[Ip-health] Science: Surprise patent ruling revives high-stakes dispute over the genome editor CRISPR

Thiru Balasubramaniam thiru at keionline.org
Thu Jun 27 02:21:33 PDT 2019


https://www.sciencemag.org/news/2019/06/surprise-patent-ruling-revives-high-stakes-dispute-over-genome-editor-crispr

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<SNIP>


Ultimately, the patent uncertainty created by the new interference
declaration may prod UC and Broad to cut a deal. “Given the complexity of
the landscape, and as the thicketing of the landscape continues, the desire
to get some form of collaboration for licensing only enhances for third
parties,” Coombes says. Broad says it long has hoped UC would enter a
“patent pool” to resolve the dispute, which effectively would allow both
parties to earn money from their inventions without becoming ensnarled in
legal wrangling with each other. Ellison would not say whether the
interference would increase pressure on UC and the Broad Institute to
arrive at this type of settlement but called it a “great question.”

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Surprise patent ruling revives high-stakes dispute over the genome editor
CRISPR

By Jon Cohen

Jun. 26, 2019 , 1:45 PM

The high-profile patent fight over who invented a key feature of the genome
editor CRISPR has been resurrected. The 3-year-old battle, which a U.S.
appeals court appeared to have put to rest in September 2018, pits parties
represented by the University of California (UC) against the Broad
Institute of Cambridge, Massachusetts. It revolves around the use of
CRISPR, originally derived from a DNA-cutting system used by bacteria, in
the more complex cells of eukaryotes, which includes humans, making the
contested patents key to the potentially lucrative development of novel
medicines. After the U.S. Patent and Trademark Office awarded the Broad
Institute several patents for the invention of CRISPR in eukaryotes, UC
requested what’s known as an interference based on its own submitted
patent. The Patent Trial and Appeal Board (PTAB) ruled against UC in
February 2017, and the U.S. Court of Appeals for the Federal Circuit denied
UC’s appeal 1 year later.

Now, based on new claims—the parts of a patent that dive into the
specifics—by UC in April 2018, PTAB has ruled there is a potential
interference that needs to be examined. Eldora Ellison, a lead attorney for
the UC team who works at Sterne, Kessler, Goldstein & Fox in Washington,
D.C., says PTAB ruled in 2017 there was no interference because the UC
patent involved far-reaching claims of the CRISPR invention for many
systems and the Broad Institute focused only on eukaryotes “What they said
is, ‘We’re actually not going to have a fight at this point in time,
because we think that these are two different inventions,’” Ellison says.
“They kind of kicked the can down the road on who was first to invent the
use of CRISPR in eukaryotes.”

But UC’s new focused claims led PTAB to declare an interference on 24 June.

The UC team, which represents Jennifer Doudna from UC Berkeley and her
collaborators, first published the use of CRISPR as a genome-editing tool
in June 2012, but it did not demonstrate that it worked in eukaryotic
cells. Broad’s team, led by Feng Zhang, published a paper that described
its success in eukaryotes in January 2013. (Both papers were published in
Science.) In the earlier rounds, UC and Broad squared off over the question
of whether it was “obvious” after the Doudna group published its 2012 paper
that CRISPR would work in eukaryotes and that researchers skilled in the
art would have a “reasonable expectation of success” if they tried their
hands at the experiment. “The Broad likes to act like the earlier decision
was some kind of a ruling about the sufficiency of UC’s patent applications
disclosure. And that’s not the case. It's just a comparison of the claims,”
Ellison says.

The Broad Institute, unsurprisingly, does not see eye to eye with this
interpretation. In a statement, it says PTAB’s new interference “challenges
the validity of [UC’s] eukaryotic claims.” The Broad group has been deemed
the “senior party,” the statement notes, which means UC “carries the burden
of proof” and must convince PTAB that the Broad team did not invent the
eukaryotic use of CRISPR.

“We welcome this action by the PTAB,” the statement says. “Broad Institute
looks forward to participating in the interference process.”

Catherine Coombes, a patent attorney at HGF in York, U.K., who does not
represent Broad or UC but is involved in CRISPR patents, says the new
interference “adds to the complexity of the landscape.” The European Patent
Office has grated “overlapping rights” to both groups and others who have
filed CRISPR patent applications, anticipating that legal fights will occur
later. “For human therapeutics, it is still too early to know where the key
patents will lie,” Coombes says, noting that different enzymes used in
various CRISPR systems ultimately may make one invention safer or more
effective than another.

Ultimately, the patent uncertainty created by the new interference
declaration may prod UC and Broad to cut a deal. “Given the complexity of
the landscape, and as the thicketing of the landscape continues, the desire
to get some form of collaboration for licensing only enhances for third
parties,” Coombes says. Broad says it long has hoped UC would enter a
“patent pool” to resolve the dispute, which effectively would allow both
parties to earn money from their inventions without becoming ensnarled in
legal wrangling with each other. Ellison would not say whether the
interference would increase pressure on UC and the Broad Institute to
arrive at this type of settlement but called it a “great question.”

The parties will first discuss the interference on 5 August in a conference
call with PTAB. If the parties do not reach a settlement, the hearing is
expected in about 8 months.


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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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