PTAB challenges

Proceedings overview

There is one active Post-Grant Review (PGR) proceeding on US patent 12569491, initiated by Neurocrine Biosciences, Inc. As this proceeding is currently pending, the patent's claims have not yet been challenged to a final determination, meaning the patent claims remain active for assertion.

PGR2026-00059 — Neurocrine Biosciences, Inc. v. Spruce Biosciences Inc

• Type: Post-Grant Review
• Filed: 2026-06-18
• Status: Pending. The petition has been filed and is awaiting a decision on institution.
• Judge panel: Not yet public.
• Petition grounds: Not yet public; this information would become public if the petition is instituted. PGRs can challenge claims under §§ 101, 102, 103, and 112 (except best mode).
• Institution decision: Not yet issued. The deadline for the institution decision is approximately six months from the filing date, around 2026-12-18.
• Final Written Decision: Not yet issued.
• Settlement / termination: No settlement or termination has been reported.
• Appeal: No appeal has been made as no Final Written Decision has been issued.
• Defensive value: This active PGR proceeding indicates that at least one party (Neurocrine Biosciences, Inc.) believes the patent's claims are vulnerable. While the claims currently remain active, the outcome of this PGR could significantly impact the patent's strength. If instituted and successful, it could invalidate some or all of the challenged claims, which would greatly benefit a defendant.

Strategic summary

Currently, all claims of US12569491 are untested through a final PTAB decision. The pending PGR2026-00059 by Neurocrine Biosciences, Inc. represents the first significant challenge to the patent's validity in an AIA trial. The outcome of this proceeding will be crucial in determining the patent's long-term viability and the scope of its enforceable claims.

The estoppel landscape will be shaped by the institution decision and any subsequent Final Written Decision in PGR2026-00059. If the PGR is instituted, Neurocrine Biosciences, Inc. and its privies would be estopped under 35 U.S.C. § 315(e)(2) from asserting in future district court litigation or other USPTO proceedings any ground of invalidity that they raised or reasonably could have raised during the PGR. For other potential defendants, the specific prior art and statutory grounds relied upon by Neurocrine Biosciences, Inc. in its petition (if instituted) would become relevant, as those grounds would be explored and adjudicated.

There are no apparent pattern signals of multiple IPRs filed by the same petitioner or aggressive PTAB appeals by the patent owner at this early stage. The involvement of Neurocrine Biosciences, Inc. as a petitioner suggests a potential interest in the technology covered by the patent, possibly in connection with its own product development or competitive landscape.

Recommended next steps

Given that PGR2026-00059 is pending, a defendant facing assertion of this patent should closely monitor this proceeding. Key upcoming milestones include the institution decision deadline, expected around 2026-12-18. If the petition is instituted, understanding the specific claims challenged and the grounds for institution will be critical.

Potential defendants should consider reviewing the PGR petition once it becomes public (if instituted) to understand the validity arguments being made against the patent. This could inform their own defensive strategies, particularly regarding available prior-art grounds not addressed or instituted in the ongoing PGR.