A federal court ruled in favor of the Massachusetts Institute of Technology and Harvard University’s Broad Institute in a patent interference case concerning CRISPR-Cas9 gene-editing technology.
A panel of three judges in the US Court of Appeals for the Federal Circuit ruled Monday that the Broad Institute’s patent on CRISPR-Cas9 did not “interfere” with the University of California Berkeley’s patent application for its own version of the technology, upholding a decision last year by the Patent Trial and Appeal Board. The case was presided over by Chief Judge Sharon Prost and circuit judges Alvin Schall and Kimberly Moore, the latter of whom wrote the opinion.
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In a statement, University of California attorney Charles Robinson said the university was evaluating further litigation options. However, a spokesman for Berkeley declined to comment further on whether the university definitively plans to appeal further. The next potential step after losing before a panel of judges in the federal circuit, aside from petitioning the Supreme Court, would be to request an en banc hearing before the appellate court, meaning with all 18 judges present.
The case has significant financial implications, with potentially billions of dollars worth of licensing fees at stake given CRISPR-Cas9’s numerous potential applications in medicine and beyond. Shares of Editas Medicine, which has licensed Broad’s technology, were up slightly on the news, closing at $32.24 Tuesday.
The PTAB had determined that a person of “ordinary skill in the art” would not have been able to apply CRISPR-Cas9 to eukaryotes – meaning plants and animals, including humans – and reasonably expect to be successful due to the difference between prokaryotic and eukaryotic systems, meaning there was no interference on the part of Broad. Because there would be no reasonable expectation of success, PTAB ruled, then if Berkeley’s claims were prior art – meaning evidence that the invention was already known – it would not have made Broad’s claims “obvious,” meaning ineligible for a patent. The Berkeley researchers demonstrated that elements of the CRISPR-Cas9 system could be used in vitro in a non-cellular experimental environment, whereas the Broad researchers’ publication described use of the technology in a human cell line, the opinion read.
In its appeal to the court, Berkeley claimed that the PTAB had “improperly adopted a rigid test for obviousness that required the prior art contain specific instructions” and “erred in dismissing evidence of simultaneous invention as irrelevant.” However, the court determined that the board “did not err in its analysis.”
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The University of California initially published its CRISPR-Cas9 research in August 2012, followed by Broad’s publication in February 2013, and both institutions subsequently sought patent protection, with Berkeley filing first. Broad requested an accelerated examination for its patent application from the US Patent and Trademark Office, which granted the patent in April 2014. The USPTO granted Berkeley two patents for its CRISPR-Cas9 technology in June.
Despite its success in the US, Broad has had a less favorable experience in Europe, where the European Patent Office revoked its foundational patient in January, a decision that will likely lead to the revocation of several more.
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