The First Inventor of Key CRISPR Patents To Be Determined by Patent Trial and Appeal Board

Key Points:

• On June 24, 2019, the Patent Trial and Appeal Board declared it would determine the first party to invent the CRISPR-Cas9 system in an interference proceeding.
• An earlier interference proceeding between the same parties did not determine which party invented the use of CRISP-Cas9 system in eukaryotic cells, which include plant and human cells.
• The PTAB will likely issue a decision determining the first inventor of the CRISPR-Cas9 system in eukaryotic cells in approximately two years.

  ---

The ongoing inventorship dispute between The University of California along with the University of Vienna and Emmanuelle Charpentier (collectively, UC) and The Broad Institute along with MIT and Harvard College (collectively, “Broad”) over the groundbreaking CRISPR-Cas9 gene-modifying system intensified last week when the Patent Trial and Appeal Board (the PTAB) of the United States Patent and Trademark Office (USPTO) announced it would decide whether UC or Broad owns rights to a key application of the technology. The potential applications for the CRISPR-Cas9 system, and systems similar to CRISPR-Cas9, range from basic research to clinical and commercial applications for humans, animals and plants. 

On June 24, 2019, the PTAB declared it would initiate an interference proceeding to determine whether UC or Broad first invented the use of the CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) system in eukaryotic cells, which includes advanced cells such as plant and human cells. As declared by the PTAB, the interference proceeding will determine the priority of invention for the patents and patent applications at issue in the interference and will identify the first inventor of the CRISPR-Cas9 system in eukaryotic cells. Although Broad was the first party to obtain issued patents covering the use of CRISPR in eukaryotic cells from the USPTO beginning in 2014, UC recently filed ten new patent applications in 2018 claiming the same use of CRISPR in eukaryotic cells, and the PTAB therefore initiated the present interference proceeding.

This is not the first interference between UC and Broad over CRISPR-related patents. In February of 2017, the PTAB determined there was no interference in fact between a patent application filed by UC and the patents and patent applications owned by Broad—the same Broad patents and applications at issue in the present interference—because they covered distinct inventions. In that earlier interference, the PTAB determined that UC’s patent application at issue claimed a method of using CRISPR to cleave nucleic acid but did not specify the cell type or environment in which the system functioned. In contrast, Broad’s claims limited the use of CRISPR to eukaryotic cells. In determining that Broad’s claims and UC’s claims were patentably distinct, the PTAB found that one skilled in the art would not have expected that CRISPR would work in eukaryotic cells based on UC’s disclosure, which included only in vitro work and did not include any experimental results in actual eukaryotic cells. Because the PTAB found that UC’s and Broad’s claims covered distinct inventions, the PTAB stopped short of deciding which party was the first to invent using CRISPR in eukaryotic cells. In September of 2018, the Court of Appeals for the Federal Circuit affirmed the earlier decision by the PTAB. Prior Akin Gump IP Newsflash posts on the earlier interference and the appeal of that decision can be found here.

Unlike the earlier interference, UC’s patent applications at issue in the present interference proceeding are directed to using CRISPR in eukaryotic cells. To decide whether UC or Broad was the first inventor, the PTAB will likely review evidence such as laboratory notebooks and email communications between scientists to determine the party that first conceived of using the CRISPR system in eukaryotic cells, and whether that party was diligent in reducing the invention to practice. Notably, the PTAB designated Broad as the “senior party” in the present interference based on the earlier filing date of its patents, and Broad is therefore presumed to be the first inventor. UC, which is designated as the “junior party”, bears the burden of proving that it invented the technology prior to Broad.

The expected timeframe for the PTAB to complete this second interference between UC and Broad is about two years. By way of example, the PTAB issued its determination in the earlier interference between UC and Broad in about 22 months. In the meantime, it is expected that UC and Broad will continue to apply for patents covering the CRISPR-Cas9 system and other aspects of that system, and the PTAB may include certain of the newly filed applications in the interference.

The current interference between UC and Broad is captioned as The Regents of the University of California v. The Broad Institute, Inc., Interference No. 106,115.

Contact Information

If you have any questions concerning this alert, please contact: