The Practical Significance of the Decision in Mayo v Prometheus to Exclude Medical Correlations from Patent Protection

Principal investigator: Dr Kathy Liddell & Dr John Liddicoat, Faculty of Law

Funded by: CRUK Cambridge Centre Early Detection Programme

This project is an empirical study of the practical effect of the 2012 US Supreme Court decision Mayo Collaborative Services v Prometheus Laboratories on the translation of biomarkers for the early detection of cancer. Broadly speaking, the Supreme Court ruled that merely applying medical correlations using well-established techniques are unpatentable in the US.

The Court’s primary reason was that working out a patient’s medical condition based on a medical correlation was akin to patenting a law of nature and, therefore, not a patentable invention. The decision also introduced a significant divergence between US and European patent law. Commentators speculate that the decision has substantially reduced the degree to which the diagnostics industry can rely on patent protection in the US to recoup R&D costs; and that since the US is the most important market for the diagnostics industry, the decision is having a significant negative global effect on diagnostic innovation. Opposing these views, other commentators argue the decision benefits the patent system by weeding out overly broad patents. The project will investigate this conjecture and, thereby, provide much-needed evidence on the impact of the case in both the US and Europe.