Congress Urged to Remove Barriers to Medical Innovation
Washington, Monday, 16 June 2025.
Recent discussions emphasize the urgent need for legislative and judicial reform to reverse the decline in U.S. medical innovation, hindered by outdated patent laws and Senate inaction.
Call for Patent Law Reforms
The U.S. medical innovation landscape is experiencing significant barriers due to outdated patent laws, notably under 35 U.S.C. 101. This has led to a situation where medical diagnostics, following the Supreme Court’s Mayo decision in 2012, have been effectively excluded from patent eligibility. This legal interpretation has deterred investment in medical research and development, reducing innovations in diagnostics and medical devices [1].
Senate Inaction Impedes Progress
Despite recognized needs, Senate inaction remains a considerable challenge. A bill introduced by Senators Thom Tillis and Chris Coons aimed at reforming patent eligibility has lingered without action for over a decade. As a result, innovators face tremendous uncertainty regarding what can be patented, dampening the pace of medical research and slowing the flow of groundbreaking treatments into the market [1].
Impact of Supreme Court Decisions
The Supreme Court’s decision in Mayo and subsequent rulings by the Federal Circuit Court have created an environment where even revolutionary medical diagnostics find it difficult to secure patents. For instance, Sequenom, Inc.’s innovative prenatal test was deemed patent-ineligible, highlighting the need for reforms to encourage medical breakthroughs [1].
Innovation Hindered by Economic Factors
Beyond legal barriers, economic factors also impede medical innovation. Senator Durbin has critiqued attempts to reduce the NIH budget, arguing that diminishing financial support for publicly funded medical research is detrimental. Without robust backing, both public and private sectors find it challenging to maintain their roles as leaders in medical research [1].