UC Berkeley and Cambridge, Mass.-based Broad Institute are in the midst of a years-long legal battle over whose researchers own the rights to CRISPR-Cas9 gene editing technology — a dispute with roots tracing back as early as 2012.
CRISPR, which stands for Clustered Regularly Interspaced Short Palindromic Repeats, is a gene-editing technology that enables scientists to modify an organism's DNA. Many scientists consider the CRISPR-Cas9 system — which creates modified RNA segments to exploit select enzymes — to be one of the most precise and least expensive gene-editing techniques in use.
As of April 2018, the U.S. Patent and Trademark Office had issued 60 CRISPR-related patents to nearly 20 different organizations, according to Futurism. However, the Broad Institute holds a particularly significant patent that covers the use of CRISPR-Cas9 to edit DNA in mammals.
Here's a breakdown of the ongoing dispute between UC Berkeley and the Broad Institute:
May 2012: UC Berkeley filed a patent application with the USPTO for the use of CRISPR-Cas9 to edit genes in various types of cells. The application was based on a landmark research study by a team of UC Berkeley researchers, which was slated to be published in June.
June 2012: The research team from UC Berkeley published what many biotechnology experts cite as the first academic paper on CRISPR-Cas9. The study, published in the journal Science, detailed how CRISPR-Cas9 may be exploited to edit genes. The research team was led by UC Berkeley biochemist Jennifer Doudna, PhD, who some experts credit with creating CRISPR, according to Futurism.
December 2012: The Broad Institute and the Massachusetts Institute of Technology, also based in Cambridge, Mass., filed a patent application for the use of CRISPR-Cas9 to modify DNA in eukaryotic cells. The patent is based on research conducted by Feng Zhang, PhD, a molecular biologist affiliated with both the Broad Institute and MIT.
April 2014: The USPTO granted the patent filed in December 2012 to the Broad Institute, MIT and Dr. Zhang. The patent, titled "CRISPR-Cas systems and methods for altering expression of gene products," covers a method of editing plant and animal DNA using CRISPR-Cas9.
- However, UC Berkeley contested the USPTO's decision to grant the Broad Institute the patent, arguing the institute's application was too similar to the patent application UC Berkeley had applied for in May 2012. As a result, UC Berkeley asked the USPTO to deem the Broad Institute's patent invalid, according to STAT. The university also asserted Dr. Doudna's research team was the first group to invent the CRISPR-Cas9 gene-editing technology.
- The Broad Institute has maintained the patent it received draws on Dr. Zhang's original research using CRISPR-Cas9 to edit plant, animal and human cells, which — while published in Science in February 2013 — was submitted in October 2012 and serves as a culmination of his work that began in early 2011. The Broad Institute has also argued Dr. Zheng's study marked the first use of CRISPR-Cas9 for mammalian genome editing.
February 2017: The USPTO ruled in favor of the Broad Institute, upholding the institute's patent on editing DNA in plants and animals. In its decision, the USPTO said Dr. Zhang's discovery was not an "obvious" extension of Dr. Doudna's research as UC Berkeley had argued, according to Gizmodo. Dr. Doudna's team appealed the decision.
April 2018: The U.S. Court of Appeals for the Federal Circuit heard oral arguments from UC Berkeley, during which the university attempted to prove the USPTO had not had "substantial evidence" to support its February 2017 finding, STAT reports. The court is expected to release a ruling on the case this summer.
June 2018: The USPTO granted a team of UC Berkeley researchers, including Dr. Doudna, the university's first-ever patents related to CRISPR gene editing — one patent that covers the use of CRISPR-Cas9 to edit single-stranded RNA, and a second patent that covers the use of CRISPR-Cas9 for editing genome regions of 10 to 15 nucleotides long, according to STAT.