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Will the Fed Circuit Hear CRISPR Patent Battle Round 2?

By Casey C. Sullivan, Esq. on April 06, 2017 | Last updated on March 21, 2019

It's one of the biggest disputes in biotech and a billion dollar question: Who owns the intellectual property behind CRISPR-Cas9, the groundbreaking gene-editing technology? The technique allows researchers to edit specific parts of a genome, removing, adding, or altering DNA. It could be the future of biotech, allowing everything from bespoke medical treatments to designer crops or even genetically superior Ubermenschen.

But both the University of California, Berkeley and the Broad Institute have claimed the technique as their own. Broad won an early battle in the USPTO in February, and now the conflict could be on its way up to the Federal Circuit.

The War Over CRISPR

The CRISPR-Cas9 technique has the potential to transform the biotechnology and genetic engineering industries. The genome editing tool can splice and dice DNA in a way that is faster, cheaper, and more accurate than other existing methods. It might not lead to a race of genetically modified supermen, but it could potentially revolutionize things like cancer treatment in the (relatively) near future.

Thus, there's a lot riding on who controls the CRISPR IP.

The gene-editing technique was developed in 2012, when the University of California, Berkeley's Jennifer Doudna and the University of Vienna's Emmanuelle Charpentier outlined how CRISPR-Cas9 could be used to edit genomes. A year later, the Broad Institute's Feng Zhang published a paper showing how the technique could be used to edit DNA in eukaryotic cells. The Broad Institute is partnered with both Harvard and MIT.

Berkeley filed for patent protection for the technique, as did Broad. But Broad's patent application was granted first. Berkeley initiated interference proceedings with the USPTO, who upheld Broad's patents in February. The parties were looking to protect "patentably distinct subject matter," the patent board determined.

The Deadline to Appeal Approaches

Berkeley, to say the least, was not pleased. "We continue to maintain that the evidence overwhelmingly supports our position that the Doudna/Charpentier team was the first group to invent this technology for use in all settings and all cell types," the university said in a statement. It is considering "all options for possible next steps."

The school has two months to file an appeal with the Federal Circuit, a deadline that is fast approaching.

Even if Broad's patent is upheld, Berkeley won't be out of the game, according to Doudna. Instead, those who want to make use of the CRISPR technique will likely have to pay licensing fees to both Broad and Berkeley.

"They have a patent on green tennis balls," Duodna said following the USPTO's ruling. "We will have a patent on all tennis balls. I don't think it really makes sense."

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