Christopher M. Holman, PhD, Executive Editor of Biotechnology Law Report, a publication of Mary Ann Liebert, Inc., explores the possible ramifications of that decision in his Editorial on “ Preliminary Thoughts on the Implications of Mayo v. Prometheus for Biotechnology,” which was released online ahead of the April issue due to the timely nature of the commentary.
“Clearly, the effect of Mayo will be felt most keenly with respect to diagnostics and personalized medicine. The identification and validation of clinically significant biomarkers will be critical in bringing to fruition the promise of the next-generation diagnostics and personalized medicine,” says Dr. Holman, Associate Professor, University of Missouri—Kansas City School of Law. “However, in the wake of Mayo, it is unclear whether effective patent protection will be available to adequately incentivize the necessary research.”
“At this point, the implications for biotechnology are far from clear, and could depend on how the Federal Circuit decides the closely related case of Association for Molecular Pathology v. Myriad Genetics,” adds Dr. Holman. On March 26, the Court set aside a ruling that said Myriad Genetics, Inc. could patent two genes linked to breast and ovarian cancers, and in a brief written decision sent the case back to the Federal Circuit to reconsider in light of its most recent pronouncements in Mayo.