In two recent cases decided on the same day in different District Courts, issued US patents to diagnostic methods were found in preliminary motions to be invalid under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter. Multiple different strategies for asserting patent eligibility were held to be ineffective.
1. In Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (D. Mass. 2017) (August 4, 2017), Athena tried to assert a patent directed to methods of diagnosing Myasthenia Gravis by detecting autoantibodies to muscle specific tyrosine kinase (MuSK), which autoantibodies are associated with Myasthenia Gravis, by detecting a complex of a man-made chemically-modified (iodinated) version of MuSK with autoantibodies in the patient’s blood. Mayo moved to dismiss the suit, asserting patent ineligibility (“the claimed method applies routine and conventional techniques to a law of nature.”). This patent was issued in 2007, prior to the landmark decision in Mayo v. Prometheus (S. Ct. 2012).
In applying the first step of the two-step patent eligibility analysis of Alice v. CLS Bank (S. Ct. 2014), basedinter alia on the holding in Prometheus, the District Court held that “the desired outcome of the Plaintiffs’ method is the detection of MuSK autoantibodies” and that the method “does not produce something useful beyond that diagnosis.” The Court further asserted that “Plaintiffs’ argument that the patent is transformed by the use of a man-made molecule is unavailing. The stated purpose of the patent is to diagnose Myasthenia Gravis, and the method is directed to a patent ineligible law of nature under § 101.”
Having found that the claims did not meet the first step of the Alice patent eligibility analysis, the Court then turned to a determination of whether the method contained an ‘inventive concept.” As in their successful arguments in Prometheus, Mayo argued that Athena’s methods claim a law of nature, and utilized only conventional detection techniques. Athena countered with arguments that “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.” However, Athena’s own patent specification stated that “[i]odination and immunoprecipitation are standard techniques in the art.” And in the final analysis, the Court held that Athena’s claim that “[a] process that requires the use of a novel non-naturally occurring patent-eligible element is necessarily a patent-eligible process” was unpersuasive, especially in view of the fact that “[o]n its face, the patent claims a process for detecting autoantibodies, not a process for creating the 125I-MuSK.”
An appeal to the Federal Circuit has been filed in this case.
2. In Cleveland Clinic Foundation v. True Health Diagnostics, LLC (E.D. VA 2017) (August 4, 2017), claims in two patents claiming priority to a parent patent that had just been declared invalid for lack of patent-eligible subject matter by the Federal Circuit (Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2017)) were also found invalid, despite being in a different format, and despite having overcome rejections for lack of patent eligible subject matter during prosecution, were similarly held to be invalid.
The patents at issue in this District Court case related to methods for detecting myeloperoxidase (MPO) in a sample from a patient. The specification common to this patent family was written before the Mayo v. Prometheus decision, and disclosed that MPO could be detected “by any of a variety of standard methods known in the art,” and that commercially available kits could be modified to detect MPO in the claimed methods. Cleveland Clinic had received and overcome § 101 rejections in these child patents during prosecution.
This current case was litigated after the companion case in the Ohio District Court in which the parent patent and other related patents were challenged. Initially, the VA District Court refused the Defendant’s motion to dismiss, as the appeal in the Ohio case was pending before the Federal Circuit on the issue of patent eligibility. After the Federal Circuit affirmed that the parent patent’s claims were invalid under § 101, the Defendant filed a renewed motion to dismiss (claims to methods for treating a patient having cardiovascular disease were not included in this renewed motion for procedural reasons), and the VA District Court applied the findings of the Federal Circuit to the claims of the child patents in the current case.
A representative claim from the invalidated parent patent was directed to a “method of assessing a test subject’s risk of having atherosclerotic cardiovascular disease, comprising comparing levels of myeloperoxidase” in patient samples to levels of MPO in samples from control samples. The claims at issue in the current case were directed to:
• “A method of detecting elevated MPO mass in a patient sample ….”
• “A method for identifying an elevated myeloperoxidase (MPO) concentration in a plasma sample from a human subject with atherosclerotic cardiovascular disease … ” [followed by four specific steps of “contact a sample,” “spectrophotometrically detecting,” “comparing said MPO levels,” and “comparing said MPO concentration”]
These claims were initially rejected under § 101. The rejections were overcome during prosecution based on Cleveland Clinic’s arguments favorably comparing them to the patent eligible claims of Example 29 of the USPTO’s “May 2016 Subject Matter Eligibility Update.”
Cleveland Clinic similarly argued in this case that the claims in the first patent were directed to a method of detecting myeloperoxidase rather than a method of diagnosing atherosclerotic cardiovascular disease, and that the claims of the second patent were directed to subject matter that amounted to significantly more than the judicial exception, as “the ordered combination of steps recited in these claims has not been previously used for this particular purpose” since “it is not well-understood, routine, or conventional to detect elevated MPO levels in plasma from a subject having atherosclerotic [cardiovascular disease]” [emphasis in original Plaintiff’s Memorandum, quoted by the Court].
Nevertheless, the District Court leveraged the decision in the Federal Circuit with respect to the parent patent claims to find these claims patent ineligible. In particular, the Court stated that the end result of these method claims was the “”observation or detection” of the natural law.” In finding the claims patent-ineligible, the Court stated that “Plaintiffs have offered no other use for these methods. If merely using existing, conventional methods to observe a newly discovered natural phenomenon were enough to qualify for protection under § 101, the natural law exception would be eviscerated.”
Most discouragingly for inventors of these types of diagnostic methods, in its Conclusion, the District Court repeated the holding of another Supreme Court decision in the recent case law which has found most diagnostic claims patent-ineligible:
By all accounts, the plaintiffs have advanced the diagnosis of CVD with the methods described in these patents; however, under present law even what appears to be a “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013). Under existing precedent, this Court is bound to conclude that the claims in the ‘065 and ‘597 patents are not eligible for protection.
Clearly, it will require legislative changes to address these patent eligibility issues with these types of diagnostic claims.