CRISPR/Cas9 Patent Wars
Updated: Dec 14, 2018
In September 2018 the US Federal Court of Appeal upheld a lower court’s decision in favour of the Broad Institute, finding that Broad’s claims concerning CRISPR editing of eukaryotic genomes were patently distinct over UC Berkeley’s. This essentially grants rights in the USA to the use of the fundamental technology in eukaryotic organisms, such as plants, animals and humans, to the Broad Institute and leaves UC Berkeley without a seminal US patent.
The CRISPR/Cas9 gene editing system offers great potential in biology, enabling the precise introduction or removal of genetic sequences. While the system has widespread applications across biology, its greatest potential and most valuable application is in eukaryotic systems, particularly in the field of medicine. Perhaps not surprisingly then, the key inventors of the system - Feng Zhang of the Broad Institute of MIT & Harvard, and Jennifer Doudna of UC Berkeley - have been embroiled in legal disputes over the ownership of the rights to the fundamental patents covering this technology for several years.
UC Berkeley filed for a US patent describing the CRISPR/Cas9 gene editing system in May 2012. However, it was the Broad Institute that succeeded in securing the first US patent, even although it filed some 7 months later, by utilising an expedited examination process. The grant of this patent was subsequently challenged by UC Berkeley who instituted interference proceedings before the US Patent and Trade Mark Office to decide which party was ‘first to invent’. In interference proceedings, where two parties claim patentably indistinct subject matter, the patent rights are generally awarded to the party that filed first. However, in 2017 the US Patent Trial and Appeal Board (PTAB) held in Broad’s favour in deciding that there was no basis for an interference because Broad’s claims did not interfere with those filed by UC Berkeley. In September 2018, the US Federal Court of Appeal upheld the PTAB decision.
Broad has been less successful in Europe despite securing a number of granted European patents to CRISPR/Cas9 technology. These patents have been challenged by multiple parties in European Opposition proceedings principally on the basis that because not all of the priority filings can validly claim priority, intervening prior art documents are novelty destructive to the granted claims. Indeed, in January 2018 the Opposition Division of the European Patent Office held that the first of Broad’s European patents (EP2771468) lacked novelty and should be revoked. Although Broad has appealed this decision it is difficult to see how it will overcome these objections.
UC Berkeley's European patent (EP2800811) is also facing challenges in Europe and is being opposed by multiple opponents. A date has not yet been set for oral proceedings to hear this matter, so it remains to be seen if UC Berkeley’s European patent can withstand the rigor and scrutiny of European Opposition proceedings.