PTAB challenges

Proceedings overview

There is currently one active AIA trial proceeding on US Patent 12576084. It is a Post-Grant Review (PGR) that is still pending, so there are no final claim-level outcomes yet. This means the patent's claims remain untested and potentially vulnerable, offering a defendant an opportunity to challenge validity.

PGR2026-00061 — Neurocrine Biosciences, Inc. v. Spruce Biosciences Inc.

• Type: Post-Grant Review
• Filed: 2026-06-18
• Status: Pending (The proceeding was filed recently and has not yet reached an institution decision or final determination.)
• Judge panel: Not yet publicly available.
• Petition grounds: Not yet publicly available. (A PGR petition typically challenges claims under § 101, § 102, § 103, or § 112, based on the patent's earliest priority date.)
• Institution decision: Not yet issued.
• Final Written Decision (if issued): Not applicable, as the proceeding is pending.
• Settlement / termination: Not applicable, as the proceeding is pending.
• Appeal: Not applicable, as the proceeding is pending.
• Defensive value: This active PGR indicates that at least one party (Neurocrine Biosciences, Inc.) believes there are strong grounds to challenge the validity of US12576084. For a defendant, this means the patent's claims have not yet been validated by the PTAB, and an opportunity exists to join or monitor this proceeding to inform their own defensive strategy.

Strategic summary

Currently, all claims of US12576084 remain untested by a final PTAB decision. The pending PGR2026-00061 initiated by Neurocrine Biosciences, Inc. is the sole AIA trial proceeding on record. As this is a Post-Grant Review, it allows for challenges under a broader range of statutory grounds (§ 101, § 102, § 103, and § 112) compared to an Inter Partes Review, which is typically limited to § 102 and § 103. The patent was only granted on March 17, 2026, and the PGR was filed shortly thereafter, within the 9-month window for filing a PGR from the patent grant date. This suggests that the petitioner identified potentially significant validity issues soon after the patent issued.

The estoppel landscape is currently minimal for this patent, as no final written decision has been issued in any AIA trial. Therefore, grounds for invalidity, whether based on prior art or other statutory challenges, are generally still available to potential defendants, assuming they are not in privity with Neurocrine Biosciences, Inc. and have not been served with a complaint alleging infringement of the patent.

The rapid filing of a PGR after grant is a strong signal that the claims of US12576084 may face substantial validity challenges. It also indicates that Neurocrine Biosciences, Inc. sees this patent as a potential threat or believes it to be invalid.

Recommended next steps

Given the pending PGR2026-00061, a defendant facing assertion of this patent should:

• Monitor the progress of PGR2026-00061 closely on the USPTO PTAB E2E system. Key upcoming milestones include the institution decision deadline (typically six months from the preliminary response), and if instituted, the oral hearing and the Final Written Decision due date (within one year of institution).
• Review the PGR petition (once publicly available) to understand the specific claims being challenged, the prior art cited, and the statutory grounds asserted by Neurocrine Biosciences, Inc. This will provide valuable insight into potential weaknesses of the patent.
• Consider intervening in the PGR if allowed and strategically beneficial, or preparing their own IPR petition to challenge additional claims or grounds not covered by PGR2026-00061. The absence of a final decision means all claims are currently open to challenge, subject to PGR filing deadlines and estoppel rules for subsequent petitions.