District Court Finds Diagnostic Claims to Be Directed to Patent Ineligible Subject Matter
Last week, in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, District Judge Indira Talwani of the U.S. District Court for the District of Massachusetts dismissed a complaint filed by Plaintiffs Athena Diagnostics, Inc., Isis Innovation Ltd., and Max-Planck-Gesellschaft zur Forderung der Wissenschaften e.V. ("Athena") that two diagnostic tests developed by Defendants Mayo Collaborative Services, LLC and Mayo Clinic ("Mayo") infringed Athena's U.S. Patent No. 7,267,820. Mayo had filed a Renewed Motion to Dismiss Athena's complaint, arguing that that the '820 patent was invalid under 35 U.S.C. § 101 because the claimed method applies routine and conventional techniques to a law of nature.
The '820 patent relates to the diagnosis of Myasthenia Gravis, a chronic autoimmune disorder. In particular, the methods of the '820 patent allow for the diagnosis of the 20% of Myasthenia Gravis patients who do not have acetyle choline receptor autoantibodies, by detecting muscle specific tyrosine kinase ("MuSK") autoantibodies instead. The inventors of the '820 patent had discovered that a portion of Myasthenia Gravis patient population had IgG antibodies that bind the N-terminal domains of MuSK, a receptor located on the surface of neuromuscular junctions. Claims 6-9 of the '820 patent, which depend directly or indirectly from claims 1-3, were at issue in the case. Claims 1-3 and 6-9 are set forth below:
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).
2. A method according to claim 1 wherein said method comprises the steps of:
a) contacting said bodily fluid with muscle specific tyrosine kinase (MuSK) or an antigenic determinant thereof: and
b) detecting any antibody-antigen complexes formed between said receptor tyrosine kinase or an antigenic fragment thereof and antibodies present in said bodily fluid, wherein the presence of said complexes is indicative of said mammal suffering from said neurotransmission or development disorders.
3. A method according to Claim 2 wherein said antibody-antigen complex is detected using an anti-IgG antibody tagged or labeled with a reporter molecule.
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.
Mayo moved to dismiss Athena's complaint on the ground that the '820 patent seeks to claim a law of nature and uses techniques that are standard in the art. Athena argued that the asserted claims of the '820 patent are not directed to a law of nature because those claims require the use of a non-naturally occurring protein, 125I-MuSK, and that applying various known types of procedures to a non-naturally occurring protein transforms the claim and makes it patent eligible.
In deciding whether the asserted claims of the '820 patent are directed to patent-ineligible subject matter, the District Court applied the two-step analysis set forth in Mayo Collaborative Servs. v. Prometheus Labs., Inc. and Alice Corp. Pty. Ltd. v. CLS Bank Int'l. In the first step, the court determines whether the claims are directed to a law of nature, natural phenomenon, or abstract idea. If the answer to this first inquiry is "yes," then the court must determine whether the elements of the claim individually, or as an ordered combination, transform the nature of the claim into a patent-eligible application. Noting that the Supreme Court in Mayo described the second inquiry "as a search for an 'inventive concept' – i.e., an element or combination of elements that is 'sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself," the District Court indicated that "[a]t step two, more is required than well-understood, routine, conventional activity already engaged in by the scientific community."
With respect to the step one inquiry, Mayo argued that the law of nature to which the '820 patent was directed was that the bodily fluid of some people with Myasthenia Gravis have autoantibodies to MuSK. Athena countered that "the claims are not directed to MuSK . . . [i]nstead, the claims recite using a man-made chemically-modified version of MuSK [i.e., 125I-MuSK] to form a specific complex that does not occur in nature." In determining that the asserted claims are directed to a patent ineligible law of nature under § 101, the District Court explained that:
Although the patented method uses man-made 125I-MuSK, the use of a man-made complex does not transform the subject matter of the patent. The focus of the claims of the invention is the interaction of the 125I-MuSK and the bodily fluid, an interaction which is naturally occurring. The purpose of the patent is to detect whether any antibody-antigen complexes are formed between the 125I-MuSK receptor and the antibodies "present in said bodily fluid." . . . Counter to Plaintiffs' argument, because the patent focuses on this natural occurrence, it is directed to a patent-ineligible concept.
The District Court also noted that "[c]ontrary to Plaintiffs' argument, the '820 patent is not a composition patent directed at the creation of the 125I-MuSK auto-antibody complex [but r]ather, the patent is directed at a method for the diagnosis of a disease."
The District Court also compared the asserted claims in the instant case to those in Mayo, pointing out that in Mayo, "a man-made substance was administered to a person, and the by-product of the metabolization of that man-made substance was observed," and in the instant case, "a man-made substance (125I-MuSK) is administered to a sample of bodily fluid, and the by-product (125I-MuSK autoantibodies) is observed." The District Court found further support for its step one determination in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1372 (Fed. Cir. 2015), noting that in Ariosa, the only subject matter that was new and useful was the discovery of the presence of cffDNA in maternal plasma or serum, and that "[l]ikewise, what is new and useful here is the discovery that some patients with Myasthenia Gravis have MuSK autoantibodies in their bodily fluid." Finally, the District Court distinguished the instant case from Rapid Litig. Mgmt., Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016), stating that in contrast with the methods at issue in CellzDirect, "the desired outcome of the Plaintiffs' method is the detection of MuSK autoantibodies" and Athena's claimed method "does not produce something useful beyond that diagnosis."
With respect to step two of the Mayo/Alice inquiry, Mayo argued that the '820 patent uses well-known techniques for identifying the presence of autoantibodies to MuSK and therefore does not contain an inventive concept. In particular, Mayo pointed to the '820 patent specification, which states that "[i]ondination and immunoprecipitation are standard techniques in the art." Athena countered that at the time the invention was made, the step of "detecting" autoantibodies was neither well understood nor routine, that the step of contacting MuSK or a MuSK epitope with a suitable label was novel, and although iodination and immunoprecipitation are standard techniques in the art, none of these steps are routine when applied to proteins. The District Court concluded that Athena's argument was "unavailing," noting that "[n]one of the complexity to which Plaintiffs cite is described or claimed in the patent," and adding that "[o]n its face, the patent claims a process for detecting autoantibodies, not a process for creating the 125I-MuSK."
Having decided that the answer to step one of the Mayo/Alice inquiry was "yes," and further, that the asserted claims of the '820 patent lack an inventive concept, the District Court granted Mayo's Renewed Motion to Dismiss.
Memorandum & Order by District Judge Talwani
