On August 25, 2016, the District Court for the District of Massachusetts denied a motion to dismiss for lack of patent eligible subject matter filed by defendants Mayo Collaborative Services, LLC and Mayo Clinic. Applying the two-step framework established by the Supreme Court in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014), the district court held that the diagnostic method claims of the asserted patent were directed to a patent ineligible law of nature (step one), but the District Court was unable to determine at the 12(b)(6) stage whether the claims contained an inventive concept that transformed them into a patent eligible invention (step two).
The plaintiffs, Athena Diagnostics, Inc., Isis Innovation Ltd. and Max-Planck-Gesellschaft zur Forderung der Wissenschaften e.V., developed and patented a method for diagnosing patients with the autoimmune disorder Myasthenia Gravis. The majority of patients with Myasthenia Gravis produce antibodies that attack their acetyl choline receptors, which causes the patients to experience waning muscle strength throughout the day. These patients are typically diagnosed by tests that detect the presence of autoantibodies to acetyl choline receptors. Approximately 20 percent of patients suffering from Myasthenia Gravis, however, do not produce acetyl choline receptor autoantibodies. The inventors of the patent asserted in this case discovered that Myasthenia Gravis patients who do not produce autoantibodies to acetyl choline receptors instead produce IgG antibodies that attack the N-terminal domains of muscle specific tyrosine kinase (“MuSK”), a receptor that is located on the surface of neuromuscular junctions. Relying on this discovery, the inventors developed an alternative method for diagnosing Myasthenia Gravis based on the detection of MuSK-specific autoantibodies. The claimed diagnostic methods are performed by attaching a radioactive isotope to the MuSK receptor protein or fragments thereof, introducing it into a sample of body fluid, and then detecting the presence of any antibody-antigen complexes formed between the radiolabeled receptor and antibodies present in the body fluid.
Defendants moved to dismiss plaintiffs’ complaint for infringement, alleging that the asserted patent claimed a law of nature, namely that certain Myasthenia Gravis patients produce autoantibodies to MuSK. Defendants further alleged that the asserted claims lack an inventive concept because they utilize standard techniques well-known in the art to perform the diagnostic method. Plaintiffs argued that the radiolabeled MuSK protein used in their methods is not a naturally occurring protein, and consequently, the claims are not directed to a law of nature. Plaintiffs also argued that utilizing a non-naturally occurring protein in a combination of known procedures transforms the claims and makes them patent eligible.
Under the first step of the Alice test, the district court rejected the plaintiffs’ assertion that their claims were patent eligible because they include the use of a radiolabeled compound that is not naturally occurring. Instead, the district court described the focus of the diagnostic methods to be the interaction of radiolabeled MuSK and patient body fluid, and held the interaction of these molecules to be naturally occurring. Turning to step two of the Alice test, the district court held that it could not determine whether the claims of the asserted patent contained an inventive concept that transformed them into patent eligible subject matter. Specifically, the district court stated that it could not determine at the motion to dismiss stage whether the combinations of steps claimed in the asserted patents were merely a series of techniques standard in the art or whether they were sufficiently inventive to deserve patent protection because it would be required to make factual determinations that went beyond what was apparent on the face of the complaint.
Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, C.A. No. 15-cv.40075-IT (D. Mass. Aug. 25, 2016).