The February 15, 2017 decision by the Patent Trial and Appeal Board (PTAB) terminated the interference before deciding who was first to invent the use of CRISPR-Cas9 for gene editing. This appeal asks the CAFC to overturn that decision, allowing the interference to continue into the priority phase, in which a determination will be made as to which party invented first.
Although the appeal asks for the PTAB’s decision to be reversed, there are three possible outcomes: (1) the PTAB decision will be upheld; (2) the PTAB decision will be reversed; or (3) the Federal Circuit will void (vacate) the PTAB decision and instruct the PTAB to re-evaluate its decision using the proper legal framework.
If the PTAB decision is upheld
If the PTAB decision is upheld, the interference remains terminated. A second interference could be initiated, however, to determine who was first to invent the use of CRISPR-Cas9 systems in eukaryotic cells, or who was the first to invent on other subject matter with sufficiently overlapping claims between the two parties.
If the PTAB decision is upheld, it is likely that the USPTO will issue a patent to the Doudna-Charpentier team for the use of CRISPR-Cas9 gene editing in any environment since those types of claims have been deemed allowable in two different patent applications. Such broader claims would overlap with the Broad patents claiming use in eukaryotic cells.
The Doudna-Charpentier patent application involved in the interference has claims covering use of the single-guide RNA format of CRISPR-Cas9 system in any environment and has been deemed allowable by the USPTO. In addition, the USPTO has allowed a separate Doudna-Charpentier patent application covering methods of using this CRISPR-Cas9 system in any cell type. Although the latter claims were suspended in view of the appeal, these claims could be granted after the CAFC decision.
If the PTAB decision is reversed
If the PTAB decision is reversed, then the case will return to the PTAB to continue the interference. A number of pending motions will need to be decided, and then the priority phase will begin, where the parties will submit evidence regarding who invented first and the PTAB will ultimately make that determination.
If the PTAB decision is vacated
If the PTAB decision is vacated, then the CAFC will return the case to the PTAB with instructions to re-evaluate its decision using the proper legal framework. Upon such re-evaluation, the PTAB can decide that use of CRISPR-Cas9 gene editing in eukaryotic cells is not separately patentable and the interference will continue, or the PTAB can come to the same conclusion as it did before (see (1) above).
Download the Doudna-Charpentier Appeal