Diagnostic Tests and Patent Eligibility: Will the Federal Circuit's Negative Treatment Chill Innovation?

In PerkinElmer, Inc. v. Intema, Ltd., the Court of Appeals for the Federal Circuit (CAFC) revisits the subject of patent eligibility as it relates to diagnostic methods and invalidates the claims of a diagnostic test for Down's syndrome as being patent-ineligible, This decision is significant as it reveals a continued expansion of the Section 101 invalidity defense since the Supreme Court's decision in Prometheus Labs, Inc v Mayo Collaborative Services and portends an evolution of the law in a dangerous direction for diagnostics companies seeking to protect their innovations through the U S. patent system.