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INSIGHT: Federal Circuit Needs to Finally Clarify Mayo‘s Patent Requirements

June 30, 2020, 8:00 AM

The U.S. Supreme Court’s Mayo test for patent eligibility continues to confound courts, innovative companies, and officials at the U.S. Patent and Trademark Office alike.

The outcomes from scores of court decisions are confusingly inconsistent. No wonder. The Mayo test includes criteria such as “drawn to” and “transforms.” Both terms are inherently unclear, entirely undefined, hopelessly vague, excessively subjective and hence nearly impossible for 1,000 federal trial judges and 8,400 patent examiners and patent judges to apply rigorously and fairly.

For many patents, I myself cannot predict the result of a judicial eligibility analysis, despite 22 years of service on the nation’s top patent court. If I cannot, how can we expect company executives and outside investors to? We can’t, and they don’t. Instead, they simply avoid uncertainty and risk by not making investments in R&D or commercialization when in doubt.

In addition to creating chaos, the Supreme Court’s test excludes vast areas of vital technology, such as medical diagnostic methods. That is part of the reason why Covid-19 caught our nation so unprepared to test its citizens for the disease or the presence of antibodies. And, most advanced technologies rely on computer implementation—another area where the mess in patent-eligibility law diminishes incentives to invest and invent.

Despite mounting evidence of Mayo’s detrimental effects, the Supreme Court has for the past eight years declined every one of almost 50 requests to rectify the situation. Congress likewise has not intervened, even though it established the categories of patent-eligible subject matter under Section 101, and even though Congress as the legislature has the prerogative and responsibility for setting national innovation policy.

Clarity Is Up to the Federal Circuit

Can my old court, the U.S. Court of Appeals for the Federal Circuit, clarify the law and restore necessary certainty? I believe it can, but only if it examines the foundations of the test.

Under the flawed Mayo two-step test, one first asks: Is the claim “drawn to” a judicial exception to the four patent-eligible categories defined in Section 101? Second, if so, do the “additional” limitations “transform” it into a patent-eligible claim?

To my eye, the Mayo test rests on two distortions of precedent, in particular Gottschalk v. Benson, 409 U.S. 63 (1972). First, Mayo asserts: “Still, as the Court has made clear, to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words ‘apply it.’” 132 S. Ct. at 1294. The court’s sole support for that statement was pages 71-72 of Benson. No other citation was provided.

Examination of the cited text of Benson, however, fails to reveal any reference to “transforming” a claim. Neither the word nor the notion appears there.

Rather, in Benson, the court denied eligibility because the algorithm had “no substantial practical application except in connection with a digital computer.” 409 U.S. at 71. According to Benson, that meant that, “if the judgment below is affirmed, the patent would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself.” Once so construed, the claims were ineligible because of course one cannot patent a mathematical formula itself.

By requiring transformation, Mayo in effect created a presumption of ineligibility for any claims with a judicial exception. Mayo also changed the criteria of Benson for what a claim is “drawn to.”

Oddly, neither alteration of Benson was discussed or analyzed, much less justified. Mayo instead asserted that the outcome is a straightforward application of Benson. Could it be that the other Justices joining this unanimous opinion assumed that Benson really did require transformation of claims containing an exception, without realizing Mayo silently changed Benson? The court’s lack of an in-depth analysis suggests this assumption is plausible.

The alteration of the meaning of “drawn to” was equally consequential and equally subtle. My reading of Benson is that “drawn to” meant that the claim covered nothing other than the exception itself, such as the mathematical formula. Mayo‘s use of “drawn to” goes far beyond Benson’s meaning, however, with the phrase now expanded to mean “includes” as one of many limitations.

Combining the two changes, transformation of a claim pursuant to Mayo is required whenever any claim limitation relates to a judicial exception. Nearly all claims contain a limitation that relates to a law of nature, natural phenomenon, or abstract idea.

Consider any claim directed to a method of treating a patient or a method of diagnosing (such as diagnosing Covid-19). In order to work, such a test has to rely on a law or phenomenon of nature. No surprise then that, in almost every case, Section 101-based invalidity motions are drafted and ready to go, often before a complaint is served.

A careful reading shows that the Mayo test is not supported by Benson. To be sure, Benson mentions several old pre-1952 Patent Act cases, including one that discusses “transforming” “an article to a different state or thing.” But to me, transforming an “article” is different from transforming a “claim,” as Mayo requires.

In any event, these pre-1952 cases seem focused on novelty, or what since 1952 is called non-obviousness, not on eligibility. To the extent these ancient cases also addressed eligibility, they may merely define how to assess what a claim is “directed to.”

They did not hold that a claim having a limitation to an exception must then be transformed by other limitations to overcome presumptive ineligibility. The latter was a jurisprudential “innovation” of the Mayo court.

Worse, though, is that the Mayo test continues to undermine certainty in patents and adds unnecessary complexity and expense for innovators, potential licensees, investors, courts, and the patent office. It has led to the routine invalidation of patents for life-saving diagnostic inventions.

Given all these harmful consequences, the Federal Circuit should clarify ineligibility law by interpreting Mayo consistently with Benson, on which it depends. That can only happen if patent owners and their counsel raise the issue.

This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.

Author Information

Judge Paul R. Michel was appointed to the Court of Appeals for the Federal Circuit in 1988 after16 years of service in the Executive and Legislative branches. He retired as Chief Judge in 2010, advocating since then for improvements in the patent system.

John T. Battaglia is a trial and appellate lawyer who has argued a range of civil and criminal cases over 22 years, focused on patent litigation. He has successfully advocated several cases before the Federal Circuit and numerous other courts, both as a partner at some of the world’s leading law firms and as DOJ’s Deputy Associate AG, trial lawyer, and federal prosecutor. He has taught for years at U.VA’s Trial College and Georgetown NITA, and been repeatedly recognized as a top advocate in peer-reviewed sources.

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