PTAB Sides with Broad in Patent Dispute over CRISPR Gene Editing of Eukaryotic Cells

Rothwell, Figg, Ernst & Manbeck, P.C.
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On February 28, 2022, the Patent Trial and Appeal Board (PTAB) issued a decision in Interference No. 106,115, which granted the Broad Institute, Massachusetts Institute of Technology, and Harvard University (collectively “Broad”) priority with respect to the invention of modifying eukaryotic systems with a CRISPR-Cas9 system over the University of California, University of Vienna, and Emmanuelle Charpentier (collectively “CVC”). Under this ruling, Broad’s thirteen patents and one application remain in force, and CVC’s fourteen applications with claims directed to gene editing of eukaryotic systems are rejected for lack of priority.

The focus of this interference is which party was the first to conceive and reduce to practice using a CRISPR-Cas9 system to edit eukaryotic genomes.

CVC contended their inventors conceived the invention on March 9, 2012, and reduced it to practice by August 9, 2012.  With evidence such as lab notes and emails, CVC argued that experiments performed by August 9, 2012, demonstrated editing of a zebrafish genome by CRISPR-Cas9.  However, the PTAB found that CVC merely “encountered one unrecognized positive result and several failures with zebrafish embryos and several months of failed experiments and doubt with human cells,” and that CVC “did not have a definite and permanent idea of how to achieve that [positive] result.”

In contrast, Broad asserted October 5, 2012, as one of its dates of reduction to practice, the date upon which the Broad inventors submitted a manuscript to Science with the results of successful experiments demonstrating the activity of CRISPR-Cas9 on eukaryotic genomes.  The PTAB found the manuscript to be sufficient to support a finding of an actual reduction to practice by the Broad inventors.  Broad also asserted earlier reduction to practice date as of July 2012.  However, the PTAB did not decide on this argument because the Broad’s actual reduction of practice as of October 5, 2012 is already sufficient to demonstrate priority over CVC.

It should be noted that CVC still holds patents directed to the use of CRISPR-Cas9 without limitations to any cell type.  Therefore, after this decision, companies using CRISPR-Cas9 to edit eukaryotic genomes (e.g., companies developing therapeutic and agricultural uses of CRISPR-Cas9) may need to license relevant patents from both Broad and CVC.  If affirmed by the Federal Circuit, the decision would also have an impact on the companies founded by the CVC inventors, such as Caribou Biosciences, Intellia Therapeutics, and CRISPR Therapeutics, because these companies may also need to obtain licenses from Broad.  On the other hand, since the relevant patents here are only related to the CRISPR-Cas9 system, this decision may have limited impact on companies developing different types of CRISPR-Cas systems, such as those based on Cas12 and Cas13.

The battle over these CRISPR-Cas9 patents is not over yet. In a statement after the decision was issued, CVC stated that they are “considering various options to challenge this decision.”  Thus, it is likely that CVC will ask for reconsideration from the PTAB and/or appeal to the Federal Circuit.  Also, there are still other pending interferences involving CRISPR patents of Broad, CVC, ToolGen, and Sigma-Aldrich. We will closely monitor the development the cases and provide further updates.

We would also note that one of our partners, Danny Huntington, was part of a team of attorneys providing input to Broad during the interference.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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