Gene-Editing Patent Challenge Rejected by U.S. Appeals Court

(Bloomberg) -- The Harvard University-affiliated Broad Institute can keep patents on the breakthrough gene-editing technology CRISPR, an appeals court said, rejecting arguments its work was already covered by patents sought by the University of California at Berkeley.

The U.S. Patent and Trademark Office was correct to say that Broad’s inventions were different than what was covered by Berkeley’s applications, the U.S. Court of Appeals for the Federal Circuit in Washington said in a ruling on its electronic docket.

The dispute is over who will get the financial and reputational credit for a gene-editing technique that’s already revolutionizing the world of genetics. CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, allows scientists to target parts of a gene and cut them out like a pair of molecular scissors.

CRISPR is a naturally occurring enzyme used by bacteria to rid itself of viruses and was discovered decades ago. The specific CRISPR-Cas9 protein that’s at the heart of the legal dispute is seen as a simple, relatively easy way to cut the gene, though researchers are considering other CRISPR proteins as well.

Scientists with UC Berkeley and the University of Vienna led by Jennifer Doudna and Emmanuelle Charpentier were first to find ways to guide those CRISPR-Cas9 molecular scissors to targeted locations on the genome and say their work could be used for any living thing. They filed their patent application in 2012 and have called it “the discovery of the century.”

The Broad Institute in Massachusetts, set up by groups including Massachusetts Institute of Technology and Harvard to experiment with the human genome, said the UC Berkeley team only showed how the technology would work in a test tube. They said their research team proved CRISPR-Cas9 could work in plants and animals, including humans.

“The patents and applications of Broad Institute and UCB are about different subjects and do not interfere with each other,” Broad said in a statement hailing Monday’s appeals court decision. “It is time for all institutions to move beyond litigation. We should work together to ensure wide, open access to this transformative technology.”

Broad filed its own applications and paid an extra fee to get them reviewed more quickly by the patent office, while UC Berkeley’s applications remain before the agency for strategic reasons. UC Berkeley sought to have the Broad patents canceled, saying its applications covered the use of CRISPR-Cas9 in animals.

The patent office disagreed, saying both groups would be entitled to patents because what they covered fell in different areas. The Federal Circuit said the agency’s decision was based on “substantial evidence.”

“The board performed a thorough analysis of the factual evidence and considered a variety of statements by experts for both parties and the inventors, past failures and successes in the field, evidence of simultaneous invention, and the extent to which the art provided instructions for applying the CRISPR-Cas9 technology in a new environment,” the court ruled.

The UC Berkeley group argued that Broad was just one of six groups using “conventional off-the-shelf tools” to employ CRISPR-Cas9 in plants and animals. The university said it was evaluating its options, which could include asking the Federal Circuit to reconsider the decision or a petition with the U.S. Supreme Court.

Scientific Consensus

“We also look forward to proving that Drs. Doudna and Charpentier first invented usage in plant and animal cells –- a fact that is already widely recognized by the global scientific community” and is in other pending patent applications, the university in a statement.

The patent office initially said the patent applications overlapped and set up a hearing to determine who was first to invent the technology. After further review, the agency said the innovations were different enough that both sides were entitled to patents on their respective work.

Just how valuable the technology will be is unknown, since most products on the market involve agriculture and the real money is human therapeutics. Broad has pledged to join a worldwide licensing pool.

DowDuPont Inc., which is using CRISPR to develop corn and soybean crops that repel insects without chemical pesticides and tolerate herbicides for easier weed control, has licenses with both Broad and UCBerkeley.

Crispr Therapeutics AG, co-founded by Emmanuelle Charpentier, and Intellia Therapeutics Inc. have licenses to UC Berkeley’s technology, while Editas Medicine Inc. is using Broad’s inventions. The companies also have each sought patents on their own work.

Crispr Therapeutics fell as much as 5.3 percent, while Intellia Therapeutics dropped as much as 2.5 percent. Editas Medicines Inc. jumped as much as 6.8 percent before trimming gains.

“This decision is highly favorable for Editas and for the Broad as it reaffirms the strength of our intellectual property foundation and has profound implications for making CRISPR medicines,” Editas Chief Executive Officer Katrine Bosley said in a statement.

By ruling that there was enough difference between the two sides’ inventions, the agency “didn’t get far enough along to decide who first invented” the use of CRISPR-Cas9, said Michael Stramiello, a patent lawyer with Paul Hastings in Washington who wasn’t involved in the case.

And the Federal Circuit noted that the case was “whether those claims are patentably distinct. It is not a ruling on the validity of either set of claims.”

That shows there are still potential legal fights ahead of the two sides that may not be resolved for some time, Stramiello said. Still, he said, “we might very well have a situation where we have to have some cross-licensing.”

The case is University of California v. Broad Institute Inc., 17-1907, U.S. Court of Appeals for the Federal Circuit (Washington).

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