Ruling Made in CRISPR Patent Case

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Ruling Made in CRISPR Patent Case

The co-inventors of CRISPR gene editing, Jennifer Doudna and Emmanuelle Charpentier won the 2020 Nobel Prize in Chemistry for their groundbreaking contributions to this revolutionary genetic technology. Doudna and Charpentier were an integral part of a now-legendary gene editing research team at the University of California, Berkeley (UC Berkeley) in the early 2010s.

In June 2012, Doudna and Charpentier published a trailblazing paper that first explained the functional processes and showed the practical application of CRISPR gene editing. Like those of many initial genetic and microbiological studies, the research presented by Doudna and Charpentier focused on simple, one-celled organisms. Specifically, the Doudna and Charpentier paper described the CRISPR gene editing of DNA in bacteria.

The early CRISPR trials detailed in the Doudna and Charpentier paper clearly give the UC Berkeley research team a viable claim to the invention of CRISPR technology as a whole. A board of the US Patent and Trademark Office (USPTO), however, denied this claim in its official ruling on February 28, 2022.

The deciding factor in the USPTO ruling involved the difference between prokaryotic (simple unicellular) and eukaryotic (complex unicellular and multicellular) lifeforms. In short, eukaryotic cells have a nucleus, but prokaryotic cells do not. This means that all UC Berkeley patents involving the use of CRISPR in the cells of humans and other higher organisms are now invalid.

Because the UC Berkeley team was not the first to prove that CRISPR works specifically in eukaryotic cells, the USPTO Patent Trial and Appeal Board determined that Doudna, Charpentier, and their colleagues can take little credit for use of the gene editing tool in the treatment of human disease. The board went on to cite the difficulties that UC Berkeley encountered when it came to getting their invention to function properly, contending that the CRISPR gene editing concept fell short of a patentable “definite and permanent idea” at the time.

The USPTO ruling came after a protracted and heated legal battle over the commercial applications of CRISPR gene editing in all areas of human biotechnology and medicine. As this incredibly powerful tool continues to change the face of biological research, the patent for its use holds incalculable value. In the wake of the recent USPTO decision, the patent for CRISPR gene editing in humans belongs to the Massachusetts Institute of Technology (MIT) and the Broad Institute of Harvard University.

Although the work of UC Berkeley undoubtedly laid the foundation for use of the CRISPR tool in the fight against human disease, the Broad Institute was the first to apply the tool to human cells. In January of 2013, Feng Zhang and his team of Broad Institute researchers reported that they had successfully employed UC Berkeley’s CRISPR techniques in eukaryotic animal cells. Furthermore, they had edited the DNA of a human being.

The USPTO ruling in favor of the Broad Institute of Harvard University and their partners at MIT was a large finical blow for UC Berkeley. In fact, University of Illinois College of Law professor Jacob Sherkow estimates that the institution stands to lose as much as $10 billion in American licensing revenue.

The news isn’t all bad for UC Berkeley, however. First of all, the institution can keep all of its previously accumulated revenue that relates to CRISPR gene editing in humans. Even better, UC Berkeley will continue to profit from the medical applications of CRISPR in Europe. In complete opposition to the ruling of the USPTO, the European Patent Office has chosen to uphold UC Berkeley’s patents on eukaryotic CRISPR applications. This difference of opinion between the US and Europe indicates just how complex and contentious the fight for CRISPR patent rights has become.