In Illumina, Inc. v.
Ariosa Diagnostics, Inc., a divided
panel of the Federal Circuit found claims directed to methods of
preparing DNA samples for analysis satisfy the patent eligibility
requirement of 35 USC § 101. Although the claimed methods
could be practiced in conjunction with a diagnostic method, the
majority decision emphasizes that "this is not a diagnostic
case." Still, stakeholders in the diagnostic space may find
hope—and take note—that the court identified eligible
subject matter.
The Patents At Issue
As described in the Federal Circuit opinion, the patents at
issue addressed a problem encountered in practicing the diagnostic
method found ineligible in
Sequenom relating to the detection of "extracellular
fetal DNA ... in maternal plasma," namely, the need "to
distinguish and separate the tiny amount of fetal DNA from the vast
amount of maternal DNA." As quoted in the opinion, the patents
explain:
