CAFC Upholds PTAB Decision On CRISPR Interference

Seemingly bringing an end to the dispute between Massachusetts Institute of Technology and University of California over CRISPR patents, the Court of Appeals for the Federal Circuit upheld the Patent Trial and Appeal Board’s decision finding MIT’s use of CRISPR-Cas9 system in eukarotes to be novel and non-obvious over UC’s earlier work. Various news agencies and experts are weighing in all over the country, and those views are summarized below.

UPDATED September 11, 2018, 1:26 PM CT to include Jacob Sherkow’s Op-Ed

UPDATED September 12, 2018, 8:34 AM CT to include coverage by PatentDocs and The Scientist

UPDATED September 12, 2018, 12:45 PM CT to include coverage from Wired.

Bloomberg reports that the decision will resolve “who will get the financial and reputational credit for a gene-editing technique that’s already revolutionizing the world of genetics.” Granted, this claim misses the mark, as the article later quotes Michael Stramiello, from the firm  Paul Hastings, who correctly explained that the patent office “didn’t get far enough along to decide who first invented” CRISPR-Cas9.

STAT more accurately reports that “The decision turned on two key and related points: whether the work that Broad scientist Feng Zhang did to make CRISPR edit the genome of mammalian cells was ‘obvious’ in light of what Jennifer Doudna, of the University of California, Berkeley, and her colleagues accomplished in editing free floating DNA in test tubes, and whether Zhang and other scientists trying to do that had a ‘reasonable expectation of success.'” Quoting New York Law School professor Jacob Sherkow, STAT reports that the CAFC’s decision “is absolutely 100 percent correct on the law” leaving no room for a re-hearing or petition to the Supreme Court.

The science journal Nature notes that “Investors have watched the case closely, even as they poured millions into companies that aim to develop medicines and crops using CRISPR–Cas9.” This “fierce and unprecedented” battle over inventorship “has been one of the single most heated disputes between two educational institutions” according to Sherkow.

Sherkow himself has penned an op-ed in STAT stating that the decision is correct, even if it got the science wrong. Sherkow explains that the standard of review applied by the CAFC is whether the PTAB “based its opinion on substantial evidence.” In fact, according to Sherkow, “there was substantial enough evidence for the Patent Office to determine that Zhang’s application of Doudna and Charpentier’s CRISPR-Cas9 system, which they developed in bacteria, to more complex eukaryotic cells (cells like human cells that have nuclei) constituted a significant enough advance to be its own invention.” Ultimately, the outcome highlights the importance of technical expertise within the patent office, as Sherkow concludes “This doesn’t mean I agree with the patent office’s interpretation of the science. …These problems [associated with moving previous gene-editing systems from bacteria to eukaryotic cells] … were widely known to scientists at the time who could have solved each with a road map of solutions.”

The Scientist has also weighed in, noting “the intellectual property battle for CRISPR continues in Europe, where the University of California, Berkeley, and the Broad Institute both have patents facing opposition from others who are trying to stake a claim on the technology.”

Kevin Noonan at PatentDocs also published an extensive summary, concluding that “Broad will maintain its extensive CRISPR patent portfolio and the University’s patent application … should grant as a patent in due course” Therefore, Noonan concludes that “a third party wishing to practice the technology in eukaryotic cells … would need a license from both the University and the Broad.”

However, Wired reports that “A wealth of innovation … is now threatening to make Cas9 obsolete.” Since the Broad/UC dispute bega, “the fast-moving field of Crispr biology has yielded more than just alternative pairs of molecular scissors. Researchers have updated the Crispr system to manipulate the code of life in myriad novel ways … ”

Meanwhile, the Broad Institute, whose research actually led to the patent claims in question, issued a statement, saying “Over the last five years we have made multiple attempts to engage the University of California. These efforts began before UC initially licensed its IP, and have continued even after the US Patent Office ruled in favor of Broad. We have continued to reach out. 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.”

A copy of the decision is available from the CAFC website.

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