Federal Circuit Punts to Supreme Court or Congress:
Athena Diagnostics, Inc. v. Mayo Collaborative Services
On July 3, 2019, the U.S. Court of Appeals for the Federal
Circuit issued an order denying a petition for rehearing en banc in the case of
Athena Diagnostics, Inc. v. Mayo
Collaborative Services, LLC (2017-2508).
More interesting than the denial, however, are the eight separate
opinions explaining the positions of the Federal Circuit judges on the
issue.
Of the 12 judges participating in the consideration, eight wrote opinions. The opinions create a patchwork of ideas with overlapping portions and portions separately extending in multiple directions. Judge Raymond Chen wrote his own opinion and joined with another one and parts of a second; Judge Todd Hughes wrote his own and signed onto another; Judge Evan Wallach did not write his own but signed onto three others; and Judge Kathleen O’Malley wrote her own, joined another, and wrote that she agreed with two others. The groupings are summarized below.
| Concurring in the denial | Dissenting to the denial |
| 1. Lourie, Reyna, Chen | 1. Moore, O’Malley, Wallach, Stoll |
| 2. Hughes, Prost, Taranto | 2. Newman, Wallach |
| 3. Dyk, Hughes, and Chen (partially) | 3. Stoll, Wallach |
| 4. Chen | 4. O’Malley |
Even though the judges did not conduct an en banc hearing, they
clearly engaged in a spirited exchange of ideas in their opinions. Not only did the opinions reference and
respond to one another, but some of them referenced and seemed to communicate
with the Senate Judiciary Committee’s Subcommittee on Intellectual Property,
which recently conducted hearings on a proposed revision to Section 101 of the Patent
Act.
Briefly, the patent in dispute of Athena Diagnostics related
to a method of diagnosing neurotransmission or developmental disorders such as
Myasthenia Gravis by detecting autoantibodies to muscle specific tyrosine
kinase (MuSK). The panel that heard the case consisted of Judges Pauline Newman,
Alan Lourie, and Kara Stoll. For
additional background on the underlying facts and dispute, see Banner Witcoff’s
previous coverage of the oral arguments and panel decision here and here.
Judge Lourie, who wrote the majority opinion for the panel,
explained his denial of the petition for rehearing stating that his hands are
tied by the Supreme Court’s decision in Mayo
Collaborative Services v. Prometheus
Laboratories, Inc., 566 U.S. 66 (2012).
If he were making the law of subject matter eligibility, ab initio, he would do it differently
than the Supreme Court has done, he wrote.
However, his reading of Mayo compels
him to the conclusion that he expressed in the panel opinion. He reads Mayo
as requiring something additional to a law of nature or natural phenomenon, and
that something additional must not be mere routine steps but must be
unconventional. Judge Lourie stated that
the only possible solution to the problem of diagnostic methods lies with “the
pens of claim drafters or legislators.”[1] Since the court is neither, he voted for
denial of rehearing.
Judge Todd Hughes, too, thought that Supreme Court precedent
tied the court’s hands. He recognized
that the current state of the law was problematic for patenting of diagnostic
methods. He articulated a need for a
mechanism to distinguish between overly broad claims to laws of nature and
claims to truly worthy, life-saving inventions. Judge Hughes indicated that
fulfilling this need could come from either the Supreme Court or Congress.
Judge Timothy Dyk believes that Sections 102 (novelty), 103
(non-obviousness), and 112 (enablement and written description) are not
sufficient to guard against overly broad claims. These sections of the patent statute do not
address the problem of preemption of future innovation. Nor do they resolve quickly in litigation, as
a threshold issue. Thus, in his view, Section
101 has a role to play in guarding against overbreadth. To the extent that Judge Dyk is critical of
the Mayo jurisprudence, he believes
that it should leave room for patentability of diagnostic methods that are
specific. Judge Dyk recognizes a tension
between the Supreme Court’s statements in Mayo
and Association for Molecular
Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), in that the former
holds that essentially no claim containing a law of nature is patentable[2]
and the latter indicates that a narrow claim containing a law of nature may be
patentable. He also recognizes a tension
between the Mayo jurisprudence and Section
101 itself (“Whoever invents or discovers….”).
Judge Dyk discusses possible “fixes” that would address his concerns,
such as permitting claims only to the extent that there is an established
utility. Any fix to the standard for
patentability of diagnostics, he thinks, must come from the Supreme Court.
Judge Chen, in the last of the concurrences, reviewed the
Supreme Court jurisprudence on laws of nature and finds an inconsistency
between cases that require analysis of the claim as a whole and cases that look
for a point of novelty. He also
criticized the analytical practice of treating the law of nature as part of the
prior art, rather than treating it as part of the invention that could
contribute to inventiveness. Finally, Judge Chen stated his belief that, in a
well-functioning patent system, claims that embody a new discovery should be
patentable subject matter. However, like
the other judges denying rehearing en banc, Judge Chen believes that the change
must come from the Supreme Court, rather than from the appellate court.
The rehearing-en-banc deniers implicitly invite the
plaintiff-appellants to petition to the Supreme Court. The dissenters would have fixed the problem
themselves by revisiting the court’s own rulings en banc. However, having failed at that, the
dissenters would also like the Supreme Court to fix the unintended consequences
of its opinions. They are also open to
Congress attempting to reorient the Section 101 jurisprudence.[3]
Judge Kimberly Moore provided a long argument in support of
the economic benefits and social good of a functioning patent system for
protection of diagnostics. She does not
doubt that all members of the court agree on these. She, unlike the deniers, however, thinks that
the Federal Circuit itself has created the current situation and could fix
it. She believes that Mayo was not a per se ruling against diagnostic patents, but that the Federal
Circuit has itself turned it into one.
She reviewed the Federal Circuit’s Section 101 law-of-nature cases since
Mayo and found that the only claims that
it held subject matter eligible were claims with at least an aspect of
therapy. Like Judge Dyk, Judge Moore
points out the inconsistency between the statute specifically mentioning people
who “discover” things and the case law that finds discoveries per se ineligible as laws of nature. In a number of locations, Judge Moore cites
to the testimony of the Senate subcommittee to support her characterization of
the problem. Judge Moore differs from the rehearing deniers in her view that
the appellate court itself could have solved the problem if it heard the case
en banc. However, since the deniers won
the poll, she now looks to either the Supreme Court or Congress to solve the
problem. She has instructed them in the
great importance of the issue to the nation.
Judge Newman, who dissented from the panel decision in the
underlying appeal, hits many of the same points as Judge Moore. She discussed the economic rationale for
patents, and noted that the rationale applies to diagnostic and therapeutic
methods alike. Judge Newman, too,
believes that the appellate court has misread and enlarged the Supreme Court’s
holding in Mayo. She stated that
analyzing a claim’s subject matter “as a whole” is established and Mayo did not disturb that. She also notes that the Supreme Court in Mayo did not set up the distinction
between diagnostic claims and therapeutic claims. Judge Newman concludes that the public gains
no benefit by the exclusion of diagnostics from patent protection. Like others, she noted that the panel
decision contravenes both the constitution and the statutory intent.
Judge Stoll was a member of the panel that decided the Athena appeal. Interestingly, she stands by her decision,
but also thinks that the bright line rule that the Federal Circuit applies
should be revisited. She called the rule
flawed and stated that it undermines the constitutional rationale for
patents. Judge Stoll thinks that the
question is exceptionally important and on that basis should have been
considered en banc. Using very strong language
that nonetheless failed sufficiently to mobilize her colleagues, she stated
that avoiding en banc hearing was an abdication of the responsibility of the
court on an issue that goes to the heart of its jurisdiction.
Judge O’Malley agreed with all the dissenters and calls on
Congress to legislatively fix the problem.
She sees the root of the problem in the Supreme Court’s interjection of
an “inventive concept” requirement into Section 101. She called this interjection “baffling”
because Congress specifically removed this requirement in its overhaul of the
patent laws in 1952. She quoted the late
Judge Giles Rich as describing the inventive concept standard as a subjective
and personally idiosyncratic standard.
Judge O’Malley wrote that the Supreme Court’s continued use of the
standard even after 1952 must be addressed by Congress.
Even though the appellate court will not formally deliberate en banc, the extensive set of opinions issued about the decision to deny such deliberation provides much guidance for the Supreme Court and Congress to consider. The Federal Circuit has mapped out multiple paths by which the Supreme Court or Congress can address the issue of patent eligibility of diagnostics. While the Senate’s Subcommittee on Intellectual Property was taking testimony in June from former U.S. Patent and Trademark Office directors David Kappos and Q. Todd Dickinson and former Chief Judge of the Federal Circuit Paul Michel, someone in the audience murmured that he would like to hear from the current incumbents of those positions. That person has now had his wish fulfilled, at least with respect to the judges of the Federal Circuit. With regard to the current incumbent of the U.S. Patent and Trademark Office directorship, Judge Moore quotes Director Andrei Iancu as saying, “It’s important for the judiciary to first recognize that there is a problem that needs to be addressed….101 remains the most important substantive patent law issue in the United States today. And it’s not even close.”
Click here to read the July 3 order in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC.
Click here to download a printable version of this article.
[1]
The meaning of a solution in the hands of claim drafters is not readily
apparent. Moreover, courts have repeated
previously that patent eligibility should not be dependent on the craft of the
claim drafters.
[2]
Mayo requires the presence of a separate inventive element beyond the law of
nature.
[3]
Judge O’Malley described the 1952 Patent Act, in part, as an effort to reign in
the judicial penchant to require “inventiveness.”