Agilent Techs., Inc. v. Synthego Corp.

Authored by: Jeremy J. Gustrowsky

In a recent decision, the U.S. Court of Appeals for the Federal Circuit upheld a ruling that all claims in two patents owned by Agilent Technologies are unpatentable, dealing a blow to efforts to protect innovations in CRISPR-Cas gene editing technology. The patents, numbered 10,337,001 and 10,900,034, focus on chemically modified guide RNAs (gRNAs)—key components that help the CRISPR system target and edit specific DNA sequences. Synthego Corp. challenged the patents through inter partes review proceedings at the Patent Trial and Appeal Board (PTAB), arguing they were invalid based on earlier inventions. The Federal Circuit agreed, finding the claims anticipated by a prior publication from Pioneer Hi-Bred and obvious in light of additional research.

At the heart of the case was whether Pioneer Hi-Bred, a 2014 publication, fully disclosed the modified gRNAs’ ability to pair with Cas proteins and direct them to target DNA without needing excessive trial and error to replicate. Agilent argued the reference only outlined a research plan without proving functionality, but the court found substantial evidence that it explicitly described these features, including examples of modifications to boost stability and reduce degradation. The judges also confirmed the reference was “enabling,” meaning a skilled researcher could recreate the inventions using known techniques from the time, like click chemistry for synthesizing long RNA strands. This rejected Agilent’s claims that the field was too unpredictable in 2014 for such modifications to work reliably.

For certain narrower claims involving specific chemical tweaks like PACE and thioPACE modifications, the court turned to obviousness. Combining Pioneer Hi-Bred with studies from Threlfall and Deleavey, the PTAB had determined a researcher would have a reasonable expectation of success in applying these stability-enhancing changes to gRNAs in CRISPR systems. The Federal Circuit saw no error here, noting the prior art’s motivations—such as improving resistance to breakdown in cells—and the lack of evidence suggesting these combos wouldn’t work. Agilent’s appeals on notice issues and overly broad interpretations were dismissed as unfounded.

This ruling underscores the high bar for patenting in fast-evolving biotech fields like gene editing, where prior publications can quickly render new claims invalid if they overlap closely. It may encourage more challenges to CRISPR-related patents, emphasizing the need for inventors to show clear novelty beyond what’s already in the public domain.