Genetic Technologies v. LabCorp. – Mayo Redux.

It was Mayo redux with a vengeance in the September 23, 2014 decision in Genetic Technologies Ltd. v. Laboratory Corp. of Amer. Holdings et al., Civil Action No. 12-1736-LPS-CJB (D. Del. 2014).  Magistrate Judge Burke released an opinion invalidating claim 1 of Genetic Technologies U.S. Patent No. 7,615,342 as claiming non-patentable subject matter under s. 101 that could have been stenciled from the PTO s.101 Guidelines. Claim 1 was directed to a method to predict potential sprinting, strength or power performance in a human. The claim had an “analyzing step” to look for variations in the ACTN3 gene of the human, a “detecting step” to determine the presence of two 577R alleles at a loci of the ACTN3 protein and (c) a “predicting step” positively associating two copies of the allele with the performance elements.

Citing Mayo v. Prometheus and PerkinElmer v. Intema copiously, the correlation between the alleles and athletic performance was held to be a natural law and the analyzing and detecting steps were the “employment of … routine conventional process[es]” that were not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law. The “predicting step” was dismissed as “’no more than an instruction [to] apply the [natural] law.’ Prometheus, 132 S Ct at 1297.”

Genetic Tech. valiantly tried to argue that the predicting step was more than a mental step, in that it requires the act of arriving at a diagnostic conclusion and making it known, but the Magistrate Judge wasn’t buying:

“The limitation fails to elevate the claim to something significantly more than the natural principle itself. Just as convention pre-solution activity does not turn an unpatentable law of nature into a patent eligible application, neither does ‘insignificant post-solution activity…transform  an unpatentable principle into a patentable process….The mere presence of this physical step [declaring or stating the diagnosis] does not render the claim patent eligible. It does not require the process user to do anything in light of the correlation (aside from simply declaring it). “ Citing Classen v. Biogen Idec in which a claim to evaluation of immunization schedules that recited the further act of immunization in accord with a lower risk schedule “moved the claim from ‘abstract scientific principle to specific application’.”

The Magistrate Judge then continued to analyze the claim “as a whole” but the outcome was the same, since he found that “recitation of an application is not enough; rather, the claim must recite an application that amounts to ‘significantly more than a patent upon the natural law itself’.” So this court’s position is clear; arriving at a diagnostic conclusion does not “confine [the reach of the claim] to a particular inventive application of the recited natural correlation.”

So this court has made it crystal clear that its interpretation of Mayo is that arriving at a diagnostic conclusion based on the discovery of a naturally occurring in vivo relationship  does not amount to an application of a law of nature to a new and useful end. Certain officials at the USPTO must have opened the bubbly when they read this decision, especially since it is from a district court known for its patent expertise. It is also crystal clear from the language of Mayo that the Supreme Court did not believe that it had invalidated a diagnostic claim, and that evaluation of such a claim was for another day. That day has come.

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