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Federal Circuit upholds Broad Institute's CRISPR gene-editing patents

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Federal Circuit upholds Broad Institute's CRISPR gene-editing patents

The U.S. Court of Appeals for the Federal Circuit ruled in favor of the Broad Institute in its battle to hang on to its patents covering its CRISPR gene-editing technology, declaring that it was not persuaded by the arguments put forth by the University of California and its partners in their challenge.

The win could potentially mean millions, if not billions, of dollars for Broad and its licensing partners.

CRISPR — clustered, regularly interspaced, short palindromic repeats — and the Cas9 tool harness the natural mechanisms of bacteria and use them to identify and then modify and repair mutated or malfunctioning DNA in genes. The idea is to use the CRISPR-Cas9 technology to treat and prevent diseases and potentially correct genetic defects.

In a Sept. 10 opinion, a three-judge panel from the Federal Circuit said the U.S. Patent and Trademark Office's Patent Trial and Appeal Board, or PTAB, had ruled correctly in February 2017 when it said the CRISPR patents granted to Broad — a venture between the Massachusetts Institute of Technology and Harvard University — in April 2014 did not interfere with the UC Berkeley team's patent application.

The PTAB is an administrative law body created by Congress in 2012 under the America Invents Act as an alternative to fighting patent litigation in the U.S. court system.

Even though the UC Berkeley team was the first to engineer CRISPR-Cas9 and was the first to file a patent application, Broad beat its competitor in obtaining patents after paying an extra fee for an expedited review of its application. The Berkeley team is led by Jennifer Doudna, a professor of molecular and cell biology and chemistry at that university, and Emmanuelle Charpentier, now at the Max Planck Institute for Infection Biology in Berlin.

Doudna co-founded CRISPR companies including Intellia Therapeutics Inc., Caribou Biosciences and Mammoth Biosciences. Charpentier is the co-founder of CRISPR Therapeutics AG.

Feng Zhang, a professor of neuroscience at MIT, who is leading the Broad team, co-founded Editas Medicine Inc.

Shares of CRISPR Therapeutics closed at $49.69 on Sept. 10, down 45 cents, or about 1%. The stock had lost as much as 5.3% earlier in the day shortly after the court's ruling was issued.

Intellia's stock closed at $26.98, down almost 1%, or 26 cents, recovering some ground after falling as low as 3.3%.

Shares of Editas closed at $31.07, up 82 cents, or 2.71%. The stock had climbed as high as 6.8% earlier in the day.

The arguments

During oral arguments in April, UC Berkeley asserted that when it disclosed the necessary and sufficient components of CRISPR-Cas9 in 2012, researchers immediately understood its revolutionary potential as a simple, elegant and powerful tool for editing genes.

"In just months, six different groups confirmed what UC predicted in 2012, which was that CRISPR-Cas9 could cleave DNA in eukaryotic cells," the university's lawyer told a three-judge panel from the Federal Circuit.

All six, including Broad, "used only conventional techniques and common sense to achieve that predictable result."

UC Berkeley argued that Broad's patent was based on an "obvious" application of the university's foundational CRISPR-Cas9 technology, and therefore, it should not have been separately patentable.

But Broad countered that its patents were about different subjects than the UC team's and therefore did not interfere with each other. It said the PTAB's decision was "clearly supported by sufficient evidence and followed applicable legal standards."

What is next for CRISPR rivals?

Katrine Bosley, president and CEO at Editas, said the Federal Circuit's "highly favorable" ruling reaffirmed the company's strength of its intellectual property foundation and has "profound implications for making CRISPR medicines."

She noted that Editas has patents covering fundamental aspects of both CRISPR-Cas9 gene editing and CRISPR-Cpf1, also known as CRISPR-Cas12a. The patents broadly cover CRISPR-Cas9 and CRISPR-Cpf1 gene editing in eukaryotic cells, which includes all human cells.

"Successfully editing this cell type is essential to making CRISPR-based medicines," Bosley said in a Sept. 10 statement.

University of California General Counsel Charles Robinson said the school was evaluating further litigation options.

"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 — as the Doudna-Charpentier team's several pending patent applications that cover use of CRISPR-Cas9 in plant and animal cells are now under examination by the patent office," Robinson said in a Sept. 10 statement.

"Separately, we are gratified that our dominant applications for the groundbreaking invention of the use of CRISPR-Cas9 in all environments, including plant and animal cells, will continue to issue as patents, adding to the patents recently granted in the United States and other countries around the world for this work," he added.

Time to move on, work together?

In its ruling, the Federal Circuit emphasized that the case before it was about the scope of two sets of applied-for claims and whether they were patentably distinct. The ruling was not on the validity of either set of claims, the court said.

Broad said it was time for all institutions to move beyond litigation.

It said it had tried multiple times over the past five years to engage with the University of California, to no avail.

"It is time for all institutions to work together to enable the broadest possible sharing and licensing of foundational CRISPR IP to accelerate research and improve human health," Broad said.

It said it has worked with MIT and Harvard for more than five years to ensure that CRISPR tools were widely available — making the technology, knowledge, methods and other intellectual property for genome editing freely available to the academic and nonprofit community.

Broad said it also has licensed its CRISPR intellectual property "non-exclusively to companies to use in their own commercial research."