In a unanimous decision, the United States Supreme Court
addressed the issue of patent eligibility of diagnostic method
claims (Mayo v. Prometheus)1. This decision
could have a significant impact on the fields of personalized
medicine and medical diagnostics since the claims at issue,
directed to a blood-testing method for optimizing a particular
therapy, were invalidated because they did not define
patent-eligible subject matter. This decision reverses the Court of
Appeals for the Federal Circuit's holding that the claims were
patentable because they included substantial physical
limitations.
In Mayo v. Prometheus, the claims recite methods
physicians may use to determine if a patient's dose of a drug
used in the treatment of autoimmune diseases is too low or too
high. The main claim of the patent essentially recites a two-step
method including an "administering" step in which a drug
is administered and a "determining step" in which levels
of a metabolite of the
