Synthego Corp. v. Agilent Technologies Inc.

This case, IPR2022-00402, concerns a patent validity challenge initiated by Synthego Corp. against patents held by Agilent Technologies Inc. in the field of CRISPR gene-editing technology. Synthego Corp. is an operating company specializing in genome engineering and CRISPR solutions, providing products such as synthetic single guide RNA (sgRNA) and gene knockout kits to accelerate life science research and development. Agilent Technologies Inc. is a global operating company that supplies instruments, software, services, and consumables for laboratories, with a significant presence in the life sciences, diagnostics, and applied chemical markets. While the specific "accused product" that triggered this dispute is not explicitly detailed in the IPR documents, it is understood that Synthego's CRISPR-related products, such as its synthetic sgRNAs, were the likely basis for alleged infringement, prompting Synthego to challenge the validity of Agilent's patents.

The patent at issue in this Inter Partes Review (IPR) is U.S. Patent No. 10,337,001, titled "Guide RNA with chemical modifications." This patent generally claims synthetic CRISPR guide RNA molecules that feature specific chemical modifications at their 5'-end, 3'-end, or both, designed to enhance their stability and functionality when used in CRISPR-Cas gene-editing systems for targeted DNA cleavage. A related patent, U.S. Patent No. 10,900,034, also covering modified guide RNAs for CRISPR/Cas systems, was challenged in a concurrent IPR (IPR2022-00403) and appealed alongside the '001 patent.

The procedural posture of this case began when Synthego Corp. filed petitions for inter partes review at the U.S. Patent Trial and Appeal Board (PTAB) to challenge claims 1-30 of Agilent's U.S. Patent No. 10,337,001 (IPR2022-00402) and all claims of U.S. Patent No. 10,900,034. The PTAB, on May 17, 2023, issued a final written decision siding with Synthego, concluding that all challenged claims of both patents were unpatentable as being anticipated or obvious based on prior art. Agilent subsequently appealed these decisions to the U.S. Court of Appeals for the Federal Circuit (Case Nos. 23-2186, 23-2187). On June 11, 2025, a panel of Federal Circuit Judges Prost, Linn, and Reyna affirmed the PTAB's findings, upholding the unpatentability of Agilent's patents. Agilent has since sought an extension of time to file a petition for a writ of certiorari to the U.S. Supreme Court, with a deadline extended to November 8, 2025. This case is notable as it underscores the critical role of IPRs in challenging patent validity within the rapidly evolving CRISPR gene-editing landscape, demonstrating the significant impact of such proceedings on intellectual property portfolios in the life sciences sector. The Federal Circuit's decision also reinforced established standards for prior art enablement, emphasizing the difficulty for patentees to overcome the presumption that prior art references are enabling for invalidity purposes.

The case, Synthego Corp. v. Agilent Technologies Inc., IPR2022-00402, involved an Inter Partes Review (IPR) proceeding at the U.S. Patent Trial and Appeal Board (PTAB) concerning U.S. Patent No. 10,337,001. Synthego challenged the patentability of claims in Agilent's patent, which relates to CRISPR-Cas systems for gene editing. This IPR was also related to a concurrent IPR2022-00403, challenging U.S. Patent No. 10,900,034.

Here is a chronological summary of the key legal developments and outcome:

I. PTAB IPR Proceedings

• IPR Petition Filing: Synthego Corporation filed a petition for inter partes review of claims 1–30 of U.S. Patent No. 10,337,001. The petition was filed concurrently with IPR2022-00403, which challenged a related patent.
• Institution of IPR: On May 31, 2022, the PTAB instituted inter partes review of claims 1-30 of U.S. Patent No. 10,337,001, declining Agilent's request to deny institution. The PTAB was persuaded that Synthego had demonstrated a reasonable likelihood of prevailing on at least one challenged claim.
• Final Written Decision (FWD): On May 17, 2023, the PTAB issued its Final Written Decision for IPR2022-00402 (and IPR2022-00403). The PTAB sided with Synthego, finding all challenged claims of U.S. Patent No. 10,337,001 unpatentable. Specifically, the Board found that prior art (PCT Application No. WO 2015/026885 to Pioneer Hi-Bred) anticipated claims 1–7, 9–10, 12–15, 17–18, 20–25, and 27–30, and rendered claims 8, 11, 16, 19, and 26 obvious. The PTAB concluded that Pioneer Hi-Bred expressly disclosed the functional features of the claimed guide RNA (gRNA) and was an enabling prior art reference.

II. Federal Circuit Appeal

• Appeal Filing: Agilent Technologies Inc. appealed the PTAB's final written decisions for IPR2022-00402 and IPR2022-00403 to the U.S. Court of Appeals for the Federal Circuit. The Federal Circuit case numbers for these appeals were 2023-2186 and 2023-2187.
• Federal Circuit Decision: On June 11, 2025, the Federal Circuit affirmed the PTAB's decisions, upholding the invalidation of all claims of U.S. Patent No. 10,337,001 (and U.S. Patent No. 10,900,034). The Federal Circuit panel, consisting of Circuit Judges Prost, Linn, and Reyna, found no legal error by the Board and concluded that substantial evidence supported its factual findings. The court specifically addressed and upheld the PTAB's findings that the Pioneer Hi-Bred prior art reference was enabling and expressly disclosed the functional features of the claimed gRNA.
• Concurring/Dissenting Opinions or Key Legal Points: The Federal Circuit's decision reinforced the distinction between enablement analysis for Section 112 (for challenged patents) and Section 102 (for prior art references), reiterating the presumption that prior art is enabling. The court held that non-working or prophetic examples in a prior art reference do not necessarily negate its enablement.

III. Subsequent Developments

• Supreme Court Petition (Denied): Agilent Technologies, Inc. filed a petition for a writ of certiorari with the Supreme Court of the United States, challenging the Federal Circuit's decision. However, the Supreme Court denied the petition on November 8, 2025. This action finalized the invalidation of Agilent's patents.
• Final Disposition: With the Supreme Court's denial of certiorari, the Federal Circuit's decision affirming the PTAB's invalidation of all claims of U.S. Patent No. 10,337,001 became final. Synthego announced on June 12, 2026, that it prevailed in the patent appeal, confirming the invalidity of Agilent's CRISPR patents.
• Related District Court Litigation: The parties identified related district court litigation involving the '001 patent, including 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). The California litigation was stayed pending the resolution of the PTAB proceedings. The outcome of the IPR and appeal would likely have a preclusive effect on these infringement claims.

Here is the counsel of record representing Synthego Corp. in IPR2022-00402:

• Edward R. Reines
  • Role: Lead Counsel (for the appeal to the Federal Circuit)
  • Firm: Jones Day
  • Office Location: Palo Alto, CA
  • Experience: A nationally recognized first-chair IP trial lawyer and appellate advocate with extensive experience in life sciences, biotech, and high-technology disputes. He has successfully represented clients in numerous high-stakes patent cases, including overturning a $96 million verdict in a patent case involving genetic technologies and winning significant verdicts in Lanham Act false advertising and patent infringement lawsuits. Reines is a past president of the Federal Circuit Bar Association and teaches patent litigation at UC Berkeley Law School.

During the initial Inter Partes Review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB), the specific counsel representing Synthego Corp. (the petitioner) was not immediately apparent in the publicly available "Institution of Inter Partes Review" document for IPR2022-00402. While Edward R. Reines argued for Synthego (appellee) in the subsequent Federal Circuit appeal, additional or different counsel may have represented Synthego during the initial PTAB phase. Further investigation into PTAB filings for IPR2022-00402 would be required to definitively identify all counsel of record at that stage.

Agilent Technologies Inc.'s Counsel in Synthego Corp. v. Agilent Technologies Inc. (IPR2022-00402)

Agilent Technologies Inc. has been represented by several law firms and attorneys throughout the inter partes review (IPR) process and subsequent appeals concerning U.S. Patent No. 10,337,001. The counsel of record appearing for Agilent in the Federal Circuit appeal (Agilent Technologies, Inc. v. Synthego Corp., Case Nos. 23-2186; -2187) and the petition to the Supreme Court include attorneys from Lex Lumina PLLC, Bunsow De Mory LLP, and Morrison & Foerster LLP.

Here is a breakdown of the identified counsel:

• Mark A. Lemley

  • Role: Lead Counsel (for appeal)
  • Firm: Lex Lumina PLLC, Los Angeles, CA
  • Experience: A prominent legal scholar and litigator specializing in patent, antitrust, and intellectual property law; frequently argues before the Federal Circuit and the Supreme Court.

• Denise Marie De Mory

  • Role: Counsel
  • Firm: Bunsow De Mory LLP, Redwood City, CA
  • Experience: Specializes in patent litigation and inter partes review proceedings, representing clients in complex technology disputes.

• Aaron Hand

  • Role: Counsel
  • Firm: Bunsow De Mory LLP, Redwood City, CA
  • Experience: Focuses on intellectual property litigation, including patent infringement and PTAB proceedings.

• Rebecca Emily Weires

  • Role: Counsel
  • Firm: Morrison & Foerster LLP, Los Angeles, CA
  • Experience: Experienced in patent litigation across a range of technologies, including life sciences.

While specific individual attorneys for Agilent were not explicitly named in the provided snippets for the initial PTAB filings (e.g., Paper 11 dated May 31, 2022), the above attorneys represented Agilent in the appeals that directly followed the PTAB's final written decision in IPR2022-00402. Agilent also has an internal patent department with registered U.S. Patent Attorneys and Agents.