Cytiva BioProcess R&D AB v. JSR Corp
Authored by: Jeremy J. Gustrowsky
In a significant decision for biotechnology patents, the Federal Circuit recently addressed the concept of inherency in obviousness determinations in Cytiva BioProcess R&D AB v. JSR Corp. The dispute centered on patents covering chromatography matrices—tools used to separate antibodies in bioprocessing—specifically those involving a mutation (G29A) in Domain C of Protein A, a protein commonly used in these matrices. The patents at issue were U.S. Patent Nos. 10,213,765, 10,343,142, and 10,875,007.
The court found that the prior art already expressly suggested making the G29A mutation in any of the five domains of Protein A, including Domain C. Because of this, the Federal Circuit held that there was no need for a formal “lead compound” analysis, which is usually required to determine if a new chemical compound is obvious. Instead, since the prior art pointed directly to the claimed modification, the claimed invention was deemed obvious.
A key issue in the case was whether certain dependent claims—those that specified the chromatography matrix’s ability to bind to the “Fab part of an antibody”—were patentable. The court ruled that this Fab-binding property was an inherent characteristic of the obvious matrix composition. Therefore, no separate showing was needed to prove a “reasonable expectation of success” for this property. In other words, if a property naturally results from an obvious invention, simply reciting that property in a patent claim does not make the claim non-obvious.
Ultimately, the Federal Circuit affirmed the Patent Trial and Appeal Board’s decision that most of the challenged claims were unpatentable as obvious, and reversed the Board’s decision on a few claims, finding them unpatentable as well. This decision reinforces that patent applicants cannot rely on inherent properties of obvious inventions to secure new patent rights, especially when those properties are already a natural result of what is taught in the prior art.