A billion-dollar patent fight over gene editing hits the courts
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Kendall Squared brings you dispatches from the world’s epicenter for biotechnology and drug discovery.

Deborah Katz was well on her way to a career as a scientist. She had excelled in graduate school and started a postdoctoral fellowship in cell biology. But working in the lab had become a slog, and Katz was growing tired of the tedium of running experiments day in, day out, with no light at the end of the tunnel.

“I felt I wasn’t developing as a scientist, but was instead being used as cheap labor,” she wrote in an essay for Science. “I became very frustrated at the lack of job prospects and the low pay.”

So in 1998, Katz abandoned her first career and headed to law school at Georgetown University. She wanted to, as she wrote, “stay in touch with science,” and became a patent attorney after graduating.

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Now, as an administrative judge for the US Patent and Trademark Office in Alexandria, Va., Katz is managing the most closely watched patent dispute in all of the life sciences — a case that pits the University of California against the Broad Institute and the Massachusetts Institute of Technology over who holds the key intellectual property rights for a revolutionary genome-editing technology.

The technology, known as CRISPR, enables scientists to snip out faulty genes in human and other animal cells and replace them with working versions.

Determining who invented the gene-editing technique could have billion-dollar implications for biotech companies and the august research institutions that make money off of licensing agreements. Throw in the possibility of a Nobel Prize and a lot’s riding on who gets credit for a tool that scientists around the world have embraced and that has transformed the speed of biomedical research.

Scientists are still refining the tool to improve its precision, but already hundreds of millions of dollars have been invested in three biotechnology startups that aim to harness the system to cure disease. The companies — Editas Medicine, Intellia Therapeutics, and CRISPR Therapeutics — all have their research operations based in Cambridge’s Kendall Square. Editas has licensed technology from the Broad, while the licenses of Intellia and CRISPR are tied to the University of California side.

Next month, all eyes will turn to Katz’s court. Two other judges will join Katz for the proceedings, which start March 9, but as the lead judge she will be calling most of the shots, wrangling the two parties, and establishing the ground rules as the proceedings move forward.

The USPTO declined a request for an interview with Katz, but interviews with people who have worked with her indicate that, both in science and law, she is deliberate and careful, taking the time to digest information and arrive at a reasoned conclusion.

“She’s a conservative judge in that she wants to get the right decision,” said Brent Babcock, a partner at the law firm Knobbe Martens, who has had cases before Katz.

“She’s more likely to take in the information and go sit down and get a written order than sort of aggressively manage the case or push the parties,” said another lawyer who asked not to be identified because Katz is involved with ongoing cases of his.

Dom Smith/STAT CRISPR is a tool that acts as a microscopic pair of scissors with the ability to slice DNA.

The proceedings will start not quite with a bang, but with a conference call. Lawyers from the warring parties will join a call with Katz and likely the other judges to discuss what motions they plan to file.

Over the next year, the scientists at the heart of the dispute — Feng Zhang of the Broad and MIT, and Jennifer Doudna of UC Berkeley — could give depositions, with both sides presenting evidence from publications and notebooks trying to show they first uncovered the central CRISPR breakthroughs in living cells.

The USPTO had granted a fundamental patent to the Broad and MIT in April 2014, but the University of California challenged that decision. In December, patent officials recommended that the dispute move through what’s known as an “interference proceeding” to determine who gets the contested patent or patents.

Much of the process will be focused just on establishing the facts. “What do the lab notebooks say? Who said what when? What do the patent applications say? That kind of stuff,” said legal scholar Jacob Sherkow of New York Law School, who has written extensively about the case.

But depending on how the proceedings go, the attorneys may have to argue before the panel, which would allow Katz and the other judges to pepper the lawyers with questions about their claims. (Also, whichever side loses before the patent board can appeal before a federal court, so this could take a long time to sort out.)

Katz studied biology as an undergraduate at Wellesley College and then headed to the University of Pennsylvania for her PhD in molecular biology, where she wrote her dissertation on the function of a thyroid hormone receptor.

Her supervisor, Dr. Mitchell Lazar, said “Debbie” (as he knew Katz) had the right amount of independence as a doctoral student and got along with everyone in the lab. He remembers her as patient with her experiments, not willing to accept the results that looked good without repeating tests. “I think she wanted to get it right,” Lazar said.

Lazar said he was torn when he found out Katz planned to head to law school because “she had the teaching skills and scientific background to be an outstanding academic scientist.” But he recognized she had given it a lot of thought, he said, and he wrote her a letter of recommendation.

After law school, Katz worked at the law firm Finnegan, Henderson, Farabow, Garrett & Dunner for six years before joining the patent office in 2007 as an attorney. She became a judge in 2011.

“While law is still new to me, I am very comfortable with the level of science I am called upon to know,” she wrote in her essay for Science, which was published soon after she finished law school, in 2001. “I finally feel that I have hit the right balance between my love for science and a way to apply it.”

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