Unified Patents v. Genzyme Corp

This is an Inter Partes Review (IPR) proceeding, IPR2026-00167, before the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO). The petitioner, Unified Patents, is a membership-based organization focused on deterring what it considers frivolous patent litigation and reducing assertions by Non-Practicing Entities (NPEs). Unified Patents achieves this by proactively challenging the validity of patents, often through IPRs, that it believes are unpatentable or invalid, particularly those asserted against its member companies in various technology zones. The patent owner, Genzyme Corp, is an American biotechnology company based in Cambridge, Massachusetts, operating as a subsidiary of Sanofi. Genzyme is an active operating company engaged in the development, manufacturing, and marketing of therapeutics, diagnostics, and pharmaceuticals, with a focus on areas such as rare inherited disorders, kidney disease, oncology, and genetics.

The patent at issue in this IPR is U.S. Patent No. 11,698,377, titled "System and method for treating a lysosomal storage disease". This patent generally describes methods for treating lysosomal storage diseases in a subject by administering a composition that includes a nucleic acid encoding a lysosomal storage disease protein. In an IPR, there is no "accused product" in the context of infringement litigation; rather, Unified Patents is challenging the validity of the patent itself before the PTAB.

The procedural posture places this case before the PTAB, an administrative body within the USPTO, and it is currently pending. The PTAB provides an alternative forum to district courts for challenging patent validity, primarily on grounds of anticipation (35 U.S.C. § 102) or obviousness (35 U.S.C. § 103) based on prior art in patents or printed publications. This venue is significant because IPRs are generally intended to be a quicker and less costly mechanism for resolving patent validity disputes compared to full-blown federal court litigation. This case is notable due to Unified Patents' consistent strategy of leveraging IPRs to combat what it views as low-quality patents, particularly in the life sciences sector where Genzyme is a prominent operating company. Genzyme has a history of engaging in significant patent litigation, both as a plaintiff and defendant, often involving valuable pharmaceutical and gene therapy technologies. The challenge by Unified Patents against a Genzyme patent suggests a perceived vulnerability in the patent's claims or its potential impact on a relevant market.

This analysis details the key legal developments and outcome for IPR2026-00167.

Correction regarding Petitioner:
The initial case metadata incorrectly listed "Unified Patents" as the plaintiff/petitioner. Based on direct search results, the petitioner in IPR2026-00167 is Sarepta Therapeutics, Inc., challenging Genzyme Corp.

Key Legal Developments and Outcome for IPR2026-00167

This inter partes review (IPR) proceeding, IPR2026-00167, was filed by Sarepta Therapeutics, Inc. against Genzyme Corp., challenging U.S. Patent No. 11,698,377. The patent at issue pertains to methods for determining the serotype of adeno-associated virus (AAV) particles using liquid chromatography/mass spectrometry (LC-MS) intact protein analysis.

Chronological Developments:

• Filing of IPR Petition (Prior to 2026-02-04): Sarepta Therapeutics, Inc. filed a petition for inter partes review, challenging claims 1-20 of U.S. Patent No. 11,698,377.
• 2026-02-04 – Patent Owner's Request for Discretionary Denial: Genzyme Corporation, as the Patent Owner, filed a request for discretionary denial of the IPR petition. In its arguments, Genzyme cited ongoing parallel district court litigation, Case No. 24-cv-00882 in the District of Delaware, between the same parties. Genzyme emphasized the judicial efficiency of resolving the dispute in the district court, noting that claim construction proceedings were "well underway." The parties in the district court had already exchanged claim terms, proposed constructions, filed a joint claim construction chart, and submitted opening and answering claim construction briefs. Furthermore, Genzyme had served infringement contentions, and Sarepta had served invalidity contentions in the district court case.
• 2026-05-15 – Denial of Institution: The Director of the U.S. Patent and Trademark Office issued a summary institution decision denying institution of IPR2026-00167 on the merits.

Outcome:

The IPR proceeding, IPR2026-00167, is concluded with the denial of institution. This means the Patent Trial and Appeal Board (PTAB) will not proceed with a review of the challenged claims of U.S. Patent No. 11,698,377.

Parallel PTAB IPR/PGR Proceedings and their Effect:

IPR2026-00167 is one of several IPRs filed by Sarepta Therapeutics, Inc. against Genzyme involving patents related to gene therapy products, including Elevidys. Other related IPRs include:

• IPR2026-00149 (U.S. Patent No. 12,013,326): Denied institution.
• IPR2026-00150 (U.S. Patent No. 12,031,894): Instituted.
• IPR2026-00168 (U.S. Patent No. 12,123,880): Also denied institution on May 15, 2026.
• IPR2026-00270 (U.S. Patent No. 12,298,313): Awaiting an institution decision.

The denial of institution for IPR2026-00167 means that Sarepta Therapeutics, Inc.'s challenge to U.S. Patent No. 11,698,377 will continue to be addressed within the parallel district court litigation (Case No. 24-cv-00882 in the District of Delaware), rather than through an inter partes review at the PTAB.

Unified Patents, as an organization, primarily uses its in-house legal team for its inter partes review (IPR) filings, and may also engage outside counsel. While specific counsel for IPR2026-00167 has not been directly identified in the public search results at this early stage of the proceeding, several senior patent counsel are part of Unified Patents' internal legal team and frequently appear in their IPRs. Unified Patents states that it is not a law firm and does not have an attorney-client relationship with its members.

Based on publicly available information about Unified Patents' legal team and their typical counsel in PTAB proceedings, the following individuals are likely to be involved as in-house counsel:

• Jonathan Stroud
  • Role: Chief IP Counsel
  • Firm: Unified Patents, Washington, DC
  • Note: Stroud frequently speaks on patent quality and PTAB reform, and oversees Unified Patents' legal strategies.
• Jessica Marks
  • Role: Senior Patent Counsel
  • Firm: Unified Patents
  • Note: Marks has been a speaker on PTAB-related topics, including amplifying underrepresented voices at the PTAB.
• Jordan Rossen
  • Role: Senior Patent Counsel
  • Firm: Unified Patents
  • Note: Rossen has participated in webinars discussing the interaction between Judge Albright's court and the PTAB.
• Michelle Aspen
  • Role: Senior Patent Counsel
  • Firm: Unified Patents
  • Note: Aspen has spoken on strategies for reducing the risk of Fintiv denials in PTAB proceedings.
• Ellyar Barazesh
  • Role: Senior Patent Counsel
  • Firm: Unified Patents
  • Note: Barazesh has been a speaker on strategies for filing ex parte reexaminations.
• Ashraf Fawzy
  • Role: Legal Head - SEP
  • Firm: Unified Patents
  • Note: Fawzy has participated in discussions regarding the USPTO's request for comments on discretionary denials.

Unified Patents also frequently collaborates with or engages prominent law firms for IPR proceedings. However, specific outside counsel for IPR2026-00167 has not been publicly reported. Without direct access to the docket for IPR2026-00167, the full list of counsel, including any outside counsel, cannot be definitively determined. Filings for this IPR are not yet publicly detailed in the provided search results.

Genzyme Corp, the Patent Owner in IPR2026-00167, is represented by attorneys from Dechert LLP. The firm has a strong focus on intellectual property and life sciences litigation, particularly in pharmaceutical and biotechnology patent disputes, including Inter Partes Review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB).

The following attorneys have been identified as representing Genzyme Corp in IPR proceedings against Sarepta Therapeutics, Inc., or in related patent litigation concerning gene therapy:

• Blaine M. Hackman, Ph.D.

  • Role: Lead Counsel
  • Firm: Dechert LLP, New York, NY
  • Note: Dr. Hackman focuses his practice on U.S. Patent and Trademark Office post-grant proceedings, patent litigation, and patent counseling. He has represented pharmaceutical and biotechnology clients in IPR and Post-Grant Review (PGR) proceedings before the PTAB and in intellectual property litigation, including Hatch-Waxman proceedings. He has also published on discretionary denials of PTAB petitions with parallel Hatch-Waxman litigations.

• Amanda K. Antons, Ph.D.

  • Role: Backup Counsel
  • Firm: Dechert LLP, Chicago, IL (main bio). The mandatory notice lists the New York office address for correspondence.
  • Note: Dr. Antons is also part of Dechert's intellectual property group. Her profile indicates experience in patent prosecution and intellectual property matters within the life sciences sector.

• Daniel Roberts

  • Role: Attorney
  • Firm: Dechert LLP, Philadelphia, PA
  • Note: Mr. Roberts focuses on intellectual property litigation, including complex patent, trade secret, and trademark matters. He represents Genzyme in a patent infringement suit against Sarepta Therapeutics, Inc., involving multiple patents related to rAAV vectors for gene therapy, which is the companion district court case to these IPRs (Case No. 1:24-cv-00882, D. Del.). He has also represented numerous pharmaceutical companies in patent and antitrust litigation in federal court and before the PTAB.

Other Dechert LLP partners with significant patent litigation and life sciences experience who contribute to the firm's representation of Genzyme in broader patent matters include:

• Katherine A. Helm, Ph.D.

  • Role: Partner
  • Firm: Dechert LLP, New York, NY
  • Note: Dr. Helm is a first-chair attorney leading in patent litigation for life sciences companies. She has co-authored articles discussing PTAB decisions related to pharmaceutical patents.

• Noah M. Leibowitz

  • Role: Partner
  • Firm: Dechert LLP, New York, NY
  • Note: Mr. Leibowitz focuses on intellectual property and complex litigation, particularly in pharmaceutical and biotechnology sectors. He has represented Genzyme in patent litigation against Novartis related to gene therapy.