A Guide to CRISPR Patent Rights

A real game-changer in the genetic engineering market has been involved in a difficult custody battle – this involved the patent rights for CRISPR-Cas9, which was simultaneously developed by Feng Zhang from MIT and Harvard’s Broad Institute and the team of Jennifer Doudna and Emmanuel Charpentier from the University of California at Berkeley.

This case was vigorously fought in December 2016 in Virginia, and the outcome had the potential to revoke patent rights which were awarded to the Broad Institute in 2014.

CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats), was initially identified in the late 1980s. However, it was not until the creation of the CRISPR-Cas9 system as a gene editing tool by Doudna and Zhang some years ago that its potential to be a revolutionary tool in genetic engineering was fully revealed.

By late 2014, hundreds of papers had been published which theorized the use of CRISPR in the development of biofuels, crop modification, immunotherapy and a wide range of other applications.

The primary appeal of CRISPR is its ability to make site-specific DNA sequence changes with a reduced margin of error, whilst targeting practically any site on a DNA molecule. Zhang - one of CRISPR’s inventors – considers this akin to fixing typos in a novel.

The Cas9 protein locates a specific sequence of bases in DNA which needs modification or repair, before cutting it at that point. This cut - or series of cuts if needed - may be used to either insert new and corrected DNA (somewhat like the find and replace function on a word processor), or introduce a mutation (similar to correcting a spelling).

Doudna included her CRISPR findings in a patent application and an article in Science in 2012, making her the first of the two researchers to do so. Zhang published his own work in 2013, obtaining a patent for it in 2014. The dispute arose while trying to ascertain who originated the idea for CRISPR-Cas9 first, developing it into a novel method for future projects and work.

UC Berkeley claimed that Doudna’s ideas acted as a basis for Zhang’s work, which were not innovative as they were essentially slight amendments to conventional methods. On the other hand, the Broad Institute asserted that Doudna’s early work only hypothesized about the use of CRISPR in eukaryotic cells (human, animal and plant) but did not include a detailed roadmap on how to achieve this.

In a priority statement issued by the Broad Institute, Zhang’s lab also argued that Zhang had been working on elements of CRISPR-Cas9 since February, 2011, justifying their claim on first patent rights.

The underlying controversy in this instance lay in which element of CRISPR is patentable, and the issue of whether Zhang’s patent attempts impacted upon Doudna’s original patent application. The Broad Institute maintained that all Doudna’s lab illustrated was that Cas9 could cleave DNA in a test tube, without any actual genetic editing happening.

They claimed that Cas9 itself could not be patented because it is a protein that occurs naturally, and that its cleaving of DNA is a routine bacterial process. With this in mind, Zhang’s lab was specifically looking to patent the processes and components developed for CRISPR-Cas9 for genome editing in eukaryotic cells.

Doudna’s lawyers, however, endeavored to prove that Doudna anticipated CRISPR working in the ways identified by Zhang, implying that she had the idea first, and was therefore the first inventor. They also insisted that when the Broad paid for the patent office to expedite the review of Zhang’s 2012 application, it therefore interfered with Doudna’s 2012 application which was still in review.

The initial hearing before three judges of the US Patent and Trademark Office (USPTO) attracted considerable crowds, including patent reviewers and researchers, who were intrigued by this unique case.

Both UC Berkeley and the Broad were allocated twenty minutes for arguments, but the former was put on the defensive early via in-depth inquiry about Doudna’s early expectations of CRISPR’s capabilities. Arguments were made by lawyers from both sides before the hearing closed with no firm decision being made by the panel.

UC Berkeley and The Broad Institute were then presented with one of three options. Should the panel side with Doudna, she would be given rights as the first inventor, meaning she will receive the patents already awarded to Zhang. Should Zhang be confirmed to be first inventor, the Broad would be provided with an extensive patent base with which they could license out CRISPR technologies.

Alternatively, both researchers could have been considered to be co-inventors, though this would have probably have resulted in more, potentially controversial debate.

A final decision was made in late 2018, with the Broad Institute being awarded the patent.

Acknowledgments

Produced from materials originally authored by Julie Munroe from OXGENE.

About OXGENE

 

OXGENE™ combines precision engineering and breakthrough science with advanced robotics and bioinformatics to accelerate the rational design, discovery and manufacture of cell and gene therapies across three core areas: gene therapy, gene editing and antibody therapeutics.

Gene therapy: We’re transforming the vision of truly scalable gene therapies into a reality; progressing our industry leading transient gene therapy systems towards alternative technologies for scalable, stable manufacturing solutions.

Gene editing: We have automated gene editing to deliver CRISPR engineered cell lines at unparalleled speed, scale and quality and generate complex disease models in mammalian cells.

Antibody therapeutics: We’re employing a novel proprietary mammalian display technology to discover antibodies against previously intractable membrane proteins.

OXGENE™ works at the edge of impossible in mammalian cell engineering. Our scientific expertise and technology solutions address industry bottlenecks. For more information, please visit www.oxgene.com


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Last updated: May 21, 2020 at 8:27 AM

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