CRISPR-Cas9 gene editing ruling: Overview and ongoing implications

Michael Yee

Where is the legal line drawn when patenting scientific progress? The Patent Trial and Appeal Board (PTAB) recently answered this question by upholding patents held by the Broad Institute of MIT and Harvard, maintaining that they are distinct from the University of California Berkeley’s pending patent application for using the CRISPR-Cas9 system for gene editing. Because the Broad Institute’s patents made the distinction that this method could be used in eukaryotic cells while the UC’s patent application did not, judges ruled that there was no interference from the Broad Institute’s patents. For more commentary and reactions, please refer to these Nature and Science articles.

As indicated by the UC Berkeley News article, the UC respects the decision and is embracing the positive side of the outcome as a move closer to receiving its patent. However, the UC still asserts that its patent would cover uses in all types of cells. UC Berkeley Vice Chancellor for Research and Professor of Chemistry Paul Alivisatos states that the use of CRISPR-Cas9 gene editing is not to be patented separately, and reaffirms claims of the invention to Drs. Jennifer Doudna and Emmanuelle Charpentier’s group. Doudna and Charpentier filed the patent in May, 2012, and soon after published the findings in Science, where their engineering methods were described. By January, 2013, multiple papers were published and patents were filed relating to the use of the CRISPR-Cas9 system, including several from the Broad Institute. However, because the Broad Institute paid an additional fee, the process of examining the patent application moved more quickly than that of UC Berkeley.

The Broad Institute has also issued a statement responding to the PTAB’s decision, accompanied by a clear, concise summary of background information related to the proceedings. The statement details that original work began in 2011 at the Broad Institute at MIT by Dr. Feng Zhang, that the manuscript was submitted in October, 2012, and published in January, 2013, highlighting that it’s the first publication of the world’s first engineering methods of the CRISPR-Cas9 system to be used in eukaryotic, mammalian cells. In its statement, the Broad Institute insists that despite the “accelerated examination” for patenting, the “standard for review” was not compromised. It goes on to explain that the patent system was changed “first to file” starting in March, 2013, “but the relevant applications for CRISPR-Cas9 fall under the previous ‘first to invent’ system.” It asserts that Dr. Zhang was the first to file for this method, in December, 2012.

Notably, UC Berkeley and the Broad Institute’s statements find common ground and show mutual respect for the efforts and scientists involved. Alivisatos’ statement emphasizes that this pursuit “keeps the public interest and the greater good” in mind, and Dr. Doudna’s statement stresses that the focus remains finding solutions “that can help solve our greatest challenges across human health, agriculture, and the environment.” The Broad Institute’s statement also punctuates the larger scope and contributions of CRISPR research as a whole “to advance the field and educate the public about this important technology.” The statement then mentions the Broad Institute’s continual work in this area of CRISPR research that is “consistent with our founding principle to propel the understanding and treatment of disease.”

Though both parties have outwardly acknowledged and respected the PTAB’s decision, the legal battle continues, with each party stating opposing claims. The battle lines have been drawn more distinctly, and the continuing possibilities are discussed here. Nature and Science have also published articles explaining what this ongoing saga might mean to companies.

Fun fact: The author of this post worked in the stock rooms for the Department of Molecular and Cell Biology at UC Berkeley, and helped the Doudna Lab with orders in its early days at UC, Berkeley.

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Mike has a Ph.D. in Biomedical Sciences from the University of California, Riverside, a M.S. in Cell and Molecular Biology from San Francisco State University, and a B.A. in English from the University of California, Berkeley.

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