he CRISPR patent dispute has two things in common with the 2016 presidential race: it’s going to last until at least November; and following who’s up and who’s down is enough to give you vertigo.
In documents made public late this week, the three-judge panel adjudicating the case revealed that oral arguments have been scheduled for Nov. 17. The judges also announced which motions they will and will not entertain, offering a peek into which arguments they are likely to base their decision on.
Handicappers had previously laid odds in favor of the University of California, partly because the onus is on the Broad Institute, as the so-called junior party, to demonstrate that the patent office’s original decision awarding it key CRISPR patents was correct. But from the tea leaves offered by the judges’ rulings on which motions can be filed, the odds have shifted toward the Broad.
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Fans of courtroom dramas might assume that attorneys can file any motions they want, but the patent office works on what Jacob Sherkow, of New York Law School, calls a “mother-may-I system.”
Which motions the judges allow, Sherkow told STAT, “give you a clue about what they think are the most important issues in the case.”
To recap: The Broad was granted about a dozen CRISPR patents for genome editing. UC claimed it, and not the Broad, was entitled to them.
Under the law at the time, patents go to the first to invent something (they now go to the first to file). The Broad paid for an accelerated review of its key patent application, and was awarded its first in April 2014. UC did not pay for such expedition, and so was left in the dust when that decision came out.
The “interference proceeding” now underway at UC’s request will resolve which organization is entitled to the key CRISPR patents.
Here’s the latest rundown (for which STAT is indebted to Sherkow for translation of phrases such as “a constructive reduction to practice is ‘a described and enabled anticipation under 35 U.S.C. § 102(g)(1)'”):
The Broad wants to show that the CRISPR-based genome-editing inventions made by its biologist, Feng Zhang, occurred at the earliest date mentioned in its patent applications. The judges said, sure, file a motion to that extent. Advantage: Broad.
The Broad also contends that UC is not entitled to a CRISPR patent because its claims cover “prior art,” arguing that what UC biochemist and CRISPR pioneer Jennifer Doudna accomplished was either obvious or lacked novelty.
That would be news, of course, to the many august groups that have showered her with scientific prizes for her CRISPR discoveries, from her $3 million Breakthrough Prize in 2014 to the Warren Alpert Foundation Prize announced earlier this month.
The judges deferred a decision on allowing that motion to be filed. Advantage: neither.
UC is arguing that Doudna’s invention occurred in May 2012. If UC convinces the judges that the invention came that early, the Broad will have to either demonstrate an earlier CRISPR invention from Zhang, or that one of Zhang’s later innovations was a significant advance over Doudna’s.
The judges said UC can file that motion. Advantage: UC.
As for UC’s assertion that Zhang engaged in inequitable conduct — basically, that he deceived the patent office about what he had accomplished with CRISPR? The judges denied UC’s request to file a motion arguing that. Advantage: Broad.
The Broad is also making one crucial argument: that UC’s claims are unpatentable because they overreach what Doudna actually accomplished.
The Broad contends that UC’s patent claims are for genome editing of cells like those of people, called eukaryotic cells, when the description of what Doudna discovered is about prokaryotic cells, like bacteria.
The judges granted the Broad’s request to file that motion. If they ultimately accept the Broad’s argument, “the whole thing is over,” Sherkow said — and the decision to grant key CRISPR patents to the Broad will stand.
In other words, it would be game, set, and match.