Federal Circuit Applies Bilski Test in Prometheus Decision

Turnabout is fair play. In Prometheus Laboratories, Inc.v. Mayo Collaborative Services, the Federal Circuit bucked the recent trend of invalidating patents for lacking patent-eligible subject matter. The court in Bilski had held that a claimed method must (1) be tied to a particular machine or apparatus or (2) transform a particular article into a different state or thing. As applied by numerous district courts, the "machine-or-transformation" test has led to several patents being invalidated for lacking patent-eligible subject matter. For this reason, some have viewed Bilski, currently awaiting review by the Supreme Court, as signaling doom to business method patents. In re Bilski, 545 F.3d 943, 954 (Fed. Cir. 2008) (en banc).

But on September 16, 2009, the Federal Circuit reversed a decision from the Southern District of California, where the trial court had held that a method of treating a disease is not a patentable subject matter under 35 U.S.C. §101. The Prometheus court applied the Federal Circuit's now famous "machine-or-transformation" test in holding that the claimed methods for calibrating drug dosages were drawn to statutory, or patent-eligible, subject matter. The Federal Circuit determined that the dosage calibration claims did not merely set forth natural correlations or data-gathering steps. Instead, the claimed methods were transformative of the human body -- "the human body necessarily undergoes a transformation" when administered a drug. Even though the reactions between the synthetic drugs and the subject’s body rely on a natural process, the treatment of the patient is not merely a natural process -- it is transformative. As part of its analysis, the Court rejected arguments that the claimed steps of “administering” and “determining” are mere data-gathering steps, because these steps are parts of a treatment protocol, such as measuring the drugs’ metabolite levels during the course of the treatment. Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 2008-1403, (Fed. Cir. Sept. 16, 2009).