Patents and Diagnostic Methods in the U.S.: The Subject Matter Eligibility Trap

Abstract

Diagnostic methods have been gaining medical recognition and social importance as innovations that can be useful to provide individuals with a diagnosis, prognosis or prediction with regard to a condition that they currently have or that they are in risk of developing. Despite the great amount of resources deployed to produce these health technologies and their potential benefits for healthcare systems and patients or prospective patients alike, their exclusive protection in the United States has faced resistance from patent examiners and courts on the basis that diagnostics constitute a dubious innovation. Inconsistent arguments used for the refusal of patent protection have led to a labyrinth where innovators in the diagnostics sector cannot reasonably expect their application or their protection after the patent is in place to stand. 

This paper aims to convey the doctrine of subject matter eligibility as applied to diagnostic methods and the relevant guidelines and case law. In doing so, it aims to depict the pitfalls resulting from the general application of a non-patentability rule to diagnostics, and to suggest opportunities still available for innovators to overcome uncertainty by filing compliant applications while maximizing the likeliness of enjoying protection once the patent is awarded.