Federal Circuit Denies En Banc Review Of Ariosa v. Sequenom

On December 2, 2015, an almost unanimous Federal Circuit decision was issued denying the en banc rehearing of Ariosa v. Sequenom, a case having significant consequences for diagnostic patents and Section 101 case law in general.1 The concurrences and dissent in the Ariosa case offer insight into how the various judges perceive the existing Section 101 case law and attempt to offer applicants guidance in obtaining patent-eligible claims in the diagnostic arena.

The patent at issue

Sequenom is the exclusive licensee of U.S. Patent No. 6,258,540 (the '540 patent), which claims a "method of detecting paternally inherited nucleic acid of fetal origin performed on the maternal serum or plasma sample from a pregnant female." '540 patent at 23:61-63. According to the '540 patent, the invention enables noninvasive prenatal diagnosis (id. at Abstract) and differs from previous noninvasive tests that detected fetal cells in a mother's bloodstream. Id. 1:18-36. The independent claims of the '540 patent recite:

A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample. A method of performing a prenatal diagnosis, which method comprises the steps of: providing a maternal blood sample; separating the sample into a cellular and a non-cellular fraction; detecting the presence of a nucleic acid of foetal origin in the non-cellular fraction according to the method of claim 1; providing a diagnosis based on the presence and/or quantity and/or sequence of the foetal nucleic acid. A method for detecting a paternally inherited nucleic acid on a maternal blood sample, which method comprises: removing all or substantially all nucleated and anucleated cell populations from the blood sample, amplifying a paternally inherited nucleic acid from the remaining fluid and subjecting the amplified nucleic acid to a test for the Paternally inherited fetal nucleic acid. A method for performing a prenatal diagnosis on a maternal blood sample, which method comprises obtaining a non-cellular fraction of the blood sample amplifying a paternally inherited nucleic acid from the non-cellular fraction and performing nucleic acid analysis on the amplified nucleic acid to detect paternally inherited fetal...