CRISPR patent ruling has little impact in laboratory setting, MIT researchers say

Faculty members voice support for Zhang and the use of patents in biotech

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The Broad Institute, home of the Zhang lab and a hub for CRISPR research.
Anselmo Cassiano–The Tech

Researchers at MIT maintained that the U.S. Patent Trial and Appeal Board’s Feb. 15 decision, which affirmed the Broad Institute’s patent claims on using CRISPR-Cas9 technology to edit eukaryotic genomes, had little impact on future laboratory research.

The PTAB decision agreed with the Broad’s claim that 13 of their patents do not interfere with a broader patent filed by the University of California, Berkeley and the University of Vienna.

MIT professor Feng Zhang, the young CRISPR leader at the Broad responsible for the patents, said he did not believe “the patent questions have slowed research at all.” In an email to The Tech, he wrote he was “glad that it has not become a distraction,” which he attributes in part to the commitment of scientists at various institutions wanting to further the field.

“It’s been a big topic for the media, but I don’t think the academic community — at least my peers — are too focused on the details of this patent, since it doesn’t prevent us from using CRISPR as a tool,” Daniel Anderson, a professor of applied biology at MIT, said in a phone interview with The Tech. Anderson’s lab was heavily involved with developing the mechanism for delivery of CRISPR components to target cells.

For Zhang and other MIT professors, patents are a crucial part of the research and development process. “I believe that academic and other non-profit institutions have a responsibility to make licensing decisions that maximize patient benefit,” Zhang said. He noted that his lab shares CRISPR tools through the non-profit Addgene for research.

Phillip Sharp, an institute professor at the Koch Institute and a laureate of the 1993 Nobel Prize in Physiology or Medicine, highlighted the role of patents in the development of pharmaceuticals: patents grant a “transient monopoly,” he said, which helps justify the billions of dollars invested in biomedical research.

Anderson agreed, adding that not enough attention has been paid to the power of patents to enable technology.

For Robert Langer, an institute professor renowned for his work in drug delivery and one of the most cited bioengineering professors in history, patents do not typically present an issue. Sorting out intellectual property rights, he wrote in an email to The Tech, is a straightforward task even when other institutions are involved, and is handled efficiently and routinely by the MIT Technology Licensing Office.

The key financial stakeholders in PTAB’s decision, aside from the institutions themselves, are the companies that have licensed CRISPR-Cas9 technology from the Broad or Berkeley, who stand to gain or lose millions of dollars.

Editas Medicine, which licensed the Broad’s patent, saw its stocks jump nearly 30 percent after the decision. Meanwhile, shares of CRISPR Therapeutics, which licensed patents from Berkeley professor Jennifer Doudna and University of Vienna professor Emmanuelle Charpentier, both of who declined to comment for this story, fell nearly 10 percent. Anderson co-founded CRISPR Therapeutics with Charpentier.

The pending patent by Berkeley and the University of Vienna makes a claim to the use of CRISPR-Cas9 in all cell types. At the time the patent was filed, however, Doudna and Charpentier had only used CRISPR-Cas9 to cut genomes in test tubes. It remains unclear whether these broader patent claims will be granted, and what that would imply for the Broad’s patents.

Berkeley said in a statement that they were pleased that their patent applications can continue with the ending of the PTAB case. “The Doudna/Charpentier patent application will be returned to the patent examiner, who previously determined that their patent application is allowable,” they wrote in the statement.

At the same time, Berkeley kept open the possibility of appealing the PTAB’s decision. The status of the patents also remains uncertain abroad, where Europe is facing similar questions.

The decision in the PTAB case, however, has left some legal scholars doubting the strength of UC Berkeley and the University of Vienna’s patent claims.

Jacob Sherkow, a professor at New York Law School who focuses on patent law in the biosciences, wrote in an email to The Tech that the Patent and Trademark Office “will have the opportunity to require [Berkeley] to narrow their current patent claims in light of the decision last week.”

Sherkow believes that even if the Berkeley patent is awarded, it would be weak and hard to enforce. “Those claims will almost certainly suffer from problems of lack of written description or lack of enablement as detailed by the PTAB's decision,” Sherkow said.

There remains the possibility, even if unlikely, that both parties’ patents are found to be valid. In this case, “overlap would possibly hurt companies who have already bet on one horse in this horse race, who may then need to obtain a license from the other institution,” Sherkow said. He believes that academic research is unlikely to be affected, however.

Langer, Sharp, and Anderson all professed that they did not have in-depth understanding of the specifics of the patent dispute and PTAB’s decision. Langer asserted that it would take many weeks to properly examine the patent claims and make an informed evaluation of the patent decision, and Anderson was similarly reluctant to “make a statement about the patent decision basis.”

Sharp, on the other hand, was comfortable agreeing with PTAB’s appraisal that Zhang’s accomplishment was not obvious and could not have been achieved by someone with ordinary skill in the subject. “It’s a major innovation,” he said. “Many things happen in a test tube, and when you go to translate that to a cell, frequently there’s interference.”

Sharp called Zhang a “wonderful guy, brilliant scientist” of whom he was “justifiably proud.” He later applied similar laudatory terms to Doudna.

Langer similarly praised Zhang for his work with CRISPR. Referencing the Canada Gairdner International Award that Zhang received in 2016, Langer said, “I have [not] done a detailed analysis on credit, but he would not have awards like that without doing very important work.”