Will the Supreme Court Reevaluate the Subject Matter Eligibility of Diagnostic Claims?



Since the Supreme Court’s decisions in Mayo Collaborative Servs. v. Prometheus Lab’ys, Inc., 566 U.S. 66 (2012), and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014), “diagnostic” patent claims have repeatedly been held to be directed to patent-ineligible subject matter by the U.S. Patent and Trademark Office (PTO) and courts. In a 2022 decision by the Federal Circuit, for example, the court affirmed a district court’s ruling that claims to noninvasive detection of graft rejection in transplant patients were ineligible under Section 101 because they were directed to the detection of a natural phenomenon/natural law using only conventional techniques. CareDx, Inc. v. Natera, Inc., 40 F.4th 1371, 1381 (Fed. Cir. 2022). And although the Supreme Court has on a number of occasions declined to reevaluate the contours of Section 101, including the subject matter eligibility of diagnostic claims, the CareDx, Inc. v. Natera, Inc. case may have piqued the Court’s interest.

Following the Federal Circuit’s decision in the CareDx case, CareDx, Inc., and the Board of Trustees of the Leland Stanford Junior University (collectively “CareDx”) filed a petition for writ of certiorari asking the Supreme Court to address the following question:

Congress has provided that any “new and useful process” is eligible for patent protection, and that “any new and useful improvement thereof” is also eligible for patent protection. 35 U.S.C. 101. The question presented is whether a new and useful method for measuring a natural phenomenon, that improves upon prior methods for measuring that very same phenomenon, is eligible for patent protection under Section 101.

Both respondents – Natera, Inc. and Eurofins Viracor, Inc. – waived their rights to respond to the petition. But just five days after the Honorable Paul R. Michel (retired Federal Circuit chief judge) and Professor John F. Duffy from the University of Virginia School of Law filed an amicus brief in support of CareDx, the Supreme Court requested that the respondents respond to CareDx’s petition. According to the amicus brief:

This case concerns Amici because it represents a continuing trend of uncertainty and inconsistency in patent-eligibility jurisprudence, now reaching the point that judge-made law in the lower courts directly contradicts statutory commands in the 1952 Patent Act designed to overrule prior 19th-century judge-made law on patentable subject matter that Congress found too restrictive. The outcome undermines the innovation-promoting goals of U.S. patent law.

It is time for the Supreme Court to reevaluate Section 101, including the subject matter eligibility of diagnostic claims, and provide the PTO and courts with clear guidance.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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