Mayo Escapes Infringement Suit Over Diagnostic Patents

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By Dana A. Elfin

Mayo Collaborative Services LLC convinced a court to toss a complaint alleging its diagnostic tests infringed a patent ( Athena Diagonistics, Inc. v. Mayo Collaborative Servs., LLC , 2017 BL 272965, D. Mass., No. 15-cv-40075, 8/4/17 ).

Judge Indira Talwani of the U.S. District Court for the District of Massachusetts threw out the infringement complaint filed by three companies—Athena Diagnostics, Inc., Isis Innovation Ltd., and Max-Planck-Gesellschaft zur Forderung der Wissenschaften e.V.—because the patent claimed an invention based on a law of nature. Laws of nature aren’t eligible for patents.

The issue of which claims are eligible for patenting has been roiling the life sciences community since 2012 when the U.S. Supreme Court found a diagnostic method claim patent ineligible in Mayo Collaborative Servs. v. Prometheus Labs., Inc. The Mayo ruling and its progeny have made it more difficult for life sciences companies to protect their intellectual property, and some groups, including the Intellectual Property Law Owners Association, the American Bar Association, and the American Intellectual Property Law Association (AIPLA), are urging Congress to amend the patent law.

Supreme Court Tests

In Mayo, the Supreme Court found that diagnostic patent claims for administering dosages of drugs were patent ineligible because they claimed a law of nature. The next year, in Assn’ for Molecular Pathology v. Myriad Genetics ( Myriad), the high court concluded that claims for a naturally occurring DNA segment associated with breast and ovarian cancer were patent ineligible, because the DNA segment is a product of nature.

In this case, Athena Diagnostics Inc., Isis Innovation Ltd., and Max-Planck-Gesellschaft zur Forderung der Wissenschaften e.V. alleged two diagnostic tests developed by Mayo Collaborative Services LLC and the Mayo Clinic infringed Athena’s patent, U.S. Patent No. 7,267,820).Mayo countered that the ‘820 patent was invalid because the claimed method for diagnosing neurotransmission disorders—in this case, myasthenia gravis, a chronic autoimmune disorder characterized by fluctuating weakness of voluntary muscle groups—merely applied routine and conventional techniques to a law of nature. The patent describes a method to diagnose myasthenia gravis patients more quickly and accurately.

Man-Made Protein

The judge agreed with Mayo, ruling Athena’s patent is similar to the patent invalidated by the Supreme Court in Mayo. Although the patented method uses a man-made complex, “the use of a man-made complex does not transform the subject matter of the patent,” the judge wrote.

Athena’s test, “FMUSK,” uses the patented method to diagnose neurotransmission or developmental disorders related to the muscle specific tyrosine kinase (MuSK) receptor located on the surface of neuromuscular junctions.

The patent describes a method in which I-MuSK, a man-made nonnaturally occurring protein, is put into a sample of bodily fluid, and then the bodily fluid is filtered to detect autoantibodies attached to the man-made protein.

Naturally Occurring Interaction

The focus of the invention’s claim is the interaction of the man-made antibody, I-MuSK and the bodily fluid, an interaction which is naturally occurring, Talwani said.

The patent’s purpose is to detect whether any antibody-antigen complexes are formed between the I-MuSK receptor and the antibodies that are naturally present in the bodily fluid, Talwani said.

"[B]ecause the patent focuses on this natural occurrence, it is directed to a patent-ineligible concept,” she concluded.

“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,” Talwani wrote.

Inventive Concept Not Claimed

She also rejected the argument that even if the patent is directed to a patent ineligible concept, it could still be upheld if the method contains an “inventive concept.”

“On its face, the patent claims a process for detecting autoantibodies, not a process for creating the I-MuSK [the man-made protein],” she said.

Robins, Kaplan, Miller & Ciresi LLP, Duane Morris LLP and Leichtman Law PLLC represented Athena Diagnostics Inc., Isis Innovation Ltd., and Max-Planck-Gesellschaft zur Forderung der Wissenschaften e.V.

Fish & Richardson P.C. represented Mayo Collaborative Services LLC, doing business as Mayo Medical Laboratories, Mayo Clinic.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

For More Information

The ruling is at http://src.bna.com/rwj.

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