A widely anticipated U.S. court ruling will soon bring to a close another chapter in the fight between the University of California, Berkeley, and Broad Institute of MIT & Harvard over legal rights to the CRISPR/Cas9 gene-editing tool.
The troubles began when the U.S. Patent & Trademark Office (USPTO) approved CRISPR/Cas9 patent applications expedited by Broad, even though UC Berkeley submitted its own patent application first. UC Berkeley then petitioned USPTO to hold a proceeding to determine the tool’s original inventor, and USPTO started by deciding if UC Berkeley and Broad claimed to invent the same thing.
While Broad’s application specified how to use CRISPR/Cas9 in eukaryotes, like plants and animals, UC Berkeley’s application described using CRISPR/Cas9 only in a test tube and on bacteria. Its broader use in all organisms, including in eukaryotes, was implied, Berkeley’s lawyers argued. But the patent court disagreed and in February 2017 deemed Broad’s invention separately patentable.
UC Berkeley appealed that ruling to the U.S. Court of Appeals for the Federal Circuit, which heard the case this April. A decision is expected soon. Intellia Therapeutics, a firm that is developing CRISPR/Cas9 human therapies and licenses the UC Berkeley patent application, held a call with investors on Aug. 28 to discuss the trio of possible outcomes.
If the federal court affirms USPTO’s decision, Broad keeps its patents and UC Berkeley’s patent application could undergo review. Alternatively, the court could say USPTO was wrong and ask it to reconsider the case. In the most extreme scenario, the court would declare that Broad’s and UC Berkeley’s inventions were the same and require USPTO to determine CRISPR/Cas9’s original inventor through new proceedings.
The legal wrangling is likely far from over. Both Broad and UC Berkeley can challenge the federal court’s decision by petitioning for a rehearing in the Federal Circuit or in the Supreme Court. Both sides have many more patents and applications in play. And a growing number of biotech start-ups are plowing ahead to independently develop CRISPR-based human therapies, unencumbered—for now—by the uncertainty surrounding CRISPR’s legal future.