Sigma-Aldrich submits CRISPR petition at USPTO
Merck KGaA-owned Sigma-Aldrich has petitioned the US Patent and Trademark Office (USPTO) to open an interference proceeding between its own pending CRISPR-Cas9 patents and patents awarded to the University of California, Berkeley (UC Berkeley).
On Friday, July 19, Sigma-Aldrich submitted the request, available on blog PatentDocs, asking for a parallel interference to the one declared by the USPTO in June between UC Berkeley and the Broad Institute of MIT and Harvard.
In June, the office revived the dispute between the Broad Institute and UC Berkeley over which first invented the CRISPR gene-editing technology by announcing that it would conduct an interference proceeding between 13 patents and one application to the Broad Institute and ten patent applications filed by UC Berkeley.
All of the Broad Institute and UC Berkeley patents and applications cover the use of CRISPR/Cas9 in eukaryotic cells.
Sigma-Aldrich’s pending patent applications (serial numbers 15/188,911, 15/456,204, and 15/188,924) are also directed to CRISPR-Cas9-based methods in eukaryotic cells.
“Of critical importance here, Sigma-Aldrich’s benefit applications pre-date the earliest possible benefit applications involved in the UC Berkeley v Broad Institute interference with respect to their respective disclosures of CRISPR-Cas9 in eukaryotic cells,” said Sigma-Aldrich in its petition.
According to the company, while its pending applications’ claims have not yet been allowed, so declaring a patent interference now would be premature in ordinary circumstances, the facts of the situation are “truly extraordinary”.
The Merck-owned unit said that it “feels compelled to apprise the director and the chief administrative patent judge (CAPJ) of the current situation and to briefly explain why the Patent Trial and Appeal Board’s (PTAB) declaration of a parallel interference in this instance would be in the long-term best interests of everyone, including the USPTO, the parties, and the public”.
Sigma-Aldrich went on to claim that the sole issue raised by the petition has already been effectively decided by both the PTAB and the US Court of Appeals for the Federal Circuit.
‘Treated unfairly’
In a comment sent to LSIPR, a spokesperson for Sigma-Aldrich said: “With this petition, our intent is to highlight a fundamental unfairness in how Merck’s patent applications covering the use of CRISPR genome-editing technology in eukaryotes are being handled compared with applications filed by others.”
We feel strongly that our scientists should be recognised for their discovery work leading to the use of CRISPR in eukaryotes.”
In February 2017, the PTAB held that the Broad Institute’s patents—which are all limited to CRISPR/Cas9 systems in a eukaryotic environment—do not interfere with patent claims (which are not restricted to any environment) filed by UC Berkeley and the University of Vienna.
UC Berkeley and the University of Vienna appealed against the decision, asking the Federal Circuit to determine whether the PTAB committed error in “ignoring overwhelming evidence” that the Broad Institute’s claims are obvious in light of UC Berkeley’s.
The PTAB’s finding was affirmed by the Federal Circuit in September 2018.
“Sigma-Aldrich respectfully submits that the PTAB’s and the Federal Circuit’s ‘no’ answer compels the grant of this petition,” said the Merck subsidiary.
Sigma-Aldrich has claimed that the USPTO is treating it “very differently and unfairly” when compared to the agency’s treatment of the Broad Institute and UC Berkeley.
It said: “Indeed, the USPTO has now granted Broad Inst over a dozen issued patents. In direct contrast, the USPTO continues to reject Sigma-Aldrich’s CRISPR-Cas9 eukaryotic claims as not patentable over those same UC CRISPR-Cas9 prokaryotic provisional applications that the USPTO has repeatedly found have been successfully overcome by Broad Inst’s eukaryotic claims.”
The petition claimed that this “blatant inconsistency” and the unfairness to Sigma-Aldrich could not be “more palpable”.
“In today’s highly charged political environment, certainly the director and CAPJ are sensitive to criticism levelled at the agency regarding issues of fairness and equity, eg whether the USPTO provides ‘a level playing field’,” added the petition.
A spokesperson for the Broad Institute said: “It is time for certainty around CRISPR and for the parties to come together to resolve these disputes and to simplify access to this important technology.”
Sigma-Aldrich is part of Merck's life science business and, in combination with Merck's other acquisition Millipore, operates as MilliporeSigma in North America.
A spokesperson for UC Berkeley said: “We remain confident that the USPTO will ultimately recognise that the Doudna and Charpentier team hold the priority of invention specific to the CRISPR-Cas9 gene-editing technology in eukaryotic cells, as well as other settings covered by the Doudna-Charpentier team’s previous patents.”
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