On April 15, 2021, H&J intellectual property attorney Nick Kuhlmann moderated a panel of attorneys and Ph.D.’s practicing in the pharmaceutical and biotech fields at the Mitchell Hamline Annual IP Symposium – “Exploring the Boundaries of Statutory Subject Matter under the AIA.” The panel discussed the U.S. Supreme Court’s Mayo and Myriad decisions and how they have impacted clients seeking protection for medical diagnostic, pharmaceutical, and vaccine inventions.
During the COVID pandemic, access to quick and effective diagnostic testing has been an important public health concern. It remains to be seen how this event may impact the Court’s decision-making going forward on the challenge of obtaining patent rights to diagnostic methods. In 2020, the U.S. Supreme Court denied on several occasions the opportunity to review on certiorari the question of diagnostic method subject matter eligibility. However, in August 2020, the U.S. Court of Appeals for the Federal Circuit gave some life to diagnostic method-related patents when it held in Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. Aug. 3, 2020) that two patents directed to methods for preparing solutions for detection of fetal DNA in maternal blood were patent eligible due to their steps of separating and extracting DNA in forms that went beyond naturally occurring, isolated DNA. A petition for writ of certiorari for review of this decision by the U.S. Supreme Court remains pending as of April 2021.