Harvard, MIT Win Major Victory in CRISPR Patent Dispute

A federal appeals court ruled Monday that the Broad Institute holds patent rights to the gene-editing technology CRISPR-Cas9, ending a years-long dispute between the University of California, Berkeley and the Harvard and MIT-affiliated institute.

CRISPR-Cas9, a revolutionary gene-editing technology, has a variety of potential biotechnological applications, including helping to cure genetic diseases such as Huntington’s disease, sickle cell anemia, and cystic fibrosis.

In 2011 and 2012, Jennifer A. Doudna of UC Berkeley and Emmanuelle M. Charpentier of Umeå University in Sweden were researching CRISPR-Cas9. Simultaneously, Feng Zhang ’04 of the Broad Institute was working on the same problem, albeit separately.

Although Doudna published her findings and applied for a patent before Zhang did, her work focused on CRISPR-Cas9 in test tubes whereas Zhang’s research focused on its usage in human and mouse cells.

The United States Patent and Trademark Office awarded the Broad Institute the rights to use CRISPR-Cas9 for eukaryotic cell-editing methods, listing Zhang as the primary inventor. Eukaryotic cells, which include animal and human cells, have the most potential for industry and commercial purposes.

A patent for CRISPR-Cas9 is valued at approximately $265 million, according to Forbes.

UC Berkeley contended that Doudna and her collaborators deserved the patent and appealed the patent office’s decision, filing interference proceedings that were approved by the trademark office in Jan. 2016.

In Feb. 2017, a U.S. Patent Trial and Appeal Board ruled that the patents held by the Broad Institute and UC Berkeley applied to different subjects. Berkeley appealed that ruling in April 2017.

Judge Kimberly Moore, one of three federal appellate judges, wrote in her decision Monday that the Patent Trial and Appeal Board “did not err in its analysis,” limiting UC Berkeley’s possible options going forward.

“We have considered UC’s remaining arguments and find them unpersuasive,” Moore wrote in the ruling.

Despite the setback, Charles F. Robinson, general counsel and vice president of legal affairs at UC Berkeley, wrote in a Monday statement that the university is considering further legal action.

“We are evaluating further litigation options,” he wrote. “We also look forward to proving that Drs. Doudna and Charpentier first invented usage in plant and animal cells.”

In a separate statement published Monday, Robinson wrote he believes that the latest ruling will not impede further efforts by UC Berkeley to claim intellectual property for CRISPR-Cas9 usage in eukaryotic cells.

“The court did not address the question of who invented the specific use of CRISPR-Cas9 in eukaryotic cells, and emphasized that its decision was ‘not a ruling on the validity of either’ Broad’s or UC’s claims,” Robinson wrote.

Disputes over the inventor of CRISPR-Cas9 have also spilled into international courts. The European Patent Office granted Doudna and Charpentier two CRISPR-Cas9 patents in March 2017 and most recently in January, providing the Doudna-Charpentier team with eukaryotic cell-editing rights in the European Union. The EPO also revoked the Broad Institute’s first patent for CRISPR-Cas9 in January.

Lee McGuire, Broad Institute communications director, wrote in a statement that the Institute agreed with the the appellate ruling that the two patents were distinct in nature.

“The Federal Circuit made the correct decision in upholding the United States Patent Trial and Appeal Board’s ruling,” he wrote. “The patents and applications of Broad Institute and UCB are about different subjects and do not interfere with each other.”

McGuire encouraged both parties to let the ruling stand and instead focus on future applications of the CRISPR-Cas9 technology.

“It is time for all institutions to move beyond litigation,” he added. “We should work together to ensure wide, open access to this transformative technology.”

— Staff writer Sanjana L. Narayanan can be reached at sanjana.narayanan@thecrimson.com

— Staff writer Cindy H. Zhang can be reached at cindy.zhang@thecrimson.com