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Supreme Court decisions may mean that some are simply unpatentable. who will protect life science innovations?
By: David Pridham & Brad Sheafe
In a move wIth far-reachIng ImplIcations for the future of diagnostic medical innovation, on March 21 Sequenom, Inc. filed a petition for a writ of certiorari with the U.S. Supreme Court challenging the ruling last year by the U.S. Court of Appeals for the Federal Circuit that the first noninvasive prenatal test for fatal conditions in a baby’s DNA was unpatentable…” in that case— Ariosa Diagnostics v.Sequenom—and in a subsequent denial of an en banc rehearing, the Federal Circuit reluctantly ruled against Sequenom by citing as precedent the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Labs.
Many believe that the court’s 2012 decision in that case, which held that a diagnostic test for a personalized medicine dosing regimen was unpatentable, was overbroad. If the Supreme Court grants Sequenom’s cert petition, which has strong support from industry and academia, it may reconsider its ruling in Mayo.
Whether or not the Supreme Court accepts cert—a decision that may have been made by the time this article goes to press—diagnostic medical innovators still have cause for hope. A close reading of the Federal Circuit’s reasoning in the case—combined with a more strategic approach to patenting in today’s uncertain IP legal and legislative environment—offers such companies (and other businesses with a similar dependence on intellectual property) a possible path to protecting and monetizing their innovations. This will be crucial if they wish to continue making the heavy investments in R&D needed for future breakthroughs in medicine and other technologies critical to our economy and quality of life.
The invention at issue in the Sequenom case involved the 1996 discovery by two doctors that cell-free fetal DNA (cffDNA) circulates in the mother’s plasma. They then invented a novel test for detecting fetal genetic conditions in early pregnancy without having to employ the dangerous invasive techniques that had previously been used for testing fetal DNA.