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

By Donald Zuhn –-

Last week, in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, the Federal Circuit affirmed the 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.  The Federal Circuit also affirmed the District Court's dismissal under Fed. R. Civ. P. 12(b)(6) of a complaint filed by Athena Diagnostics, Inc., Oxford University Innovation Ltd., and the Max-Planck-Gesellschaft zur Forderung der Wissenschaften E.V. against Mayo Collaborative Services, LLC 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 affirming the District Court's determination that claims 6-9 are invalid under § 101, Judge Lourie, joined by Judge Stoll (with Judge Newman dissenting) begins by noting that "[u]nder the law as set forth by the Supreme Court, § 101, while broad, 'contains an important implicit exception,'" namely that laws of nature, natural phenomena, and abstract ideas are not patentable, citing Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 70 (2012) (quoting Diamond v. Diehr, 450 U.S. 175, 185 (1981)).  The panel majority also notes that while "[l]aws of nature are not patentable, . . . applications of such laws may be patentable," and sets forth the Supreme Court's two-part test for "distinguish[ing] claims to patent-eligible applications of laws of nature from claims that impermissibly tie up such laws":

First, we examine whether the claims are "directed to" a law of nature.  If they are, then we proceed to the second inquiry, where we ask whether the limitations of the claim apart from the law of nature, considered individually and as an ordered combination, "'transform the nature of the claim' into a patent-eligible application" [citations omitted].

On appeal, Athena argued that claims 7-9 are patent eligible because they recite innovative, specific, and concrete steps that do not preempt a natural law and are directed to a new laboratory technique that makes use of man-made molecules.  Mayo responded that the asserted claims are directed to a natural law, namely, the correlation between naturally-occurring MuSK autoantibodies and MuSK-related neurological diseases like MG, that the remaining steps apart from the natural law are standard immunoassay techniques that still leave the claims directed to a natural law, and that it makes no difference with respect to patent eligibility whether the claimed diagnostic method uses man-made materials.  The panel majority "ultimately agree[d] with Mayo that, under Mayo, 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."  With regard to Athena's argument that the claimed methods make use of man-made molecules, the opinion "reaffirm[s] that use of a man-made molecule in a method claim employing standard techniques to detect or observe a natural law may still leave the claim directed to a natural law."

Before turning to step two of the Mayo/Alice test, the panel majority took a moment "to note the difference between the claims before us here, which recite a natural law and conventional means for detecting it, and applications of natural laws, which are patent-eligible," specifically citing the Court's decision in Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018).  In particular, the opinion points out that "[c]laiming a natural cause of an ailment and well-known means of observing it is not eligible for patent because such a claim in effect only encompasses the natural law itself," and notes that "claiming a new treatment for an ailment, albeit using a natural law, is not claiming the natural law."  The panel majority also includes a lengthy footnote in response to Judge Newman's dissent:

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].

With regard to step two of the Mayo/Alice test, Athena argued that the claims provide an inventive concept, namely, an innovative sequence of steps involving man-made molecules, and that the existence of factual disputes precluded dismissal under Rule 12(b)(6).  Mayo countered that the claims lack an inventive concept because the specification describes the steps for detecting MuSK autoantibodies as standard techniques in the art, and that no factual issues precluded dismissal under Rule 12(b)(6).  The panel majority 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 response to Athena's assertion that the claimed steps were unconventional because they had not been applied to detect MuSK autoantibodies prior to Athena’s discovery of the correlation between MuSK autoantibodies and MG, the panel majority concludes that "we cannot hold that performing standard techniques in a standard way to observe a newly discovered natural law provides an inventive concept."

Following its analysis of claims 7-9, the panel majority next considers claim 6, noting that while the former claims recite a radioimmunoassay, the latter recites an ELISA method.  Noting that Athena did not make any particularized arguments regarding claim 6 at trial, the panel majority "agree[d] with Mayo that Athena waived its arguments specific to claim 6 by not making them before the district court," adding that "[e]ven if we had reached the issue, we would hold claim 6 ineligible."  Finding that "claims 6–9 of the '820 patent recite only a natural law together with conventional steps to detect that law," and therefore are patent ineligible under § 101, the panel majority affirmed the judgment of the District Court.

In a dissent that runs a little more than fourteen pages (five and a half pages less than the majority opinion), Judge Newman begins by declaring 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 contends 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."

Judge Newman argues that the majority's "analysis of patent-eligibility is incorrect," noting that "[e]ligibility is determined for the claim considered as a whole, including all its elements and limitations," and cites Diehr, 450 U.S. at 188, for the proposition 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."  She points out, therefore, that "[i]t is incorrect to excise from the claims any steps that are performed by conventional procedures," asserting that "[t]his is misconstruction of claims, and misapplication of Section 101."  With respect to the claims at issue, Judge Newman concludes that:

Applied to the '820 patent, the claimed method is a new method of diagnosing Myasthenia Gravis.  After eliminating the "conventional" procedures, my colleagues rule that this new method is a "law of nature."  However, these inventors are not claiming the scientific fact of a newly described autoantibody; they are claiming a new multi-step diagnostic method.  This is not a law of nature, but a man-made reaction sequence employing new components in a new combination to perform a new diagnostic procedure.

Judge Newman also contends that "Section 101 does not exclude new methods of diagnosis of human ailments."

The dissent concludes with a discussion of the amici curiae briefs (five of which were submitted for the Court's consideration).  Noting that "[t]his court's decisions have not been consistent," Judge Newman declares that "[a]mici curiae point out that the public interest is poorly served by adding disincentive to the development of new diagnostic methods," asserting that "[t]his is a severe criticism; and when presented by the entire industry, and stressed by thoughtful scholars, it warrants judicial attention."  In particular, she argues that "[t]he judicial obligation is to provide stable, consistent application of statute and precedent, to implement the legislative purpose."  Judge Newman concludes by stating that:

[F]or procedures that require extensive development and federal approval, unpredictability of patent support is a disincentive to development of new diagnostic methods.  The loser is the afflicted public, for diagnostic methods that are not developed benefit no one.

Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)
Panel: Circuit Judges Newman, Lourie, and Stoll
Opinion by Circuit Judge Lourie; dissenting opinion by Circuit Judge Newman

Comments

[EG]

Hey Don,

Another horrible decision by the Federal Circuit which is eventually going to doom any research or development of diagnostics. Even the majority agrees with Newman's dissent that SCOTUS' Mayo decision is awful, but hasn't got the guts to challenge it. The Federal Circuit, as a whole, simply needs to buck the application of the ill-advised and nonsensical Mayo decision to medical diagnostics and dare SCOTUS to take cert to fix the mess it's created.

[Skeptical]

EG,

I would have to distinguish your view by pointing out a deeper and more pernicious take on the current case.

To say "we have no choice" is a L I E.

Not only IS there such choice, but given the (growing awareness) that such choices HAVE BEEN MADE in a seriously growing sense of contradictions (as I have noted with the occasional "ping pong" comments), there is a more fundamental problem with how Common Law has intersected (and in actuality, scrivined over) the statutory law.

There IS a lack of guts for challenging the Supreme Court.

That lack of guts is NOT limited to the CAFC.

As I have ALSO noted, every attorney (outside of arguably the attorneys under the State Oath of Massachusetts), has a DUTY to not put the Supreme Court ABOVE the Constitution (and thus, to speak out when the Supreme Court has acted improperly).

[Cass L. Singer]

One ignores Newman at one's peril.

Having said that ... yes, Mayo was a bad decision, but a successful challenge or reversal needs to take some history and neo-reactionary judicial philosophy into account.

Mayo conflated the subject-matter and obviousness tests of the common law. Congress explicitly separated them in 101 and 103 of the 1952 act.

However ... the 1952 act was intended to codify the common law. It can be argued (very wrongly, IMO) that Congress did not intend to and did not change the interaction between the two.

SCOTUS got off track when, ten years ago, J. Thomas suggested in dictum there was a constitutional standard for obviousness. Mayo explicitly held there was one for subject matter.

The mess has been coming for a long time, kids. The answer isn't challenge, it's replace.