• R. Scott Kimsey

UC Berkeley Loses in CRISPR Interference

Scientists like acronyms, which is why the technology at the heart of an important patent ruling has a name like CRISPR. It stands for "Clustered Regularly Interspaced Short Palindromic Repeats," which is a name that itself was probably chosen to result in a cool acronym. The ruling was made by the Patent Trial and Appeal Board ("PTAB"), which is the body within the United States Patent & Trademark Office that hears appeals. But what is CRISPR, and why is the PTAB decision important? Allow me to explain.

CRISPR is a bacterial defense mechanism against viruses. In combination with a protein called "Cas9," which is a DNA endonuclease (meaning that it can cut strands of DNA), CRISPR can be used to edit DNA sequences. Gene editing is important for a variety of reasons, including gene therapy for treating various disorders. CRISPR-Cas9 (which I'm just going to call CRISPR for the sake of simplicity) makes gene editing faster, easier, and more specific than earlier techniques.

The CRISPR technology was discovered in bacterial cells by researchers at U.C. Berkeley. They showed the technology could be used to alter DNA in prokaryotic cells (like bacteria) and in vitro. In March of 2013, the Regents of the University of California ("Regents") filed a patent on use of the CRISPR method in all cells.

Researchers at the Broad Institute of MIT and Harvard ("Broad Institute") demonstrated that the technology could be used to alter DNA in eukaryotic cells. Eukaryotic cells are found in higher organisms, like humans, and differ from prokaryotic cells in a number of ways. The Broad Institute filed a patent application for its more narrow method in October of 2013, and that one went through the USPTO on an accelerated basis and was issued in April of 2014.

The patent examiner reviewing the Regents' application declared an "interference," which means that two different entities are trying to patent potentially overlapping subject matter, and the patent office has to decide who is entitled to it. The cases are decided by the PTAB.

A patent examiner declares an interference on a fairly meager record, so the first thing the PTAB has to do in an interference proceeding is determine whether there is an intereference-in-fact. If not, then both parties are entitled to their respective patentable subject matter. In this case, the PTAB made the important determination that there was no interference-in-fact.

This seems confusing at first glance. How can the Regents have a patent covering the use of CRISPR in all cells, while the Broad Institute has a patent covering use of the technology in eukaryotic cells. After all, eukaryotic cells are a subset of "all cells." Although it sometimes seems odd, it is well-settled that a patent can issue on a species that falls within an already-patented genus. In this case, since the CRISPR system was discovered in bacterial cells (prokaryotes), and manipulated by U.C. Berkeley in vitro, the PTAB agreed with the Broad Institute that there was no reasonable expectation that the system would be successful in eukaryotic cells. In fact, the U.C Berkeley inventors who discovered the CRISPR system wrote, at the time of their discovery, of the "exciting possibility" that CRISPR could be used for site-specific gene editing, but went on to say that "it was not known whether such a bacterial system would function in eukaryotic cells."

The end result here is that the Regents are able to pursue their patent claims for a method of using CRISPR technology in all cells, while the Broad Institute is able to keep its patent for a more specific method of using CRISPR in eukaryotic cells. Because the real monetary value of the technology lies in its use in eukaryotic cells (estimates run into the billions of dollars), the Broad Institute won here. It's not all bad news for the Regents, however. Depending on what their patent looks like if and when it issues, those who want to use CRISPR technology may need a license from both the Regents and the Broad Institute.

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