Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC

927 F.3d 1333 (Mem)

ATHENA DIAGNOSTICS, INC., Oxford University Innovation LTD., Max-Planck-Gesellschaft Zur Forderung Der Wissenschaften E.V., Plaintiffs-Appellants

v.MAYO COLLABORATIVE SERVICES, LLC, dba Mayo Medical Laboratories, Mayo Clinic, Defendants-Appellees

2017-2508

United States Court of Appeals, Federal Circuit.

Date July 3, 2019

ORDER

Per Curiam.

A petition for rehearing en banc was filed by appellants Athena Diagnostics, Inc., Oxford University Innovation Ltd., and the Max-Planck-Gesellschaft zur Forderung der Wissenschaften E.V. A response to the petition was invited by the court and filed by appellees Mayo Collaborative Services, LLC and Mayo Clinic. Several motions for leave to file amici curiae briefs were filed and granted by the court. The petition for rehearing, response, and amici curiae briefs were first referred to the panel that heard the appeal, and thereafter, to the circuit judges who are in regular active service. A poll was requested, taken, and failed.

Upon consideration thereof,

IT IS ORDERED THAT :

1) The petition for panel rehearing is denied.

2) The petition for rehearing en banc is denied.

3) The mandate of the court will issue on July 10, 2019.

FOR THE COURT

Lourie, Circuit Judge, with whom Reyna and Chen, Circuit Judges, join, concurring in the denial of the petition for rehearing en banc.

I concur in the court's decision not to rehear this case en banc. In my view, we can accomplish little in doing so, as we are bound by the Supreme Court's decision in Mayo. Some of us have already expressed our concerns over current precedent. E.g. , Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC , 915 F.3d 743, 753 n.4 (Fed. Cir. 2019) ; Ariosa Diagnostics, Inc. v. Sequenom, Inc. , 809 F.3d 1282, 1284 (Fed. Cir. 2015) (Lourie, J., concurring in the denial of rehearing en banc); id. at 1287 (Dyk, J., concurring in the denial of rehearing en banc).

If I could write on a clean slate, I would write as an exception to patent eligibility, as respects natural laws, only claims directed to the natural law itself, e.g. , E=mc2, F=ma, Boyle's Law, Maxwell's Equations, etc. I would not exclude uses or detection of natural laws. The laws of anticipation, obviousness, indefiniteness, and written description provide other filters to determine what is patentable.

But we do not write here on a clean slate; we are bound by Supreme Court precedent. In Mayo Collaborative Services v. Prometheus Laboratories, Inc. , the claims at issue were held by the Court to be directed to the relationship between the concentration of metabolites in the blood and the likelihood that a drug dose will be ineffective, which it referred to as a law of nature. 566 U.S. 66, 74–75, 77, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012). The other steps—administering a drug and detecting the level of a specific metabolite—added only "[p]urely ‘conventional or obvious’ ‘[pre]-solution activity’ " that was "not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law." Id. at 79, 132 S.Ct. 1289 (second alteration in original) (quoting Parker v. Flook , 437 U.S. 584, 590, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978) ); see Bilski v. Kappos , 561 U.S. 593, 610–11, 130 S.Ct. 3218, 177 L.Ed.2d 792 (2010) ("[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant postsolution activity.’ " (quoting Diamond v. Diehr , 450 U.S. 175, 191–92, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981) )); Flook , 437 U.S. at 590, 98 S.Ct. 2522 ("The notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance."). Because the claims recited only what the Court called a natural law together with well-understood, conventional activity, the Court concluded the claims were ineligible under § 101. Mayo , 566 U.S. at 73, 79–80, 132 S.Ct. 1289.

In applying Mayo , we have accordingly held claims focused on detecting new and useful natural laws with conventional steps to be ineligible. E.g. , Cleveland Clinic Found. v. True Health Diagnostics LLC , 859 F.3d 1352, 1363 (Fed. Cir. 2017), cert. denied , ––– U.S. ––––, 138 S. Ct. 2621, 201 L.Ed.2d 1026 (2018) ; Ariosa Diagnostics, Inc. v. Sequenom, Inc. , 788 F.3d 1371, 1378 (Fed. Cir. 2015), cert. denied , ––– U.S. ––––, 136 S. Ct. 2511, 195 L.Ed.2d 841 (2016). In Cleveland Clinic , the claims recited a specific assay to detect the protein MPO, the enzyme-linked immunosorbent assay. 859 F.3d at 1357–58, 1362. Ariosa similarly involved a specific technique to amplify and detect DNA, the polymerase chain reaction. 788 F.3d at 1377. But in both cases, the patents' specifications described these techniques as well-understood and conventional. Cleveland Clinic , 859 F.3d at 1355 ; Ariosa , 788 F.3d at 1377. We concluded that using these routine assays to detect new natural phenomena did not transform the claims into patent eligible applications. Cleveland Clinic , 859 F.3d at 1362–63 ; Ariosa , 788 F.3d at 1376–77.

In contrast, new method of treatment patents do not fall prey to Mayo 's prohibition. E.g. , Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd. , 887 F.3d 1117, 1136 (Fed. Cir. 2018). Nor have unconventional arrangements of known laboratory techniques, even if directed to a natural law. Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc. , 827 F.3d 1042, 1051 (Fed. Cir. 2016). But this case involves neither scenario. Athena's claims recite observing a natural law using a radioimmunoassay that the specification describes as "standard" and "known per se in the art." U.S. Patent 7,267,820 col. 3 ll. 33–37, col. 4 ll. 10–12. The claims do not recite a new method of treatment or an unconventional combination of steps to detect the natural law. The only unconventional aspect is the inventors' discovery of what the Supreme Court would call the natural law—the correlation between MuSK autoantibodies and the neurological disorder myasthenia gravis —but we cannot premise eligibility solely on the natural law's novelty. Mayo , 566 U.S. at 73, 132 S.Ct. 1289 (concluding that "the steps in the claimed processes (apart from the natural laws themselves ) involve well-understood, routine, conventional activity previously engaged in by researchers in the field" (emphasis added)); Flook , 437 U.S. at 591–92, 98 S.Ct. 2522 ("[T]he novelty of the mathematical algorithm is not a determining factor at all" and "is treated as though it were a familiar part of the prior art."). Under Supreme Court precedent, I do not believe that specific yet purely conventional detection steps impart eligibility to a claim that otherwise only sets forth what the Court has held is a natural law. That is the situation presented in Ariosa , Cleveland Clinic , and now Athena . Accordingly, as long as the Court's precedent stands, the only possible solution lies in the pens of claim drafters or legislators. We are neither.

Amici and others have complained that our eligibility precedent is confused. However, our cases are consistent. They have distinguished between new method of treatment claims and unconventional laboratory techniques, on the one hand, and, on the other hand, diagnostic methods that consist of routine steps to observe the operation of a natural law, a clear line. Beyond that, I do not see a way clear to distinguish Mayo in a useful, principled, fashion. Software is another matter, but such patents are not before us here.

I therefore concur in the decision of the court not to take this case en banc because I do not believe we can convincingly distinguish Mayo in this case.

Hughes, Circuit Judge, with whom Prost, Chief Judge, and Taranto, Circuit Judge, join, concurring in the denial of the petition for rehearing en banc.

The multiple concurring and dissenting opinions regarding the denial of en banc rehearing in this case are illustrative of how fraught the issue of § 101 eligibility, especially as applied to medical diagnostics patents, is. I agree that the language in Mayo , as later reinforced in Alice , forecloses this court from adopting an approach or reaching a result different from the panel majority's. I also agree, however, that the bottom line for diagnostics patents is problematic. But this is not a problem that we can solve. As an inferior appellate court, we are bound by the Supreme Court.

I, for one, would welcome further explication of eligibility standards in the area of diagnostics patents. Such standards could permit patenting of essential life saving inventions based on natural laws while providing a reasonable and measured way to differentiate between overly broad patents claiming natural laws and truly worthy specific applications. Such an explication might come from the Supreme Court. Or it might come from Congress, with its distinctive role in making the factual and policy determinations relevant to setting the proper balance of innovation incentives under patent law.

Dyk, Circuit Judge, with whom Hughes, Circuit Judge, joins, and with whom Chen, Circuit Judge, joins as to Parts IV, V, and VI, concurring in the denial of the petition for rehearing en banc.

I

In the realm of abstract ideas, the Mayo / Alice framework has successfully screened out claims that few would contend should be patent eligible, for example, those that merely apply well-known business methods and other processes using computers or the Internet.¹ The Mayo / Alice framework has thus proven to be both valuable and effective at invalidating overly broad, non-inventive claims that would effectively "grant a monopoly over an abstract idea." Alice Corp. v. CLS Bank Int'l , 573 U.S. 208, 216, 134 S.Ct. 2347, 189 L.Ed.2d 296 (2014) (quoting Bilski v. Kappos , 561 U.S. 593, 611–612, 130 S.Ct. 3218, 177 L.Ed.2d 792 (2010) ). As the Supreme Court has recognized, the concern with such patents is that ...