Out-Law News 1 min. read

Patent dispute over gene-editing tech reignited in the US


The US Patent and Trademark Office (USPTO) has reopened the debate over who has the right to control the use of CRISPR, the gene-editing technology, after declaring there is an overlap between patents held by rival universities.

The intervention by the USPTO comes after the US Court of Appeals ruled last year that the Broad Institute of Massachusetts Institute of Technology (MIT) and Harvard University were entitled to patents covering the use of the CRISPR gene editing technology in eukaryotes despite claims from the University of California, Berkeley (UCB), the University of Vienna and French genetics professor Emmanuelle Charpentier that they own the rights in the invention as a result of research undertaken in respect of CRISPR's use in prokaryotes.

Eukaryotes and prokaryotes are different types of organisms. Prokaryotes are simple cells that are commonly associated with bacteria, while eukaryotes are more complex cells that are mostly associated with animals and plants. Use of CRISPR in eukaryotes is considered to have the greatest commercial value.

"The decision to start proceedings of its own accord is an unusual step taken by the USPTO, especially as only last year similar proceedings had been initiated by Broad," said Asawari Churi, a part qualified patent attorney at Pinsent Masons, the law firm behind Out-Law. "The earlier proceedings, involving 12 granted patents and one pending application belonging to Broad and one pending application belonging to UCB, centred around who succeeded first in implementing the CRISPR-Cas9 system in eukaryotes. These new proceedings involve the same patents from Broad plus an additional patent and 10 of UCB’s pending applications." 

"Interference proceedings are initiated to determine which party first invented the invention claimed by two, or more, parties. These proceedings do not necessarily result in one party’s patents being invalidated, although this can happen. The earlier proceedings were terminated because the US Patent Trial and Appeal Board concluded that there was no overlap between the subject matter claimed by the two parties, thus according victory to Broad but simultaneously allowing UCB’s application to proceed to grant. The outcome of this new interference, which will most likely be next year, is going to eagerly awaited by many. Whether it simplifies the licensing landscape or complicates it further remains to be seen," she said.

Gene editing has been the subject of controversy in recent times. Chinese state media reported earlier this year that an investigation in the country had found that a scientist who claimed to have used gene-editing technology to alter the DNA of two new babies in China had done so illegally.

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