No. 25A233

Agilent Technologies, Inc. v. Synthego Corp.

Lower Court: Federal Circuit
Docketed: 2025-08-28
Status: Presumed Complete
Type: A
Tags: biotechnology crispr federal-circuit patent-enablement prior-art research-and-development
Key Terms:
Patent
Latest Conference: N/A
Question Presented (AI Summary)

Whether the Federal Circuit's presumption of enablement for prior art publications in unpredictable technological fields improperly undermines patent protection for innovative research and development

Question Presented (OCR Extract)

No question identified. : judgment plus any extension granted by the Circuit Justice, and invoke the jurisdiction of this Court under 28 U.S.C. § 1254. EXTENSION REQUEST To the Honorable John G. Roberts, Jr., Chief Justice of the United States and Circuit Justice for the United States Court of Appeals for the Federal Circuit: Pursuant to Supreme Court Rules 13.5, Applicant Agilent Technologies, Inc. (“Agilent”) respectfully requests an extension of sixty (60) days to file a petition for a writ of certiorari in this Court to and including Monday, November 8, 2025. The Federal Circuit issued its opinion on June 11, 2025. Without an extension, the original 90 day deadline to file a petition is September 9, 2025. With an additional 60 days, the deadline extends to November 8, 2025. That date being a Saturday, the effective deadline would roll over to Monday, November 10, 2025. This application is filed more than 10 days prior to the original deadline. Respondent does not oppose Petitioner’s requested extension. CASE BACKGROUND 1. Each of these cases presents important issues regarding how the Federal Circuit has interpreted and failed to consistently apply the enablement requirement of the Patent Act when considering whether the claims of an issued patent are enabled, and when considering enablement of prior art that is alleged to invalidate duly issued patent claims. 2. In the underlying Inter Partes Review proceedings, a panel of administrative law judges invalidated the claims of two related Agilent patents directed to modified guide RNA for use in the CRISPR system. More particularly, Agilent’s patents claimed certain chemical modifications that, when applied to CRISPR guide RNA, did not disrupt the guides’ functionality within the CRISPR system. Given the unpredictability of the art and limitless potential modifications, Agilent’s inventors undertook systematic and painstaking synthesis and laboratory testing of hundreds of guide RNA modifications—both of the types and locations thereof—to ascertain what worked, and what did not. The results of those efforts were claimed in the issued patents, which described the inventors’ methodology, testing, and results, enabling skilled artisans to make and use their claimed inventions—and to further build on Agilent’s contributions. This groundbreaking work was also the subject of a June 2015 collaborative research paper published in Nature Biotechnology: 6 publications citing the paper called the work “pioneering,” “seminal,” and “a major contribution.” Synthego itself called it “landmark” work that “set the bar ... as the method of choice for CRISPR-Cas9 in primary human immune cells.” All of this was necessary because, as was understood in the art, it was impossible to predict which modifications to guide RNA would be beneficial, or which would render them nonfunctional. 3. Notwithstanding the unpredictability of the art and the need for a skilled artisan to actually make and test whether a chemically modified guide would actually work in the CRISPR system, the Federal Circuit held that a prior art publication is presumed to be enabling. On that basis, Agilent’s issued claims, which were enabled only because they were synthesized and tested, were invalidated based on an abandoned patent publication that simply listed a litany of possible modifications, while suggesting that someone else would need to manufacture and test whether they actually worked. This dichotomy, created and applied by the Federal Circuit, effectively allows anyone to create invalidating prior art simply by offering untested and unverified pronouncements, thus dedicating subject matter to the public since they are simply presumed enabling. This outcome creates perverse disincentives to undertake expensive and time consuming research in the unpredictable arts— including the research and development of life-saving therapeutics. REASONS FOR REQUESTING AN EXTENSION 1. Good cause exists for an extension of time to fi

Docket Entries

2025-09-02
Application (25A233) granted by The Chief Justice extending the time to file until November 8, 2025.
2025-08-25
Application (25A233) to extend the time to file a petition for a writ of certiorari from September 9, 2025 to November 8, 2025, submitted to The Chief Justice.

Attorneys

Agilent Technologies, Inc.
Denise Marie De MoryBunsow De Mory LLP, Petitioner
Denise Marie De MoryBunsow De Mory LLP, Petitioner