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Intrigue and Outdated Rules Complicate Big Biotech Patent Fight

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to another CRISPR/Cas9 startup, Editas Medicine in Cambridge, MA. Editas launched a year ago with big backing from three blue-chip Boston-area venture firms and several of the area’s academic boldface names—plus Doudna herself—as founders. At the time of Editas’s launch, it was often reported that the company had some rights to Doudna’s work. That wasn’t so. She helped found Editas even though Caribou had exclusive rights to her foundational work.

As of Dec. 15, she was still listed as a founder. But Doudna is no longer affiliated with Editas, as first reported by MIT Technology Review earlier this month. Via e-mail, she told me she resigned from the scientific advisory board in June. She otherwise declined to comment, calling it her matter of policy not to “comment on processes and procedures while they are pending before the US PTO.”

Editas has plenty of other intellectual property in hand. It announced December 1 a first set of licenses that include work from nearly all its scientific cofounders as well as from Duke University’s Charles Gersbach, who specializes in Duchenne muscular dystrophy.

Emphasizing that there’s much more beneath the surface, Editas CEO Katrine Bosley gave me an outline of what the licenses bring to Editas. From Feng Zhang of the Broad Institute/MIT and George Church of Harvard University comes the use of CRISPR/Cas9 in eukaryotic cells; from Keith Joung of Massachusetts General Hospital, methods to make CRISPR/Cas9 perform more accurate cuts in DNA; and from David Liu of Harvard, delivery technology. Delivery—getting the right amount of CRISPR/Cas9 editing machinery into the right cells—will be no easy task. (Just ask anyone familiar with the slow progress of RNA interference-related therapeutics.)

Feng Zhang: First CRISPR/Cas9 patent.

Zhang: First CRISPR/Cas9 patent.

“Together it’s a unique combination and foundational to the field,” says Bosley. “The concept of genome editing been around a long time” but creating a molecular entity that can do it is another thing entirely, she said.

Only Feng Zhang has received a patent for his work. Indeed, it was the first and remains the only CRISPR-related patent to be granted.

That patent is at odds with the work of Doudna, Charpentier, and colleagues (I’ll call them the Berkeley group for shorthand purposes). An examination of patent records shows why.

Before the U.S. patent office awarded Zhang and the Broad the patent, it rejected it. This isn’t unusual; most patents that are eventually granted go through temporary rejections, says Richard Blaylock, a patent attorney with Pillsbury Winthrop Shaw Pittman in San Diego, and a former biochemist.

But in one of its rejection notices, the PTO specifically pointed to the Berkeley group’s patent application, saying it “anticipates the claimed invention” described in the Zhang/Broad application. Zhang submitted a 15-page addendum, using dates of his own experiments and reports about the Berkeley group’s work to assert that he was first to invent the use of CRISPR/Cas9 to modify eukaryotic cells (that is, anything more advanced than bacteria or archaea).

Three months later, Zhang had his patent.

In a conversation this September, according to PTO records, the Berkeley group’s lawyers asked PTO to reconsider and open a type of appeal trial. It’s called interference and happens when two groups claim to invent the same subject matter. But this form of dispute resolution (there are others) is a legacy of the old patent system. “This kind of proceeding has gone away under the new law,” says Blaylock of Pillsbury.

The old system rewards those who were first to invent; the new system rewards those who are first to file a patent application. Because of the timing of the applications, this battle is being fought under the old rules. If indeed the PTO opens an interference hearing, each side will try to prove with lab notebooks, photographs, e-mail and other evidence that it was the first to invent this new gene-editing technology.

“So much of what happens in an interference proceeding is how good the notebook records and data are,” says Pat Granahan of Wolf, Greenfield. “I might have the best data in the world, get it to work in human cells, but I didn’t put the month, day, year on the page.”

No one I contacted for this story would tell me, on or off the record, if PTO has in fact agreed to re-open the case, or when the agency might make a decision.

So that’s one outstanding question: Will the PTO look at the Broad and Berkeley claims side by side? If so, says Granahan, it could be a “lengthy expensive process.”

“It’s not unusual for some of everyone’s claims to fall,” she says. “It’s unlikely for any party to come out of the proceeding with all the claims in their pocket.”

There’s a deeper issue at play that straddles the scientific and legal realms. Even if Zhang and colleagues say they were first to … Next Page »

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2 responses to “Intrigue and Outdated Rules Complicate Big Biotech Patent Fight”

  1. anon says:

    Breakthrough Prize FAILED to honor ACTUAL INVENTOR who truly first harnessed CRISPR-Cas. Feng Zhang. See US Patents 8,945,839; 8,932,814; 8,906,616; 8,895,308; 8,889,418; 8,889,356; 8,871,445; 8,865,406; 8,795,965; 8,771,945 and 8,697,359; allowed US applications 14/226,274 and 14/105,017: EP 2771468; EPA 14170383.5; US 13/842,859; EP 2800811; and US 14/318,933.

    • anon says:

      why are you quoting patents to make a point about first to INVENT? This article was largely about that fact that those patents are being challenged because Zhang WASN’T THE FIRST TO INVENT (allegedly).