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IP Alert: Federal Circuit Affirms Athena's Diagnostic Method Claims to Be Patent Ineligible Under Section 101

February 19, 2019

On February 6, in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, the Federal Circuit issued an important decision under the “natural law” exception to patentability under 35 U.S.C. § 101. Holding that patent claims drawn to a method for diagnosing neurological disorders were invalid, the court gave guidance on how it will analyze such “method of treatment” claims in future decisions. Significantly, this decision by the Federal Circuit comports with earlier Federal Circuit decisions where patent claims directed to methods for diagnosing were found to be patent-ineligible under the test established by the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (“Prometheus”).

Athena Diagnostics is the exclusive licensee of U.S. Patent No. 7,267,820, which covers methods for diagnosing neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase (“MuSK”). Athena also markets a test called “FMUSK” that functions by evaluating those antibodies. After Mayo established two competing diagnostic tests, Athena sued Mayo for infringement. The district court granted Mayo’s motion to dismiss under Rule 12(b)(6), concluding that the claims were invalid under § 101 for claiming ineligible subject matter. The Federal Circuit appeal was solely concerned with the questions of whether dependent claims 6–9 of the ’820 patent are eligible subject matter under § 101.

On appeal, the Federal Circuit affirmed the district court decision in a split decision. The majority held that the “district court correctly concluded that the claims at issue are directed to a natural law.” The majority did so after applying the two-part test established by the Supreme Court in Prometheus: (1) whether the claim at issue is directed to a law of nature, and if so, (2) whether the limitations of the claim apart from the law of nature, considered both individually and as an ordered combination, “transform the nature of the claim into a patent-eligible application” (i.e., whether the additional limitations amount to “significantly more” than the natural law itself).

Using this test, the Federal Circuit analyzed the following claims of the ’820 patent:

(Claim not at issue on appeal): 1. A method for diagnosing neurotransmission or developmental disorders related to [MuSK] in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of [MuSK].

(Claim at issue on appeal): 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 [MuSK].

(Claim at issue on appeal): 8. A method according to claim 7 wherein said label is a radioactive label.

(Claim at issue on appeal): 9. A method according to claim 8 wherein said label is 125I.

Athena argued that claims 7–9 are not directed to a natural law at step one because they recite innovative, specific, and concrete steps that do not preempt a natural law. Rather, Athena contended that the claims are directed to a new laboratory technique that makes use of manmade molecules. Mayo responded that the claims are directed to a natural law, namely, the correlation between naturally occurring MuSK autoantibodies and MuSK-related neurological diseases such as myasthenia gravis (“MG”).

With respect to the first inquiry, the majority agreed with Mayo in that the asserted claims were directed to a natural law, namely, the “correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological diseases like MG.” Even with respect to dependent claim 9, which was acknowledged to be “the most specific claim at issue,” the majority concluded, with citations to Cleveland Clinic Found. v. True Health Diagnostics LLC and Ariosa Diagnostics, Inc. v. Sequenom, Inc., that “the claimed advance was only in the discovery of a natural law, and that the additional recited steps only apply conventional techniques to detect that natural law.” Notably, the majority pointed out that “the specification [of the ’820 patent] describes the claimed concrete steps for observing the natural law as conventional.”

Athena argued that the claims at issue, like the claims in Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., were directed to an innovative laboratory technique instead of a law of nature. However, the majority pointed out that “Athena does not point to any innovation other than its discovery of the natural law,” and it distinguished CellzDirect, asserting that in CellzDirect, “the ‘end result’ of the claims at issue was ‘not simply an observation or detection’ of a natural law,” whereas the claims at issue in the present case “only involve detecting a natural law ‘with no meaningful non-routine steps.’”

Athena also argued that the claims at issue differ from prior diagnostic claims held ineligible under § 101 because the claims at issue require labeling MuSK with a manmade substance. The majority disagreed, pointing out that the use of a manmade molecule is not decisive if it amounts to only a routine step in a conventional method for observing a natural law, and reaffirming that use of a manmade 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.

The majority was careful to distinguish claims at issue, which “recite a natural law and conventional means for detecting it,” from the claims at issue in Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd. According to the majority, the claims there were directed to “applications of natural laws, which are patent-eligible.” In particular, the majority pointed 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. But claiming a new treatment for an ailment, albeit using a natural law, is not claiming the natural law.”

With respect to step two of the Prometheus test, Athena argued that the claims provided an inventive concept, namely an innovative sequence of steps involving manmade molecules. The majority disagreed, pointing out that the specification of the ’820 patent “plainly states that ‘[t]he actual steps of detecting autoantibodies in a sample of bodily fluids may be performed in accordance with immunological assay techniques known per se in the art,’ such as radioimmunoassays,” and that “Iodination and immunoprecipitation are likewise described as standard techniques.” The majority pointed out that the Federal Circuit decisions in CellzDirect and BASCOM Glob. Internet Servs., Inc. v. AT&T Mobility LLC are consistent with the principle that applying standard techniques in a standard way to observe a natural law does not provide an inventive concept, and held that “the inventive concept necessary at step two [of the Prometheus test] cannot be furnished by the unpatentable law of nature itself.”

The majority dismissed Athena’s argument that the claims recite an inventive concept because they use a manmade molecule, i.e., labeled “MuSK,” stating that the claims at issue here are distinguishable from the claims found to be patent-eligible by the Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., since they were directed to a new composition of matter and not a natural product. Finally, the majority concluded that appending labeling techniques to a natural law does not provide an inventive concept where, as here, the specification describes 125I labeling as a standard practice in a well-known assay. In view of the foregoing, the majority held that because claims 6–9 of the ’820 patent recite only a natural law together with conventional steps to detect that law, they are ineligible under § 101.

Judge Newman dissented, asserting that the majority “again departs from the cautious restraints in the Supreme Court’s Mayo [v. Prometheus]/Alice application of laws of nature and abstract ideas.” In her view, the majority had incorrectly applied step one of the Prometheus test by failing to consider the claimed diagnostic method “as a whole.” In her view, the claims of the ’820 patent were patent-eligible under step one because the claimed “method of diagnosing Myasthenia Gravis is not a law of nature, but a man-made chemical-biomedical procedure.” She also stated that even if the claimed techniques were conventional, the “appropriate analysis of the role of conventional process steps in claims to a new method is under Sections 102 and 103, not Section 101.” 

The present Athena decision is significant in that it shows the Federal Circuit’s continued inclination to hold diagnostic method claims patent ineligible under 35 U.S.C. § 101. The Athena decision also highlights the potentially critical importance of the specification on the issue of patent eligibility. In applying both steps one and two of the Prometheus
test against the patent holder, the majority relied on the specification statements that immunological assay techniques are “known per se in the art” and “standard.”

For more information on this case, please contact Fitch Even partner David M. Kogan, author of this alert.

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