Opening a potential new front in the bitter legal wrangle over who invented CRISPR gene-editing technology, Sigma-Aldrich is seeking an interference between three pending patent applications and patents issued to the Regents of the University of California (UC) related to CRISPR-Cas9-based methods in eukaryotic cells.

Sigma-Aldrich has submitted a petition to 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).

A unit of Merck KGaA, Darmstadt, Germany, Sigma-Aldrich is seeking an interference finding along the lines of the interference declared last month by the PTAB between 10 separate U.S. patent applications owned by UC, the University of Vienna, and CRISPR pioneer Emmanuelle Charpentier, PhD, director and scientific member at the Max Planck Institute of Infection Biology, Berlin—and 13 of the 15 patents held by the Broad Institute, Harvard University, and the Massachusetts Institute of Technology, plus one patent application.

In its 13-page “urgent petition,” Sigma-Aldrich acknowledged that its request would normally be deemed premature since it seeks an interference finding with UC based not on any patents awarded to the company but on the patent applications that are also directed to CRISPR-Cas9-based methods in eukaryotic cells:

  • S. Application No. 15/188,911, a method for integrating an exogenous sequence into a chromosomal sequence of a eukaryotic cell.
  • S. Application No. 15/188,924, a method for modifying a chromosomal sequence in a eukaryotic cell by integrating a donor sequence
  • S. Application No. 15/456,204, a method for modifying a chromosomal sequence in a eukaryotic cell.

The three applications cited by Sigma-Aldrich are among five U.S. patent applications cited by the company on its website. The other two are No. 15/188,927, and No. 15/188,931.

Sigma-Aldrich asserted that the circumstances surrounding CRISPR methods in eukaryotic cells were extraordinary enough to warrant an exception allowing the interference.

“The PTAB’s 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 stated in its petition, filed July 19.

The company said its interference should run in parallel with last month’s interference, initiated by the USPTO, rather than consecutively, saying that would support “the effective administration of justice, efficiencies of the USPTO and the parties, conservation of valuable resources, and the public interest.”

‘Detriment of the Public’

The public interest would especially be served, Sigma-Aldrich asserted, saying that its interference proceeding would resolve the ongoing legal wrangle by competing entities over CRISPR patent rights for researchers, institutions, companies, and their investors.

“This ongoing uncertainty in the patent landscape provides a significant chilling effect on the funding of both research efforts and commercial endeavors. And of course, some scientific and marketplace potential actors may choose to sit on the sidelines and observe the ongoing IP battle until the smoke clears,” Sigma-Aldrich contended. “All of this uncertainty and trepidation inures to the detriment of the public, who could potentially benefit greatly from the treatments and therapies that CRISPR-based gene-editing therapies promise.”

Sigma-Aldrich argued that UC’s disclosure in its applications of CRISPR-Cas9 methods applied in prokaryotic cells had not rendered obvious claims directed to CRISPR-Cas9 in eukaryotic cells—citing the first interference process over CRISPR patents that was requested by UC and partners against the Broad Institute.

That first interference proceeding resulted in a ruling by the U.S. Court of Appeals in September 2018 that upheld a PTAB judgment finding no interference-in-fact between UC claims and patents already issued to Broad, stating that the claims were not directed to the same subject matter.

However, the appeals court ruling made no specific determination regarding priority of invention of genome editing within eukaryotic cells. Since then, UC and partners filed their series of applications.

Sigma-Aldrich took issue in its petition with the refusal of patent Examiner Jennifer Ann Dunston to allow its claims for CRISPR methods in eukaryotic cells for reason of obviousness, despite what the company called the “controlling precedent” of the decision in the first interference proceeding. Sigma-Aldrich also cited offering the Examiner “multiple declarations from prominent experts” that were not named in the petition why its claims were not obvious and why UC’s provisional applications did not enable or adequately describe use of CRISPR-Cas9 in eukaryotic cells.

“In this situation, the Agency is treating Sigma-Aldrich very differently and unfairly when compared to the Agency’s treatment of Broad [Institute] and UC,” Sigma-Aldrich stated, citing the PTAB’s earlier conclusion that the Broad Institute’s CRISPR-Cas9 eukaryotic claims were patentable over UC’s disclosures of CRISPR-Cas9 in prokaryotic cells.

“The disparity in Sigma-Aldrich’s treatment by the Agency could not be more glaring, and is punctuated by the fact that the Supervisory Patent Examiner(“SPE”) on Sigma-Aldrich’s applications is the same SPE who supervised the above-quoted allowance for Broad Inst[itute].”

Effect of USPTO-Launched Interference

Sigma-Aldrich expressed concern that the USPTO-launched interference may further hinder review of the applications, especially if it is blocked from presenting arguments and evidence while they are under review by the PTAB: “To deny Sigma-Aldrich the opportunity to participate in a parallel Sigma-Aldrich v. UC interference, thereby allowing Sigma-Aldrich a full and fair opportunity to present its own arguments and evidence, could effectively amount to a “justice delayed is justice denied” scenario.”

The Broad has defended its patents, and has stated that it welcomed the second interference proceeding begun last month by the PTAB. The Broad also noted that the USPTO had designated Broad, MIT, and Harvard as the Senior Parties and UCB as the Junior Party: “This further underscores the significance of Broad’s prior claims. The Senior Party is presumed to be the “first to invent,” and the Junior Party carries the burden of proof.”

Despite the request for a new interference by Sigma-Aldrich, Merck KGaA’s MilliporeSigma and the Broad Institute this month agreed to a framework through which they will offer non-exclusive licenses to CRISPR intellectual property (IP) for use in commercial research and product development. The Broad and MilliporeSigma said their framework was designed to allow other key patent holders to participate in the future—either through this framework or via a third-party patent pool or collaboration—in order to further streamline non-exclusive access to key CRISPR technology.

That framework, combined with Sigma-Aldrich’s interference petition and the recently-launched USPTO interference, has prompted a packager and provider of one-stop licenses for standards and other tech platforms to call publicly for resolving the CRISPR patent wars through creation of a patent pool.

“To maximize the benefits of CRISPR, the market needs a patent pool option in which all stakeholders participate and the market’s confusion and uncertainty concerning the patent landscape can be addressed,” stated MPEG LA, which has operated licensing programs consisting of more than 21,000 patents in 90 countries with some 250 patent holders and more than 6,000 licensees.

Citing its non-alignment with any of the parties to the CRISPR legal wrangle, MPEG LA added; “we stand ready to assist all stakeholders with formation of a CRISPR patent pool that addresses competitive market needs and realities.”

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