Questioning Conventionality and Redefining Course of in Patent Eligibility Regulation

by Dennis Crouch

In CareDx v. Natera, an intriguing amicus temporary was not too long ago filed by the Honorable Paul Michel (Ret.) and Professor John Duffy in help of the patentee petitioners Stanford and CareDx. The temporary advocates for the clarification of patent-eligibility regulation, and criticizes the Federal Circuit’s dealing with of the case. The submitting of the temporary has seemingly prompted the Supreme Court docket to request a response from the accused infringers, after they initially waived their proper to take action. This transfer displays some significance of the arguments introduced within the temporary.  [Read the Brief]

In keeping with Michel and Duffy, the Federal Circuit’s resolution within the case neglected the textual content of the Patent Act and conflicts with Supreme Court docket precedent comparable to Diehr and Cochran v. Deener. They argue that the choice fails to acknowledge the distinction between patent eligibility (beneath § 101) and patentability (beneath §§ 102, 103, and 112). They additional criticize the choice for an unduly simplified description of the invention that leaves out vital particulars and for improper emphasis on “conventionality.”  The idea of “conventionality” is extra appropriately related to problems with novelty and nonobviousness, as regulated by §§ 102 and 103 respectively, slightly than being a key criterion for patent eligibility beneath § 101.

The temporary spends some period of time specializing in landmark patent instances comparable to Diehr and Cochrane v. Deener (whereas rejecting Flook) for example how a course of could be patent eligible regardless of encompassing standard components.  And, all through this argues that the Federal Circuit misunderstood the definition of “course of,” which beneath 35 U.S.C. § 100(b) is outlined to incorporate “a brand new use of a recognized course of.” The temporary contends that this definition permits patents on new functions or enhancements of recognized applied sciences, and that such enhancements must be presumed to be patent eligible.  However, the Federal Circuit’s eligibility standards of “conventionality” prohibits this interpretation although not rooted within the Patent Act’s textual content or the Supreme Court docket’s precedent.

As with different current eligibility briefs, this one additionally underscores a necessity to deal with confusion and uncertainty surrounding patent eligibility, significantly in relation to biomedical and diagnostic patents.

Now that we’re virtually to June, the petition is unlikely to be determined earlier than the recess and as a substitute can be held-over till the autumn 2023 earlier than we get a choice on whether or not the court docket will grant certiorari.

See, A. Sasha Hoyt, The Impact of Uncertainty Regarding Patent Eligible Subject Matter for Investment in U.S. Medical Diagnostic Technologies, 79 Wash. & L. Rev. 397 (2022)