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Appeals Court Backs Broad Institute in Crispr Case

Crispr genome edits illustration

(NIH.gov)

11 September 2018. A U.S. appeals court supported the Broad Institute’s claims it invented a separate Crispr technology from University of California, affirming a previous U.S. patent office ruling. The decision yesterday by the the U.S. Court of Appeals for the Federal Circuit, the court established to hear intellectual property appeals, rejected arguments by University of California that discoveries at its Berkeley campus of Crispr genome editing using a Cas9 enzyme made it possible for the Broad Institute, to develop its Crispr-Cas9 applications.

Crispr, short for clustered regularly interspaced short palindromic repeats, is a technique for editing genomes based on bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA. The actual editing of genomes with Crispr in most cases today uses an enzyme known as Crispr-associated protein 9 or Cas9. RNA molecules guide the editing enzymes to specific genes needing repair, making it possible to address root causes of many diseases, but also adjust traits in plant crops by removing or changing specific genes.

Genome-editing discoveries spawned work on Crispr by many researchers, particularly those at the Broad Institute, a medical research center affiliated with Harvard University and MIT, led by geneticist Feng Zhang developing implementations they claimed were independent of studies by geneticists Jennifer Doudna at University of California in Berkeley and Emmanuelle Charpentier, the senior authors on the original paper describing the technique in 2012. Charpentier is now director of the Max Planck Institute for Infection Biology in Braunschweig, Germany.

As a result, Broad Institute filed its own U.S. patent for Crispr, leading to a challenge from University of California that said Broad interfered with its patent claims, meaning Broad took unfair advantage of California’s previous work. In response, Broad pointed out that Zhang’s work with Crispr focuses on eukaryotes, plant and animal cells where genetic material is found in the nucleus. The California research, in contrast, is conducted with prokaryotes, organisms without a cell nucleus, such as bacteria and other single-cell microorganisms. These differences, said Broad, call for different methods and techniques.

In February 2017, the Patent Trials and Appeal Board at the U.S. Patent and Trademark Office, or USPTO, found Broad Institute’s arguments more persuasive, and agreed that Broad’s technology would not have been an obvious derivative of University of California’s discoveries, ruling in effect that Broad Institute and University of California had distinct technologies, both eligible for patents. As reported by Science & Enterprise in June, USPTO went on to grant University of California a patent for its Crispr-Cas9 technology.

The appeals court yesterday reaffirmed the Patent Trials and Appeals Board decision. “We have considered UC’s remaining arguments and find them unpersuasive,” said the court. “We note that this case is about the scope of two sets of applied-for claims, and whether those claims are patentably distinct.” The court added that it did not rule on the validity of either claim.

In a statement yesterday, UC-Berkeley noted that “The decision thus does not preclude other proceedings, either in the U.S. Patent and Trademark Office or in the courts, by which UC may seek to establish that it is the actual inventor of use of the CRISP-Cas9 system in eukaryotic cells.” The university added that it’s evaluating further legal options in the courts or USPTO.

Since these cases were filed, Crispr technology has advanced with enhancements to improve its precision, as well as the discovery of drawbacks to Cas9 as an editing enzyme. Crispr is becoming widely commercialized, with licenses issued to spin-off enterprises from both UC-Berkeley and Broad Institute, and further licenses to other companies and labs developing a number of medical and agricultural applications.

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