Mayo Collaborative Services v. Prometheus Labs., Inc., No. 10-1150 (U.S. 2012)
On Tuesday, in a unanimous opinion authored by Justice Breyer, the United States Supreme Court addressed the issue of patent eligibility of diagnostic method claims. The issue was simple: is a claim to a method of optimizing a particular therapy using specific diagnostic steps eligible for patent protection under 35 U.S.C. § 101? The Supreme Court answered with a resounding "no." The exemplary patent claim reviewed in the decision was as follows:
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 8x108 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 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
The Court's decision was that this claim was not eligible for patent protection because it merely recites laws of nature. In arriving at this decision, the Court stated that a claim to "a process that focuses upon the use of a natural law [must] also contain other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself."
In addition to making an obviousness inquiry part of the patent-eligibility analysis, the Court also recognized that there may be an "overlap" between the § 101 patent-eligibility inquiry and the § 102 novelty inquiry. The United States government filed an amicus brief in which it urged the Court to find the patent claim eligible for patent protection, but also unpatentable based on prior art grounds. The Supreme Court declined to accept the government's position in preference of the "better established inquiry under §101," hence making the "law of nature" exception a strong defense against diagnostic method claims. It appears that this decision subsumes the patentability requirements from §§ 102, 103 and possibly 112 as well into the initial patent-eligibility inquiry under § 101.
While raising the patent-eligibility bar for diagnostic method claims by making it clear that additional steps are needed to render such claims patent-eligible, the decision includes very little guidance as to what type of steps would be "significant" enough to pass muster in converting a law of nature to a patent-eligible application. The decision did categorically note that claims to "a new drug" or "a new way of using an existing drug" are patent-eligible.
This decision has significant ramifications for diagnostic companies and the field of personalized medicine. The decision may push such companies towards trade secret protection for diagnostic methods. The Court noted that "we must recognize the role of Congress in crafting more finely tailored rules where necessary . . . . We need not determining here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable."
The decision decreases the protections available to the diagnostic methods industry as compared to all other industries and takes away rights that were previously available to a valuable economic sector of the biotechnology industry. The decision also may influence the Supreme Court's decision whether to review AMP v. Myriad Genetics, which is pending the Court’s decision on petition for certiorari.