American courts have long held that “laws of nature, natural phenomena, and abstract ideas” may not be patented. As a policy matter, the disadvantages of allowing a patent holder to preempt use of natural laws and ideas are considered to outweigh the advantages of conferring patent rights in order to encourage the discovery of natural phenomena. On March 20, 2012, in Mayo Collaborative Services v. Prometheus Laboratories, 132 S.Ct. 1289 (2012), a unanimous Supreme Court reaffirmed the power and reach of that rule, reversing the U.S. Court of Appeals for the Federal Circuit and invalidating patents related to a method to determine the proper dose of a drug.

The patents considered in Mayo instructed doctors how to determine the dose of thiopurine drugs used to treat autoimmune disorders such as Crohn’s disease and ulcerative colitis, a difficult issue because of the variation in the way that different patients metabolize those drugs. Before the claimed inventions were made, researchers knew that the levels of metabolites of thiropurine in the blood are related to the likelihood that a particular dose of the drug was too small to be effective, or so large as to risk harm. The patents identified “with some precision” the levels of metabolites associated with doses that are either too high or too low and instructed doctors to use standard blood tests to measure metabolite levels after administering the drug.

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