Recent Developments in Intellectual Property Law
In Mayo Collaborative Services v. Prometheus Laboratories, Inc., the U.S. Supreme Court considered whether a process using a newly recognized law of nature (i.e., newly established correlations between drug dosage and measured metabolites in the patient’s body) to determine the optimal drug dosage to be administered to a specific patient is patent eligible subject matter under 35 U.S.C. 101.
The Court held unanimously that claims to a process employing a law of nature, to be patent eligible, must have “additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.” Although the claims of the patentee in this case were not directed to the law of nature per se, the additional process steps were considered to be “conventional or obvious” “[pre]-solution activity,” and therefore added nothing of a practical, limiting nature to the claimed process that would be sufficient to avoid ineligibility under 101. Moreover, the ordered combination of the additional process steps added nothing to the laws of nature not already present when the steps were considered separately.
This conclusion was based upon the Court’s understanding that anyone who wants to make use of the identified laws of nature would necessarily have to first administer the drug specified to a human subject and measure the resulting metabolite concentrations. As such, the process of administering and measuring added nothing of significance to the stated law of nature other than an instruction to apply it when treating a patient. The Court further explained how its conclusions in this case are consistent with the holdings in each of its previous decisions in Diamond v. Diehr, Parker v. Flook, Bilski v. Kappos, and Gottschalk v. Benson…