The U.S. Supreme Court's ruling
in Bilski last week reestablished a patenting environment that is more
inclusive to process claims for molecular diagnostics, which had been under attack
for the past few years. The fact that the decision was narrow and vague is good
news for MDx companies, as it put the threshold for eligibility of MDx patents
back to where it was three years ago, before the Court of Appeals for the
Federal Circuit put forth its machine-or-transformation test.
The CAFC's test requires that a
process be tied to a machine or perform a transformative step. The key question
concerning MDx companies in Bilski et al. v. Kappos was whether
the machine-or-transformation test is the sole test for determining whether a
process is eligible for a patent.