Biologics Blog

Sigma-Aldrich Files “Urgent” Petition for Patent Interference on CRISPR-Cas9

On July 19, 2019, Sigma-Aldrich filed a petition with the Director of the U.S. Patent and Trademark Office (“USPTO”) and the Chief Administrative Patent Judge (“CAPJ”) of the Patent Trial and Appeal Board (“PTAB”) seeking an interference between itself and the Regents of the University of California (“UC”) that would parallel an interference that was recently declared between UC and the Broad Institute (“Broad”).  The claims at issue are directed to methods of genetically modifying a eukaryotic cell using a CRISPR-Cas9 system.  The petition is unusual because it seeks to provoke an interference although Sigma-Aldrich’s pending claims have not been allowed, contrary to 37 C.F.R. § 41.102 and MPEP § 2303.  Sigma-Aldrich argues that the circumstances here are extraordinary and warrant an exception to the rule.  

CRISPR-Cas9 is an exciting new biotechnology that involves retooling a bacterial immune system for genome editing purposes.  We previously reported here and here on a closely-watched earlier interference between UC and Broad involving claims to CRISPR-Cas9.  That interference involved claims by UC to CRISPR-Cas9 in an unspecified environment (i.e., covering in vitro, prokaryotic, and eukaryotic environments) and claims by Broad to CRISPR-Cas9 in eukaryotic cells.  Broad ultimately won its argument that there was no interference-in-fact between the parties’ claims.  On June 24, 2019, PTAB declared a new interference between UC and Broad in which both parties claim CRISPR-Cas9 based methods and compositions of matter in eukaryotic cells. 

Sigma-Aldrich owns three patent applications covering CRISPR-Cas9-based methods of genetic modification in eukaryotic cells.  The patent applications are numbered 15/188,911; 15/188,924; and 15/456,204. 

In its “urgent” interference petition, Sigma-Aldrich begins by arguing that CRISPR-Cas9 in a eukaryotic environment would not have been obvious over CRISPR-Cas9 in a prokaryotic environment.  Sigma-Aldrich points to the fact that the first interference between UC and Broad already litigated this very issue to completion.  There, PTAB concluded that the disclosure of CRISPR-Cas9 in a prokaryotic environment in UC’s priority applications did not render obvious Broad’s claims to CRISPR-Cas9 in eukaryotic cells, and the Federal Circuit affirmed.  Notwithstanding this “controlling precedent,” Sigma-Aldrich argues, as well as unspecified additional evidence Sigma-Aldrich offered during examination of its pending applications, the examiner has continued to reject the claims based on the previously litigated UC priority applications.  Petition at 4.  The rejections have been maintained despite an in-person interview to discuss the issue with the examiner, her Supervisory Patent Examiner, two Interference Patent Specialists, and the Group Art Unit Director.

Sigma-Aldrich’s petition then turns to the reasons PTAB should grant the extraordinary request for an interference now, rather than after Sigma-Aldrich has appealed the examiner’s rejections to PTAB, and thereafter to the Federal Circuit.  First, Sigma-Aldrich argues that the USPTO is treating it “very differently and unfairly” compared to UC and Broad.  Id. at 7.  According to Sigma-Aldrich, the USPTO’s decisions with respect to its applications are directly inconsistent with the USPTO’s decisions with respect to the Broad’s eukaryotic CRISPR-Cas9 claims.  Notably, Sigma-Aldrich points out, the Supervisory Patent Examiner on Sigma-Aldrich’s applications is the same one who supervised the allowance of Broad’s claims from the first interference. 

Second, Sigma-Aldrich argues that conducting an entirely separate interference in the distant future between itself and UC—instead of allowing such an interference to occur in parallel with the second interference between UC and Broad—would be an inefficient use of resources.  Sigma-Aldrich pointed to the immense resources consumed in the first UC-Broad interference, and the likelihood that the same will be true of the newly declared UC-Broad interference.  It further points out that the newly declared interference is still at an early stage, thus making it possible to coordinate case schedules, if the Sigma-Aldrich interference is granted quickly.   

Finally, Sigma-Aldrich contends that the public interest favors declaring the requested parallel interference, as resolving patent rights in the CRISPR space sooner rather than later benefits stakeholders, such as scientists and investors.  Sigma-Aldrich expressed concern that the ongoing uncertainty in the patent landscape for CRISPR chills funding of both research efforts and commercial endeavors in this area of great therapeutic promise. 

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