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Patent eligible diagnostic methods

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In Mayo Collaborative Services v Prometheus Laboratories Inc. (2012), the Supreme Court recited a two-part test for determining whether claims to diagnostic methods recite patent eligible subject matter. Step one whether the claim is directed to a patent ineligible concept, such as a natural phenomenon; and step two assesses considers whether the elements of a claim at issue are inventive such that they are sufficient to ensure practice of the claim is more than practice of the natural phenomenon. If the elements are deemed routine, the court concludes that the elements are not inventive.

Diagnostic methods by necessity involve assessing a something that occurs in the body; and, thus, always assess something that occurs in nature. Thus, it is tautological that any diagnostic method that measures or detects something in a sample from a living being fails step one. In general, measurement or detection employ routine steps. Courts then find such claims invalid.

In Ariosa Diagnostics Inc. v Sequenom Inc., (Fed. Cir. June 12, 2015), the court applied the Mayo test to assess whether claims in the patent at issue are directed to patent-eligible subject matter. The claims in the patent recite methods for detecting paternally inherited nucleic acid of fetal origin in a serum sample from the mother. The court held the claims invalid because the presence of fetal nucleic acid in the mother’s serum is a natural phenomenon, and the preparation, amplification and detection steps recited in the claims are routine and conventional, and, thus, not inventive.

In reaching such conclusions and applying the step two of the test so literally, and not in accord with standards for assessing obviousness, the courts are confusing a naturally-occurring phenomenon with the exploitation of the phenomenon for diagnosis and/or treatment. The exploitation, no matter how implemented, may be inventive. While the particular steps by which the phenomenon is exploited may be conventional, the application of such steps still can be inventive because the ordinarily skilled person at the time of filing of the application would never have practiced such steps.

For example, in the Ariosa case, at the time of filing of the patent, that patent states that it was not known that fetal DNA is detectable in maternal serum; there is no reason why anyone would have tested for paternal nucleic acid in the mother’s serum. Merely because the DNA in serum could be detected by conventional methods, it was not obvious to detect paternal nucleic acid in the serum to identify fetal markers. Thus, step two of the Mayo test is satisfied because the exploitation of the naturally-occurring phenomenon is inventive. The distinction renders diagnostic methods patent eligible.

Since the courts are not applying the standards by which inventiveness is assessed, it is time to consider changes to the U.S. statute that defines patent eligible subject matter. Amendment of the statute to recite the well known standards by which inventiveness of the elements of claims are assessed would again render diagnostic methods that are novel and inventive also patent-eligible.

-Submitted by Stephanie Seidman, McKenna Long & Aldridge LLP.

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