Federal Circuit Invalidates Myriad Primer And Method Claims As Lacking Subject Matter Eligibility

In a case styled as In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (also known as Myriad v. Ambry), the Federal Circuit held four of Myriad's "primer" claims and two of Myriad's detection method claims invalid for lack of subject matter eligibility under 35 USC § 101. The timing of this decision–coming two days after the USPTO's Interim Guidance on subject matter eligibility which led many of us to believe that biotechnology inventions could be patented once again–makes it tempting to refer to the Federal Circuit as the Grinch Who Stole Christmas. But while the Grinch changed his mind just in time, it may take Congressional action before diagnostic and personalized medicine innovators have reason to celebrate.