After three years of intense legal battles over the patent rights to CRISPR genome editing technology, lawyers for the University of California, Berkeley, and the Broad Institute in Cambridge, Massachusetts faced off in court again.
Legal representatives for the institutions appeared before the US Court of Appeals for the Federal Circuit in Washington last week to make oral arguments before a panel of three judges.
In 2012, researchers from UC Berkeley applied for a patent for CRISPR genome editing technology that allows precisely targeted changes to be made to genomic DNA through the use of a bacterial enzyme called Cas9.
Though the patent to Berkeley was eventually granted, a similar patent for the use of CRISPR technology in eukaryotic cells was applied for a few months later by researchers at the Broad Institute, a research centre associated with MIT and Harvard. This application was fast-tracked, and granted before Berkeley was granted its patent.
An initial decision by the administrative Patent Trial and Appeal Board (PTAB) in 2017 (see BioNews 889) upheld the validity of both patents, but this lead to confusion over who had the right to charge fees for the use of the technology. Kevin Noonan, a biotechnology lawyer from Chicago, Illinois, summarised the problem in a comment to Bloomberg: '[If] I'm a company and I want to practice CRISPR, who do I license, who do I pay?'
Berkeley is now arguing that the Broad Institute's patent infringes on their own and should be invalidated. 'The PTAB committed several legal errors, including disregarding Supreme Court and Federal Circuit precedent,' said UC Berkeley's lead attorney Donald Verrilli in a statement.
The Broad Institute maintains that its scientific contributions are distinct enough to justify part ownership of the technology. Though the judges on the Appeals court have yet to make a decision, lawyers from the institute appeared optimistic. 'Based on the oral arguments today, we are even more confident the Federal Circuit will affirm the PTAB's judgment and recognise the contribution of Broad, MIT and Harvard in developing this transformative technology,' representatives of the institute said in a statement.
CRISPR/Cas9 is able to edit DNA by using complementary RNA sequences as a guide, telling it where to cut. It presents a significant breakthrough compared with other genome editing technologies, many of which are more time consuming and costly. The outcome of the trial is considered to be particularly relevant given the potentially high commercial value of such a technology.
Michael Stramiello, a patent lawyer from Washington, commented in Bloomberg. 'Human therapeutics is really the money maker here. If someone ends up with the lion share of rights, that's extremely valuable.'