GLR readers will recall that just last summer the Supreme Court passed-up a major opportunity to clarify the status of method or process patents. The patentability of business methods, computer-implemented processes, and diagnostic and other medical methods has long been both controversial and uncertain. In Bilski v. Kappos, the Court confronted a method for hedging against fluctuations in commodities prices. All nine justices thought the method was too abstract to comprise patentable subject matter as defined in section 101 of the Patent Act, but they couldn’t agree on why. The five-member majority held that the machine-or-transformation test (which states that the method must be tied to a particular machine or change something into a different state) propounded by the Federal Circuit in its initial Bilski decision could not be the exclusive test for patentability, but it failed to come up with a test of its own.
The day after issuing its decision in Bilski, the Supreme Court dealt, temporarily, with another closely watched case, Prometheus v. Mayo. In Prometheus, the Federal Circuit used Bilski’s machine-or-transformation test to uphold a method for administering a drug, measuring its level in the body, and then adjusting the dosage. The Supreme Court granted certiorari in Prometheus, as well as in a similar biotechnology method case (Classen Immunotherapies v. Biogen IDEC), and then immediately vacated both decisions and remanded the cases to the Federal Circuit for reconsideration in light of Bilski. Neither of those decisions have yet been issued by the Federal Circuit.
Earlier today the Supreme Court handed down its opinion in what some patent observers have termed “the most highly anticipated patent decision of all time“: Bilski v. Kappos (pdf). The Bilski case was widely watched not for the significance of the particular patent at issue but for the far-reaching effect on patent law that the case might have.
Would the Court treat Bilski as a referendum on the patentability of so-called “business methods”? Would it speak more broadly still, using Bilski as an opportunity to clarify the patentability of a range of emerging technologies, particularly in the areas of software and biotechnology? These questions took on added significance for biotechnology companies, investors, researchers and observers earlier this spring when a federal court in New York used Bilski’s machine-or-transformation test to invalidate several of Myriad Genetics’ diagnostic method claims.