On June 28, 2010, the U.S. Supreme Court issued a decision in Bilski v. Kappos, No. 08- 964, slip op. (U.S. June 28, 2010) rejecting the rigid “machine-or-transformation” test for patent-eligible subject matter proffered by the U.S. Court of Appeals for the Federal Circuit as an unduly restrictive interpretation of the Patent Act. Bilski follows the Court’s decision in KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007), which similarly rejected the Federal Circuit’s rigid “teaching-suggestion-motivation” test for obviousness.

While the Bilski decision is most directly applicable to business-method-type claims, pharmaceutical and biotechnology companies likely will see its application to claims directed to, for example, diagnostic, dose titration, or characterization methods.