PTAB challenges

Proceedings overview

There is one AIA trial proceeding on file for US patent 12031894. This proceeding, IPR2026-00150, has been instituted for trial and is currently active. The institution of trial against a significant number of claims indicates that the PTAB found a reasonable likelihood of Sarepta Therapeutics, Inc. et al. prevailing, which presents a significant challenge to the patent's validity.

IPR2026-00150 — Sarepta Therapeutics, Inc. et al. v. Genzyme Corporation et al.

• Type: Inter Partes Review
• Filed: 2025-11-25
• Status: Trial Instituted. The PTAB has decided to move forward with a trial on the challenged claims. The status was last modified on 2026-05-20.
• Judge panel: The institution decision was made by USPTO Director John A. Squires, consistent with the new policy effective October 20, 2025, where the Director decides whether to institute IPRs. The specific Administrative Patent Judge panel for the ongoing trial phase has not been publicly identified in the available information.
• Petition grounds: Sarepta challenged claims 1-7 and 10-30 of U.S. Patent No. 12,031,894. The petition argues that these claims are unpatentable as obvious under 35 U.S.C. § 103, based on the prior art references Le Bec, de la Maza, Sommer, and Cole.
• Institution decision: Instituted on 2026-05-06. The Director granted institution on the merits, determining that the petition demonstrated a reasonable likelihood that at least one challenged claim is unpatentable.
• Final Written Decision (if issued): Not yet issued. The trial is ongoing.
• Settlement / termination: Not applicable at this stage.
• Appeal: Not applicable at this stage, as no Final Written Decision has been issued.
• Defensive value: The institution of trial means that a significant portion of the patent's claims (claims 1-7 and 10-30) are currently under review for obviousness. If the claims are ultimately canceled, any infringement theory relying on them would be severely undermined. For now, the patent's validity is actively being challenged, which could influence litigation strategy.

Strategic summary

As of the current date, only one AIA trial proceeding, IPR2026-00150, has been filed and instituted against US patent 12031894. Claims 1-7 and 10-30 are currently under active review at the PTAB. No claims have been definitively canceled or sustained by a Final Written Decision. Therefore, all claims currently remain legally active, but their patentability is being challenged.

The estoppel landscape under 35 U.S.C. § 315(e)(2) will only fully develop upon the issuance of a Final Written Decision. If Sarepta (and its privies) were to receive an unfavorable FWD on any of the challenged claims, they would be estopped from asserting invalidity on any ground that was raised or reasonably could have been raised during the IPR. For other potential defendants, however, these prior art grounds (Le Bec, de la Maza, Sommer, and Cole for obviousness) may still be available unless they are in privy with Sarepta or otherwise estopped.

Regarding pattern signals, this is the first IPR filed against US12031894. It was filed by Sarepta Therapeutics, Inc. et al., which is also involved in ongoing district court litigation (Case No. 1:24-cv-00882, D. Del.) where Genzyme has asserted this patent. This suggests the IPR is a defensive maneuver in response to that litigation. The fact that institution was granted by Director Squires, who recently took over institution decisions and has introduced new factors, is noteworthy.

Recommended next steps

For a defendant facing assertion of US12031894, the ongoing IPR2026-00150 is a critical development. Since the trial was instituted on 2026-05-06, a Final Written Decision is statutorily due approximately one year later, around 2027-05-06. It is advisable to closely monitor the progress of IPR2026-00150 for any developments, particularly the issuance of the Final Written Decision, which will determine the patentability of claims 1-7 and 10-30. The institution decision can be accessed via the USPTO Open Data Portal.