Page 61 - Breeding Edge ebook

who owns the patent to the technology – and some countries view the patent ownership differently
than others.

In May 2012, Doudna and Charpentier respectively filed for patent claims in the U.S. In December
2012, a team led by bioengineer Feng Zhang from the Broad Institute of MIT and Harvard also filed
patent claims. But the U.S. Patent and Trademark office reviewed Zhang’s filing first because Broad
paid for a fast-track review process. In 2014, the Patent and Trademark office granted the first CRISPR
patents to the Broad Institute for showing that the CRISPR system could be used to edit more advanced,
eukaryotic cells, including animal and human cells.

UC-Berkeley asked for an “interference proceeding” to re-assess and determine who was the first to
invent the genome editing tool.

However, in February 2017, the US Patent Trial and Appeal Board (PTAB) again ruled that the
Broad/MIT group could keep its patents on using CRISPR-Cas9 in eukaryotic cells. In essence, the
PTAB said there is no interference between the two groups' patent claims because the patent issued to
the Broad/MIT group is sufficiently different from that filed by the UC team, including Doudna and
Charpentier who said they had first successfully demonstrated the technology.

The University of California is now appealing this decision. In a brief, the UC team asserted that the
PTAB “ignored key evidence” and “made multiple errors” when assessing whether CRISPR/Cas9 gene
editing in eukaryotes was an obvious extension of the UC invention.

In response, the Broad Institute said that PTAB’s
judgment was supported by substantial evidence and
in full conformity with the law. “We are confident
the Federal Circuit will affirm the PTAB’s
judgment and recognize the contribution of the
Broad, MIT and Harvard in developing this
transformative technology,” the Institute noted.

Further muddying the patent and legal environment is
a recent decision by the European Patent Office
(EPO) which revoked the first of several patents
obtained by the Broad Institute, citing a lack of
novelty.

That decision was heralded by ERS Genomics, which Bioengineer Feng Zhang, Broad Institute
was co-founded by Charpentier.

“We have always felt confident that the Broad’s patents would be overturned in Europe based on
lack of novelty in light of the Charpentier/Doudna patent filings, but the simple confirmation of
this technical deficiency in the Broad’s priority claims made it unnecessary for the European
Patent Office to pursue this line of questioning in their revocation decision,” said Eric Rhodes,
CEO of ERS.

“The technical fault was sufficient for the Patent Office to quickly come to a determination that the
Broad claims to their earlier priority dates were not legitimate and therefore their claims lacked novelty
in light of several publications which predated their allowed priority date.”

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