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Patent Office Decides for Broad and Editas in Crispr Case

Feng Zhang

Feng Zhang (Mass. Institute of Technology)

16 February 2017. The U.S. Patent and Trademark Office decided that the genome editing processes developed by Broad Institute and licensed to Editas Medicine do not interfere with techniques for genome editing created by University of California at Berkeley. The decision, handed down on 15 February, enables Editas Medicine, founded by geneticist Feng Zhang and colleagues from Broad Institute — a medical research center affiliated with Harvard University and MIT — to continue developing therapies based on its version of Crispr genome editing.

Crispr, short for clustered regularly interspaced short palindromic repeats, is based on bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA. The actual editing of genomes with Crispr uses an enzyme known as Crispr-associated protein 9 or Cas9. With this approach to Crispr, RNA molecules guide Cas9 proteins to specific genes needing repair, making it possible to address root causes of many diseases.

UC-Berkeley disputed Broad Institute’s patent awards for Crispr, claiming that the institute’s technology would not have advanced without taking advantage of UC-Berkeley’s discoveries, made by molecular biologists Jennifer Doudna and Emmanuelle Charpentier, now at Max Planck Institute for Infection Biology in Berlin. Thus claimed UC-Berkeley, Broad Institute and by implication its licensees, are interfering with UC-Berkeley’s patents and gaining rewards as a result.

Broad Institute, however, claimed Zhang’s and colleagues’ discoveries are sufficiently different from Doudna’s and Charpentier’s to be considered a separate technology. 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 UC-Berkeley 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 its arguments, Broad Institute cited an interview published in 2012 where Doudna noted that “it is not known whether such a bacterial system would function in eukaryotic cells.” Another interview cited by Broad and published in 2013 quotes Doudna as saying, “the techniques for making these modifications in animals and humans have been a huge bottleneck in both research and the development of human therapeutics.”

The Patent Trials and Appeal Board or PTAB hearing the case found Broad Institute’s arguments more persuasive. The three administrative patent judges said in their decision

We agree that the statements by and attributed to the UC inventors do not demonstrate a reasonable expectation of success. Although the statements express an eagerness to learn the results of experiments in eukaryotic cells and the importance of such results, none of them express an expectation that such results would be successful.

Thus Broad’s technology would not have been an obvious derivative of UC-Berkeley’s discoveries.

The judges conclude as well that the technologies are sufficiently different that UC-Berkeley’s approach to Crispr-Cas9 does not interfere either with Broad Institute’s processes. “Because UC’s claims would not anticipate Broad’s claims either,” say the judges, “we conclude that the parties’ claims are not drawn to the same patentable subject matter and that there is no interference-in-fact between them.”

Because of this conclusion by the judges, UC-Berkeley plans to pursue a separate patent for Crispr-Cas9 covering all type of cells, not just eukaryotes. The university statement also notes that further legal steps are possible challenging the decision. “UC will carefully consider all options for possible next steps in this legal process,” says the statement, “including the possibility of an appeal of the PTAB’s decision.”

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