Strong Support For Sequenom's Petition For Rehearing En Banc

In Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015), a Federal Circuit panel held that Sequenom Inc.'s prenatal diagnosis patent claims patent ineligible subject matter under the two-step test of Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012). Sequenom's patent is premised on the breakthrough discovery that paternally inherited cell-free fetal DNA ("cffDNA") can be found in maternal plasma, material which prior to this discovery was discarded as waste. Although Sequenom's application of this discovery revolutionized prenatal diagnostics—making possible a noninvasive method for detecting prenatal defects without having to obtain fetal DNA directly from the fetus or placenta—the panel held that the claimed method was patent ineligible under Mayo. Applying Mayo's two-step test, the panel determined that 1) the claimed method "begins and ends with a natural phenomenon," and 2) the method steps are "well-understood, routine, and conventional." As a result, the panel concluded that the claimed method is not substantially more than a claim to the natural phenomenon itself. Judge Linn felt constrained by Mayo, stating that "[b]ut for the sweeping language in the Supreme Court's Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible."

Sequenom petitioned the court for rehearing en banc, arguing that the panel's failure to consider the claimed method as a whole was contrary to Diamond v. Diehr, 450 U.S. 175 (1981), Ass'n for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and Mayo itself. The petition stated that "[i]t is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements," particularly because "a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made." Petition 8 (quoting Diehr). Sequenom's petition received strong support from amici from numerous organizations, companies and academic groups. There were 12 amicus briefs in total, raising a variety of additional arguments in support of en banc review.

A number of amici argued that preemption (of abstract ideas, laws of nature, and natural phenomena) had to be considered in assessing patent eligibility. The panel expressly recognized that "[t]he Supreme Court has made clear that the...