Protecting Diagnostic Methods: Athena’s Patent Eligibility Wisdom

October 16, 2019

At the same time Congress is weighing a proposal that would amend Section 101 of the Patent Act, Athena Diagnostics has asked the US Supreme Court to review its diagnostic method patent case and thus clarify the Court’s Section 101 precedent. Action by either body could affect patent eligibility law for years to come.

What jurisprudential guidance do companies have for navigating the patent eligibility maze? Here’s the latest one: a case decided by eight separate opinions from eight separate judges. In Athena Diagnostics v. Mayo Collaborative, the US Court of Appeals for the Federal Circuit denied Athena’s petition for rehearing en banc in a case that invalidated Athena’s patent for methods of diagnosing neurotransmission or developmental disorders.[1] On October 1, 2019, Athena filed a petition for a writ of certiorari, asking the US Supreme Court to review the Federal Circuit’s decision.[2]

Athena’s Petition

In denying Athena’s request for rehearing, many Federal Circuit judges joined with Athena’s request for certiorari—several judges expressly called on the Supreme Court to reassess the two-part framework set forth in its 2014 decision in Alice v. CLS Bank and credited to its 2012 decision in Mayo Collaborative v. Prometheus Laboratories.[3] For example, Judge Hughes stated in a concurring opinion that he “would welcome further explication of eligibility standards in the area of diagnostics patents.”[4] Similarly, in Judge Dyk’s concurrence, he stated that the Supreme Court should “refine the Mayo framework as to diagnostic patents.”[5]

Athena used such calls in its October 1 petition to the high court. Indeed, in its leading argument, the petition states:

All twelve active judges of the Federal Circuit agreed that the current patent-eligibility standard as applied by the Federal Circuit is problematic, particularly in the context of diagnostic claims. Numerous judges thus solicited this Court’s review of this case to clarify the patent eligibility standard.[6]

Although Athena’s petition is peppered with references to the state of subject matter eligibility in a general sense, Athena presented its question to the Court in relatively narrow terms. Athena asked the Court to decide

[w]hether a new and specific method of diagnosing a medical condition is patent-eligible subject matter, where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.[7]

On the one hand, this question is limited to the diagnostic method patent context, and more specifically, to patents purportedly containing some level of novelty. On the other hand, the petition is largely phrased in more general terms, and expressly urges that “the Court should review this case to clarify its Section 101 precedent.”[8]

Impending Congressional Action

The Athena case is being teed up for Supreme Court review at the same time Congress is weighing a proposal that would amend Section 101 of the Patent Act (the Proposed Bill). The Proposed Bill, introduced by Senators Chris Coons and Thom Tillis, along with Representatives Doug Collins, Hank Johnson, and Steve Stivers in May, includes, inter alia, the following provisions:

  1. The provisions of Section 101 shall be construed in favor of eligibility.
  2. No implicit or other judicially created exceptions to subject matter eligibility, including “abstract ideas,” “laws of nature,” or “natural phenomena,” shall be used to determine patent eligibility under Section 101, and all cases establishing or interpreting those exceptions to eligibility are hereby abrogated.
  3. The eligibility of a claimed invention under Section 101 shall be determined without regard to: the manner in which the claimed invention was made; whether individual limitations of a claim are well known, conventional or routine; the state of the art at the time of the invention; or any other considerations relating to Sections 102, 103, or 112 of this title.
  4. Whoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. The term “useful” means any invention or discovery that provides specific and practical utility in any field of technology through human intervention.

The reader should especially note that the third proposed change is the Proposed Bill’s express de-emphasis of the newness or “novelty” of an invention.[9] In fact, in the Proposed Bill, the word “new” is removed from the statute entirely. Another significant change is the proposed abrogation of years of Supreme Court precedent through the Proposed Bill’s elimination of the “judicially created exceptions to subject matter eligibility.” Two of those enumerated exceptions—laws of nature and natural phenomena—are implicated in the diagnostic method patent cases.

There is a potential for major changes to patent subject matter eligibility. In theory, both the Supreme Court and Congress could act on these important issues in ways that would have far-reaching implications. Whether and how the high court and legislature change the law will soon be seen, but any action could drastically impact the landscape for diagnostic method patents for decades to come.


If you have any questions or would like more information on the issues discussed in this LawFlash, please contact the authors, Nathan S. Smith (Orange County) and Calvin Brien (Washington, DC), or any of the following lawyers from Morgan Lewis’s intellectual property 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
Dion M. Bregman

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

[1] Athena Diagnostics, Inc. v. Mayo Collaborative Servs., L.L.C., 927 F.3d 1333 (Fed. Cir. 2019).

[2] Petition for Writ of Certiorari, Athena Diagnostics, Inc., No. 19-430.

[3] This two-part framework consists of first determining whether a claim is directed to unpatentable subject matter—i.e., laws of nature, natural phenomena, and abstract ideas—and 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. See 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).

[4] 927 F.3d at 1337.

[5] Id. at 1344.

[6] Petition for Writ of Certiorari at 13, Athena Diagnostics, Inc., No. 19-430.

[7] Id. at i.

[8] Id. at 13.

[9] 35 U.S.C. § 101 currently 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.”