Patent Judges Agree that Patent Eligibility Law Needs Fixing: Part 1August 8, 2019

On July 3, 2019, the U.S. Court of Appeals for the Federal Circuit issued an interesting, though not surprising, opinion discussing patent eligibility for inventions and discoveries. In Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, all 12 judges of the Court considered whether the full court should rehear an appeal of a patent regarding a medical diagnostic invention, with which a 3-judge panel earlier held to be ineligible for patent protection pursuant to the precedent of the U.S. Supreme Court. The decision included the majority opinion, three concurring opinions, and four dissenting opinions. 

While the Court denied the en banc rehearing of the appeal, each of the 8 opinions requested that the Supreme Court or Congress do something to clarify the confusion about patent eligibility. The majority opinion (Judges Lourie, Rayna and Chen) noted that prior opinions of the court expressed concern over the patent eligibility issue. Judge Lourie, author of the majority opinion, stated that if he could write on a clean slate, the only exception to patent eligibility would be natural laws themselves. But alas, the judges of the Federal Circuit do not have a clean slate, but rather are bound by Supreme Court precedent. Thus, Athena’s diagnostic testing patent was found to be ineligible for patent protection in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). Thus, even though the invention was new, non-obvious, and useful, the majority suggested that the solution to this patent eligibility dilemma lies in the pens of patent attorneys and agents or legislators.

The first concurring opinion (Judges Hughes, Prost, and Taranto) acknowledges that the multiple opinions of the case “are illustrative of how fraut the issue of 101 eligibility, especially as applied to medical diagnostics patents, is.” Judge Hughes invited further explication from the Supreme Court or from Congress of eligibility standards in the area of diagnostics patents.

The second concurring opinion (Judges Dyke, Hughes, and Chen) acknowledged that the problem of §101 arises from the Supreme Court Mayo decision. Judge Dyke also noted the tension between various Supreme Court decisions on §101, including discoveries with proven utility. Thus, Judge Dyke suggests that the Supreme Court refine its patent eligibility framework.

In the third concurring opinion, Judge Chen cited additional Supreme Court precedent, Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980), the Supreme Court explained that “Congress plainly contemplated that the patent laws would be given wide scope.” Judge Chen believes that it would be beneficial from additional Supreme Court guidance regarding patent eligibility under the various Supreme Court decisions, which take different analytical approaches which are often difficult to reconcile. For example, some Supreme Court precedent instructs that the claimed invention must considered, whereas in other precedent, the claims are dissected into old and new elements for the patent eligibility analysis. Judge Chen acknowledged that there is a serious question today in patent law regarding claim analysis and competing Supreme Court precedent for patent eligibility. Even though §101 provides that “whoever invents or discovers” a new or useful process, manufacture, machine or composition of matter entitled to a patent,” the Supreme Court has proclaimed that “groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Association for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S. 576, 591 (2013). Judge Chen then stated his belief that: diagnostic inventions and discoveries are contributions to the “useful arts,” as stated in Article 1, §8, Clause 8 of the U.S. Constitution. These real-world medical steps to diagnose patient health conditions seem to be the kind of subject matter the patent system was designed for, to encourage the risky, expensive, unpredictable technical research and development that people would not otherwise pursue. Such practical application of science and technology should be patentable, but recent Supreme Court direction precludes such protection, according to Judge Chen.

Kirk Hartung is Chair of the Mechanical Patent Practice Group at McKee, Voorhees & Sease, PLC. For additional information, please visit or contact Kirk directly via email at

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