Gene Editing Patent Fight Continues–With a Double-Helix Twist


 

The dispute over patent rights for the revolutionary CRISPR gene editing process is going forward, and there has even been a last minute twist, just like in the movies.

There was a chance that the story and the drama were largely over. But the University of California at Berkeley decided April 13 that it would continue to assert its argument that it invented claims for the CRISPR-Cas-9 technology first.

Analysts say the technology, which allows scientists to edit genomes precisely and could lead to cures for inherited diseases and cancer, is one of the most important inventions in recorded history and cite a potential value of billions of dollars.

UCB had asked the Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) to confirm that the UCB team had invented the technology first, even though the PTO had already issued the Broad Institute of the Massachusetts Institute of Technology and Harvard University a combined total of 11 CRISPR-Cas-9 technology patents. The dispute was governed by the first-to-invent system for determining patent ownership rather than the first-to-file system that became U.S. law in March 2013.

On Feb. 15, 2017, the PTAB concluded that the two inventions were distinct because the Broad Institute’s claims were narrower—limited to using CRISPR-Cas-9 in cells in higher organisms like animals, plants and humans.

Consequently, the PTAB stated that it didn’t need to decide who invented what first. This left the Broad Institute and Harvard with 11 patents and UCB with its pending patent application.

UCB could have chosen to take the path of completing the process of obtaining its own patent. But instead, UCB filed an appeal of the PTAB’s ruling with the U.S. Court of Appeals for the Federal Circuit. This will revive the issue of whether the inventions are distinct and, most likely, who invented what when. You can read my full story on the appeal here.

Jacob S. Sherkow, an associate professor at New York Law School who has been following the case, told me that the appeal will mean the dispute is likely to go into 2018.

And then there was the other twist. The day before UCB’s appeal was filed, the PTO published an "Issue Notification" for an application by Virginijus Siksnys, Tautvydas Karvelis and Giedrius Gasiunas, whose claims will issue on May 2, 2017, as U.S. Patent No. 9,637,739. You see, in 2012, the UCB team beat Siksnys and his team in the race to publish their research findings first, even though the Siksnys paper had been submitted for publication first. Sherkow noted that the Siksnys claims are broad.

And so, the CRISPR technology patent dispute landscape will soon contain a federal circuit appeal, at least 12 issued patents from three teams and UCB’s pending application. If nothing else, it shows how complicated it may become to determine who will be “the winner” in this very important patent dispute, which Bloomberg BNA, of course, will continue to follow.

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