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Broad Institute Wins CRISPR-Cas9 Patent Lawsuit Appeal

By Lisa M. Schaffer, Esq. on September 11, 2018 | Last updated on March 21, 2019

The U.S. Court of Appeals upheld the U.S. Patent and Trademark Office's assertion that Harvard-affiliated Broad Institute can keep its patents on CRISPR, Clustered Regularly Inspected Short Palindromic Repeats. The court found that Broad's applications do not overlap with those of the University of California, Berkeley's, and that the two are patently distinct. Not only are billions of dollars at stake, but also scientific reputations, and the lives of generations to come.

Test Tube and Plants/Animals Are Patently Distinct

CRISPR allows scientists to cut out unwanted gene sequences with a pair of molecular scissors. This gene editing "surgical" technique, called CRISPR-Cas9, was originally created by scientists at U.C. Berkeley and University of Vienna, Jennifer Doudna and Emmanuelle Charpentier. The duo already had received a patent focused on using CRISPR-Cas9 to edit RNA and shorter snippets of DNA in small organisms, like bacteria. Their pending patent application was to target more locations on the genome, and they believed it could work on any living thing.

However, their testing had only been done in a test tube, and their patent application was for using CRISPR Cas-9 on loose DNA in test tubes. Broad Institute, on the other hand, proved CRISPR-Cas9 could actually work on organisms with complex cells in plants and animals, including humans. They rush filed for, and received, a patent for this technology in 2017. U.C. Berkeley filed a suit saying the Broad patent infringed on theirs. The courts ruled that the patents and applications are about different subjects, and do not interfere with one another. They based this decision on "substantial evidence," which makes the chances of overturning this decision look improbable. Nonetheless, U.C. Berkeley states it is contemplating legal next steps.

Molecular Snipping -- What's the Big Deal?

It is understandable why U.C. Berkeley is digging in its heels on this. First, the patent office initially said that there was overlap, and set up a hearing to determine who was first in time to invent the technology. Second, according to the University of California, it is widely recognized among the scientific community that Doudna and Charpentier's invention was for usage on plant and animal cell, not only in test tubes, and therefore bolstering the notion of overlap. Third, the technology has far reaching scientific, and monetary, implications. Chemical companies are jumping at the chance to license technology to genetically modify foods instead of spraying them with pesticides and herbicides. And with the possibility of curing genetic diseases such as sickle cell to cystic fibrosis, the medical and pharmaceutical industries are salivating at the chance to use this technology.

Note that the federal court only ruled that the two applications are patently distinct, and that Broad's use of CRISPR is non-obvious. It did not decide who was first in time, and the U.S. Patent and Trademark Office did state that they see many more patents coming down the line for CRISPR. There are still numerous intellectual property arguments to be had, and in the end, perhaps both sides will come out victorious if cross-licensing is required to have any commercial applications of the technology.

If you are interested in patenting technology you have created, contact an experienced patent attorney, who can review your work and offer you sound legal advice to navigate the often hazy arena of patent law.

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