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Supreme Court Invalidates Medical Treatment Claims as Unpatentable Subject Matter
March 22, 2012

 

The Supreme Court’s March 20, 2012 decision in Mayo v. Prometheus, 566 U.S. __ (2012), invalidated patent claims when they invoke a law of nature but do not “confine their reach to particular applications of those laws.” The court discussed the following representative claim:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

 (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

 wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

 wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

 The two “wherein clauses” state a newly discovered correlation.  Drug levels below 230 pmol per 8×108 red blood cells are insufficient and the amount of drug administered should be increased.  On the other hand, drug levels above 400 pmol per 8×108 red blood cells are too high and the amount of drug administered should be decreased.  The Court stated that the steps (a) and (b) were “well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Thus, the claim attempted to patent a law of nature itself, without any restriction on how it is applied, and was invalid.

A patent claim will be invalid as directed to non-patentable subject matter if it recites application of a law of nature by well-understood, routine, or conventional activity previously engaged in by those in the field.  This rule will hold even if the law of nature is newly discovered, and the remaining steps are concrete, tangible, and useful – but previously engaged in by those in the field.

Going forward, claims applying a law of nature should separately recite method steps that are novel and non-obvious in the absence the law of nature.  This should be done to frame application of the law of nature as restricted to the particular “inventive concept” embodied in the separately recited method steps.

 

By: Douglas J. Bucklin, PhD

The post was originally run in the Legal Intelligencer Blog.