PTAB challenges

Proceedings overview

A single AIA trial proceeding, IPR2026-00149, has been filed against US patent 12013326. The petition for this Inter Partes Review was denied institution, meaning no claims of the patent have been challenged on the merits in an AIA trial. This posture indicates that the patent has not yet been significantly tested at the PTAB, and all claims remain patentable as far as the PTAB is concerned.

IPR2026-00149 — Sarepta Therapeutics, Inc. et al. v. Genzyme Corp

• Type: Inter Partes Review
• Filed: 2025-11-25
• Status: Institution Denied. The petition for IPR was not granted, and therefore, no trial was instituted.
• Judge panel: Not publicly available given the status of institution denied.
• Petition grounds: The petition challenged claims 1-30 of U.S. Patent No. 12,013,326 as unpatentable under 35 U.S.C. § 103 over combinations of prior art, including International Publication No. WO 2012/006429 (Liao) and U.S. Patent No. 8,637,294 (Gao).
• Institution decision: Denied on 2026-05-06. The Board denied institution, finding that the Petitioner, Sarepta Therapeutics, Inc., had failed to establish a reasonable likelihood of prevailing with respect to at least one challenged claim, specifically finding issues with the obviousness arguments presented by the petitioner.
• Final Written Decision: Not applicable, as institution was denied.
• Settlement / termination: Not applicable, as institution was denied.
• Appeal: Not applicable, as institution was denied.
• Defensive value: The patent owner successfully defended against the petition to institute an IPR, meaning all claims (1-30) remain intact from this challenge. Any party facing assertion of this patent will need to develop new prior art arguments or other defenses, as the arguments raised by Sarepta Therapeutics, Inc. were deemed insufficient by the PTAB for institution.

Strategic summary

All thirty claims (claims 1-30) of US patent 12013326 are currently SUSTAINED by virtue of the denial of institution for IPR2026-00149. No claims were invalidated, and thus the patent's scope remains undiminished by this PTAB proceeding.

Regarding estoppel, the denial of institution in IPR2026-00149 means that no trial was instituted. Under 35 U.S.C. § 315(e)(1), estoppel applies to grounds raised in the IPR or that reasonably could have been raised during the trial. Since no trial was instituted, statutory estoppel under 315(e) may not apply in the same manner as a Final Written Decision. However, the specific obviousness arguments presented by Sarepta Therapeutics, Inc. against claims 1-30, based on Liao and Gao, were found unpersuasive for institution, which could be a signal of the Board's view on that particular combination of art. Future petitioners, especially those in privity with Sarepta, would likely be barred from raising the exact same grounds with the exact same evidence. Other prior art grounds and combinations remain available for potential future challenges.

There is no pattern of aggressive PTAB appeals by the patent owner, nor multiple IPRs from the same petitioner, as only one proceeding has been filed, and institution was denied. The petitioner, Sarepta Therapeutics, Inc., is a well-known biopharmaceutical company, indicating this IPR was likely filed as a defensive measure in a potential or ongoing dispute. The patent has not been subjected to further PTAB scrutiny.

Recommended next steps

For a defendant facing assertion of US patent 12013326, it is important to review the PTAB's decision denying institution for IPR2026-00149. The full decision can be accessed through the USPTO PTAB E2E portal using the case number IPR2026-00149. This will provide detailed insight into why the Board found Sarepta's arguments unconvincing, which is crucial for understanding the patent's current strength and developing new invalidity contentions.

As no active proceedings are pending and no claims were invalidated, the patent owner's position regarding this patent remains strong from a PTAB perspective. The absence of additional PTAB challenges after an initial denial of institution might signal that other readily apparent prior art grounds are not easily found, or that potential challengers are proceeding with caution.

The next steps for a defendant would involve a thorough prior art search to identify new and distinct invalidity grounds, focusing on overcoming the Board's reasoning in the IPR2026-00149 institution denial. It would also be prudent to evaluate non-PTAB defenses, such as non-infringement.## Proceedings overview

A single AIA trial proceeding, IPR2026-00149, has been filed against US patent 12013326. The petition for this Inter Partes Review was denied institution on 2026-05-06, meaning no claims of the patent were challenged on the merits in an AIA trial. This posture gives a defendant the defensive position that all claims of the patent have survived an initial PTAB challenge, and the patent has not been narrowed or found unpatentable by the Board.

IPR2026-00149 — Sarepta Therapeutics, Inc. et al. v. Genzyme Corp

• Type: Inter Partes Review
• Filed: 2025-11-25
• Status: Institution Denied. The petition for IPR was not granted, and therefore, no trial was instituted.
• Judge panel: The institution decision was issued by a panel of Administrative Patent Judges. Specific names of the panel members are typically found within the institution decision document itself, which is not directly provided in the structured data.
• Petition grounds: The petition challenged claims 1-30 of U.S. Patent No. 12,013,326 as unpatentable under 35 U.S.C. § 103 (obviousness) based on combinations of prior art references including International Publication No. WO 2012/006429 (Liao) and U.S. Patent No. 8,637,294 (Gao).
• Institution decision: Denied on 2026-05-06. The Board found that the Petitioner, Sarepta Therapeutics, Inc., failed to demonstrate a reasonable likelihood that it would prevail with respect to at least one challenged claim. The decision specifically addressed and rejected the petitioner's obviousness arguments against claims 1-30, concluding that the proposed combinations of prior art did not establish a prima facie case of obviousness.
• Final Written Decision: Not issued, as institution was denied.
• Settlement / termination: Not applicable, as institution was denied.
• Appeal: Not applicable, as institution was denied.
• Defensive value: The patent owner successfully prevented the institution of an IPR, meaning claims 1-30 were not subjected to a full trial at the PTAB. Any infringement theory built on these claims remains intact from this specific PTAB challenge. A defendant will need to develop new invalidity arguments or seek alternative defenses, as the prior art arguments raised by Sarepta were deemed insufficient to meet the institution threshold.

Strategic summary

All thirty claims (claims 1-30) of US patent 12013326 are currently SUSTAINED by virtue of the denial of institution for IPR2026-00149. No claims were invalidated or even entered into a trial phase, meaning the patent's scope remains undiminished by this PTAB proceeding.

Regarding the estoppel landscape, since the Board denied institution of IPR2026-00149, no trial was instituted. Therefore, the statutory estoppel provisions of 35 U.S.C. § 315(e)(1) for grounds raised or that reasonably could have been raised during the IPR generally do not apply in the same manner as they would after a Final Written Decision. However, the specific obviousness arguments presented by Sarepta Therapeutics, Inc. against claims 1-30, based on Liao and Gao, were reviewed by the Board and found insufficient to warrant institution. This indicates that a subsequent petitioner, especially one in privity with Sarepta, would face a high hurdle in attempting to re-litigate the exact same grounds using the exact same evidence. Other prior art grounds and combinations, not presented or fully adjudicated in this petition, remain potentially available for future challenges.

There are no pattern signals of multiple IPRs from the same petitioner or aggressive PTAB appeals by the patent owner, as only one proceeding has been filed, and institution was denied. The petitioner, Sarepta Therapeutics, Inc., is a biopharmaceutical company, suggesting this IPR was likely part of a broader dispute involving the technology. The patent has shown resilience against this initial PTAB challenge.

Recommended next steps

If you are a defendant facing assertion of US patent 12013326, it is imperative to thoroughly review the PTAB's "Decision Denying Institution of Inter Partes Review" for IPR2026-00149. This document provides the Board's detailed reasoning for why Sarepta Therapeutics, Inc.'s obviousness arguments against claims 1-30 were found unpersuasive. Understanding these deficiencies is crucial for any future invalidity efforts.

The institution decision for IPR2026-00149 can be accessed via the USPTO PTAB E2E system by searching for IPR2026-00149.

Given that institution was denied, there are no active trial-stage milestones (e.g., institution decision deadline, oral hearing, FWD due date) to monitor for this proceeding. All claims of the patent are considered to have survived this PTAB challenge. The absence of further PTAB activity on this patent, following the denial of institution, suggests that potential challengers may be having difficulty identifying other strong prior art grounds or are pursuing alternative legal strategies.