CVC argued in the April 30, 2018 hearing before the U.S. Court of Appeals for the Federal Circuit (CAFC) that the PTAB incorrectly concluded that the use of CRISPR-Cas9 to edit eukaryotic cells was separately patentable from its use in other settings when it terminated the interference without deciding priority of invention. The appeal centers on the fundamental errors in the PTAB’s legal analysis; any decision in this appeal will not determine who invented the use of CRISPR-Cas9 technology for genome editing, which will be decided in a later interference before the PTAB.
During the argument, a three-judge panel asked questions of attorneys for both sides, and each side had the opportunity to explain its arguments. Questions included whether there was “substantial evidence” for the PTAB’s decision, the relative weight given to inventor statements versus successful application of CRISPR-Cas9 genome editing in eukaryotic cells by other groups, whether the PTAB applied the correct legal standard, and whether the PTAB had improperly shifted the burden of proof to CVC.
In making a decision, the CAFC can remand the matter back to the PTAB to correct its errors and reconsider its decision, it can reverse the PTAB decision (in which case the original interference will move into the priority phase), or it can affirm the PTAB decision (and the original interference will remain terminated).
Even if the PTAB decision is affirmed, this will not determine which group actually invented genome editing applications of the CRISPR-Cas9 technology, but rather whether the particular interference that was previously declared and terminated should move forward. Regardless of the CAFC outcome, CVC will have ongoing opportunities to seek and participate in one or more interferences with the Broad, as well as to obtain issued patents in the U.S. and globally that cover compositions and applications of CRISPR-Cas9 editing systems, including use in eukaryotic cells.
As the parties wait for a decision, CVC continues to receive patents globally covering the CRISPR-Cas9 genome editing technology and its use in all environments. Patents have been granted recently in Europe, China, Australia, and other countries, and applications have been allowed in the United States and Japan.