Broad defeats Berkeley CRISPR patent

Credit: Science Photo Library / Alamy Stock Photo

A ruling by the US Patent and Trademark Office (USPTO) Appeals Board resolves a conflict over rights to the foundational CRISPR–Cas9 genome editing technology in eukaryotic cells. It may also give the Broad Institute, and the companies licensing this technology, an advantage in intellectual property (IP) negotiations.

“This decision is momentous because it resolves the issue between CVC [the University of California, the University of Vienna and Emmanuelle Charpentier] and the Broad Institute [of] who was the first to invent CRISPR–Cas9 in eukaryotes,” says Jacob Sherkow, law professor at the University of Illinois. Sherkow adds, however, that it’s not the end of the road for CRISPR patent tussles in general, as more CRISPR–Cas9 patent disputes are ongoing. Broad, for example, has open interference motions with ToolGen and Sigma-Aldrich.

The current dispute is over who was first to invent a method for editing eukaryotic genomes using a single-guide RNA, which would apply to all human therapeutic applications. The contest began in 2014, when the USPTO granted Feng Zhang from the Broad Institute of MIT and Harvard patent number 8697359 and nine others over the use of CRISPR–Cas9 gene editing in eukaryotes.

Establishing who invented the CRISPR method in eukaryotic cells hinges on a date. Before 16 March 2013, the USPTO operated under a ‘first to invent’ system, rather than the ‘first to file’ system implemented under the America Invents Act. At that time, the inventor was the first to conceive of an invention and reduce it to practice. Jennifer Doudna and her co-inventor Charpentier are acknowledged as the first to conceive of CRISPR–Cas9 gene editing, dating to 1 March 2012. But patent judges Sally Gardner Lane, James T. Moore and Deborah Katz were persuaded by Broad’s claim that the Zhang lab, working on the same idea in parallel, was the first to achieve a “reduction to practice” by 5 October 2012, documented in a manuscript submitted to Science.

The first set of patents was thus awarded to the Broad team in 2015, prompting attorneys for the CVC group to request the first interference proceeding (106,048) against Zhang. By 2017 the US patent office (USPTO) had determined that there was no conflict between the Broad’s patent claims and those from UC Berkeley over CRISPR–Cas9 use in a cellular setting. Whereas UC Berkeley’s claims were for CRISPR–Cas9 systems in any environment, the Broad’s claims were limited to CRISPR–Cas9 systems used in eukaryotic cells. As such, they were separately patentable.

Then in 2019 the Appeals Board reopened the dispute, declaring a second interference (106,115) around the use of the technology in eukaryotic cells. This was in response to patent applications made by CVC that required the appeals board to determine the original inventor of the technology.

Although the latest ruling maintains CVC’s original patents for uses in vitro and in prokaryotes, the University of California said in a press release that it “is disappointed by the PTAB’s decision and believes the PTAB made a number of errors.” CVC is likely to challenge this decision, possibly through the Court of Appeals for the Federal Circuit or the District Court for Washington, DC, according to Katie Rubino, a lawyer with Caldwell Intellectual Property Law. It will be an uphill battle, however, says Rubino, because the USPTO decision has already met the standard of “substantial evidence” that is required to prevail in an appeal.

Companies commercializing CRISPR–Cas9 products, particularly those licensing University of California patents, such as CRISPR Therapeutics and Intellia Therapeutics, will likely be affected by the Broad ruling. Intellia’s stock tumbled 21%, despite releasing promising data on its lead drug candidate that same day. Intellia is a biotech company based on CRISPR gene editing IP from Doudna’s group. In a written statement, Intellia says the decision will not impact its ongoing research and development plans: “We are carefully reviewing the decision and are confident CVC will find a path forward to affirm their IP rights, including the possibility of an appeal to the Federal Circuit.”

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Author: admin