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Is the Federal Circuit Playing with Fire?

By Tammy Van Heyningen

Less than two months before the Supreme Court is scheduled to review the Federal Circuit's en banc decision in In re Bilski that found Bilski's business method claims unpatentable under 35 U.S.C. ' 101, the Federal Circuit held in Prometheus Labs., Inc. v. Mayo Collaborative Servs. (Fed. Cir. 2009) that claims to a diagnostic method are patent-eligible subject matter. The Federal Circuit reversed the district court's decision and held that Prometheus' personalized medicine claims satisfied the machine or transformation test set out in Bilski. 545 F.3d 943 (Fed. Cir. 2008) (en banc), cert. granted, argument set for Nov. 9, 2009. The timing of this decision cannot be overlooked. While the claims at issue in Bilski were drawn to business methods, many groups (as evidenced by the amicus briefs) are concerned that application of the strict machine or transformation test would render diagnostic and personalized medicine methods, particularly in the medical and biological fields, invalid and unpatentable under ' 101.

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.

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