On July 3, the Federal Circuit issued a per curiam Order in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, denying a petition for rehearing en banc filed by Plaintiffs-Appellants Athena Diagnostics, Inc., Oxford University Innovation Ltd., and the Max-Planck-Gesellschaft zur Forderung der Wissenschaften E.V. The Court also denied Plaintiffs-Appellants a panel rehearing.
The four page per curiam Order was accompanied by eight opinions, four concurring in the denial of the petition and four dissenting in the denial of the petition, adding an additional 82 pages to the Order. The four concurring opinions were authored by Circuit Judges Lourie, Hughes, Dyk, and Chen, with Chief Judge Prost and Circuit Judges Reyna, Taranto, and Hughes joining in one of the concurrences and Circuit Judge Chen joining in one concurrence and several parts of another. The four dissenting opinions were authored by Circuit Judges Moore, Newman, Stoll, and O'Malley, with Circuit Judges O'Malley and Stoll joining in one of the dissents and Circuit Judge Wallach joining in three of the dissents. Thus, a total of seven members of the Court (Chief Judge Prost and Circuit Judges Lourie, Dyk, Reyna, Taranto, Chen, and Hughes) authored or joined opinions concurring in the denial, and a total of five members (Circuit Judges Newman, Moore, O'Malley, Wallach, and Stoll) authored or joined opinions dissenting in the denial.
Last week, we reviewed the procedural history of the case and provided a brief summary of the eight concurring and dissenting opinions (see "Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)"). On Sunday, we reviewed the four opinions concurring in the Order's denial of the petition for rehearing en banc (see "Athena Diagnostics v. Mayo Collaborative Services -- The Concurrences"). In this post, we focus more closely on the four opinions dissenting in the Order's denial of the petition for rehearing en banc. As we noted last week, several of the dissenting authors disagreed with the concurring authors that Mayo compelled a finding of patent ineligibility in this case.
In the first dissent (which at just over twenty-two pages is the longest of the four dissents), Judge Moore, joined by Judges O'Malley, Wallach, and Stoll, disagrees with the majority of her colleagues that "believe that our hands are tied and that Mayo requires this outcome," indicating instead that "[t]he claims in this case should be held eligible, and they are distinguishable from Mayo." Judge Moore contends that the Court "should reconsider this case and clarify our precedent."
Judge Moore begins her opinion by noting that:
This is not a case in which the judges of this court disagree over whether diagnostic claims, like those at issue in Athena, should be eligible for patent protection. They should. None of my colleagues defend the conclusion that claims to diagnostic kits and diagnostic techniques, like those at issue, should be ineligible. The only difference among us is whether the Supreme Court's Mayo decision requires this outcome. The majority of my colleagues believe that our hands are tied and that Mayo requires this outcome. I believe Mayo does not.
Citing Cleveland Clinic Found. v. True Health Diagnostics LLC (Fed. Cir. 2019) ("Cleveland Clinic II"); Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC (Fed. Cir. 2019); Roche Molecular Sys., Inc. v. CEPHEID (Fed. Cir. 2018); Cleveland Clinic Found. v. True Health Diagnostics LLC (Fed. Cir. 2017) ("Cleveland Clinic I"); Genetic Techs. Ltd. v. Merial L.L.C. (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015); In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litig. (Fed. Cir. 2014); and PerkinElmer, Inc. v. Intema Ltd. (Fed. Cir. 2012), Judge Moore notes that "[s]ince Mayo, we have held every single diagnostic claim in every case before us ineligible," concluding that "[w]e have turned Mayo into a per se rule that diagnostic kits and techniques are ineligible." According to Judge Moore, the per se rule is a result of the Federal Circuit's "fervor for clarity and consistency." However, she does not fault her colleagues, "who under protest have concluded that they have no choice but to hold the claims in Athena ineligible because of Mayo," explaining that:
There is surely some broad language in Mayo which could lead to this conclusion. I, however, think we have extended Mayo too far. Reading the entirety of Mayo and the subsequent Myriad decision, the Supreme Court did not intend Mayo to be the "sweeping" decision my colleagues have concluded it is.
Nevertheless, her opinion calls of the members of the Court "to rethink our interpretation of Mayo."
In the second part of her opinion, Judge Moore asserts that "diagnostic techniques and kits when narrowly claimed are precisely the type of innovation the patent system exists to promote," pointing out that "[t]he importance of diagnostics and their cost-reducing effects on patient treatment cannot reasonably be questioned." She contends that "when there are specific advances, discoveries, or inventions in the diagnostics industry, they must be eligible for patent protection," explaining that:
Unless one opposes the notion of patent protection entirely, it cannot be reasonably disputed that claims to diagnostic kits and techniques, like pharmaceuticals, which require enormous initial investments in terms of both time and money, are the reason we suffer the promise of a monopoly. As many have explained, without patent protection, there will be little incentive for companies to invest the monumental amount of time and money necessary to develop diagnostic kits, tools and techniques.
Judge Moore concludes the second part of her opinion by stating that:
The math is simple, you need not be an economist to get it: Without patent protection to recoup the enormous R&D cost, investment in diagnostic medicine will decline. To put it simply, this is bad. It is bad for the health of the American people and the health of the American economy. And it is avoidable depending on our interpretation of the Supreme Court’s holding in Mayo.
Turning to Athena's claims in the third part of her opinion, Judge Moore declares that "[i]t is my view that § 101 and Mayo, when read together and in their entireties, compel the holding that the claims in Athena are eligible." Looking at Mayo, Judge Moore explains that:
The breadth and generality of the Mayo claims led to their demise, as they recited nothing more than the natural law. We have since ignored these considerations, treating every claim that includes a law of nature as directed to that law, even if the claim as a whole recites a specific way of applying that law of nature to a new and useful end.
And she concludes that "[t]he Athena claims differ significantly from the Mayo claims." In particular, she finds that "[t]he [Athena] claims are not directed to a natural law or phenomenon." More specifically, Judge Moore explains that:
Athena discovered that 20% of people suffering from MG [Myasthenia gravis] generate autoantibodies that bind to a MuSK protein. Its claims recite concrete steps to detect the presence of autoantibodies to MuSK to diagnose MG. These antibody/MuSK complexes had never been used by prior art MG diagnostic tests. In contrast, the claims in Mayo recited a generic "determining" step, with no laboratory test at all specified by the claims, and the specification itself stated that the methods were "well-understood, routine, and conventional activity already engaged in by the scientific community."
Judge Moore concludes her opinion by stating that she did "not believe that the Supreme Court intended Mayo to be the sweeping decision it has become," adding that:
I do not understand Mayo to render ineligible a claim which covers a specific, concrete application of a natural law simply because such a claim is diagnostic as opposed to therapeutic. Both should be eligible. The last word on this from the Supreme Court came in Myriad where the Court made clear "patents on new applications of knowledge about BRCA1 and BRCA2 genes" could be eligible. 569 U.S. at 596. To the extent that this Court has read Mayo so broadly that it precludes exactly that sort of patent, we have erred. Doing so leaves Mayo at odds with the patent statutes and the later Myriad decision.
As for diagnostic method claims, Judge Moore finds that their eligibility "is no longer uncertain," reiterating that "[s]ince Mayo, every diagnostic claim to come before this court has been held ineligible," and suggesting that there was no need for patentees "to waste resources with additional en banc requests," as "[y]our only hope lies with the Supreme Court or Congress."
In the second dissent (which a numbers just over thirteen pages), Judge Newman, who dissented in the panel decision, asserts in her opinion dissenting in the denial of the petition for rehearing en banc (which was joined by Judge Wallach) that:
The majority's position is a flawed interpretation of the Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). The Court did not hold that methods of diagnosis are subject to unique patent-eligibility rules. We have mistakenly enlarged the Court's holding, in substance and in application.
Judge Newman begins her opinion by noting that with respect to Athena's claims, "[t]he reaction between the specified antibodies and the MuSK protein was not previously known, and the specified claim steps had not previously been performed, separately or in combination." She then reminds that in Diamond v. Diehr, 450 U.S. 175, 188 (1981), the Supreme Court stressed that "[i]t is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis." Judge Newman states that "[t]his established rule does not evaporate when the subject matter is a diagnostic method," adding that "[t]he Mayo Court did not effect such a change."
According to Judge Newman, the Mayo Court also did not create a § 101 distinction between diagnostic methods and therapeutic methods. Nevertheless, she points to the Federal Circuit's "inconsistent rulings between diagnosis and treatment of disease," citing In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation (Fed. Cir. 2014); Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015); Genetic Technologies Ltd. v. Merial L.L.C. (Fed. Cir. 2016); Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2017); Roche Molecular Systems, Inc. v. CEPHEID (Fed. Cir. 2018); and Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2019), as examples of cases in which "the claims were held ineligible under section 101, whether or not the method of diagnosis was new and unobvious, and independent of patentability under sections 102, 103, and 112"; and citing Rapid Litigation Management Ltd. v. CellzDirect, Inc. (Fed. Cir. 2016); Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int'l Ltd. (Fed. Cir. 2018); Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC (Fed. Cir. 2019); and Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2019), as examples of cases in which method of treatment claims were held to be patent eligible.
As for the instant case, Judge Newman concludes by stating that:
This case presents an opportunity for judicial review and judicial remedy. Although diagnostic methods are not the only area in which section 101 jurisprudence warrants attention, Federal Circuit precedent is ripe for reconsideration specific to diagnostic methods, to correct our application of the Mayo decision and to restore the necessary economic incentive.
In the third dissent (which at three pages is the shortest of the four dissents), Judge Stoll, joined by Judge Wallach, contends that the Federal Circuit had, "[i]n a series of cases since the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), . . . established a bright-line rule of ineligibility for all diagnostic claims." While conceding that "[t]his rule as applied to the facts of this case dictated that the majority panel find the claimed invention ineligible," she asserts that "this court's bright-line rule is based on an over-reaching and flawed test for eligibility, a test that undermines the constitutional rationale for having a patent system—promoting the progress of science and useful arts," and therefore she concluds that the Federal Circuit "should take this opportunity to correct its erroneous rule."
Despite indicating that she "stand[s] by the panel decision in this case," Judge Stoll explains that her dissent is warranted "because the question of the eligibility of diagnostic inventions is exactly the type of exceptionally important issue that warrants full consideration by this court." She also states that:
En banc rehearing would not only permit us to have a more extensive view of the various considerations underlying Mayo, but it would also allow us to create judicial doctrine geared toward the practical application of Mayo's principles. At the very least, en banc review would help the court develop an articulable standard for its § 101 jurisprudence moving forward.
Judge Stoll concludes by declaring that "[i]n my view, by consistently bypassing en banc review of a critical issue that goes to the heart of this court's jurisdiction, we are abdicating our responsibility."
In the fourth and final dissent (which numbers five pages), Judge O'Malley agrees with her dissenting colleagues that the Federal Circuit's precedent "applies the Supreme Court's holding in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) too broadly." However, she also opines that:
[C]onfusion and disagreements over patent eligibility have been engendered by the fact that the Supreme Court has ignored Congress's direction to the courts to apply 35 U.S.C. sections 101, et seq ("Patent Act") as written. Specifically, 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. I encourage Congress to amend the Patent Act once more to clarify that it meant what it said in 1952.
Judge O'Malley begins her opinion by providing some "historical perspective" on "the 'invention requirement'—itself 'invented' by the Supreme Court rather than Congress or the Constitution," noting that "[i]f the invention requirement and its criticisms sound familiar, that is because they are." And Judge O'Malley suggests that even though, in 1952, "Congress attempted to address these criticisms by amending the Patent Act to replace the ill-defined and judicially-created invention requirement with the more workable anticipation and obviousness tests codified in Sections 102 and 103," "the search for an inventive concept—now enshrined in the § 101 inquiry via Mayo—calls back to the invention requirement that Congress quite deliberately abrogated through the Patent Act of 1952."
Judge O'Malley wonders whether the outcome in Athena would be different "[h]ad the Supreme Court not disregarded Congress's wishes for a second time." She concludes by stating that:
Because the Supreme Court judicially revived the invention requirement and continues to apply it despite express abrogation, I dissent to encourage Congress to clarify that there should be no such requirement read into § 101; to clarify that concepts of novelty and "invention" are to be assessed via application of other provisions of the Patent Act Congress designed for that purpose.
