The Federal Circuit Court of Appeals issued a nonprecedential decision January 23 in *Guardant Health, Inc. v. University of Washington*, addressing a patent dispute between the biotechnology company and the academic institution over patent validity standards.
The case, numbered 2024-1129, originated from an inter partes review proceeding before the Patent Trial and Appeal Board (IPR2022-00817). Guardant Health appealed the Board's final written decision that held claims 1-30 of the University of Washington's U.S. Patent No. 10,760,127 not unpatentable under 35 U.S.C. § 103, the federal statute governing obviousness determinations.
The patent at the center of the dispute appears to involve biotechnology methods, specifically relating to amplification and sequencing techniques. While the full scope of the patent claims was not detailed in the available portions of the decision, the technology likely relates to genetic analysis or diagnostic procedures, areas where both parties have significant interests.
Guardant Health, represented by a team from Orrick, Herrington & Sutcliffe LLP and Wilson, Sonsini, Goodrich & Rosati, PC, challenged the Patent Trial and Appeal Board's decision on multiple grounds. The company argued that the Board erred by requiring both a motivation to combine prior art references and a reasonable expectation of success when the elements of amplification followed by sequencing were disclosed together in a single embodiment within a single reference.
This argument goes to the heart of obviousness analysis under patent law. When determining whether a patent claim is obvious, courts and the Patent Trial and Appeal Board must consider whether a person of ordinary skill in the relevant field would be motivated to combine teachings from prior art references and would have a reasonable expectation that such combination would be successful.
Guardant's position was that when elements are already disclosed together in a single reference, additional requirements for motivation to combine and expectation of success should not apply. This represents a more permissive approach to obviousness challenges that could make it easier to invalidate patents based on prior art.
The University of Washington, defended by attorneys from Sterne Kessler Goldstein & Fox PLLC, successfully argued before the Patent Trial and Appeal Board that the challenged patent claims were not obvious. The university's position was that even when elements appear together in prior art, additional analysis of motivation and reasonable expectation of success remains necessary.
In addition to the legal standard challenge, Guardant argued that substantial evidence did not support the Board's findings regarding the lack of motivation to combine prior art or reasonable expectation of success. This evidentiary challenge suggests that Guardant believed the technical record supported a finding of obviousness even under the Board's applied legal standards.
The three-judge Federal Circuit panel consisted of Chief Judge Kimberly Moore and Circuit Judges Jimmy Hughes and Kara Stoll, with Judge Stoll writing the opinion. The Federal Circuit has exclusive jurisdiction over patent appeals and frequently addresses questions of patent validity and the standards for obviousness determinations.
The decision was marked as nonprecedential, meaning it cannot be cited as binding authority in future cases. However, nonprecedential decisions still provide insight into how courts apply patent law principles to specific factual situations and can influence future litigation strategies.
The case highlights ongoing tensions in patent law regarding the appropriate standards for obviousness analysis. Biotechnology companies like Guardant Health often seek to challenge patents that may block their research and development activities or commercial products. Universities and research institutions, meanwhile, rely on patent protection to commercialize their research discoveries and fund further innovation.
Guardant Health is a prominent player in the liquid biopsy and cancer screening market, developing blood tests that can detect circulating tumor DNA. The University of Washington is a major research institution with significant biotechnology research programs. Patent disputes between commercial entities and academic institutions have become increasingly common as universities seek to monetize their research discoveries.
The timing of the decision, coming in early 2026, reflects the typical timeline for Federal Circuit appeals, which often take 12-18 months from filing to decision. The case began with the inter partes review filing in 2022, proceeded through Patent Trial and Appeal Board proceedings, and concluded with this Federal Circuit decision.
For the biotechnology industry, the decision reinforces the importance of careful prior art analysis and the challenges of invalidating patents through obviousness arguments. Companies seeking to challenge competitor or institutional patents must meet rigorous standards for demonstrating that claimed inventions would have been obvious to skilled practitioners.
The University of Washington's success in defending its patent rights demonstrates the value of robust patent prosecution and the strategic importance of building comprehensive technical records during patent examination and post-grant proceedings.