Classen — A Guide For Post-Prometheus Patent Claims

July 30, 2012Articles Law360

In the wake of the U.S. Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories Inc., 132 S.Ct. 1289 (2012), the 35 U.S.C. § 101 threshold for patentability of claims to medical diagnostic methods is still a bit murky. It is clear that an active step is required and that the active step must be something more than a “well-understood, routine, conventional activity previously engaged in by scientists who work in the field.” Id at 1291.

But, to date, no post-Prometheus decision has provided biotechnology practitioners with any further guidance. Until such interpretative decisions are made, the question remains of what the standard should be for drafting a valid claim under 35 U.S.C. § 101.

The answer to this question may have already been provided by the Federal Circuit. Its decision in Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), while prior to Prometheus, provides an analysis that appears to satisfy the U.S. Supreme Court’s requirements.

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