Yesterday, Tues., Mar. 20, 2012, in Mayo Collaborative Svcs v. Prometheus Labs, No. 10-1150, the Supreme Court (Breyer) unanimously reversed the Federal Circuit and ruled that a claimed process for assessing proper drug dosage was unpatentable under Section 101 because it was broadly directed to simply applying a law of nature in otherwise conventional drug treatment procedures. This decision may significantly impact not only pharmaceuticals, but software or other technology that involve applying laws of nature or mathematical formulas.
The technology concerns determining proper drug dosage in light of the varying metabolism rates among patients. The industry knew that certain metabolite levels in patients were correlated with the drug’s effectiveness, but the precise correlation was not known. The patent was based on an empirical determination of that correlation, which correlation the Court deemed a natural process (or law of nature). The Court characterized the claimed process as “administering” the drug, “determining” the level of metabolites in the patient, and considering the correlation of metabolite levels with the drug effectiveness (i.e., consider the natural law). Both the “administering” and “determining” steps were well-known, so the claim essentially covered applying the natural law to what physicians already were doing.
The Court’s ruling was premised on laws of nature being “the basic tools of scientific and technological work” such that a patent broadly covering a law of nature may improperly cover both known and unknown uses of a natural law (e.g., natural processes or mathematical relationships). A broad coverage of such basic technological building blocks would hinder innovation more than promote it. In this case, all of the claimed steps – except for applying the specific law of nature – were conventional steps that did not provide an “inventive concept” that was “significantly more than a patent upon the natural law itself.”