January 2012

Looking Ahead

On December 7, 2011, the United States Supreme Court heard arguments in Mayo Collaborative Services v. Prometheus Laboratories, Inc., Supreme Court No. 10-1150.

The question presented is:

Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.

The patents-at-issue are directed to methods for optimizing patient treatment in which the level of a certain drug metabolite is measured to identify a need to increase or decrease dosage levels.  The 
district court ruled that the claims were invalid, finding the inventors’ discovery was just “a natural body process . . . preexisting in the patient population.”  Prometheus Labs., Inc. v. Mayo Collaborative Servs.,
No. 04-CV-1200, 2008 WL 878910, 86 U.S.P.Q.2d 1705 (S.D. Cal. Mar. 28, 2008).  

The Federal Circuit reversed, holding the claims patent eligible because they involve a physical transformation and thus are not merely directed to a law of nature.  Prometheus Labs., Inc. v. Mayo Collaborative Servs., 581 F.3d 1336 (Fed. Cir. 2009).  The Supreme Court remanded the case to the Federal Circuit in light of its decision in Bilski v. Kappos, 30 S. Ct. 3218, 561 U.S. __ (2010).  After the Federal Circuit again ruled in favor of Prometheus, 628 F.3d 1347 (Fed. Cir. 2010), the Supreme Court, on June 20, 2011, again agreed to hear the case.  

The Supreme Court is expected to issue its decision in the spring of 2012.