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Federal Court Dismisses Athena Diagnostics' IP Infringement Lawsuit Against Mayo

NEW YORK (360Dx) – A federal court last week dismissed a patent infringement lawsuit filed by Athena Diagnostics and others against the Mayo Clinic, saying the patent at the center of the dispute applies routine and conventional techniques to a law of nature.

The decision by the US District Court District of Massachusetts is the latest in a small handful of influential decisions rendered by the courts in recent years that have found that methods and technologies claimed by test makers cannot be patented for a similar reason.

Athena filed its lawsuit against Mayo in June 2015.

At issue, in particular, are claims 6 through 9 of the patent, US Patent No. 7,267,820, which broadly cover methods for detecting autoantibodies against the muscle specific tyroisine kinase (MuSK) for the diagnoses of the autoimmune disorder Myasthenia Gravis.

For most patients with the condition, a diagnosis can be made with tests that detect the presence of antibodies that attack the acetyle choline receptor (AchR). But about 20 percent of Myasthenia Gravis patients do not have the AchR autoantibodies, and the method covered by the '820 patent is intended to diagnose them.

The patent describes a method in which a radioactive label is attached to MuSK, which is then introduced into a sample of body fluid from the patient. According to court documents, the radioactive label specified by the patent is 125I. When introduced to the patient sample, the MuSK autoantibodies attach to the labeled fragment. After being immunoprecipitated, the presence of the radioactive label on any antibody indicates that the patient has Myasthenia Gravis.

In suing Mayo, Athena, along with fellow plaintiffs Isis Innovation and Max-Planck Gesellschaft zur Forderung der Wissenschaften, alleged the clinic and Mayo Collaborative Services developed two tests that copied Athena's FMUSK test to avoid paying Athena for use of its test.

In a renewed motion to dismiss the case, Mayo countered that Athena sought to patent a law of nature, and used techniques that are standard "in the arts." Athena argued that the '820 patent is not directed at a law of nature as it requires the production and use of 125I-MuSK, a protein that does not occur in nature. They further said that "applying various known types of procedures to a non-naturally occurring protein transforms the claim and makes it patent eligible."

In rendering a decision last week, Judge Indira Talwani applied a two-step approach that was used in earlier cases, Mayo Collaborative Servs v. Prometheus and Alice Corp. Pty. Ltd. V. CLS Bank Intern. In the first step, the court considered whether the '820 patent claims cover a method found in nature, or is natural phenomena or an abstract idea. Secondly, it considered whether the patent claims, individually or as an ordered combination, are an "inventive concept" which the US Supreme Court had described as an element or combination of elements that are "'sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the (ineligible concept) itself.'"

On whether the '820 patent covers a method found in nature, the court decided that although the 125I-MuSK and the antibody/MuSK complexes are not found in nature, "this does not transform the patent at issue here to a patent eligible concept," and the patent "is not a composition patent directed at the creation of the 125I-MuSK autoantibody complex."

Instead, the patent covers a method for diagnosing the disease, and while the method uses 125I-MuSK, which is man-made, "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."

On the question of whether the patent claims constitute an "inventive concept" the court also sided with Mayo. The plaintiffs had claimed that the production of MuSK, or an epitope, or an antigenic determinant thereof, required steps that were neither well-known, nor standard or conventional for MuSK. The court, said, however, that this claim contradicts earlier language used by the plaintiffs, which described that the suitable label is 125I or the like "and that iodination of the label is a standard technique in the art."

"On its face, the patent claims a process for detecting autoantibodies, not a process for creating the 125I-MuSK," Talwani wrote.

On deadline, Athena and its parent company Quest Diagnostics did not respond to a request for comment. Mayo Clinic and Mayo Medical Laboratories said that they "remain committed to providing high-quality comprehensive testing at an affordable price," but declined further comment.

Last week's decision is the latest blow to the industry, which in recent years has seen a few but far-reaching court decisions stating that methods covering laws of nature cannot be patented. In 2012, the US Supreme Court unanimously invalidated patent claims of Prometheus Laboratories for gauging metabolites to dose thiopurine drugs.

A year later, the court unanimously ruled that human genes cannot be patented, but that synthetic DNA, or cDNA, can.