity of a competitor’s patents, the U.S. District Court in Wilmington has held. The competitor had not brought an infringement suit or taken any affirmative action toward enforcement, so there was no case or controversy (Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc., No. 1:25-cv-00059-JDW (D. Del. Jun. 9, 2025)).

Spruce Biosciences, Inc. (Spruce) was the owner of several patents related to the use of CRF1 receptor antagonists in the treatment of congenital adrenal hyperplasia (CAH), U.S. Patents Nos. 10,849,908 (the ‘908 patent), 11,007,201 (the ’201 patent), 12,115,166 (the ’166 patent), and 11,344,557 (the ’557 patent.) Neurocrine Biosciences, Inc. (Neurocrine) was a pharmaceutical company and the manufacturer of CRENESSITY™, an FDA-approved CRF1 receptor antagonist used to treat classic CAH.

Neurocrine petitioned for post-grant review of the ’908, ’201, and ’166 patents and obtained a decision from the Patent Trial and Appeal Board invalidating all claims of the ’908 and ’201 patents. The proceedings as to the ’166 patent remain pending. After seeking and not obtaining a covenant not to sue, Neurocrine filed a petition for declaratory judgment seeking a declaration of invalidity as to the ’557 patent. Spruce moved to dismiss for lack of subject matter jurisdiction, arguing there was no present case or controversy.

Subject matter jurisdiction. The court found that Neurocrine failed to plausibly allege any affirmative act by Spruce asserting its patent rights. There was no enforcement action and no cease-and-desist letter or threat to sue, Spruce had only declined to enter into a covenant not to sue when requested by Neurocrine. Ongoing administrative litigation was entirely one-sided: Neurocrine attempted to invalidate Spruce’s patents and Spruce defended those cases. The court ultimately held that Neurocrine’s “subjective or speculative fear” of patent enforcement, absent any affirmative act by Spruce, was not sufficient to support declaratory judgment jurisdiction.

The court granted the motion to dismiss.

The Case is No. 1:25-cv-00059-JDW.

Judge: Wolson, J.

Attorneys: Rodger Dallery Smith (Arsht & Tunnell LLP) for Neurocrine Biosciences, Inc. David Ellis Moore (Potter Anderson & Corroon, LLP) for Spruce Biosciences, Inc.

Companies: Neurocrine Biosciences, Inc.; Spruce Biosciences, Inc.

Cases: Patent DelawareNews