Patent Office: 1924 |
Fight for coveted CRISPR patents gets knottier,
as MilliporeSigma makes new claims
STAT, Sharon Begley, 7-22-19
After nearly seven years of failing to win
fundamental patents on the genome-editing technology CRISPR, a unit of one of
the world’s largest life sciences companies has thrown a Hail Mary: Late last
Friday, MilliporeSigma petitioned the U.S. Patent and Trademark office to open
an interference proceeding between CRISPR-Cas9 patents that it applied for way
back in 2012 and patents that the University of California has applied for or
been awarded.
The unusual move — New York Law School patent
expert Jacob Sherkow’s reaction was “holy s***,” and MilliporeSigma itself
described the circumstances as “extraordinary” — seems to be the company’s
last-ditch effort to pull out a CRISPR victory at the patent office, which it
believes has treated its applications in a way that is inconsistent with how it
has treated others.
“What we’re trying to do with this petition is
highlight a fundamental unfairness in how Sigma-Aldrich’s patent applications”
covering the use of CRISPR in plants and animals, or eukaryotes, “are being
handled compared to others’,” company attorney Benjamin Sodey said, referring
to the MilliporeSigma unit.
The move could have implications beyond
intellectual property rights. MilliporeSigma argues that two scientists at its
St. Louis lab, Greg Davis and Fuqiang Chen, were the first to get the CRISPR
system to edit eukaryotes. That system is a “guide RNA” that finds a specific
nucleotide sequence on a genome, paired with an enzyme that cuts the DNA so a
disease-causing segment can be excised or a repair segment can be inserted.
“We have not been very visible” in discussions of
CRISPR credit, said geneticist Supriya Shivakumar, head of strategy for gene
editing at MilliporeSigma, a unit of Germany-based Merck KGaA. “We would like
it to be recognized that our scientists did some amazing discovery work that
led to the use of CRISPR in eukaryotes.”
The Broad Institute of MIT and Harvard pushed
back hard against the implication that its scientists, led by Feng Zhang, came
in second.
“Feng Zhang first used CRISPR in eukaryotic
cells,” Broad spokesman David Cameron told STAT.
An interference proceeding determines whether two
patents describe essentially the same invention. If so, then (under the law
that prevailed when the disputed patents were all filed) the scientists who
were the first to invent are awarded the patent.
Last month, the patent office declared an
interference between UC and the Broad, meaning it believes that a dozen key
CRISPR patents awarded to the Broad and 10 CRISPR patent applications by UC and
its partners describe substantially similar
inventions.
MilliporeSigma is asking the patent office to
conduct a parallel interference proceeding, between the company and UC,
concurrent with its Broad/UC interference. The latter will determine whether
Zhang’s invention of CRISPR-Cas9 to edit eukaryotes is essentially the same as
inventions by UC’s Jennifer Doudna and her colleagues. Although the UC team
showed that CRISPR can edit DNA floating in a test tube, and not in cells, its
patents (eight so far) cover the use of CRISPR in all systems — inside cells,
outside cells, genomes of eukaryotes and genomes of lower organisms.
A representative for UC’s attorney said she has
no comment in the MilliporeSigma petition.
For years, the patent office has denied
MilliporeSigma’s applications (including 15/188,911, 15/456,204, and
15/188,924) to patent CRISPR-Cas9 editing in eukaryotic genomes. The first of
these was filed on December 6, 2012, six days before the Broad’s application on
Zhang’s work.
MilliporeSigma has petitioned the patent office
for an interference between it and UC, and not between it and the Broad,
because the patent examiner has cited only the UC patents in denying the
company’s applications.
The reason for the denial, according to
MilliporeSigma’s petition, is the examiner’s conclusion that the Chen-Davis
work in eukaryotes is obvious given Doudna’s on DNA in test tubes. As it
happens, a previous interference between UC and the Broad revolved around this
“obviousness” point. But last year a federal court upheld the patent office’s
2017 decision that Doudna’s test tube breakthrough did not make Zhang’s success
getting CRISPR to edit genomes inside mammalian cells “obvious.” The Broad got
to keep its key CRISPR patents.
MilliporeSigma argues that the same reasoning
should clear the way for its patents on CRISPR in eukaryotes. That is, if the
Broad’s eukaryote work was not obvious given UC’s, then Sigma-Aldrich’s isn’t
either. “UC’s disclosure of CRISPR-Cas9 in in vitro cell-free and nucleus-free
test tube environments … [does not] render obvious claims directed to
CRISPR-Cas9 in eukaryotic cells,” its petition says.
The company is clearly aggrieved, sprinkling its
petition with words such as “frustratingly,” a quote from Yogi Berra (“it’s
like déjà vu all over again”), and assertions that the examiner “simply
responds again and again that she finds Sigma-Aldrich’s evidence
‘unpersuasive’,” dismissed its arguments “in little more than a single paragraph,
superficially,” and is guilty of “blatant inconsistency” and “demonstrable
unfairness” to MilliporeSigma. In contrast, it has won CRISPR patents in
Australia and Europe.
If the patent office conducts an interference
proceeding between the company and UC, there are two possible outcomes. It can
conclude that their CRISPR inventions are different enough that both can be
granted patents, as happened with the first UC-Broad interference. Or, it can
conclude that the two parties’ CRISPR inventions are substantially the same. In
that case, the next step is to determine who invented it first. MilliporeSigma
believes Davis and Chen did.
“If the patent office is deciding” who invented
CRISPR in eukaryotes, MilliporeSigma’s lawyer Sodey said, “we believe [we]
should be part of that conversation.”
That argument runs counter to all CRISPR
histories. Numerous prizes have honored Doudna and her chief colleague,
Emmanuelle Charpentier, as well as Zhang, for inventing CRISPR genome editing.
One author who has extensively researched that history said none of the experts
he interviewed ever mentioned Davis and Chen. The pair did not publish on
CRISPR, though industry scientists often skip journals and file patent
applications instead.
Attorneys
who have worked on the seemingly endless CRISPR patent fights, who asked not to
be named to preserve client confidentiality, called MilliporeSigma’s move
“interesting” and even “fascinating.” But “I have never seen a parallel
interference declared,” said one. “I don’t think the patent office will be
moved.”
Source: Email from UC Daily News Notes of 7-22-19
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