Synthego Corporation v. Agilent Technologies, Inc.

Synthego Corporation, a genome engineering company specializing in platforms for CRISPR-based research and therapeutics, initiated an Inter Partes Review (IPR) against Agilent Technologies, Inc., a global provider of laboratory instruments, software, and services for life sciences and chemical analysis. This case concerned the validity of US Patent No. 10,900,034 (the '034 patent), which broadly covers modified guide RNA compositions and methods for use in CRISPR/Cas gene-editing systems. Specifically, the '034 patent relates to guide RNAs with at least one 2'-O-methyl modification and their application in CRISPR gene editing, critical for enhancing nuclease specificity and stability in gene-editing applications.

The procedural posture involved Synthego filing a petition for IPR2022-00403 with the U.S. Patent Trial and Appeal Board (PTAB), a specialized administrative tribunal within the USPTO designed to efficiently review patentability challenges. While the prompt mentions "patent infringement litigation," this specific case before the PTAB was a patent validity challenge, where Synthego sought to invalidate Agilent's patent rather than being accused of infringement. The PTAB issued a Final Written Decision on May 17, 2023, concluding that 33 claims of the '034 patent were unpatentable.

This case is particularly notable due to its significant impact on the CRISPR gene-editing landscape. Agilent had been pressing Synthego to license these patents, which were considered to cover "fundamental chemical modifications to CRISPR guide RNAs" essential for nearly all CRISPR-based therapeutic programs currently under development. Synthego's successful challenge, upheld by the Federal Circuit in June 2025 and finalized by the Supreme Court's denial of certiorari in April 2026, effectively removed a major patent roadblock. This outcome is widely seen as fostering a more open and innovative environment for researchers and therapeutic developers in the CRISPR field, allowing them to utilize essential guide RNA modifications without the burden of potential infringement claims or licensing fees.

The case IPR2022-00403, Synthego Corporation v. Agilent Technologies, Inc., involved a challenge to the patentability of U.S. Patent No. 10,900,034 (the '034 patent). This Inter Partes Review (IPR) proceeding has seen significant developments, including an institution decision, a final written decision, and an appeal to the Federal Circuit, ultimately reaching the Supreme Court.

Key Legal Developments and Outcome:

1. IPR Filing and Institution:

• Filing of Petition: Synthego Corporation filed a Petition for Inter Partes Review of claims 1–33 of U.S. Patent No. 10,900,034 B2 (the '034 patent) against Agilent Technologies, Inc. in 2022.
• Institution Decision: On May 31, 2022, the Patent Trial and Appeal Board (PTAB) instituted the IPR, finding that Synthego had demonstrated a reasonable likelihood of prevailing on at least one challenged claim. The PTAB declined to exercise its discretion to deny institution under 35 U.S.C. §§ 325(d) or 314(a).

2. Related District Court Litigation:

• At the time of institution, the parties identified two related district court cases involving the '034 patent: Synthego Corp. v. Agilent Techs., Inc., 21-cv-07801 (N.D. Cal. filed Oct. 5, 2021) and Agilent Techs., Inc. v. Synthego Corp., 21-cv-01426 (D. Del. filed Oct. 6, 2021).

3. Final Written Decision (FWD):

• PTAB Decision: The PTAB issued its Final Written Decision on May 17, 2023. The Board found that claims 1–5, 8–21, and 24–33 of the '034 patent were unpatentable as anticipated by a prior art reference known as "Pioneer Hi-Bred". Additionally, claims 6–7 and 22–23 of the '034 patent were found to be unpatentable as obvious in view of Pioneer Hi-Bred and other references (Threlfall or Deleavey). The existing case summary stated "33 claims related to the patent are unpatentable," and the FWD confirmed that all claims 1-33 of the '034 patent were found unpatentable, either as anticipated or obvious.

4. Federal Circuit Appeal:

• Appeal Filed: Agilent Technologies, Inc. appealed the PTAB's Final Written Decision to the U.S. Court of Appeals for the Federal Circuit. The appeal was consolidated with IPR2022-00402, concerning U.S. Patent No. 10,337,001, and assigned case numbers 23-2186 and 23-2187.
• Federal Circuit Decision: On June 11, 2025, the Federal Circuit affirmed the PTAB's decision, finding that all claims of both the '001 and '034 patents were unpatentable. The Federal Circuit upheld the PTAB's findings that Pioneer Hi-Bred anticipated certain claims and that others would have been obvious.

5. Supreme Court Proceedings:

• Certiorari Petition: Agilent Technologies, Inc. filed an application to extend the time to file a petition for a writ of certiorari with the Supreme Court, which was granted, extending the deadline to November 8, 2025. Agilent subsequently filed the petition for a writ of certiorari on November 8, 2025, challenging the Federal Circuit's judgment. The questions presented to the Supreme Court related to the presumption of enablement for printed publications as anticipatory prior art and the interpretation of proof of efficacy for enablement.
• Current Status: As of today's date (2026-06-19), the Supreme Court docket shows ongoing activity related to Agilent's petition for a writ of certiorari, with Synthego Corp. having waived its right to respond on December 5, 2025. The case remains active at the Supreme Court level.

Synthego Corporation was represented by counsel from Jones Day and Weil, Gotshal & Manges LLP during the various stages of the IPR and subsequent appeals.

The following attorneys represented Synthego Corporation:

• Edward R. Reines

  • Role: Lead Counsel (Federal Circuit and Supreme Court appeal).
  • Firm: Jones Day, Palo Alto, CA.
  • Note: Edward R. Reines has a strong Federal Circuit patent validity track record. He argued for Synthego Corp. at the Federal Circuit.

• Derek C. Walter

  • Role: Lead Counsel (Federal Circuit appeal); Attorney for Petitioner (PTAB).
  • Firm:
    • Weil, Gotshal & Manges LLP (during the PTAB proceedings for IPR2022-00402, a related case, which indicates his firm for the IPR stage of 00403 as well).
    • Jones Day (during the Federal Circuit appeal).
  • Note: Derek C. Walter was identified as lead counsel for Synthego in the Federal Circuit appeal, and was also an attorney for Synthego during the IPR proceedings.

Here is the counsel of record representing Agilent Technologies, Inc. in IPR2022-00403:

• Denise Marie De Mory

  • Role: Counsel
  • Firm: Bunsow De Mory LLP, Redwood City, CA
  • Experience Note: Represented Agilent Technologies in its appeal of the PTAB's final written decision in IPR2022-00403 to the Federal Circuit and its subsequent petition to the U.S. Supreme Court.

• Aaron Hand

  • Role: Counsel
  • Firm: Bunsow De Mory LLP, Redwood City, CA
  • Experience Note: Represented Agilent Technologies in its appeal of the PTAB's final written decision in IPR2022-00403 to the Federal Circuit.

• Mark A. Lemley

  • Role: Counsel
  • Firm: Lex Lumina PLLC, Los Angeles, CA
  • Experience Note: Argued for Agilent Technologies (appellant) before the U.S. Court of Appeals for the Federal Circuit in the consolidated appeals from IPR2022-00402 and IPR2022-00403.

• Rebecca Emily Weires Setrakian (née Rebecca Emily Weires)

  • Role: Counsel
  • Firm: Morrison & Foerster LLP, Los Angeles, CA
  • Experience Note: Represented Agilent Technologies in its appeal of the PTAB's final written decision in IPR2022-00403 to the Federal Circuit.