Questioning Conventionality and Redefining Course of in Patent Eligibility Legislation

by Dennis Crouch

In CareDx v. Natera, an intriguing amicus transient 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 transient advocates for the clarification of patent-eligibility regulation, and criticizes the Federal Circuit’s dealing with of the case. The submitting of the transient 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 offered within the transient.  [Read the Brief]

In accordance with Michel and Duffy, the Federal Circuit’s determination within the case neglected the textual content of the Patent Act and conflicts with Supreme Court docket precedent similar to Diehr and Cochran v. Deener. They argue that the choice fails to acknowledge the distinction between patent eligibility (below § 101) and patentability (below §§ 102, 103, and 112). They additional criticize the choice for an unduly simplified description of the invention that leaves out essential 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, relatively than being a key criterion for patent eligibility below § 101.

The transient spends some period of time specializing in landmark patent circumstances similar to Diehr and Cochrane v. Deener (whereas rejecting Flook) as an instance how a course of could be patent eligible regardless of encompassing typical components.  And, all through this argues that the Federal Circuit misunderstood the definition of “course of,” which below 35 U.S.C. § 100(b) is outlined to incorporate “a brand new use of a recognized course of.” The transient contends that this definition permits patents on new purposes or enhancements of recognized applied sciences, and that such enhancements ought to be presumed to be patent eligible.  However, the Federal Circuit’s eligibility standards of “conventionality” prohibits this interpretation despite the fact that 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 handle confusion and uncertainty surrounding patent eligibility, notably 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 an alternative might be held-over till the autumn 2023 earlier than we get a call on whether or not the courtroom 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)