CRISPR Controversy Continues Despite Patent Win for Zhang

Damian McNamara

March 03, 2017

LA JOLLA, California — In his first public presentation since he was awarded a contested patent for CRISPR gene-editing technology, Feng Zhang, PhD, from the Broad Institute of MIT and Harvard University in Cambridge, did not address the controversial court case until asked about it during a Q&A session.

"What we have done is develop a CRISPR system for genome editing, and there are many, many researchers from around the world who have made different contributions," he told the audience here at the 10th Future of Genomic Medicine Conference.

"But it's really great that what the US Patent and Trademark Office has decided is Berkeley has Berkeley's patent, and we have our patent," he added.

It's good for the world. It means that many different contributions will likely get recognized and awarded patents, he pointed out.

The patent dispute started in May 2012, when Jennifer Doudna, PhD, from the University of California, Berkeley, filed for a patent after her research team, along with a team led by Emmanuel Charpentier, used CRISPR–Cas9 to alter specific stretches of bacterial DNA (Nature. 2016;540:326-327). Later that year, Dr Zhang filed his own claim on the patent, demonstrating that CRISPR can be used on more complex eukaryotic cells, like those found in humans.

The US Patent and Trade Office awarded Dr Zhang the rights to CRISPR–Cas9 in 2014. Berkeley then filed a case based on patent interference, and asked the patent office to investigate further. On February 15, Dr Zhang and his team again prevailed.

Why does anybody own CRISPR?

Not everyone agrees that this is how the dispute should have been settled. The issue "often gets reduced to who owns CRISPR," said Michael Eisen, PhD, professor of genetics, genomics, and development at the University of California, Berkeley, during a subsequent session at the meeting that addressed controversies in genomic medicine.

"I'm not taking sides — Berkeley or Broad — but what I want to talk about is, why does anybody own CRISPR?" Dr Eisen explained.

"The core of what I want to argue," he said, is that "if CRISPR had been discovered in labs [in which] no one had patented it, I think everyone would be using it. It's a high-profile invention."

Others see the patent process as a way to protect business interests and provide financial incentive to researchers.

"The overall point Dr Zhang made is that there was some necessity to protect intellectual property here, so companies can make a business out of it," said session moderator Ali Torkamani, PhD, director of genome informatics at Scripps Translational Science Institute in La Jolla.

"But there are also a lot of different indications and approaches out there, so other patents will be awarded in this field," Dr Torkamani told Medscape Medical News. "There will be plenty of opportunities in the applications of this technology, so it's not locked into a single company."

"I don't think this is a blocking patent per se, but I guess time will tell," he added. He pointed out that Jennifer Doudna and Manuel Charpentier were invited to the FOGM conference "but were unable to attend due to a conflict."

People are not going to do the research unless they get some kind of return on their work.

"In general, it's worth having a patent system," said Jerome Sinsky, MD, an ob/gyn in private practice in Escondido, California.

"People are not going to do the research unless they get some kind of return on their work," he told Medscape Medical News. And without the financial incentive of a patent, researchers would be more likely to stick with the current CRISPR or any other technology, he added.

Exclusive licenses can limit use and stifle innovation.

The patent dispute has caused its own problems. "A lot of universities are scared about using CRISPR because of the uncertainty about who owns it," said Dr Eisen. Schools with limited resources are reluctant to invest time, money, and other resources without knowing if they will owe licensing fees or other costs for using the technology.

"For widely desired technology like CRISPR, exclusive licenses can limit use and stifle innovation," he argued. "From the perspective of the public — and people at Berkeley hate me for making this statement — this is a net loss."

Dr Eisen explained that the current situation can be traced back to passage of the Bayh–Dole Act of 1980, which is also known as the Patent and Trademark Law Amendments Act. It allows universities to own a patent on technology developed by faculty. The thinking at the time was that universities would promote the discoveries and translate the research into products that would benefit the public — one of the goals of the legislation.

"Does Bayh–Dole work? I'll give you a hint, no," he said. Instead of exclusive licensing in which universities are charged to access technologies like CRISPR, a better approach, he suggested, would be to tax companies at the point of economic activity, once a product is ready for marketing.

Dr Zhang is a core institute member of the Broad Institute of MIT and Harvard. Dr Eisen is director of the Eisen Lab at UC Berkeley. Dr Torkamani and Dr Sinsky have disclosed no relevant financial relationships.

10th Future of Genomic Medicine (FOGM) Conference. Presented March 2, 2017.

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