Bayer v. Mylan (Fed. Cir., September 23, 2025) 2023-2434

This opinion from the United States Court of Appeals for the Federal Circuit concerns a patent infringement appeal case, Bayer Pharma Aktiengesellschaft v. Mylan Pharmaceuticals Inc. The appeal concerns the Patent Trial and Appeal Board's (PTAB) final written decision holding claims of Bayer's U.S. Patent No. 10,828,310, which describes methods using rivaroxaban and aspirin to reduce cardiovascular risk, unpatentable. The Court affirms-in-part and vacates-in-part the PTAB's decision, specifically upholding the unpatentability of claims 1–4, but vacating the judgment for claims 5–8 due to an incorrect claim construction of the term "first product." The Court also determined that the phrase "clinically proven effective" did not make the claims patentable because it lacked a necessary "functional relationship" with the claimed method. Furthermore, the Court found the PTAB provided sufficient rationale for combining prior art references, Foley and Plosker, and dismissed Bayer's argument about unexpected results because the evidence lacked the required nexus to the claimed invention's merits.

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