The US Supreme Court earlier this year denied a petition to review a lower court's decision in the Sequenom v. Ariosa Diagnostics patent case, leaving uncertainty in the field, write Arizona State University's Robert Cook-Deegan and Duke University's Subhashini Chandrasekharan in a commentary appearing in the New England Journal of Medicine.
The case centered on a patent awarded to the Chinese University of Hong Kong's Dennis Lo and his co-inventors in 2001 for detecting cell-free fetal DNA in maternal serum or plasma that they licensed exclusively to Sequenom.In 2013, a California court found part of Sequenom's patent to be ineligible as it covers a natural phenomenon, a finding that was subsequently upheld by an appeals court in 2015. Sequenom then petitioned the Supreme Court to review the decision, which the court denied.
Though the decision not to review the case was "unsurprising," Cook-Deegan and Chandrasekharan write that this state of affairs leaves patent attorneys and their clients "frustrated by the uncertainty about patent eligibility." Recent decisions in Mayo Collaborative Services v. Prometheus Laboratories and Association for Molecular Pathology v. Myriad Genetics have introduced greater ambiguity into what is and is not patentable, they add.
Cook-Deegan and Chandrasekharan say that the court may have decided not to review the case, not only because of its heavy case load, but also because it might be waiting for a narrower patent claim to clarify the rules established by the Mayo and Myriad cases.
"In the meantime, [cell-free fetal DNA] prenatal screening is being increasingly integrated into pregnancy management and offered by many more laboratories as global market competition continues," they add. "A powerful new medical technology has been launched, and the Supreme Court has decided not to alter its trajectory."