November 1, 2013

Prometheus Case

Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 182 L. Ed. 2d 321, 101 U.S.P.Q.2d 1961 (2012) was a landmark decision that has been said to make personalized medicine unpatentable. But not so fast.

In this decision, The Supreme Court held that a law of nature (specifically the effect of concentrations of metabolites, of a particular drug administered to a patient, on the efficacy and toxicity for the patient) is not patentable subject matter. A patent claim must use the law of nature in a substantially different (read that "limited") way. In the facts of this case, the patent claims recited a method that involved checking the concentration level of the metabolites in the blood of the patient, wherein certain metabolite levels indicated a need to change a dosage. The Supreme Court further held that, in this particular case, these claims did not change enough to make the claims more than the law of nature itself; and, therefore the claims were not directed to patentable subject matter.

This is not to say that any method that changes treatment based on a natural law is not patentable subject matter. The particulars of this case caused that decision to be reached. In this case, the particular drug was already being administered to appropriate patients. Furthermore, the measurement of the concentrations for these particular metabolites was already being done by others. Still further, the claims did not require a quantified amount of dosage to add or cut based on the amount the levels exceeded each threshold. A "wherein" clause that recited the thresholds was not a step to change the dosage at all; and, was thus considered too vague to be an actual particular application of the law of nature. Instead, the Court concluded that the claims were drafted in an attempt to cover all possible uses of the correlation law.

So it stands to reason that if you discover a law of nature that suggests a new drug be administered, or different measurement be performed, not formerly done on such patients, or you give particular quantified guidance on dose changes based on test results, then yours is a different fact pattern from Mayo v. Prometheus. Claims to administering such a drug or performing such a test or making such quantified treatment changes, or any combination, are arguably directed to patentable subject matter. And personalized medicine is not dead.