Agilent Technologies v. Synthego Corp.

Agilent Technologies, Inc. v. Synthego Corp. is a significant patent dispute centered on foundational CRISPR gene-editing technology, involving two operating companies. Agilent Technologies, a global leader in life sciences, diagnostics, and applied chemical markets, provides instruments, software, and consumables for laboratories. Synthego Corp. is a biotechnology company specializing in CRISPR-based genome engineering solutions, offering synthetic guide RNA (gRNA) and related tools for genetic research and therapeutic development. The patents at issue are U.S. Patent Nos. 10,900,034 and 10,337,001, both claiming chemically modified guide RNAs (gRNAs) designed to enhance stability and performance within CRISPR-Cas gene-editing systems. Synthego, a direct competitor, challenged these patents, asserting they were unpatentable.

The procedural journey began with Synthego filing Inter Partes Review (IPR) petitions against Agilent's patents at the Patent Trial and Appeal Board (PTAB), where the PTAB found all claims unpatentable. Agilent appealed these decisions to the U.S. Court of Appeals for the Federal Circuit (Case Nos. 23-2186; -2187), which affirmed the PTAB's findings on June 11, 2025. Agilent then petitioned the U.S. Supreme Court (Case No. 25-570) for a writ of certiorari on November 14, 2025, seeking review of the Federal Circuit's judgment. The Supreme Court ultimately denied Agilent's petition on April 1, 2026, thereby finalizing the invalidation of Agilent's patents.

This case is particularly notable for its implications concerning the standard for prior art enablement, especially in rapidly evolving biotechnology fields like CRISPR gene editing. Agilent's appeal to the Supreme Court centered on whether printed publications, particularly abandoned patent applications filled with prophetic examples (described but not necessarily performed experiments), should be presumed enabling as prior art to invalidate an issued patent. The Federal Circuit's decision reinforced the distinction between enablement standards for prior art under 35 U.S.C. § 102 (which has a lower bar, requiring only a single enabled embodiment) and for a patent's validity under § 112. The Supreme Court's denial of certiorari allows this Federal Circuit interpretation to stand, establishing that abandoned patent applications and prophetic examples can serve as effective prior art, even without demonstrated efficacy, which has significant consequences for IP portfolios and patenting strategies in the competitive life sciences sector.

Agilent Technologies' patent litigation against Synthego Corp., concerning U.S. Patent No. 10,900,034 (and related Patent No. 10,337,001), primarily involved inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB), followed by appeals to the Federal Circuit and ultimately a petition for certiorari to the U.S. Supreme Court. The core legal dispute centered on the standard for prior art enablement in the context of CRISPR gene-editing technology.

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

Parallel PTAB IPR Proceedings

• IPR Petitions Filed: Synthego Corp. initiated inter partes review (IPR) proceedings against Agilent Technologies' U.S. Patent Nos. 10,337,001 and 10,900,034. These patents claim chemically modified guide RNAs (gRNAs) used in CRISPR-Cas systems for gene editing. Synthego argued that the patents were unpatentable based on prior art, specifically a "Pioneer Hi-Bred" patent application from 2014, sometimes combined with other references like Threlfall or Deleavey.
• PTAB Final Written Decisions (2023-05-17): The PTAB issued final written decisions on May 17, 2023, ruling in favor of Synthego. The Board found all challenged claims of both U.S. Patent No. 10,337,001 and U.S. Patent No. 10,900,034 to be unpatentable as anticipated or obvious by the cited prior art.

Federal Circuit Appeal

• Appeal Filed (2023-07-25): Agilent Technologies appealed the PTAB's final written decisions to the U.S. Court of Appeals for the Federal Circuit (Case Nos. 23-2186 and 23-2187). Agilent challenged the PTAB's findings, particularly arguing that the "Pioneer Hi-Bred" prior art reference was not enabling.
• Federal Circuit Decision (2025-06-11): On June 11, 2025, the Federal Circuit issued a precedential decision affirming the PTAB's invalidation of Agilent's CRISPR patents. The court reinforced the distinction between the enablement requirements for challenged patents under 35 U.S.C. § 112 and for prior art under 35 U.S.C. § 102. It held that for prior art enablement under § 102, the reference "need not enable the [challenged] claim in its entirety, but instead the reference need only enable a single embodiment of the claim." The Federal Circuit found that the PTAB properly concluded that the Pioneer Hi-Bred reference was enabling and anticipated Agilent's patents, even in the absence of working examples, provided undue experimentation would not have been required.

U.S. Supreme Court Petition for Review

• Petition for Certiorari Filed (2025-11-14): Agilent Technologies petitioned the U.S. Supreme Court for a writ of certiorari, seeking review of the Federal Circuit's judgment (Case No. 25-570). The petition was docketed on November 13, 2025. Agilent's petition raised fundamental questions regarding the presumption of enablement for printed publications asserted as anticipatory prior art and whether "proof of efficacy" is required for such a reference to anticipate. It specifically challenged the Federal Circuit's holding in Rasmusson v. SmithKline Beecham Corp.
• Supreme Court Calls for Response (2025-12-23): The Supreme Court initially called for a response from Synthego, indicating that at least one Justice believed the questions warranted further consideration, though this does not guarantee certiorari would be granted.
• Petition Denied (2026-03-27): The U.S. Supreme Court denied Agilent's petition for a writ of certiorari following its conference on March 27, 2026.

Outcome

The Supreme Court's denial of certiorari finalized the invalidation of Agilent's U.S. Patent Nos. 10,337,001 and 10,900,034. This decision leaves the Federal Circuit's judgment intact, affirming the PTAB's finding that the patents were unpatentable due to anticipation or obviousness by prior art. The ruling has confirmed Synthego's freedom to operate concerning the modified guide RNA technology claimed in the invalidated patents.

Agilent Technologies is represented by the following counsel in its petition for a writ of certiorari before the U.S. Supreme Court:

• Denise Marie De Mory

  • Role: Counsel of Record
  • Firm: Bunsow De Mory LLP, Redwood City, CA
  • Experience Note: Specializes in patent litigation and has represented clients in the biotechnology and life sciences sectors, including in appeals to the Federal Circuit and petitions to the Supreme Court.

• Aaron R. Hand

  • Role: Counsel
  • Firm: Bunsow De Mory LLP, Redwood City, CA
  • Experience Note: Practices in patent litigation, particularly in technology and life sciences.

• Abigail Lubow

  • Role: Counsel
  • Firm: Bunsow De Mory LLP, Redwood City, CA
  • Experience Note: Involved in intellectual property litigation, including patent disputes.

• Kenneth Wang

  • Role: Counsel
  • Firm: Bunsow De Mory LLP, Redwood City, CA
  • Experience Note: Focuses on patent and other intellectual property matters.

• Mark A. Lemley

  • Role: Of Counsel (previously argued at the Federal Circuit)
  • Firm: Lex Lumina PLLC (Los Angeles, CA office listed for Federal Circuit filing)
  • Experience Note: A prominent Stanford Law professor and intellectual property scholar, he is a highly experienced appellate advocate in patent cases, having argued before the Federal Circuit in this case and in other significant patent disputes.

• Rebecca Emily Weires Setrakian

  • Role: Of Counsel (previously represented Agilent at the Federal Circuit)
  • Firm: Morrison & Foerster LLP, Los Angeles, CA
  • Experience Note: Specializes in intellectual property litigation, including patent appeals to the Federal Circuit.

The following counsel represents Synthego Corp. in Agilent Technologies v. Synthego Corp. before the U.S. Supreme Court (Case No. 25-570):

Edward R. Reines

• Role: Counsel of Record
• Firm: Jones Day, Palo Alto, CA office
• Relevant experience: Edward R. Reines is a well-known patent litigator, particularly active in biotechnology and pharmaceutical patent cases, with extensive experience at the Federal Circuit and Supreme Court. He represented Synthego during the Federal Circuit oral argument in the underlying case.

Daniel Paul Johnson

• Role: Counsel
• Firm: Jones Day, Pittsburgh, PA office
• Relevant experience: Daniel Paul Johnson is also listed as counsel for Synthego Corp. in the Supreme Court brief. His involvement suggests a focus on appellate patent litigation.

Synthego Corp.'s Chief Legal Officer is Stephanie Adamany, who serves as in-house counsel.