BioCentury
ARTICLE | Politics, Policy & Law

Processing Bilski

November 16, 2009 8:00 AM UTC

Molecular diagnostic companies have been worried that a ruling by the U.S. Supreme Court in Bilski v. Kappos could render many existing MDx patent claims moot and narrow the scope of allowable claims. But comments and questions by the justices during oral argumentslast week suggest the high court's decision is unlikely to address the issues that were most likely to affect molecular diagnostics.

Bilski is focused on a claim for hedging risk in the field of commodities, including the use of algorithms to determine prices. As the case progressed, MDx companies became alarmed when the U.S. Court of Appeals for the Federal Circuit in 2008 introduced a new test for the patent eligibility of process claims under Section 101 of the Patent Act. Specifically, CAFC ruled en banc that to be eligible for patenting, a process must be tied to a machine or perform a transformative step...