Parties: Cytiva Bioprocess R&D AB v. JSR Corp., et al.
Date of Decision: December 4, 2024
Judges: Prost, Taranto, and Hughes
Appeal of: Six IPR final written decisions
Background
- The patents cover chromatography matrices and processes for isolating biomolecules, particularly antibodies, via affinity chromatography.
- JSR filed six IPRs, alleging that various claims in the patents were unpatentable due to obviousness.
- The PTAB held most claims unpatentable but upheld four claims based on the lack of evidence of a reasonable expectation of success.
Court’s Decision
- Affirmed: The PTAB’s determination that 79 claims were unpatentable due to obviousness.
- Reversed: The PTAB’s finding that claims 4 and 17 of the ‘142 patent and claims 11 and 29 of the ‘007 patent were not unpatentable. The court concluded these claims were unpatentable due to inherent properties in the claimed features.
Cytiva Patents in Dispute
1. U.S. Patent No. 10,213,765 (‘765 Patent)
- Disputed Claims:
- Claims Held Unpatentable: 1–7, 10–20, 23–26
- Key Dependent Claim: Claim 4: “The chromatography matrix of claim 1, wherein the ligand is capable of binding to the Fab part of an antibody.”
2. U.S. Patent No. 10,343,142 (‘142 Patent)
- Disputed Claims:
- Claims Held Unpatentable: 1–3, 5–7, 10–16, 18–20, 23–30
- Claims Reversed as Not Unpatentable: Claim 4 and Claim 17
- Claim 4: “The process of claim 1, wherein the ligand binds to the Fab part of an antibody.”
- Claim 17: Similar binding process claim.
3. U.S. Patent No. 10,875,007 (‘007 Patent)
- Disputed Claims:
- Claims Held Unpatentable: 1–10, 12–14, 16–28, 30–32, 34–37
- Claims Reversed as Not Unpatentable: Claim 11 and Claim 29
- Claim 11: “The process of claim 1, wherein the ligand binds to the Fab part of an antibody.”
- Claim 29: Similar binding process claim.
Summary of Cited Prior Art
- Linhult (2004): Discussed improving ligand stability in alkaline conditions by modifying specific amino acid sequences in Protein A domains.
- Abrahmsén (1992): Proposed substituting glycine at position 29 with alanine to enhance protein stability, forming a basis for the disputed claims.
- Hober (2003): Provided further background on designing stable and effective ligands for affinity chromatography.
These references collectively supported the court’s conclusion that the modifications claimed by Cytiva were obvious extensions of prior art.
Analysis
- The court emphasized that the prior art explicitly taught the claimed modifications, negating the need for a lead-compound analysis. It found that the disputed claims involved inherent properties, such as the ligand’s binding ability to the Fab part of an antibody, which were found to be obvious based on prior knowledge. Cytiva’s argument of “unexpected results” was dismissed, as the results were found to be predictable from the known art.
Conclusion
This ruling reaffirms the importance of distinguishing between inherent properties and novel, patentable innovations.