The Court in Prometheus highlights that determining subject matter eligibility under section 101 is now a necessary inquiry of patentability. Some had argued that other requirements of patentability, such as novelty and nonobviousness, could do the work of section 101 in a more predictable and objective way.  Now, section 101 becomes a gatekeeper, despite its difficulty in application, particularly by examiners that may be ill-equipped to determine whether an application of a natural law is significant enough to make it patent eligible or if it too broadly preempts use of a natural law.

Despite the reinvigoration of section 101, the Court’s decision risks tainting the eligibility determination with the analysis of novelty and nonobviousness.  In asking whether the application of a natural law is significant enough or has some inventive concept that is different enough from the natural law, the Court seems to blur the inquiries that it classifies as distinct.  This risk is magnified by the Court’s dissection of the claims, removing the parts that pertain to natural laws, and asking whether the remaining parts of the claim were already known in the art.

Although the Prometheus decision relates to process claims, it may still affect the Myriad composition of matter patents related to isolated human DNA. Composition claims may be excluded under section 101 as covering products of nature, unless the invention requires human intervention, making such claims patent eligible.  In this context, the policy reasons for rejecting the Prometheus process claims seem particularly relevant to Myriad’s composition claims: “the underlying functional concern here is a relative one: how much future innovation is foreclosed relative to the contribution of the inventor.”  Additionally, the recent trend moving away from strict distinctions between composition and method claims suggests that Prometheus may have some bearing on Myriad’s composition claims.

Click here for more CLB commentary and analysis of the Prometheus decision.