Agilent Technologies Inc. v. Synthego Corp.

Agilent Technologies Inc. v. Synthego Corp. was a significant patent dispute within the rapidly evolving field of CRISPR gene-editing technology, culminating in a U.S. Court of Appeals for the Federal Circuit (CAFC) decision that affirmed the unpatentability of Agilent's key patents. Agilent Technologies Inc. is an American global operating company that provides instruments, software, services, and consumables for laboratories, with a focus on life sciences, diagnostics, and chemical analysis markets. Synthego Corp., also an operating company, is a CRISPR solutions provider and genome engineering company leveraging machine learning, automation, and gene editing to advance CRISPR cell and gene therapies.

The patents at issue, US Patent 10,337,001 (and related patent US 10,900,034), concern synthetic CRISPR guide RNAs (gRNAs) with specific chemical modifications designed to improve their stability and functionality in CRISPR/Cas gene-editing systems. These modifications allow the guide RNAs to more effectively associate with Cas proteins and target specific DNA sequences for cleavage. Synthego challenged the validity of these patents, arguing that its own CRISPR genome engineering tools did not infringe, and subsequently seeking to invalidate Agilent's patents through inter partes review (IPR) proceedings.

The procedural posture of this case involved an appeal to the U.S. Court of Appeals for the Federal Circuit (CAFC Case No. 23-2186) from decisions by the Patent Trial and Appeal Board (PTAB). Synthego initiated two IPRs, successfully challenging all claims of Agilent's '001 and '034 patents as unpatentable due to anticipation or obviousness based on prior art, particularly the "Pioneer Hi-Bred" patent application. On June 11, 2025, the Federal Circuit affirmed the PTAB's findings, upholding that the claims were unpatentable. The CAFC is the exclusive appellate court for patent cases, making its rulings critical for establishing uniform patent law. This case is particularly notable because the Federal Circuit's decision clarified the standard for enablement in prior art under 35 U.S.C. § 102, distinguishing it from the enablement required for a patent under § 112. The court reinforced that prior art disclosures, even those with prophetic examples, can be enabling for invalidity purposes if they sufficiently disclose the invention, even in unpredictable fields like gene editing. This outcome impacts the broader CRISPR therapeutics market by keeping the field open for innovation in chemically modified gRNAs. Agilent sought an extension to file a petition for a writ of certiorari with the Supreme Court, underscoring the legal significance and high stakes of the Federal Circuit's ruling.

Key Legal Developments and Outcome for Agilent Technologies Inc. v. Synthego Corp.

This case primarily involved inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB) concerning the patentability of U.S. Patent No. 10,337,001 (and U.S. Patent No. 10,900,034), followed by appeals to the U.S. Court of Appeals for the Federal Circuit and the Supreme Court. There is no public record of an initial district court patent infringement litigation that led to these IPRs.

Parallel PTAB IPR Proceedings:

• Filing & Initial Pleadings (IPR Petitions): Synthego Corp. filed two petitions for inter partes review (IPR) challenging the patentability of Agilent Technologies Inc.'s U.S. Patent No. 10,337,001 and U.S. Patent No. 10,900,034. Synthego asserted that the claims of these patents, which relate to chemically modified guide RNAs (gRNAs) used in CRISPR-Cas gene-editing systems, were unpatentable as anticipated or rendered obvious by prior art. The primary prior art relied upon was the "Pioneer Hi-Bred" patent application (WO 2015/026885 A1).
• PTAB Final Written Decision: On May 17, 2023, the PTAB ruled in favor of Synthego, finding all challenged claims of both U.S. Patent Nos. 10,337,001 and 10,900,034 to be unpatentable as anticipated or obvious. The PTAB determined that the Pioneer Hi-Bred reference was enabling and disclosed the claimed gRNA functionality and relevant chemical modifications.

Appeal to the Federal Circuit:

• Appeal Filing: Agilent Technologies Inc. appealed the PTAB's adverse decisions to the U.S. Court of Appeals for the Federal Circuit. The appeal regarding U.S. Patent No. 10,900,034 was docketed as Case No. 23-2187 and filed on July 25, 2023, with Case No. 23-2186 for U.S. Patent No. 10,337,001 likely filed around the same time. Agilent argued that the PTAB's anticipation determination was not supported by substantial evidence, that the prior art was not enabling, and that a person of ordinary skill would not have had a reasonable expectation of success in combining the references.
• Federal Circuit Decision: On June 11, 2025, the Federal Circuit affirmed the PTAB's decision, upholding that all claims in U.S. Patent No. 10,337,001 (and U.S. Patent No. 10,900,034) are unpatentable. The court clarified the distinction between enablement requirements for challenged patents under 35 U.S.C. § 112 and for prior art under § 102, noting that the standard for enablement of prior art is lower. It held that prophetic examples in prior art can be enabling for anticipation purposes, provided they contain sufficient enabling disclosure and do not require undue experimentation.

Supreme Court Review:

• Certiorari Petition Denied: Agilent Technologies Inc. subsequently filed a petition for a writ of certiorari with the Supreme Court of the United States. On April 1, 2026, the Supreme Court denied this petition, which effectively concluded the multi-year legal challenge and finalized the invalidation of both Agilent CRISPR-related patents.

Outcome:

The final outcome of the litigation is that all claims in U.S. Patent No. 10,337,001 (and U.S. Patent No. 10,900,034) were found unpatentable, a decision affirmed by the Federal Circuit on June 11, 2025, and solidified by the Supreme Court's denial of certiorari on April 1, 2026.

The following counsel represented Agilent Technologies Inc. in Agilent Technologies Inc. v. Synthego Corp., Case No. 23-2186, at the U.S. Court of Appeals for the Federal Circuit:

• Mark A. Lemley

  • Role: Lead Counsel (argued for appellant).
  • Firm: Lex Lumina PLLC, Los Angeles, CA.
  • Experience Note: A highly regarded scholar and litigator in intellectual property, frequently appearing before the Federal Circuit.

• Denise Marie De Mory

  • Role: Counsel. (Identified as "Counsel of Record" in a Supreme Court reply brief for Agilent related to this case, indicating a significant role in the appellate process.)
  • Firm: Bunsow De Mory LLP, Redwood City, CA.
  • Experience Note: Focuses on patent infringement litigation and other intellectual property disputes.

• Aaron Hand

  • Role: Counsel. (Also listed on a Supreme Court reply brief for Agilent related to this case.)
  • Firm: Bunsow De Mory LLP, Redwood City, CA.
  • Experience Note: Practices patent litigation.

• Rebecca Emily Weires

  • Role: Counsel.
  • Firm: Morrison & Foerster LLP, Los Angeles, CA.
  • Experience Note: Involved in patent litigation.

While Jeffrey E. Ostrow has a background in patent litigation for technology companies, including Agilent, there is no direct evidence in the provided search results to confirm he was counsel of record in this specific Federal Circuit case (23-2186). His firm, Meister Seelig & Schuster, was not listed among the firms representing Agilent in the Federal Circuit opinion or the Supreme Court filings related to this case. Therefore, he is not identified as counsel of record for Agilent in this particular CAFC case.

Synthego Corp. was represented by counsel from Jones Day in the Federal Circuit case Agilent Technologies Inc. v. Synthego Corp., case number 23-2186. The counsel identified are:

• Edward R. Reines

  • Role: Lead Counsel
  • Firm: Jones Day, Silicon Valley (Palo Alto), CA
  • Note on experience: A first-chair trial lawyer and appellate advocate with extensive experience in life sciences, biotech, and high-technology patent disputes. His notable achievements include overturning a $96 million patent verdict, winning a $45 million Lanham Act false advertising lawsuit verdict, and securing a $24 million verdict in a case related to prenatal genetic testing methods. He is also a past president of the Federal Circuit Bar Association and teaches patent litigation at UC Berkeley Law School.

• Derek C. Walter, Ph.D.

  • Role: Lead Counsel
  • Firm: Jones Day, San Francisco, CA
  • Note on experience: Focuses on patent litigation in biological and chemical disciplines, including genomics, diagnostics, DNA sequencing, and bioinformatics. He has represented clients in all phases of patent litigation, including before the Federal Circuit and the PTAB, where he has successfully challenged patents related to CRISPR gene editing and defended patents in areas such as PCR instrumentation and DNA sequencing. His experience includes securing a $24 million verdict in a case related to prenatal genetic testing and a $27 million jury verdict in a microfluidic droplet technology case, as well as securing the reversal of a $96 million jury verdict.