The biotech and medical diagnostic worlds eagerly await a decision from the Supreme Court’s review of Prometheus Laboratories, Inc. v. Mayo Collaborative Services. An oral hearing before the court was conducted December 7, 2011, so a decision could emerge in the first half of 2012.
The issue is whether the Prometheus diagnostic method claims are patent-eligible subject matter under 35 U.S.C. § 101. Those claims are drawn to a method of optimizing suitable dosage ranges of thiopurine drugs to treat an immune-mediated gastrointestinal disorder. There was nothing new about the thiopurine drugs themselves or their use to treat gastrointestinal or autoimmune diseases. The invention was, instead, directed to the method of adjusting the dosage based on levels of patient metabolite levels (as would be determined in a blood test).
The court questioned whether there was a test by which the courts could determine what is a patentable application of a law of nature and an unpatentable law of nature. What has to be added to a law of nature to make it a patentable process?
The mere scope of the claims also appeared to be bothersome to the court. The justices questioned the extent to which Prometheus’ patent foreclosed competitors. Mayo argued that the sweeping patent claims in this case chill medical research and increase health care costs. Prometheus criticized that position as imposing an analysis of whether a claimed invention hindered or promoted medical research, which would create unpredictable case-by-case results.