Opinions — Thursday, February 19, 2026

The Federal Circuit affirmed the District of New Jersey's finding of no infringement by Teva Pharmaceuticals of Corcept Therapeutics' patents covering methods of co-administering mifepristone with strong CYP3A inhibitors to treat Cushing's syndrome. Although Teva's proposed ANDA label was materially identical to Corcept's 2019 label and included instructions for the patented dosing regimen, the district court found Corcept failed to prove that direct infringement would actually occur if Teva's generic product reached the market. The court relied on physician testimony and other evidence showing that doctors avoid the claimed methods due to safety concerns, prefer a noninfringing alternative drug (osilodrostat), and had never practiced the patented methods in the past.

The panel applied Genentech, Inc. v. Sandoz Inc. to hold that district courts may consider outside-the-label evidence of actual physician practice even where a proposed label expressly recommends an infringing use. Reviewing the district court's factual findings for clear error, the court found no error in weighing physician testimony about clinical risk-benefit judgments, medical literature showing experts do not recommend co-administration, and the availability of noninfringing alternatives against the label's instructions. The decision reaffirms that in an ANDA-based induced infringement case, a patent owner must prove by a preponderance that direct infringement will in fact occur, not merely that the label makes infringement possible.

The Federal Circuit affirmed the District of Delaware's grant of summary judgment of noninfringement in favor of Sony Group Corporation and Sony Interactive Entertainment LLC in Genuine Enabling Technology LLC's suit alleging that PlayStation 3 and 4 controllers and consoles infringed claims 10, 14, 16–18, and 21–23 of U.S. Patent No. 6,219,730. The central issue concerned a means-plus-function limitation—"encoding means for synchronizing" two input data streams—for which the district court had construed the corresponding structure as "the logic design at block 34 in Figure 4A and equivalents thereof." The court held that GET failed to establish a genuine issue of material fact on literal infringement because its expert, Dr. Fernald, failed to account for substantial elements of logic block 34 when conducting the function-way-result test for structural equivalence under 35 U.S.C. § 112(f). Dr. Fernald's analysis focused exclusively on the bit-rate clock signal, ignoring other elements such as the data selector and codec depicted in the specification's detailed circuit diagram, without explaining why those components could be disregarded as insubstantial to the synchronization function.

The decision reinforces that a patentee asserting infringement of a means-plus-function limitation cannot prevail by selectively analyzing only portions of the corresponding structure disclosed in the specification. Following Traxcell Technologies, LLC v. Sprint Communications Co., 15 F.4th 1121 (Fed. Cir. 2021), the court emphasized that when a specification discloses a detailed structure—whether an algorithm or a multi-element circuit—an expert cannot simply focus on functional results while ignoring the "way" those results are achieved through the disclosed structural components. The holding has particular significance for cases where patent owners lack direct discovery of accused products' internal schematics: GET never obtained a schematic of Sony's Bluetooth module after serving late-stage subpoenas on manufacturing partners, yet the court held that this evidentiary gap did not excuse Dr. Fernald's failure to analyze the full scope of block 34 as construed. The decision signals that evolving or inconsistent expert positions on what structural elements matter to equivalence analysis—here, Dr. Fernald's shifting from a multi-element description in his report to a single-element focus at the Daubert hearing—will not satisfy the patentee's burden at summary judgment.