<em>Agilent Techs., Inc. v. Synthego Corp. </em>
The Court of Appeals for the Federal Circuit affirmed the Patent Trial and Appeal Board’s decision that all claims of the ’001 and the ’034 patents were unpatentable.
Agilent Technologies, Inc. v. Synthego Corp., 139 F.4th 1319 (Fed. Cir. 2025).
CRISPR-Cas is a revolutionary gene editing system used by scientists around the world. Agilent Techs., Inc. v. Synthego Corp., 139 F.4th 1319, 1321 (Fed. Cir. 2025). In particular, the system employs two major components: guide RNA (gRNA), which is composed of CRISPR RNA (crRNA) and trans-acting RNA (tracrRNA), and the associated Cas protein.1 The efficacy of the CRISPR-Cas system hinges on the ability of the gRNA to bind to the proper polynucleotide site, resist degradation, and maintain functionality. Id. at 1322.
Agilent Technologies (“Agilent”) and Synthego Corporation (“Synthego”) are both biotechnology corporations that provide resources and services to scientists, laboratories, and companies both nationally and internationally. Agilent focuses primarily on the general life sciences and chemical markets, while Synthego offers products almost exclusively related to CRISPR systems. Agilent, Who We Are, https://www.agilent.com/about/companyinfo/index.html (last visited Oct. 16, 2025); Synthego, About Us, https://www.synthego.com/company (last visited Oct. 16, 2025).
Agilent received two patents directed at the chemical modification of gRNAs within the CRISPR-Cas system; U.S. Patent No. 10,337,001 (“the ’001 patent”) was issued in July of 2019, and U.S. Patent No. 10,900,034 (“the ’034 patent”) was issued in January of 2021. 139 F.4th at 1321. Both patents claim priority to a provisional application filed in December 2014. Id. at 1322. Synthego filed a petition for inter partes review of both the ’001 and the ’034 patents on the grounds of anticipation and obviousness. Id. at 1324. Inter partes review is a type of proceeding conducted before the Patent Trial and Appeal Board (“Board”) aimed at reviewing the patentability of the claims of an existing patent under 35 U.S.C. §§ 102 (novelty) or 103 (non-obviousness), specifically with relation to prior art within separate patents or printed publications. U.S. Patent & Trademark Office, Inter Partes Review, https://www.uspto.gov/patents/ptab/trials/inter-partes-review (last updated Oct. 10, 2022; last visited Oct. 16, 2025). In its petitions, Synthego cited “Pioneer Hi-Bred”, a patent application that was filed in August of 2014. 139 F.4th at 1323. The Board found that, in light of Pioneer Hi-Bred and two scientific articles published before December 2014, all of Agilent’s disputed patent claims were either anticipated or obvious. Id. at 1324. Agilent appealed the decision. Id.
The Court of Appeals for the Federal Circuit found that the Board did not err in its analysis or decision that all claims of the ’001 and ’034 patents were unpatentable. Id. Agilent made three main arguments on appeal, none of which persuaded the Federal Circuit. Id. at 1325. First, it argued that the Board’s finding that Pioneer Hi-Bred expressly disclosed the functionality of gRNA, a major component of its claims, was not supported by substantial evidence. Id. Second, it argued that, even if there was express disclosure, Pioneer Hi-Bred was not enabling. Id. Finally, it argued that there was no substantial evidence to support the Board’s finding that a skilled artisan could reasonably expect to successfully modify the gRNA in a way that would reduce degradation. Id.
In evaluating the Board’s decision regarding substantial evidence of express disclosure of gRNA functionality, the Federal Circuit provided some clarity on the matter. Id. Agilent argued that since some of the data in Pioneer Hi-Bred did not show cleavage activity, it did not properly disclose gRNA functionality. Id. at 1326. Both the Board and the Federal Circuit disagreed, stating that while functional gRNA could exhibit cleavage activity, its presence was not necessary for functionality. Id. Agilent’s own expert’s testimony also supported this assertion. Id. The Federal Circuit highlighted that the inclusion of non-working examples in a patent does not necessarily undermine any of the working examples. Id. Since Pioneer Hi-Bred also included functional examples, the Federal Circuit held that the Board’s finding that the patent effectively disclosed gRNA functionality did not lack substantial evidence. Id.
The Federal Circuit also sided with the Board on the anticipation and enablement issues, holding that anticipation requires an enabling disclosure and does not necessarily require reduction to practice. Id. at 1327. Furthermore, it held that enablement requires that the reference teach a skilled artisan how to create the claimed invention without the need for undue experimentation. Id. If any parts of the disputed claims are enabled by the prior art, they are unpatentable. Id. The Board used the Wands factors to counter Agilent’s argument that it would be extremely challenging for one having ordinary skill in the art to perform the disclosures without undue experimentation. Id. In supporting its holding, the Board noted that by December 2014, the mechanisms described were well-researched within the scientific community. Id. The Federal Circuit agreed. Id. at 1328.
On appeal, Agilent brought up two cases that seemed to provide some defense. Id. The first was Impax, in which the Federal Circuit held that a certain prior art disclosure was not enabling of a later claim. Impax Labs., Inc. v. Aventis Pharms., Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008). The Federal Circuit distinguished Impax by noting that it had disclosed a vast number of compounds as well as broad and general dosage guidelines, information that would be insufficient for one having ordinary skill in the art to craft a narrow treatment plan. 139 F.4th at 1328. In this case, however, the prior art provided instructions that were mostly related to the disputed claims regarding crRNAs and gRNAs. Id. Additionally, the scope of the components in Pioneer Hi-Bred was comparatively narrower. Id.
The second case Agilent referenced was Amgen, in which a patent application had attempted to claim an entire class of antibodies based on their respective functions. 598 U.S. 594, 614 (2023). Here, the Supreme Court ruled that a person having regular skill in the art would need to subject themselves to painstaking experimentation due to the antibody’s broad categorization to see what worked. Id. Though Agilent had hoped this case would show that Pioneer Hi-Bred was too broad to be enabling, the Federal Circuit dismissed its argument for multiple reasons. 139 F.4th at 1328. First, it noted that Amgen required sufficient enablement for the patent to be valid, while the present case only required enablement of prior art to support anticipation. Id. In fact, the two cases discuss different sections of Title 35 of the US Code; Amgen is a § 112 dispute, while the current case is a § 102 dispute. Id. Finally, the Federal Circuit found that since no painstaking experimentation was warranted by the Pioneer Hi-Bred patent, the disclosure was enabling. Id. at 1329.
Agilent’s final argument on appeal stated that it would not be obvious for one skilled in the art to innovate with PACE or thioPACE modifications based on just the information contained in Pioneer Hi-Bred, since the patent made no mention of such modifications. Id. at 1330. PACE modifications add an extra layer of screening to the CRISPR-Cas system. Id. The Federal Circuit used information from Pioneer Hi-Bred, combined with two previously written scientific articles, to determine whether the PACE modifications set forth by Agilent were obvious. Id. KSR states that courts may take into account the creative steps and inferences a person having ordinary skill in the art would employ to bridge the gap between prior art and a future claim. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The Board gave a detailed explanation, using each of the sources, as to why one would be motivated to experiment with Agilent’s particular claimed modification. 139 F.4th at 1331. The Federal Circuit agreed with the Board that the disputed claims were obvious in light of the prior art. Id.
The distinction the Federal Circuit draws between the enablement requirement for patentability under § 112 and the requirement for anticipation under § 102 is demonstrative of a larger underlying issue in the patent world. Id. at 1329. § 112 has a higher bar in that a patent’s specification must enable a skilled artisan to use the invention set forth by the claims. Id. This restriction does not exist in § 102. Id. Instead, in a § 102 argument, the petitioner only has the burden of showing that the prior art would enable a skilled artisan to perform one embodiment of one of the claims set forth by the patent owner. Id. The higher bar for enablement in § 112 ensures that patenting parties do not overreach in their claims, thereby growing their monopoly over the subject matter without the proper research to support it. 598 U.S. at 614. Similarly, the broader terminology in § 102 prevents the patentability of claims that are anticipated by prior art and not novel, allowing a patent to be evaluated on a claim-by-claim basis in relation to a piece of prior art during inter partes review. 139 F.4th at 1329. Overall, this distinction is crucial to protecting the public’s interest in innovation and preventing individuals from patenting what is already in the public domain.