Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)

By Donald Zuhn --

Last week, 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.

Before turning to the eight opinions concurring or dissenting in the Order's denial of the petition for rehearing en banc, it may be helpful to review the procedural history of this case.  In February, a divided panel affirmed a decision by the District Court for the District of Massachusetts, holding claims 6-9 of U.S. Patent No. 7,267,820 invalid under 35 U.S.C. § 101, and dismissing under Fed. R. Civ. P. 12(b)(6) a complaint filed by Plaintiffs-Appellants for infringement of the '820 patent.

Athena Diagnostics is the exclusive licensee of the '820 patent, which is directed to methods for diagnosing neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase (MuSK).  Athena markets a test called FMUSK that functions by evaluating those antibodies.  After Mayo developed two competing tests, Athena filed suit against Mayo for infringement of the '820 patent, and Mayo moved to dismiss under Rule 12(b)(6), arguing that the asserted claims of the '820 patent were invalid under § 101 for claiming patent ineligible subject matter.  The District Court granted Mayo's motion, and Athena appealed for a determination of whether claims 6-9 are patent eligible under § 101.

The '820 patent notes that about 80% of patients with Myasthenia gravis (MG) produce acetylcholine receptor autoantibodies, and that the remaining 20% do not.  The named inventors of the '820 patent discovered that many of the 20% of MG patients without acetylcholine receptor autoantibodies instead generate autoantibodies to MuSK.  The '820 patent discloses and claims methods of diagnosing neurological disorders such as MG by detecting autoantibodies that bind to a MuSK epitope.  The '820 patent contains only one independent claim, which, while not at issue in the case, recites:

1.  A method for diagnosing neurotransmission or developmental disorders related to muscle specific tyrosine kinase (MuSK) in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of muscle specific tyrosine kinase (MuSK).

Claims 6-9, which were at issue in the case, recite:

6.  A method according to claim 3 whereby the intensity of the signal from the anti-human IgG antibody is indicative of the relative amount of the anti-MuSK autoantibody in the bodily fluid when compared to a positive and negative control reading.

7.  A method according to claim 1, comprising contacting MuSK or an epitope or antigenic determinant thereof having a suitable label thereon, with said bodily fluid, immunoprecipitating any antibody/MuSK complex or antibody/MuSK epitope or antigenic determinant complex from said bodily fluid and monitoring for said label on any of said antibody/MuSK complex or antibody/MuSK epitope or antigen determinant complex, wherein the presence of said label is indicative of said mammal is suffering from said neurotransmission or developmental disorder related to muscle specific tyrosine kinase (MuSK).

8.  A method according to claim 7 wherein said label is a radioactive label.

9.  A method according to claim 8 wherein said label is 125I.

In the panel opinion, authored by Judge Lourie and joined by Judge Stoll (with Judge Newman dissenting), the Court affirmed the District Court's determination that claims 6-9 are invalid under § 101.  The panel majority "ultimately agree[d] with Mayo that, under Mayo [Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 70 (2012)], the claims are directed to a natural law," and that in the instant case, the natural law "is the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK related neurological diseases like MG."  The panel majority also agreed with Mayo that "the steps of the claims not drawn to ineligible subject matter, whether viewed individually or as an ordered combination, only require standard techniques to be applied in a standard way."  In a lengthy footnote, the panel majority responded to Judge Newman's dissent by explaining that:

The dissent states much that one can agree with from the standpoint of policy, and history, including that "the public interest is poorly served by adding disincentive to the development of new diagnostic methods."  We would add further that, in our view, providing patent protection to novel and non-obvious diagnostic methods would promote the progress of science and useful arts.  But, whether or not we as individual judges might agree or not that these claims only recite a natural law, . . . the Supreme Court has effectively told us in Mayo that correlations between the presence of a biological material and a disease are laws of nature, and "[p]urely 'conventional or obvious' '[pre]-solution activity' is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law," . . . .  Our precedent leaves no room for a different outcome here [citations omitted].

In her dissent, Judge Newman declared that "[t]he court again departs from the cautious restraints in the Supreme Court's Mayo/Alice application of laws of nature and abstract ideas," adding that "[t]his court's decisions on the patent-ineligibility of diagnostic methods are not consistent, and my colleagues today enlarge the inconsistencies and exacerbate the judge-made disincentives to development of new diagnostic methods, with no public benefit."  She contended that "[t]he '820 inventors did not patent their scientific discovery of MuSK autoantibodies," but rather "applied this discovery to create a new method of diagnosis, for a previously undiagnosable neurological condition."

Turning to the eight opinions concurring or dissenting in the Order's denial of the petition for rehearing en banc, the general theme of the concurrences is that the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. left the members of the Court with no choice other than to deny the petition:

• Judge Lourie, joined by Judges Reyna and Chen, declared that the Court "can accomplish little in [rehearing the case en banc], as we are bound by the Supreme Court's decision in Mayo," adding that:

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," as Judge Lourie stated, "we do not write here on a clean slate; we are bound by Supreme Court precedent."

• Judge Hughes, joined by Chief Judge Prost and Judge Taranto, noted that "[t]he 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."  However, he also noted that while "the bottom line for diagnostics patents is problematic . . . this is not a problem that we can solve," adding that "[a]s an inferior appellate court, we are bound by the Supreme Court."

• Judge Dyk, joined by Judges Hughes and Chen (with Judge Chen only joining the last three parts of the concurrence), pointed out (to begin Part IV of his opinion) that:

[T]here is tension between Mayo and the Supreme Court's later decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and that the holding of Mayo may be overbroad.  The language of § 101 does cover "discover[ies]," 35 U.S.C. § 101, and there is no doubt that determining the relationship between specific genetic abnormalities and specific diseases constitutes an important discovery with proven utility.  There is much to be said for the patentability of claims to such discoveries, if not drafted overbroadly.

• Judge Chen stated that "[w]hile I believe our court would benefit from the Supreme Court's guidance as to whether it intended to override central tenets of [Diamond v.] Diehr [450 U.S. 175 (1981)], Mayo's reasoning is clear and we are bound by it," adding that the analysis in Mayo "requires the affirmance of the district court’s decision to invalidate Athena's claims." Judge Chen concluded his opinion by noting that "[e]ven though Athena's claims likely would be found patent-eligible under Diehr's framework, it is not an inferior court's role to dodge the clear, recent direction of the Supreme Court."

Several of the dissenting authors disagreed with the concurring authors that Mayo compelled a finding of patent ineligibility in this case:

• Judge Moore, joined by Judges O'Malley, Wallach, and Stoll, disagreed with "[t]he majority of my 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 contended that the Court "should reconsider this case and clarify our precedent."

• Judge Newman, who dissented in the panel decision, asserted in her dissenting opinion (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 Stoll, joined by Judge Wallach, contended 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 asserted 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 concluded that the Federal Circuit "should take this opportunity to correct its erroneous rule."

• While Judge O'Malley agreed with her dissenting colleagues that Federal Circuit precedent "applies the Supreme Court's holding in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) too broadly," she also opined 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.

In subsequent posts, we will focus more closely on the concurring and dissenting opinions.

Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)
Per curiam
Circuit Judge Lourie concurring in the denial of the petition for rehearing en banc, joined by Circuit Judges Reyna and Chen;
Circuit Judge Hughes concurring in the denial of the petition for rehearing en banc, joined by Chief Judge Prost and Circuit Judge Taranto;
Circuit Judge Dyk concurring in the denial of the petition for rehearing en banc, joined by Circuit Judge Hughes and joined as to Parts IV, V, and VI by Circuit Judge Chen;
Circuit Judge Chen concurring in the denial of the petition for rehearing en banc;
Circuit Judge Moore dissenting from the denial of the petition for rehearing en banc, joined by Circuit Judges O'Malley, Wallach, and Stoll;
Circuit Judge Newman dissenting from the denial of the petition for rehearing en banc, joined by Circuit Judge Wallach;
Circuit Judge Stoll dissenting from the denial of the petition for rehearing en banc, joined by Circuit Judge Wallach;
Circuit Judge O'Malley dissenting from the denial of the petition for rehearing en banc.

Comments

[EG]

Hey Don,

Now that all 12 Federal Circuit judges have said such diagnostic methods should be eligible under 101 but for the nonsensical Mayo decision, SCOTUS needs to take the eventual petition for cert and fix the mess that they've created. That SCOTUS failed to do so in the earlier Sequenom case is utterly irresponsible on their part.

[Skeptical]

What
A
Mess.

The last time that I saw such a discordant cacophony from the ensembled CAFC was the en banc "decision" in the Alice case.

Of course, that case then went up to the Supreme Court, which promptly made matters worse.

[Sean Brennan]

"...the Supreme Court has effectively told us in Mayo that correlations between the presence of a biological material and a disease are laws of nature"
I didn't know the Supreme Court were scientific experts - quite a multi-talented bunch!

[Skeptical]

It gets even better, Sean. Since ALL medication utility merely comes from the body’s response to whatever it is that has been given to it, the effective utility is thus nullified from having any patentable weight under 35 USC 101 (after all, all that is happening is the body is only following “laws of nature” in creating any metabolite (or any metabolic action). ;-p

[Atari Man]

Her colleagues still don't get it: when Judge Newman dissents, it means the majority got it wrong.