The University of California (UC) has asked the U.S. Patent & Trademark Office (USPTO) to reconsider who was first to invent a hugely valuable gene-editing tool called CRISPR-Cas9, currently credited to the MIT/Harvard Broad Institute in Cambridge, MA.
A potentially billion-dollar, likely Nobel-winning technology, CRISPR is able to cut and replace DNA in an organism’s genome with remarkable precision and ease. The method is revolutionizing the study of all kinds of species, from mice to potatoes, and is likely to lead to advancements in gene therapy to treat human disease.
USPTO issued ten patents to the MIT/Harvard Broad Institute concerning the CRISPR technology, but now UC is claiming the rights belong to them. If the patent office approves UC’s request for an interference proceeding, it will result in a winner-take-all scenario in which either the Broad Institute or UC and two co-petitioners, including the University of Vienna, will come away with all the rights to CRISPR, leaving the opposing party with nothing.
“Expect this battle to be very expensive, very contentious, given the stakes involved,” says Greg Aharonian, director of the Center for Global Patent Quality, which works on patent law issues. “I can see many hundreds of thousands of dollars being spent.”
Although the technology was publicly described in Science by UC biologist Jennifer Doudna and microbiologist Emmanuelle Charpentier in 2012, Broad Institute scientist Feng Zhang was first to win a patent on CRISPR after submitting his lab notebooks, which he says prove he invented the method.
Under the USPTO’s current “first to file” patenting policy, Doudna and Charpentier would seem to have won, given that their application is dated seven months before Zhang’s. However, because of the dates of the discoveries, the case is being viewed under the older “first to invent” rules, where whoever is able to show they were first to make the invention work, or simply conceive of it, gets the patent.
The universities have more than the patent or the money to lose because of the case; if products or treatments based on CRISPR are delayed, the legal battle could end up reflecting poorly on the schools, which all used public tax dollars or philanthropic gifts to develop the inventions. In addition, not only does a Nobel Prize for gene editing seem likely, but several well funded start-ups have been created to start developing gene-therapy treatments. Zhang is involved in Editas Medicine, Doudna’s start-up is called Caribou Biosciences, and Charpentier is a founder of CRISPR Therapeutics.
While other technology disputes have resulted in cross-licensing or the creation of patent pools that offer wide access to basic inventions, these scenarios are unlikely concerning CRISPR since it’s unclear who really owns the key rights.
“It would be mutually beneficial to develop as many products as possible with the technology, because it’s the products that will generate the revenue,” says Dan Voytas, a gene-editing researcher at the University of Minnesota. “With CRISPR, it’s still anyone’s guess how it’s going to work out.”
Source: MIT Technology Review