Bayer Pharma Aktiengesellschaft v. Mylan Pharmaceuticals Inc., et al., No. 2023-2434 (Fed. Cir. (PTAB) Sept. 23, 2025). Opinion by Moore, joined by Cunningham and Scarsi (sitting by designation).
Bayer owns a patent directed to methods for reducing the risk of cardiovascular events in patients with coronary artery disease or peripheral artery disease by administering specific doses of rivaroxaban and aspirin “in amounts that are clinically proven effective.” Mylan, Teva, and Invagen filed substantively identical IPR petitions challenging the claims. The Patent Trial and Appeal Board joined the proceedings and issued a final written decision finding claims 1–2 unpatentable as anticipated and claims 1–8 unpatentable as obvious. Bayer appealed.
The Federal Circuit addressed four issues: (1) whether, as the Board determined, the claim phrase “clinically proven effective” is non-limiting; (2) the construction of the claim phrase “first product comprising rivaroxaban and aspirin”; (3) whether the Board sufficiently articulated a motivation to combine the prior art references with a reasonable expectation of success; and (4) whether the Board erred in analyzing evidence of unexpected results. The Federal Circuit affirmed-in-part, vacated-in-part, and remanded.
First, the Federal Circuit ruled that it need not decide whether “clinically proven effective” is limiting because, even if limiting, the phrase “would still be a functionally unrelated limitation that fails to make the challenged claims patentable.” The court explained: “Even if the term required clinical proof of efficacy, such proof in no way transforms the process of taking the drugs at the amounts and frequencies expressly recited in the claims.” In other words, the actual method is the same “irrespective of whether the anticipated treatment regime is proven to be clinically effective.”
Second, the Federal Circuit disagreed with the Board’s construction of “first product comprising rivaroxaban and aspirin” as encompassing both single and multiple dosage forms. The court instead agreed with Bayer that the “first product” must be “a single dosage form” that includes or contains both rivaroxaban and aspirin. The Federal Circuit explained that the plain language of the claims and the remainder of the specification support that construction. The Federal Circuit thus remanded for further consideration of the parties’ obviousness arguments under the correct construction.
Third, the Federal Circuit affirmed the Board’s finding of a motivation to combine the references with a reasonable expectation of success. Contrary to Bayer’s arguments, the Federal Circuit saw “no failure by the Board to articulate an adequately supported rationale for why a skilled artisan would have combined [the two prior art references] with a reasonable expectation of success,” particularly where “the record indicates that both references taught a dosage regimen for ‘reducing the risk of myocardial infarction, stroke, or cardiovascular death.’”
Finally, the Federal Circuit affirmed the Board’s handling of Bayer’s secondary evidence of unexpected results. Bayer argued that the clinical trial described in the patent “provided clinical proof of efficacy” and “was itself an unexpected property.” The court disagreed because Bayer’s arguments and evidence of unexpected results “rely solely on the term ‘clinically proven effective,’” which the court already concluded failed to “breathe patentability” into the claims. Thus, the court ruled that Bayer’s evidence “has no connection to the merits of the claimed invention,” and “absent such nexus,” the evidence did not compel a holding of nonobviousness.
Finesse Wireless LLC v. AT&T Mobility LLC, et al., No. 2024-1039 (Fed. Cir. (E.D. Tex.) Sept. 24, 2025). Opinion by Moore, joined by Linn and Cunningham.
Finesse sued AT&T for infringement of two patents that generally relate to methods for mitigating intermodulation product (IMP) interference in radios. Finesse directed its infringement allegations to AT&T’s use of a passive intermodulation product cancellation feature in Nokia radios. Nokia intervened.
A jury found all asserted claims valid and infringed, and awarded Finesse over $166 million in lump-sum damages. The district court then entered judgment for Finesse and denied AT&T and Nokia’s motions for judgment as a matter of law (JMOL) of noninfringement, JMOL on damages, and a new trial. AT&T and Nokia appealed.
The Federal Circuit reversed the denial of JMOL of noninfringement. As to the first patent, the asserted claims require sampling both “signals of interest” and “interference generating signals.” At trial, Finesse’s expert testified that the radio frequency analog-to-digital converter (RF ADC) in the accused radios performs the claimed sampling. The expert mapped the claimed sampled signals to signals generated downstream of the RF ADC based on his understanding of a technical document, but cross-examination revealed that the RF ADC cannot sample downstream signals because the signals had not yet been generated. In response, the expert “pivoted” his analysis but continued to refer to the mapped downstream signals as the claimed sampled signals.
The Federal Circuit ruled that “this sort of confusing change of course is not sufficient to support the jury verdict.” “When the party with the burden of proof, such as Finesse, rests its case on an expert’s self-contradictory testimony, we may conclude the evidence is insufficient to satisfy that standard.” The Federal Circuit thus reversed the denial of JMOL of noninfringement.
As to the second patent, the asserted claims require digitally multiplying three signals in seven multiplications to generate IMP cancellation signals. The Federal Circuit noted that “the key claim limitation at issue on appeal is that seven third order multiplications of the three signals must take place to meet the claim limitation.”
In the appeal, AT&T and Nokia argued that no reasonable jury could have found that the accused radios generate cancellation signals by multiplying three signals because the accused radios use only two signals plus a copy of one of those same signals. They argued that Finesse surrendered claim scope over two signals when it amended the claims during prosecution to recite “three signals,” instead of “two or three signals.”
The Federal Circuit “d[id] not agree that Finesse surrendered claim scope over two signals.” The court explained that Finesse’s claim amendment “does not rise to the level of ‘clear and unambiguous’ disavowal of claim scope over products, like the accused radios, with two unique input signals.” “At most, Finesse’s amendment requires three separately identifiable signals and does not require any specific number of unique input signals.”
Even so, the Federal Circuit ruled that “no reasonable jury could have found the accused radios perform the seven claimed multiplications.” The document relied on by Finesse’s expert “only lists three distinct multiplications” and “does not show the accused radios perform the seven claimed multiplications.” Also, the expert “did not testify how those three distinct multiplications map onto the seven claimed multiplications.” The Federal Circuit thus reversed the district court’s denial of JMOL of noninfringement because, “under these circumstances, no reasonable jury could have found that the accused radios perform the seven claimed multiplications.”
Because the Federal Circuit reversed the denial of JMOL of noninfringement for all asserted claims of both patents, the court also vacated the damages award.