This week the United States Supreme Court issued a key decision in which it struck down a patent covering a medical testing method, holding that the subject matter is ineligible for patenting under Section 101 of the Patent Act. In Mayo v, Prometheus (No. 10-1150, March 20, 2012), the Court held that U.S. Patents 6,355,623 and 6,680,302 covered mere “laws of nature” that are not patent eligible under Section 101 of the U.S. Patent Act.
What does the ruling mean for life science businesses? To assess that, a brief summary of the case will be helpful:
The patent claims at issue in the case related to a “personalized medicine” process, which in simple terms can be described as a method of administering a drug (thiopurine) for a gastrointestinal disorder and then testing the patient to determine whether to decrease the amount of the drug that is administered in subsequent doses.
The Court analyzed the claims and determined that they covered “laws of nature – namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” While the claims also included steps relating to the delivery of the drug, as well as steps for giving the medical professional a recommendation for future action, the Court did not consider them sufficient to transform the claims into patent-eligible processes. As the Court explained:
The upshot is that the three steps simply tell doctors to gather data from which they may draw in inference in light of the correlations. To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged by the scientific community.
Notably, the Court did not go so far as to say that processes of providing personalized medicine can never be patentable. Rather, the Court focused on the specific claims of the patents at issue, and noted that “[u]nlike, say, a typical patent on a new drug or a way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws. ” The Court was concerned that the patents at issue risked disproportionately tying up the use of natural laws.
The significance of the Court’s decision for life sciences businesses may depend on how broadly lower courts apply the ruling in the future. Patent claims that cover novel personalized medicine delivery processes — including novel applications of laws of nature — may be unaffected by the decision.
In the meantime, life science businesses with pending patent applications covering methods of treatment and assessment of disease should consider reviewing the claims to determine whether amendments would help secure patent-eligibility in view of the decision.
UPDATE: In November 2012, the Federal Circuit relied on Mayo v. Prometheus to strike down claims for another medical diagnostic test. See PerkinElmer Inc. v. Intema Limited, No. 2011-1577 (Nov. 20, 2012).