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UC Berkeley Loses CRISPR Gene-Editing Technology Patent Decision, But Remains Optimistic

Posted By Jason Churchill, Feb 28, 2017

PTAB Issues Decision in UC Berkeley v Broad Institute Patent Dispute

On February 15, 2017, the Patent Trial & Appeal Board (PTAB) issued a ruling in a high-profile case, handing a loss to UC Berkeley in a long-standing fight with the Broad Institute of MIT and Harvard over patent rights to the CRISPR technology. The 51-page per curiam decision can be found here.

The CRISPR technology—described as “one of the greatest life sciences inventions ever”— has vast potential both as a research tool and for treatment of genetically-based diseases. Scientists discovered that some bacteria possess a form of acquired immunity that allows them to recognize invading viruses and destroy them by cutting the viral DNA into pieces. Researchers quickly harnessed this remarkable discovery and adapted these bacterial anti-viral defense systems into a revolutionary genetic engineering tool, called the CRISPR technology. It offers fast and easy genomic editing, that is, programmable alteration of DNA sequences at any desired location in the genome. The method is a substantial improvement over earlier available genomic editing approaches, and the stakes are high. Some observers have suggested that the patent rights may be worth billions of dollars. Certainly, whoever controls the patent rights to CRISPR stands to collect extraordinary sums of money through licensing fees.

In June 2012, Jennifer Doudna, a UC Berkeley biochemist, and her collaborator Emmanuelle Charpentier, from University of Vienna, published the first paper demonstrating the use of CRISPR to edit DNA. Before its publication, UC Berkeley filed a patent application with the U.S. Patent & Trademark Office (USPTO) in May 2012. The application, which is still pending, claimed the use of the CRISPR technology for editing genes in any cell type, including simple single-celled organisms (“prokaryotes,” comprising the bacteria), as well as cells from higher organisms (“eukaryotes,” such as plants, humans, and other animals). However, at the time the UC Berkeley team filed its application, the researchers had demonstrated the use of the technique only in bacteria. Although the UC Berkeley team shortly thereafter demonstrated the successful use of the CRIPSR technique in eukaryotes, a legal battle took shape in December 2012 when the MIT research team led by Feng Zhang, from the Broad Institute, filed a patent application claiming the use of CRISPR in eukaryotic organisms.

The Broad Institute’s patent filing prompted UC Berkeley to initiate an interference proceeding held by the PTAB, an administrative law body of the USPTO. An interference proceeding pursuant to 35 USC §135 takes place when rival inventors assert claims to the same invention. The PTAB determines which of the rival inventors invented the subject matter first and awards the patent to the first inventor, regardless of the date of the filing. (The U.S. patent system has transitioned from a “first to invent” to a “first inventor to file” system following the enactment of the America Invents Act (AIA). The AIA took effect on March 16, 2013, eliminating interferences for patents filed after that date. However, interference proceedings may still take place under pre-AIA § 135 for any rival patent applications filed prior to the date the AIA took effect.)

Processing of the UC Berkeley patent application was delayed during the interference proceedings. Meanwhile, the Broad Institute’s patent moved quickly through the patent system because it had fewer claims and was eligible for an expedited examination. In April 2015, the USPTO issued a patent to the Broad Institute. The UC Berkeley patent approval is still pending.

On February 15, 2017, the PTAB issued its decision, finding that there was “no interference in fact” because the parties claim “patentably distinct subject matter.” In other words, the PTAB found that the rival teams were not claiming the same invention. In effect, the PTAB’s judgment of “no interference in fact” leaves the Broad Institute’s patent standing. The PTAB declared that its ruling “neither cancels nor finally refuses either parties’ claims.” Consequently, UC Berkeley’s pending patent application will now be returned to the Patent Examiner, moving the Doudna and Charpentier group’s application closer to issuance.

UC Berkeley responded optimistically to the PTAB’s decision. It emphasized that the decision clears the way for the UC Berkeley team to receive its patent. Further, UC Berkeley has not exhausted its options in challenging the Broad Institute’s patent. For example, UC Berkeley could opt to appeal the decision to the U.S. Court of Appeals for the Federal Circuit (CAFC). Following the decision, UC Berkeley stated in a news release that it will be “considering all possible options for moving forward in the current legal dispute, including other legal challenges to the Broad Institute’s patent, and the possibility of appealing the PTAB’s decision.”

The decision leaves open the possibility that UC Berkeley will receive a patent granting its broader claim to the use of CRISPR in all organisms, while the Broad Institute might retain its more limited patent rights for using CRISPR in eukaryotic cells. In that case, it is likely that anyone wanting to practice CRISPR in eukaryotic cells for commercial purposes would need to obtain a license from both UC Berkeley and the Broad Institute. Both parties allow researchers to use CRISPR for purely academic purposes without a license.

Regardless of the outcome in the patent dispute, the impact of the Doudna and Charpentier group’s scientific accomplishment is profound. Many experts are predicting that the two researchers will ultimately be awarded a Nobel Prize.

References:

Ryan Cross, CRISPR Patent Dispute Ends Well for Broad Institute. Berkeley Says: Not So Fast, Chem. & Eng’g News (Feb. 16, 2017), http://cen.acs.org/articles/95/i8/CRISPR-patent-dispute-ends-well.html.

Deborah Netburn, UC Berkeley Suffers Big Loss in CRISPR Patent Fight: What's Next for the Powerful Gene-editing Technology?, L.A. Times (Feb. 15, 2017 8:00PM), http://www.latimes.com/science/sciencenow/la-sci-sn-crispr-patent-decision-20170215-story.html.

Robert Sanders, Appeals Board Clears Way for UC Berkeley to Receive Patent on CRISPR-Cas9 Gene Editing, Berkeley News (Feb. 15, 2017), http://news.berkeley.edu/2017/02/15/patent-office-determines-uc-broad-institute-patent-claims-on-crispr-cas9-genome-editing-are-separately-patentable.

Evelyn Warner, CRISPR Will Win the Nobel Prize, But When? Not This Year…, Labiotech (Apr. 10, 2016), http://labiotech.eu/crisps-denied-nobel-prize-autophagy.