New and developing efforts by Congress may change the way patent subject matter eligibility is determined for years to come, changing the landscape for medical diagnostic methods. This congressional action comes following intense pleas from some judges of the US Court of Appeals for the Federal Circuit and has the potential to unravel decades of US Supreme Court precedent relating to the current patent eligibility test.
In recent years, US courts have increasingly scrutinized the eligibility of patents covering methods of diagnosing medical conditions. New diagnostic methods require intense and costly research to develop and are vital to the medical industry. Some have argued that they are among the most meritorious candidates for patent protection. But diagnostic methods often rely on scientific concepts that are ineligible for patenting, such as naturally occurring phenomena in the human body.
The eligibility of diagnostic methods for patent protection is governed by 35 U.S.C. § 101,[1] under a two-part test set forth in the Supreme Court’s 2014 decision in Alice v. CLS Bank, and credited to the Court’s 2012 decision in Mayo Collaborative v. Prometheus Laboratories.[2] The Court set forth a two-part framework for assessing patent eligibility. First, a court must determine whether a claim is directed to unpatentable subject matter: laws of nature, natural phenomena, and abstract ideas. If so, the claim is eligible for patent protection only if it contains an inventive concept that transforms the unpatentable natural law into a patent-eligible invention.
Naturally, the Court’s analysis implicates diagnostic method patents because laws of nature and natural phenomena are used in the medical field. Indeed, in Mayo itself, the Court invalidated the diagnostic method patent at issue, which claimed a method of evaluating medication dosage levels. In applying the two-part framework, the Court reasoned that the patent concerned the naturally occurring relationships between metabolites in the blood and that the “the steps add nothing of significance to the natural laws themselves.”
The Mayo decision has restricted patentability of diagnostic method patents in the years since the decision, leading to the invalidation of patents in other high-profile cases such as the Supreme Court’s 2013 decision in Molecular Pathology v. Myriad Genetics, the Federal Circuit’s 2015 decision in Ariosa Diagnostics v. Sequenom, the Federal Circuit’s 2017 decision in Cleveland Clinic v. True Health Diagnostics, and the Federal Circuit’s 2018 decision in Roche Molecular Systems v. Cepheid.[3]
This pattern of striking down diagnostic method patents has led to intense lobbying on Capitol Hill and proposals put forth by the American Intellectual Property Law Association, American Bar Association, and Intellectual...
