With the Supreme Court sidestepping Audio Evolution Diagnostics, stakeholders should prepare for litigation risk and engage on PERA reform efforts.
On July 14, 2025, the Supreme Court once again declined to clarify the scope of patentable subject matter under 35 U.S.C. § 101, denying certiorari in Audio Evolution Diagnostics v. United States, a case challenging the application of its Alice/Mayo abstract-idea framework to telemedicine diagnostics. This latest refusal continues a years-long pattern of inaction and leaves the fractured landscape of patent eligibility intact.
For industries such as biotechnology, diagnostics and software, the absence of further guidance leaves contradictory federal circuit decisions undisturbed. Outcomes often hinge on narrow factual distinctions—and sometimes simply on the composition of an appellate panel—making results difficult to predict. The current climate complicates R&D investment strategies, heightens litigation risk, and can hinder securing effective protection for innovative technologies.
On the legislative front, the Patent Eligibility Restoration Act (PERA) remains under discussion in Congress. If enacted, PERA would codify a more expansive interpretation of patent eligibility, expressly abrogating parts of Alice and Mayo and offering a more explicit statutory baseline. The legislation also explicitly excludes from patent eligibility any invention that is: (1) a mathematical formula that is not part of a claimed invention; (2) a process that is substantially economic, financial, business, social, cultural , or artistic, even if one step in the process refers to a machine or manufacture; (3) a process that is mental and performed solely in the human mind or occur in nature wholly independent of, and prior to, any human activity; (4) an unmodified gene as it exists in the human body; and (5) an unmodified natural material as it exists in nature. Although the legislation was reintroduced in the House and Senate this past spring, the bill’s fate remains uncertain. A previous version of the legislation failed to make it through either house of Congress last year after facing bipartisan opposition.
Key implications for stakeholders:
- Innovators and R&D-driven companies should anticipate heightened scrutiny of patent claims in advanced technology fields and structure filings to withstand challenging eligibility analyses.
- Defendants in infringement cases will continue to find Section 101 motions a compelling early-stage strategy.
- Patent counsel must prioritize layered claim designs, technical specificity and robust enablement to improve defensive positions.
Given the potential impact of PERA, clients are urged to stay actively engaged with policymakers and collaborate closely with policy-focused legal counsel. Participation in comment forums, industry coalitions and legislative outreach can influence the shape of reform and help ensure that innovation priorities are duly represented.
