Federal Circuit Denies En Banc Request, but Calls for Help by Supreme Court and/or Congress in Applying 35 U.S.C. § 101 After Mayo

The Federal Circuit, in a lengthy opinion consisting of 81 pages of eight separate concurrences and dissents, denied patent owner’s petition for rehearing en banc. The denial effectively affirmed the district court’s finding that the claims, which relate to a diagnostic test for myasthenia gravis (an autoimmune neuromuscular disease), were not eligible for patent protection under 35 U.S.C. § 101. Many of the judges used their concurrences and denials to express their views on problems with the state of § 101 law, and to call upon Congress and/or the Supreme Court to step in. 

Judge Lourie, joined by Judges Reyna and Chen, concurred with the denial of en banc review because they are “bound by Supreme Court precedent,” namely: Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) (Mayo 1). Under Mayo 1, claims that are “focused on detecting new and useful natural laws with conventional steps” are ineligible for patent protection. In contrast, claims directed to natural laws in addition to new methods of treatment and/or unconventional arrangements of known laboratory techniques may be patent-eligible. Judge Lourie commented that if he “could write on a clean slate,” he would not exclude claims directed to the detection of natural laws, and instead would only exclude “claims directed to the natural law itself, e.g., E=mc2, F=ma, Boyle’s Law, Maxwell’s Equations, etc.” In his view, the “laws of anticipation, obviousness, indefiniteness, and written description provide other filters to determine what is patentable” instead of a broad application of 35 U.S.C. § 101. He concluded by stating that “the only possible solution lies in the pens of claim drafters or legislators.”

Judge Hughes wrote a separate concurrence, joined by Judges Prost and Taranto. The trio similarly found the issues foreclosed by Mayo 1, but noted that the “multiple concurring and dissenting opinions . . . are illustrative of how fraught the issue of § 101 eligibility, especially as applied to medical diagnostics patents, is.” Judge Hughes expressed that he “would welcome further explication of eligibility standards in the area of diagnostics patents” and the “patenting of essential lifesaving inventions based on natural laws” – but this change must come from the Supreme Court or Congress. 

Judge Dyk, joined by Judge Hughes and joined in part by Judge Chen, wrote the third separate concurrence. Judge Dyk praised the Alice/Mayo framework as “valuable and effective” in screening out claims “that few would contend should be patent eligible” such as well-known business methods and other processes using computers or the Internet.” That being said, Judge Dyk noted that he “share[s] the concerns expressed by [his] dissenting colleagues that the Mayo test . . . should leave room for sufficiently specific diagnostic patents.” This “approach would help ensure that the reward of a patent goes to those who have actually done the work to develop a specific application of a natural law, not those who are the first to the patent office with broad, conceptual claims lacking proven utility in many applications.” But, he noted that only the Supreme Court can “reconsider the breadth of Mayo.” The concurrence also noted the “tension” between Mayo 1 and a later Supreme Court decision: Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), which found eligibility for claims directed to “the discovery of an unknown natural phenomenon and its application for a diagnostic purpose” – a concept that Judge Dyk stated would not, “no matter how narrow and specific,” supply an inventive concept supporting eligibility under Mayo 1. 

Judge Chen wrote a separate concurrence observing that there is a “considerable tension” between Mayo 1 and an earlier Supreme Court opinion: Diamond v. Diehr, 450 U.S. 175 (1981). Diehr considered the “claim as a whole” in looking for an inventive concept, and disapproved of “dissecting claims into elements and ignoring non-novel elements in the § 101 analysis.” Mayo 1, in contrast, was characterized as an “inventive concept/point of novelty framework, which is a more far-reaching, aggressive version.” Under Mayo, the inventive concept analysis dismisses claim “elements that lack novelty.” Judge Chen noted that the Mayo 1 test is “is considerably harder to apply consistently than the Diehr framework” and requires a “highly subjective and impressionistic” as to what the “claim is ‘really about’.” Judge Chen expressed that the Federal Circuit “would benefit from the Supreme Court’s guidance as to whether [Mayo 1] intended to override central tenets of Diehr.” Under Judge Chen’s view: Diehr had provided 30 years of settled expectations in intellectual property rights, and provided a framework that might allow for eligibility for “[n]ew methods of diagnosing medical conditions . . .the kind of subject matter the patent system is designed for.”

The remaining four separate opinions, authored or joined by Judges Moore, O’Malley, Wallach, Stoll, and Newman, dissented from the denial of en banc review. Judge Moore noted that since Mayo 1, the Federal Circuit has “held every single diagnostic claim in every case before us ineligible.” Judge Moore contrasted these results with the purpose of the patent system to “promote exactly this sort of specific, targeted application of a life-saving discovery, which is characterized by extraordinarily high initial market entry cost.” Judge Moore would have ordered en banc review in order to reconsider Federal Circuit precedent that interpreted Mayo 1 as broadly excluding diagnostic test claims reciting “specific, concrete steps applying the law of nature,” as opposed to a narrower view of Mayo 1 as excluding claims directed to a natural law itself. Judge Moore concluded by warning future diagnostic test litigants to not “waste resources with additional en banc requests. Your only hope lies with the Supreme Court or Congress.” The remaining dissents also stressed the importance of diagnostic tests patents and identified how application of claim-as-a-whole eligibility test (like in Diehr) would have resulted in an eligibility finding. Judge O’Malley in particular to note that “the Supreme Court has instructed federal courts to read into Section 101 an ’inventive concept’ requirement—a baffling standard that Congress removed when it amended the Patent Act in 1952” and to “encourage Congress to amend the Patent Act once more to clarify that it meant what it said in 1952.”