By Micheline Gravelle and Melanie Szweras
What to do after Bilski? S
takeholders in biotechnology long awaited the U.S. Supreme Court's Bilski v. Kappos decision, hoping for guidance on patentability of
inventions relating to diagnostic methods. In Bilski, the court held that the machine- or-transformation test is a useful indicator of patentability of method claims but that it is not the sole test. The court reiterated that laws of nature, abstract ideas, and physical phenomena are not patentable. Bilski constrained its discussion
to business-method patents and did not comment on patentability of other technologies, such as diagnostic methods. At the time of Bilski, two cases
on diagnostic assays had filed petitions to be heard by the U.S. Supreme Court pursuant to rulings by the U.S. Court of Appeals for the Federal Circuit (CAFC): Classen Immunotherapies Inc. v. Biogen Idec, and Prometheus Laboratories Inc. v. Mayo Collaborative Sciences. Right after Bilski came out, the Supreme
Court vacated and remanded both Classen and Prometheus to the CAFC signaling that they want the CAFC to clarify patentability of diagnostic methods. Prometheus and Classen relied on the
machine-or-transformation test but came to different conclusions. In Classen, the CAFC held that the claims failed the machine-or-transformation test because
they were neither "tied to a particular machine or apparatus" nor did they "transform a particular article into a different state or thing." The Classen claims related to a method of determining whether an immunization schedule affects disease comprising immunizing mammals according to the schedule and comparing results of a treatment group with a control. In contrast, in Prometheus the CAFC
held that the machine-or-transformation test was satisfied. The Prometheus claims related to a method of optimizing therapeutic efficacy comprising admin- istering a drug and determining the drug's level, wherein the level indicates a particular treatment protocol. The CAFC held that both the "administering" and the "determining" steps were transformative.
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INHOUSE OCTOBER 2010 •
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