PTAB Hears Oral Arguments in CRISPR Patent Dispute

  • Dec 21 2016
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  • Category: News

What is at stake in the CRISPR patent dispute?

The Patent Trial and Appeal Board is weighing claims over who invented CRISPR (clustered regularly interspaced short palindromic repeats) gene-editing technology, arguably the most significant biotechnology breakthrough in decades. This method of gene editing has been described as molecular scissors that snip unwanted parts of the genome away and replaces them with new sections of DNA.

In what is likely to be one the last interference proceedings, a three-judge panel heard oral arguments on December 6 by the University of California, Berkeley, and the Broad Institute of the Massachusetts Institute of Technology, both claiming their scientists invented CRISPR first.

The Backdrop

In 2012 Berkeley’s team led by Jennifer Doudna published a paper demonstrating the use of CRISPR editing in a bacterial system and applied for a patent on March 15, 2013. Six months later, the Broad Team led by MIT’s Feng Zhang filed a patent application for the use of CRISPR to edit animal cells.

After paying for an expedited review, Broad was awarded a CRISPR patent in April 2014, even though Berkley filed first. And therein lies the rub: the U.S. switched to a first-to-file system under the AIA on March 16, 2013, one day after Berkeley’s application was filed. So in April 2015 the Berkeley team petitioned the PTAB for the interference proceeding claiming they were the first to invent.

In short, Berkeley is claiming the Broad patent covers the same invention and that moving from a bacterial system into animal cells was obvious. Broad’s argument is that the use of CRISPR specifically in animal cells is a significant breakthrough and that the two inventions are not the same at all. Zhang also claimed the team’s gene editing technology has been in development long before Doudna’s paper was published.

Can CRISPR Patents Coexist?

The issue before the PTAB at the hearing was not which team was the first to invent, but rather whether the two patents define the same invention and if the interference proceeding should continue. If the judges agree with the Broad team, the proceeding will end and its patent will stand. Alternatively, Berkeley’s challenge could prevail and Broad will lose its patent rights. Lastly, the judges could determine the patents do not cover the same inventions and that both patents can coexist.

The Takeaway

At this juncture, it is uncertain how the PTAB will rule. Nonetheless, hundreds of millions of dollars are at stake because of the potential commercial applications of CRISPR gene editing in the biomedical, pharmaceutical and agricultural sectors. It is also important to note that interference proceedings are essentially a thing of the past as re-examinations under the AIA’s first to file system have dramatically altered the patent landscape. Ultimately, this case illustrates how protecting biotech innovations requires the advice and counsel of a leading intellectual property law firm.