Untitled case

This case, IPR2025-01194, involves a challenge to U.S. Patent No. 9,051,542 before the Patent Trial and Appeal Board (PTAB). The Petitioner is Sarepta Therapeutics, Inc., a biopharmaceutical company focused on gene therapy, while the Patent Owner is Genzyme Corporation, a subsidiary of Sanofi, also a global healthcare company with a significant presence in rare diseases and gene therapies. The underlying dispute likely stems from potential patent infringement related to Adeno-Associated Virus (AAV) gene therapy products or development, as evidenced by district court litigation in Delaware (e.g., C.A. No. 21-1736-RGA and 1:24-cv-00882) involving Genzyme Corporation and Novartis Gene Therapies, Inc., which also challenged this patent in other IPRs.

The patent at issue, U.S. Patent No. 9,051,542, is titled "Compositions and methods to prevent AAV vector aggregation". It describes formulations and techniques designed to prevent the aggregation of AAV vectors during their preparation and storage. Specifically, the patent focuses on using high ionic strength solutions, often achieved with multivalent salts like sodium citrate, which are isotonic with the intended target tissue, to maintain the infectivity and transduction efficiency of these crucial gene therapy vectors, even after multiple freeze-thaw cycles. Preventing aggregation is critical for the safety and efficacy of gene therapy products.

The procedural posture of IPR2025-01194 is notable as it was filed at the Patent Trial and Appeal Board but was "Not Instituted - Procedural". This outcome reflects significant shifts in PTAB practice during 2025, which made it "materially harder to institute inter partes review (IPR)". The USPTO implemented a new bifurcated institution regime where the Director first considers discretionary factors before a PTAB panel addresses the merits of the petition. Common procedural grounds for denial in 2025 included the Fintiv factors (related to parallel district court litigation), the doctrine of "settled expectations" (where institution is denied if a patent has been in force for a long time without challenge, creating an expectation of its validity), and issues with filing multiple petitions against the same patent. The IPR's non-institution on procedural grounds highlights the impact of these policy changes on petitioners attempting to challenge patent validity at the PTAB.

This case involves patent infringement litigation concerning US Patent 9,051,542, primarily in the District of Delaware, alongside parallel inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB).

Key Legal Developments and Outcome

1. District Court Litigation Filing & Initial Pleadings (Genzyme Corporation et al. v. Novartis Gene Therapies, Inc. et al., No. 1:21-cv-01736, D. Del.)

• Filing: Genzyme Corporation and Aventis Inc. (Plaintiffs) filed a patent infringement lawsuit against Novartis Gene Therapies, Inc., Novartis Pharmaceuticals Corporation, and Novartis AG (Defendants) in the U.S. District Court for the District of Delaware on December 10, 2021. The complaint asserted infringement of six patents, including US Patent 9,051,542, related to recombinant adeno-associated virus (AAV) vector technology, which is central to Novartis's Zolgensma gene therapy.
• Motion to Dismiss (Novartis AG): On February 13, 2023, the District Court granted Novartis AG's motion to dismiss for lack of personal jurisdiction, removing Novartis AG from the case.

2. Parallel PTAB IPR Proceedings (IPR2023-00608 and IPR2023-00609)

• Filing of IPR Petitions: Novartis Gene Therapies, Inc. and Novartis Pharmaceuticals Corporation (Petitioners) filed two IPR petitions, IPR2023-00608 and IPR2023-00609, challenging claims 1, 2, 5, and 6 of US Patent 9,051,542. These petitions were filed in February 2023.
• Disclaimer of Claims: During the IPR2023-00608 proceeding, Genzyme Corporation (Patent Owner) disclaimed claims 1 and 2 of the '542 patent.
• Denial of Institution (Merits): On August 30, 2023, the PTAB denied institution for both IPR2023-00608 and IPR2023-00609 on the merits. The Board determined that the Petitioners had not demonstrated a reasonable likelihood of success in proving claims 5 or 6 (the remaining challenged claims after disclaimer in IPR2023-00608) unpatentable. The PTAB also noted that filing two petitions against the same patent to challenge a small number of claims was generally discouraged by PTAB guidance.

3. Claim Construction (Markman) Outcome

• Markman Order: On August 18, 2023, Judge Richard G. Andrews of the District of Delaware issued a Memorandum Opinion providing claim construction for multiple terms across the asserted patents, including US Patent 9,051,542.
• Motion for Reargument on Indefiniteness: On January 12, 2024, the District Court denied Plaintiffs' motion for reargument and reconsideration of certain claim terms previously ruled indefinite in other patents involved in the litigation.

4. Final Disposition of District Court Litigation

• Dismissal with Prejudice: The District of Delaware case, Genzyme Corporation et al. v. Novartis Gene Therapies, Inc. et al., Case No. 1:21-cv-01736, was dismissed with prejudice on February 14, 2024. This mutual dismissal, which occurred after 796 days of litigation, meant the case concluded without a trial, verdict, or public ruling on the merits of infringement or validity. Each party absorbed their own legal costs.

5. Parallel PTAB IPR Proceeding (IPR2025-01194)

• Procedural Denial: The IPR petition IPR2025-01194, concerning US Patent 9,051,542, was not instituted on procedural grounds. The denial likely occurred after October 20, 2025, when USPTO Director John Squires assumed full personal control over IPR institution decisions and began issuing summary denials without detailed reasoning for routine cases. These summary denials, which began on October 31, 2025, with a notice denying 13 petitions, and another 21 on November 6, 2025, often cited general procedural reasons such as "settled expectations," petitioner delay, or issues with real party-in-interest identification, rather than the merits of the patentability challenge. The specific procedural ground for IPR2025-01194 was not publicly detailed, consistent with the new policy of summary notices.

Other Noted Litigation:

• A separate US case (1:24-cv-00882) was filed in the Delaware District Court, also associated with US Patent 9,051,542. Details regarding parties or its relationship to the Genzyme v. Novartis dispute are not publicly available.

The counsel of record for the plaintiff(s) (Petitioner) in IPR2025-01194 cannot be identified through public web searches.

Inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB) involve a Petitioner challenging the validity of a patent owned by a Patent Owner. The case IPR2025-01194 was "Not Instituted - Procedural," indicating that the petition was likely denied based on discretionary factors rather than a review of the merits of the patentability challenge.

Despite extensive searching using the IPR case number, public records available through general web searches do not explicitly name the Petitioner or Patent Owner for IPR2025-01194. Without this foundational information, identifying their respective counsel is not possible.

The counsel of record representing Genzyme Corporation, the Patent Owner in IPR2025-01194 (and thus the "defendant" in this patent validity challenge context), are primarily from Dechert LLP. While the provided IPR number is for a PTAB proceeding, this IPR is related to an ongoing patent infringement case, Genzyme Corp v. Sarepta Therapeutics, Inc., C.A. No. 1:24-cv-00882-RGA (D. Del.), where Genzyme is the plaintiff.

Based on the Patent Owner's Mandatory Notices filed in the concurrently filed and related IPR2025-01195, the following attorney served as lead counsel for Genzyme Corporation, and it is highly probable they also represented Genzyme in IPR2025-01194 due to the related nature of the proceedings:

• Blaine M. Hackman
  • Role: Lead Counsel (for IPRs)
  • Firm: Dechert LLP, New York, NY
  • Note: Blaine Hackman is a partner in Dechert's intellectual property practice. His experience includes representing clients in patent litigation across various industries, including life sciences. He was also involved as "of counsel" for Genzyme in the related district court infringement case against Sarepta Therapeutics.