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Major contentious CRISPR patent to be overturned?

In 2012, CRISPR/Cas9 burst onto the genetic scene with the limitless promise of gene editing, the ability to remove or replace genetic material in living cells. The landmark discovery has since become tangled in a bitter patent dispute, however, that could shape how the technology can be developed going forward.

CRISPR stands for "clustered regularly interspaced short palindromic repeats." First discovered in bacteria in 1987, CRISPR refers to a system used by cells to recognize and excise foreign DNA, such as from viruses. The CRISPR/Cas9 technology introduces a strand of RNA that guides the Cas9 enzyme to specific locations in the genome and precisely cuts DNA, like a pair of scissors. The target gene is either replaced with a new genetic sequence or is deleted entirely, and the change to the genetic sequence of that cell is permanent. CRISPR/Cas9 has already been used in many organisms and, once fully developed, could point the way toward repairing faulty genes in human genetic disorders.

First, however, CRISPR/Cas9 must endure a patent fight to decide which of the several scientists involved in the technology's discovery can claim the sole right to license CRISPR/Cas9 to laboratories and reap the profits of such exclusivity.

The key players: Jennifer Doudna of UC Berkeley. Doudna and Emmanuelle Charpentier published the first CRISPR/Cas9 paper in 2012, describing use of the technique in a bacterial cell - a prokaryotic cell without a nucleus. Doudna's patent application for the technique, filed first, is still pending.

Feng Zhang of the Broad Institute in Cambridge, Mass. Independent of Doudna and Charpentier, Zhang published a paper in early 2013 that first showed use of CRISPR/Cas9 in a eukaryotic cell, or a cell with a nucleus. Zhang had his patent application expedited, however, and although he filed later than Doudna, his patent was awarded in 2014. Doudna's challenge to Zhang's patent triggered the current dispute, called an "interference."

A complicating wrinkle in the dispute is a law that took effect on March 16, 2013 that changed patent priority from "first to invent" to "first to file." The trouble in this case is that Zhang's filings may contain inventions made both before and after March 16, complicating interpretation of which rules apply to the patent.

Zhang's argument is that although Doudna's group showed an earlier use of the building blocks of CRISPR/Cas9, he first applied it in the actual target system, the eukaryotic cell. Doudna's argument is that her earlier use of the technology and filing of a patent establishes priority, and that Zhang's lab may have misrepresented when they developed key steps of the method. Other parties are also claiming a share of the credit for discovering CRISPR.

At stake is the right to own the CRISPR/Cas9 enterprise, technology that would be licensed out to laboratories that want to engage in gene editing. Several groups, including Doudna and Zhang, have started gene editing companies that, together, have raised more than $1 billion in funding. The patent could be worth an untold amount of money, given the excitement and promise of CRISPR/Cas9.

Opening motions in the case were filed in March. On November 17, 2016, a three-judge panel will hear oral arguments. A decision could take months, however, and any appeals could extend the process of rendering a final judgment.

Will a decision be issued in the CRISPR/Cas9 patent interference case by the end of 2017 that overturns Zhang's 2014 patent?

This questions will resolve as positive if the US Patent and Trademark Office three-judge panel issues its decision regarding the rights to the CRISPR/Cas9 patent on or before December 31, 2017, and that decision overturns at least some claims of the Zhang 2014 patent. This does not speak to appeals of the decision, and the question resolves as negative if a settlement or other event precludes judgement, or if the judgement confers some benefits to Doudna but leaves all claims in the original Zhang patent standing.

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