On March 20, 2012, the U.S. Supreme Court unanimously held in Mayo Collaborative Services v. Prometheus Laboratories that a method for administering a drug and determining a personalized medicine dosing level constituted patent ineligible subject matter because it fell within the prohibition against patenting laws of nature. The decision was surprising to many observers, given recent guidance by the Supreme Court in Bilski v. Kappos (2010), which suggested that including transformative steps would qualify a method of using a natural law or abstract idea as a patentable application. The Court also relied on the well-known and conventional nature of the drug’s administration to invalidate the claims.

On March 26, the first aftershocks of this decision were felt when the Court issued an order vacating the U.S. Court of Appeals for the Federal Circuit’s decision and remanding the case of Association for Molecular Pathology v. Myriad, directed to patent eligibility of genes, mutated gene fragments and diagnostic tests, back to the Federal Circuit for further consideration in view of its opinion in Mayo. The lower courts must now determine whether a claimed invention that encompasses a law of nature includes significantly more inventive features to qualify for patentability.