Patent Board Issues Decision on CRISPR Patents

The Patent Trial and Appeal Board (PTAB) has issued a decision awarding inventive priority to the Broad Institute (Broad), MIT, and Harvard over the University of California (UC), University of Vienna, and Emmanuelle Charpentier on an invention covering applications of the CRISPR-Cas9 gene editing system in eukaryotic cells.

As New Scientist explains,

CRISPR is a technology that can be used to edit genes and, as such, will likely change the world.

The essence of CRISPR is simple: it’s a way of finding a specific bit of DNA inside a cell. After that, the next step in CRISPR gene editing is usually to alter that piece of DNA. However, CRISPR has also been adapted to do other things too, such as turning genes on or off without altering their sequence.

There were ways to edit the genomes of some plants and animals before the CRISPR method was unveiled in 2012 but it took years and cost hundreds of thousands of dollars. CRISPR has made it cheap and easy.

“CRISPR” stands for Clustered Regularly Interspaced Short Palindromic Repeats. University of California, Berkeley, Professor Jennifer Doudna and her colleague Emmanuelle Charpentier, along with their teams, won the 2020 Nobel Prize in Chemistry for their work on the technology.

Among other things, CRISPR technology was used to develop COVID-19 vaccines.

As the PTAB explained in the recent case,

Briefly, a CRISPR-Cas9 system uses two RNAs and a protein to target a DNA molecule and cleave it at a specific sequence. Count 1 is limited to a system in which the two RNAs are fused into a single RNA molecule, sometimes referred to as a “single guide RNA,” “sgRNA,” or “chimeric RNA.” In Broad’s terminology the single guide or chimeric fused RNA comprises a “guide sequence” fused to a “tracr sequence” and in CVC’s terminology it comprises a “targeter- RNA” (also called a “crRNA”) fused to an “activator-RNA” (also called a “tracrRNA”). Under both parties’ terminology, the fused RNA hybridizes to the targeted DNA to achieve specific cutting of the targeted DNA.

The PTAB concluded that the UC group failed

to provide sufficient, persuasive evidence of an earlier reduction to practice or conception, as they are legally defined, of each and every element of [the disputed claims] before Broad’s evidence of reduction to practice.

Thus, the UC group’s claims were unpatentable under 35 U.S.C. § 102(g), which states:

(g) (1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.

It wasn’t enough for the UC group to prove that their inventors conceived of the system first. Instead, they had to prove the inventors

had a definite and permanent idea of an operative invention, that is of a system they knew would produce the effects on genes in a eukaryotic cell recited” in the technology

The decision is likely to have implications for the licensing of the technology by UC.