Updates on Diagnostic Method Patent Eligibility

July 25, 2019

New and developing efforts by Congress may change the way patent subject matter eligibility is determined for years to come, changing the landscape for medical diagnostic methods. This congressional action comes following intense pleas from some judges of the US Court of Appeals for the Federal Circuit and has the potential to unravel decades of US Supreme Court precedent relating to the current patent eligibility test.

In recent years, US courts have increasingly scrutinized the eligibility of patents covering methods of diagnosing medical conditions. New diagnostic methods require intense and costly research to develop and are vital to the medical industry. Some have argued that they are among the most meritorious candidates for patent protection. But diagnostic methods often rely on scientific concepts that are ineligible for patenting, such as naturally occurring phenomena in the human body.

The eligibility of diagnostic methods for patent protection is governed by 35 U.S.C. § 101,[1] under a two-part test set forth in the Supreme Court’s 2014 decision in Alice v. CLS Bank, and credited to the Court’s 2012 decision in Mayo Collaborative v. Prometheus Laboratories.[2] The Court set forth a two-part framework for assessing patent eligibility. First, a court must determine whether a claim is directed to unpatentable subject matter: laws of nature, natural phenomena, and abstract ideas. If so, the claim is eligible for patent protection only if it contains an inventive concept that transforms the unpatentable natural law into a patent-eligible invention.

Naturally, the Court’s analysis implicates diagnostic method patents because laws of nature and natural phenomena are used in the medical field. Indeed, in Mayo itself, the Court invalidated the diagnostic method patent at issue, which claimed a method of evaluating medication dosage levels. In applying the two-part framework, the Court reasoned that the patent concerned the naturally occurring relationships between metabolites in the blood and that the “the steps add nothing of significance to the natural laws themselves.”

The Mayo decision has restricted patentability of diagnostic method patents in the years since the decision, leading to the invalidation of patents in other high-profile cases such as the Supreme Court’s 2013 decision in Molecular Pathology v. Myriad Genetics, the Federal Circuit’s 2015 decision in Ariosa Diagnostics v. Sequenom, the Federal Circuit’s 2017 decision in Cleveland Clinic v. True Health Diagnostics, and the Federal Circuit’s 2018 decision in Roche Molecular Systems v. Cepheid.[3]

This pattern of striking down diagnostic method patents has led to intense lobbying on Capitol Hill and proposals put forth by the American Intellectual Property Law Association, American Bar Association, and Intellectual Property Owners Association, all culminating in discussions of amending § 101. Last month, the Senate Judiciary Committee held extensive hearings on “The State of Patent Eligibility in America” to discuss potential amendments to the subject matter eligibility sections in the Patent Act.[4]

Under the proposed amendments to § 101, diagnostic method patents would survive eligibility challenges more often. The proposals would statutorily abrogate the so-called “judicial exceptions” that are directed to unpatentable subject matter—laws of nature, natural phenomena, and abstract ideas—and require only a practical application: “The term ‘useful’ means any invention or discovery that provides specific and practical utility in any field of technology through human intervention.”[5] This amendment has the potential to upend the patent subject matter eligibility analysis.

At the other end of Pennsylvania Avenue, many Federal Circuit judges have expressed a need for changes in the § 101 analysis. This criticism came to a head earlier this month in Athena Diagnostics v. Mayo Collaborative, when the Federal Circuit, sitting en banc, denied Athena’s petition for rehearing in a case that invalidated Athena’s diagnostic method patents. Professor Dennis Crouch’s blog post on this case nicely sums up the unusual decision: “Athena Loses on Eligibility – Although 12 Federal Circuit Judges Agree that Athena’s Claims Should be Eligible.”[6] As Professor Crouch points out, Federal Circuit judges, in eight separate opinions, called for Supreme Court or congressional intervention on the question of patent eligibility of diagnostic method patents. No matter which branch decides to act, all those with vested interests in diagnostic method patents should pay close attention to these developments. Although the timeline is not entirely certain, the system of evaluating the eligibility of such patents may soon be drastically changed.


If you have any questions or would like more information on the issues discussed in this LawFlash, please contact the authors, Dion M. Bregman in Silicon Valley or Calvin M. Brien in Washington, DC, or any of the following lawyers from Morgan Lewis’s IP Medical Device Practice:

Century City
Olga Berson, Ph.D.

Michael J. Abernathy
Christopher J. Betti, Ph.D.
Scott D. Sherwin
Kevin P. Shortsle
Jason C. White

Orange County
Kenneth Cheney
M. Todd Hales
Soyeon Pak “Karen” Laub
Nathan S. Smith

Louis W. Beardell, Jr.
Kenneth J. Davis
John L. Hemmer
Michael S. Ryan

San Francisco
Brent A. Hawkins
Brett A. Lovejoy, Ph.D.
Michael J. Lyons

Shaobin Zhu

Silicon Valley
Douglas J. Crisman

Washington, DC
Hosang Lee
Janice H. Logan, Ph.D.

[1] 35 U.S.C. § 101 states: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

[2] Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).

[3] Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2014); Roche Molecular Systems, Inc. v. Cepheid, 905 F.3d 1363 (Fed. Cir. 2018); Cleveland Clinic Found. v. True Health Diagnostics, L.L.C., 859 F.3d 1352 (Fed. Cir. 2017); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).

[4] A high level summary of the proposed changes to § 101 can be found on Senator Thom Tillis’s website.

[5] In the proposed amendments, this clause would be added to Title 35 at Subsection 100(k).