Supreme Court Dodges Patent Eligibility Standards Again

Insights

Overview

Patent eligibility under Section 101 remains a hot topic at all federal courts. Still, the Supreme Court has again refused to take up the issue—this time rejecting a writ of certiorari in a medical diagnostics case.

In CareDx, Inc. v. Natera, Inc., 40 F.4th 1371 (Fed. Cir. 2022), three patents related to methods for detecting organ transplant rejection were at issue. The district court and the Federal Circuit held that these patent claims were patent ineligible under Section 101 because they are directed to a natural phenomenon with only conventional steps for quantifying it.

Petitioners CareDx and Stanford argued that recent Federal Circuit patent eligibility rulings are contrary to Section 101 and have been so restrictive as to result in “a virtually per se rule of invalidity” in medical diagnostic cases. Here, petitioners took the position that their claimed methods were a “new and useful improvement” of an existing process and thus should be patent-eligible under the plain language of Section 101.

Moreover, petitioners took issue with the Federal Circuit’s application of the Section 101 test under Alice Corp. Pty. Ltd. v. CLS Bank Int’l and Mayo Collaborative Servs. v. Prometheus Laboratories, Inc., arguing that the Court has improperly included obviousness considerations in the inquiry of patent eligibility.

The Court determined that the techniques recited in the claims were simply a “logical combination” of conventional techniques, and thus did “not result in an inventive concept that transforms the natural phenomena into a patentable invention.” In the petitioner’s view, this determination was “tantamount to a finding of obviousness,” which should have no bearing on whether a claim is patent-eligible under Section 101. However, the Federal Circuit asserted that its decision was consistent with the existing patent-eligibility test established by the Alice and Mayo decisions.

Ultimately, on October 2, 2023, the Supreme Court opted not to review the case, leaving patentees in the medical diagnostics field (and outside of it) to struggle to determine what types of inventions are patent eligible and whether existing patents will be later deemed invalid under the Court’s Section 101 jurisprudence.

Given that CareDx’s request follows several previous petitions to the Supreme Court on patent eligibility that were also denied (see, e.g., American Axle & Manufacturing Inc. v. Neapco Holdings LLC; Interactive Wearables, LLC v. Polar Electro Oy; Tropp v. Travel Sentry, Inc.) it is uncertain whether the Supreme Court will weigh in on this topic, or wait for a legislative solution. But one thing is clear—patent owners and practitioners are begging for more clarity on applying Section 101 moving forward.

Professionals

Key Takeaways

Medical diagnostic claims have come under increased scrutiny by the courts on Section 101 grounds.
Critics argue that the courts are imposing additional requirements for patent eligibility—in this case, obviousness requirements—that should have no bearing on whether an invention is eligible for patenting.
In the meantime, patent applicants should avoid drafting medical diagnostic claims that only include a combination of “conventional” techniques for detecting a naturally occurring phenomenon and try to include features that provide additional inventive aspects.
The lack of clarity on the application of Section 101 will continue to increase the pressure on the Supreme Court to weigh in.