Questioning Conventionality and Redefining Course of in Patent Eligibility Legislation

by Dennis Crouch

In CareDx v. Natera, an intriguing amicus temporary was just lately 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 legislation, and criticizes the Federal Circuit’s dealing with of the case. The submitting of the temporary has seemingly prompted the Supreme Courtroom 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 temporary.  [Read the Brief]

In response to Michel and Duffy, the Federal Circuit’s determination within the case neglected the textual content of the Patent Act and conflicts with Supreme Courtroom precedent corresponding 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 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 below § 101.

The temporary spends some period of time specializing in landmark patent instances corresponding to Diehr and Cochrane v. Deener (whereas rejecting Flook) as an instance how a course of might be patent eligible regardless of encompassing standard 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 identified course of.” The temporary contends that this definition permits patents on new functions or enhancements of identified 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 though not rooted within the Patent Act’s textual content or the Supreme Courtroom’s precedent.

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

Now that we’re nearly to June, the petition is unlikely to be determined earlier than the recess and as an alternative will likely 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)