On March 20, 2012, the Supreme Court unanimously reversed the Court of Appeals for the Federal Circuit holding that Prometheus's patents claiming methods for determining the optimal dosages of thiopurine drugs to treat certain diseases were directed to non-statutory subject matter pursuant to 35 U.S.C. § 101 and therefore not patent-eligible. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. ___ (2012) (''Mayo''). The Supreme Court's opinion is its second recent major decision in the field of patent-eligible subject matter of method claims and comes less than a year and a half after its decision in Bilski v. Kappos, 130 S.Ct. 3218 (2010).
Notably, in holding that Prometheus's claims were directed to non-patentable laws of nature, the Court specifically contrasted the claims with patents directed to new drugs or new ways of using existing drugs. Thus, while the outcome of this case may have implications for specific areas of drug development and biotechnology, most notably in the growing field of personalized medicine, the Court's decision should not endanger common patent claims directed to applications of natural laws as found in pharmaceutical composition and method of treatment claims.
In this alert, we provide a description of the background of the case, discuss the aspects of the holding which will be important in practice, and set forth considerations for future implications of the decision. Read the Courts decision here.