Federal Circuit IP
Cytiva Bioprocess R&D AB v. JSR Corp.
Federal Circuit 2023-2074, etc.
December 4, 2024
(Prost, Taranto, Hughes)
Summary: First, the Federal Circuit upheld the PTAB’s decision that 79 claims are unpatentable as obvious, determining that a lead compound analysis was not required where the claimed compounds were explicitly suggested. Second, the Federal Circuit reversed the PTAB’s determination that 4 process claims were not unpatentable, finding that process claims to an inherent feature are unpatentable as inherent where the feature is actually inherent.
Background:
- JSR Corp filed six IPR petitions on three patents (U.S. Patent Nos. 10,213,765; 10,343,142 & 10,875,007) related to a ligand for use in affinity chromatography.
- The PTAB found 79 claims of the three patents unpatentable without performing a lead compound analysis.
- The PTAB found 4 process claims to an inherent function of antibody-ligand binding not unpatentable because the petitions did not show a reasonable expectation of success.
Key Issue:
- Whether lead compound analysis is required to show that a claimed modification is obvious, or such a modification may be obvious-to-try when expressly suggested by prior art.
- Whether a reasonable expectation of success is necessary to show that a process would perform an inherent function.
Applicable Rule/Statute:
- Ordinarily, whether a new chemical compound would have been prima facie obvious over particular prior art compounds follows a lead compound analysis. Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1291 (Fed. Cir. 2012).
- When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp. . . . In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
- A lead-compound analysis is not required where the prior-art references expressly suggest the proposed modification. SIBIA Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d 1349, 1359 (Fed. Cir. 2000).
- If a property of a composition is in fact inherent, there is no question of a reasonable expectation of success in achieving it.” Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1332 (Fed. Cir. 2020).
Holding:
- Genetically modifying a highly homogeneous domain (domain-C) of Staphylococcus aureus with the same G29 modification as prior art domain-B was unpatentable where prior art expressly suggested that the G29 modification could be made to any domain (A-E).
- If a claim limitation is inherent, there is no question of a reasonable expectation of success in achieving it. Hospira, v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1332 (Fed. Cir. 2020).
Takeaways:
- If a prior art reference expressly suggests a claim invention, consider relying on the suggestion and including an obvious-to-try analysis if appropriate.
- Argue inherency in the alternative.
- Consider whether reasonable expectation of success (and/or motivation) applies to show that functional aspects of a claimed invention would have been obvious. Here, a reasonable expectation of success in preforming a process where the ligand bonded to the Fab part of an antibody. (See also e.g., Motivation to modify – a la Honeywell Mexichem Amanco, 865 F.3d 1348 (Fed. Cir.2017).