On March 20, 2012, the U.S. Supreme Court handed down its decision in Mayo Collaborative Services, et al v. Prometheus Laboratories, Inc (“Mayo”) and ended an eight-year legal battle over patents covering processes for determining patient-specific dosing for a thiopurine drug to treat autoimmune diseases. In a unanimous decision, the Court held that the claimed processes are not patent-eligible subject matter under 35 U.S.C. §101 of the U.S. patent laws, and overturned the decision of the Court of Appeals for the Federal Circuit.
The Supreme Court decision in Mayo established that the machine-or-transformation test is not the definitive test for determining the patent-eligibility of process claims, including process claims that embody laws of nature or natural phenomena. In its analysis, the Court determined considered whether the claims were drawn to patent eligible subject matter as provided under 35 U.S.C. §101 of the U.S. patent laws, or patent ineligible subject matter excepted from §101. The Court held that the process claims were essentially drawn to the laws of nature themselves and thus fell into the laws-of-nature exception to §101. The process claims did not cover patent-eligible processes of applying certain laws of nature. This decision has clear implications for the biotechnology industry that go beyond diagnostics and personalized medicine. As such, biotechnology companies should consider re-evaluating their patent position and adapting their patent strategies in view of Mayo.
Full details at the Journal of Commercial Biotechnology