Is the Federal Circuit Playing with Fire?

The court's decision in Classen Immunotherapies, Inc. v. Biogen Idec (Fed. Cir. 2008), rendered shortly after Bilski, turned the concern of those interested in patenting diagnostic methods into fear. Classen's claims were held invalid under ' 101 because the claims were neither tied to a particular machine nor did they transform a particular article into a different state or thing. The claim at issue was drawn to a method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-related disorder. The claim recited immunizing mammals with immunogens according to a schedule and comparing the incidence, prevalence, frequency, or severity of the chronic immune-related disorder in the treatment group to a control group. The Classen decision seemed to indicate that the Federal Circuit would follow the views expressed in Justice Breyer's dissent in Laboratory Corp. v. Metabolite Labs., Inc. 548 U.S. __ (2006) (“LabCorp“) in which he criticizes the scope of claims directed to identifying a vitamin deficiency based on measuring increased levels of homocysteine in blood. The patent eligibility of diagnostic or personalized medicine methods was uncertain.

The Prometheus decision offers a spark of hope and provides some insights to avoiding invalidity. The Prometheus court held that each of the claims required at least one transformation in the administering and/or determining steps of the claims. Therefore, the claims were drawn to statutory subject matter under the Bilski test. The decision is available at www.cafc.uscourts.gov/opinions/08-1403.pdf.