The U.S. Supreme Court has issued its decision on the patentability of correlation procedures in Mayo Collaborative Services v. Prometheus Labs., Inc. The Court unanimously reversed the CAFC and held that the claims were effectively directed to laws of nature and therefore unpatentable.
The Court posed the question to be determined as determining the line between unpatentable laws of nature and patentable applications of the laws of nature, noting that merely reciting the laws of nature and adding the words “apply it” is insufficient.
The Court cautioned against “interpreting patent statutes in ways that make patent eligibility ‘depend simply on the draftsman’s art’ without reference to the “principles underlying the prohibition against patents for [natural laws].” [p3]
The Court concluded that:
In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.[p4]
For these reasons, we conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves. [p24]
A typical claim at issue was claim 1 from U.S. 6,355,623:
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 Court concluded that the ‘wherein’ clauses “simply tell a doctor about the relevant natural laws, at most adding a suggestion that he should take those laws into account when treating his patient.”, pointing out that the physical steps were known in the art. The combination, the Court said, does not add anything not found in the steps taken separately.
The Court also considered the role other criteria for patentability including novelty and written descriptions but stated that the Court “decline[d] the [amici’s] invitation to substitute §§102, 103, and 112 inquiries for the better established inquiry under §101.”
In other patentable subject matter news, the Canadian Patent Office announced it would be releasing consultation documents on patentable subject post-Amazon on April 2, 2012.