Doubting UC Researchers May Sink CRISPR Appeal
Initial concerns that gene editing technology might not work on humans are substantial evidence supporting subsequent Broad Institute patents, judges suggest Monday.
April 30, 2018 at 06:48 PM
5 minute read
It doesn't look as if Harvard and MIT will have to share its patents on revolutionary CRISPR-Cas9 gene editing technology with the University of California any time soon.
The U.S. Court of Appeals sounded skeptical of the appeal brought Monday by UC and Munger, Tolles & Olson partner Donald Verrilli Jr. The former solicitor general argued that after UC made the breakthrough discovery in 2012, Harvard's and MIT's Broad Institute simply applied it to human cells using obvious, conventional techniques.
The Patent Trial and Appeal Board disagreed, finding the Broad Institute's application represented patently distinct subject matter. On Monday, Federal Circuit Judge Kimberly Moore sounded as if she strongly agreed.
“The problem for you is you have multiple statements by multiple of the UC inventors that are pretty strongly worded about many frustrations getting CRISPR to work in human cells,” she told him. She quoted one researcher's reaction to Broad's discovery: “'I hope you're sitting down, because CRISPR tuns out to be absolutely spectacular. A Harvard geneticist just figure[d] out how to make it work in human cells.'”
Chief Judge Sharon Prost was sympathetic at times to Verrilli's arguments, but she pointed out the Federal Circuit must show some deference to the PTAB.
“You're under substantial evidence review,” she told Verrilli. “The board pointed us to statements, testimony, declarations that used words like 'very frustrating,' 'weren't the same,' 'it's not known whether'” CRISPR will succeed on human cells, Prost said. “How do you get around that?”
Paul Hastings life sciences IP associate Michael Stramiello, who is not involved in the case but attended Monday's arguments, said UC faced an uphill battle given the results of the PTAB proceeding. “I'd be surprised if today's arguments moved the needle at all,” he said.
CRISPR, which stands for clustered regularly interspaced short palindromic repeats, can be used to add or delete DNA from cells in order to fight diseases, reverse genetic mutations or to improve crop resistance to pests and drought. The technique is sparking a gold rush in medical research despite uncertainty over who holds the most valuable patents.
Berkeley said it was first to apply the technique in simple-celled organisms, but Broad argued it was first to expand the technique to multicelled organisms. Berkeley filed its patent first, but the Broad Institute's patents were approved first, sparking Berkeley's interference claim.
In the PTAB's per curiam ruling, the board held there's “no interference in-fact.” The judges said Broad successfully proved its patents were distinct from Berkeley's. Broad's related to editing in an eukaryotic, or multicellular organisms, unlike Berkeley's, which are limited to prokaryotic, or single-celled organisms.
UC has had more success before the European Patent Office, which ruled recently that a handful of Broad Institute CRISPR patents do not antedate the UC versions. Plus, Stramiello pointed out, the technology is rapidly evolving, opening up opportunities for others. “There's a lot of attention on innovation in this area, and it hasn't stopped at Cas-9,” he said.
On Monday, Verrilli tried to get things back on track for UC at the Federal Circuit. He argued the UC researcher statements weren't negative, but simply neutral. The appeal “has to be decided on the entire record,” not just those few statements, he told the court.
“The problem you have here,” Moore replied, “is you're trying to convince me there's substantial evidence for the outcome you want. I may agree with you, but that doesn't mean there isn't substantial evidence for the outcome the other side” wants.
Quinn Emanuel Urquhart & Sullivan partner Raymond Nimrod said the researchers were well aware of the challenges facing application of the CRISPR technology to multicelled organisms.
“This is a situation where substantial evidence supports the decision here, and the other side is simply asking your honors to second-guess the PTAB's decision,” he told the court.
As time was winding down, Verrilli tried one last time to persuade Moore. He argued the PTAB failed to consider evidence that Broad and other researchers used simple, conventional techniques to implement CRISPR-Cas9 on human and animal cells.
“That's how science works, Mr. Verrilli,” Moore replied. “You start with the conventional techniques, and then when they don't work you spend the time, energy and money coming up with the new technique. The fact that they started with the easiest, off-the-shelf stuff doesn't mean they thought it would work.”
“Respectfully, your honor,” Verrilli tried to interject.
“That's what the board found, Mr. Verilli, and it's hard for me to say there's not substantial evidence for that.”
This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.
To view this content, please continue to their sites.
Not a Lexis Subscriber?
Subscribe Now
Not a Bloomberg Law Subscriber?
Subscribe Now
NOT FOR REPRINT
© 2025 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.
You Might Like
View AllUS Judge Cannon Blocks DOJ From Releasing Final Report in Trump Documents Probe
3 minute readPrivate Equity Giant KKR Refiles SDNY Countersuit in DOJ Premerger Filing Row
3 minute readThree Akin Sports Lawyers Jump to Employment Firm Littler Mendelson
Trending Stories
- 1Decision of the Day: Judge Dismisses Defamation Suit by New York Philharmonic Oboist Accused of Sexual Misconduct
- 2California Court Denies Apple's Motion to Strike Allegations in Gender Bias Class Action
- 3US DOJ Threatens to Prosecute Local Officials Who Don't Aid Immigration Enforcement
- 4Kirkland Is Entering a New Market. Will Its Rates Get a Warm Welcome?
- 5African Law Firm Investigated Over ‘AI-Generated’ Case References
Who Got The Work
J. Brugh Lower of Gibbons has entered an appearance for industrial equipment supplier Devco Corporation in a pending trademark infringement lawsuit. The suit, accusing the defendant of selling knock-off Graco products, was filed Dec. 18 in New Jersey District Court by Rivkin Radler on behalf of Graco Inc. and Graco Minnesota. The case, assigned to U.S. District Judge Zahid N. Quraishi, is 3:24-cv-11294, Graco Inc. et al v. Devco Corporation.
Who Got The Work
Rebecca Maller-Stein and Kent A. Yalowitz of Arnold & Porter Kaye Scholer have entered their appearances for Hanaco Venture Capital and its executives, Lior Prosor and David Frankel, in a pending securities lawsuit. The action, filed on Dec. 24 in New York Southern District Court by Zell, Aron & Co. on behalf of Goldeneye Advisors, accuses the defendants of negligently and fraudulently managing the plaintiff's $1 million investment. The case, assigned to U.S. District Judge Vernon S. Broderick, is 1:24-cv-09918, Goldeneye Advisors, LLC v. Hanaco Venture Capital, Ltd. et al.
Who Got The Work
Attorneys from A&O Shearman has stepped in as defense counsel for Toronto-Dominion Bank and other defendants in a pending securities class action. The suit, filed Dec. 11 in New York Southern District Court by Bleichmar Fonti & Auld, accuses the defendants of concealing the bank's 'pervasive' deficiencies in regards to its compliance with the Bank Secrecy Act and the quality of its anti-money laundering controls. The case, assigned to U.S. District Judge Arun Subramanian, is 1:24-cv-09445, Gonzalez v. The Toronto-Dominion Bank et al.
Who Got The Work
Crown Castle International, a Pennsylvania company providing shared communications infrastructure, has turned to Luke D. Wolf of Gordon Rees Scully Mansukhani to fend off a pending breach-of-contract lawsuit. The court action, filed Nov. 25 in Michigan Eastern District Court by Hooper Hathaway PC on behalf of The Town Residences LLC, accuses Crown Castle of failing to transfer approximately $30,000 in utility payments from T-Mobile in breach of a roof-top lease and assignment agreement. The case, assigned to U.S. District Judge Susan K. Declercq, is 2:24-cv-13131, The Town Residences LLC v. T-Mobile US, Inc. et al.
Who Got The Work
Wilfred P. Coronato and Daniel M. Schwartz of McCarter & English have stepped in as defense counsel to Electrolux Home Products Inc. in a pending product liability lawsuit. The court action, filed Nov. 26 in New York Eastern District Court by Poulos Lopiccolo PC and Nagel Rice LLP on behalf of David Stern, alleges that the defendant's refrigerators’ drawers and shelving repeatedly break and fall apart within months after purchase. The case, assigned to U.S. District Judge Joan M. Azrack, is 2:24-cv-08204, Stern v. Electrolux Home Products, Inc.