Are diagnostic methods patentable? Until quite recently, the answer to this question would have been an unqualified “yes.” Recent court decisions concerning subject matter eligibility for patenting have changed the answer to this question to a hesitant “maybe.”
In 2013, the U.S. Supreme Court held that that isolated naturally-occurring genomic DNA was a non-patentable product of nature, even though isolating the DNA required breaking chemical bonds. Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107, 2110 (2013). The Myriad decision followed on the heels of another Supreme Court decision addressing the patent eligibility of a diagnostic method for determining whether a patient was receiving a safe and effective dosage of a drug by measuring the level of drug metabolite in the patient’s blood. Mayo Collaborative Services v. Prometheus Laboratories Inc.,132 S.Ct. 1289, 1291 (2012). The Supreme Court held the diagnostic method was not patentable because the patent claim had a natural law — the relationship between concentration of drug metabolite in the patient’s blood and the likelihood that the dosage would prove either ineffective or harmful — at its core, and the additional steps in the claim were not enough to transform the unpatentable natural correlation into a patentable application of the natural law.
