Short Summary
The PTAB held that Neurocrine Biosciences’ challenge to Spruce Biosciences’ ’201 patent succeeded; all 19 claims were found unpatentable for lack of written description under §112(a).
Detailed Summary
In PGR2022‑00025, the Patent Trial and Appeal Board reviewed Neurocrine Biosciences’ petition challenging claims 1‑19 of Spruce Biosciences’ U.S. Patent No. 11,007,201 (the ’201 patent), which claims methods of treating congenital adrenal hyperplasia using CRF1 receptor antagonists. After extensive briefing on claim construction and written‑description issues, the Board concluded that the specification discloses only a single compound (tildacerfont) and fails to provide either a representative number of species or common structural features for the broader genus claimed. Relying on Ariad and related precedent, the Board found the claims lack adequate written description support under 35 U.S.C. §112(a) and declared all 19 claims unpatentable. Motions to exclude evidence and a motion to strike were denied or dismissed as moot.
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before local courts. Understanding the court's reasoning in Neurocrine Biosciences, Inc. vs Spruce Biosciences, Inc. is valuable context for structuring arguments or assessing risk in similar proceedings.
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