The United States Supreme Court on December 7, 2011, heard oral argument in Prometheus Laboratories v. Mayo Collaborative Services, U.S. No. 10-1150, 12/7/2011, which addressed the issue, in general, of when natural phenomena becomes patentable under Section 101 of the Patent Act. Just last year, the Supreme Court in Bilski v. Kappos, 130 S.Ct. 3218 (2010), addressed the related issue of what constitutes an abstract idea under Section 101.
Prometheus Laboratories sued Mayo Medical Laboratories for infringing its patent on a diagnostic method for treating Crohn’s disease. The Federal Circuit in 2009 reversed a summary judgment that the claimed method is ineligible for patent protection under 35 U.S.C. Section 101, and Mayo sought Supreme Court review. The case was remanded to the Federal Circuit for reconsideration in light of the Supreme Court’s ruling in Bilski.
The Federal Circuit then held that claims reciting the application of naturally occurring correlations between metabolite levels and efficacy or toxicity, and the method of calibrating proper dosage of drugs to treat autoimmune diseases are patentable. In particular, the claims state that a level less than 230 “indicates” a need to increase the medicine, and that a level greater than 400 “indicates” a need to decrease the medicine.
The Federal Circuit rejected Mayo’s assertion that the patent impermissibly claims natural phenomena and, thus, should be rejected under Section 101 of the Patent Act. According to the court, the claims “recite specific treatment steps, not just the correlations themselves. And the steps involve a particular application of the natural correlations: the treatment of a specific disease by administering specific drugs and measuring specific metabolites. As such, and contrary to [defendant’s] assertions, the claims do not preempt all uses of the natural correlations; they utilize them in a series of specific steps.”