CRISPR Technology: A First-To-Invent Dispute in a Now First Inventor to File Patent Regime

On March 16, 2013, with the enactment of certain provisions of the America Invents Act (AIA), the United States’ patent system moved from being a first to invent patent system (first-to-invent) to a first inventor to file patent system (first-to-file) and retired the use of interference proceedings to determine priority of invention. Prior to and after the initiation of first-to-file system, there has been much debate as to the virtues of both systems. One aspect of this debate was that inventors with less resources and universities benefited more from the first-to-invent patent system rather than the first-to-file where resources can impact the ability to file quickly. It was in this atmosphere and as forecasted, that there was a surge in pre-March 16 application by inventors who sought to have their application reviewed under the first-to-invent system.

Two pre-March 16 filings that have captured attention recently involves CRISPR/Cas9 technology and the recipients of the 2015 Breakthrough Prize in the life sciences category. This dispute may be one of the last high profile priority of invention disputes that will be resolved by an interference proceeding.

CRISPR/Cas9 has been described as a molecular scalpel for genomes. Professor Jennifer Doudna and Emmanuelle Charpentier were the recipients of the 2015 Breakthrough Prize in the life sciences category for their use of CRISPR/Cas9 technology in cutting and replacing a specific section of human DNA. However, while Doudna and Charpentier have a patent application pending (Doudna application) for their award winning work, on April 15, 2014 the first patent to issue on the use of CRISPR technology on complex eukaryotic cells such as human cells, was issued to Feng Zhang, a scientist who had been working in parallel to Doudna and Charpentier. It is not disputed that Doudna and Carpentier were the first to successfully use the CRISPR technology. However, Zhang argues that the Doudna and Charpentier patent application does not disclose the use of CRISPR technology on more complex eukaryotic cells. Notably, it is CRISPR’s application on eukaryotic cells that has great commercial potential.

Because both the Doudna and Zhang applications are pre-March 16 filings, the issue here is who was the first to invent the use of CRISPR technology on more complex eukaryotic cells. In April 2015, Doudna and Charpentier have filed a suggestion of interference to trigger a determination by the USPTO of who is entitled to the patent under the first-to-invent patent system. On the other hand, a third party has filed documentation in support of a claim against the Doudna application for failure to comply with the duty of candor and good faith, which encompasses the duty to disclose prior art; thus, invalidating any patent that might issue from the Doudna application.

This dispute is both substantively interesting and procedurally important, as we will be able to observe how the USPTO handles a very public first-to-invent dispute in a now first inventor to file patent regime.

Estelle J. Tsevdos, Ph.D. is a Director in the Gibbons Intellectual Property Department.