April 16, 2017

UC Berkeley Appeals Adverse CRISPR Genome Editing Patent Interference Decision

A recent inventorship dispute between the University of California at Berkeley (UC) and the Broad Institute at MIT centered on which institution was entitled to patents for the use of CRISPR-Cas9 (CRISPR) genome editing methods in eukaryotic cells (an interference proceeding). In its recent adjudication of the conflict, the United States Patent and Trademark Office Patent Trial and Appeal Board (PTAB) declared no conflicting patent rights between a UC patent application and the already issued patents of MIT; therefore, the existing grant of patents to MIT for the use of CRISPR in eukaryotic cells was upheld, and the UC application for the use of CRISPR in all cells could continue prosecution. In the decision, the PTAB found that the patent claims of the Broad Institute to the use of CRISPR in eucaryotic cells was not obvious in view of the originally filed UC patent application, therefore, the subject matter of Broad did not overlap with that of UC. MIT has already issued patents, while UC's patent application is still pending. Now, UC has announced an intention to file an appeal with the Federal Circuit of the adverse PTAB ruling in February. From the UC press release:
Given the revolutionary nature of the CRISPR-Cas9 technology, UC believes that obtaining a timely confirmation that its scientific team was the first to invent the use of the technology in all environments, including eukaryotic cells, is important for current and potential users of the technology, including academia, industry and the public at large.
 In parallel, UC intends to pursue continuing applications in the U.S. and globally to obtain patents claiming the CRISPR-Cas9 technology and its application in non-cellular and cellular settings, including eukaryotic cells. Corresponding patents have already been granted to UC in the United Kingdom, and the European Patent Office has announced that it will grant UC’s patent on May 10, 2017.
The Broad Institute has issued a statement on the appeal: 
UCB has filed a Notice of Appeal asking the United States Court of Appeals for the Federal Circuit, based in Washington DC, to review the recent decision by the PTAB (Patent Trial and Appeals Board) that there is no interference between the Broad Institute, MIT and Harvard claims concerning the use of the CRISPR system in eukaryotic cells and the patent application of UCB because the claims are patentably distinct.
Given that the facts have not changed, we expect the outcome will once again be the same.
We are confident the Federal Circuit will affirm the PTAB decision and recognize the contribution of the Broad, MIT and Harvard in developing this transformative technology.
The Federal Circuit can review the PTAB ruling for any error or law or lack of substantial evidence, but will defer to the factual findings from the board. If the ruling is left in place, UC can still move ahead with its patent application to the use of CRISPR in all cells. Theoretically, such a UC patent could coexist with the Broad patent to the use of CRISPR in eucaryotic cells. A potential user might then have to seek permission or license from both patent holders to use the CRISPR system in eucaryotic cells. The parties themselves (UC, Broad) might need to seek cross-licensing from each other to utilize CRISPR in eucaryotic cells. While the current dispute centers on the specific and valuable CRISPR-Cas9 system, other permutations of the CRISPR methodology can utilize different enzymes (e.g., CRISPR-Cpf1) and are therefore separately eligible for patenting, unconnected to this particular UC/Broad conflict.

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