The US Patent and Trademark Office (USPTO) has upheld the right of the Broad Institute of MIT and Harvard to the genome-editing tool CRISPR/Cas9.
In a judgment issued last week, the USPTO held that there was no 'interference' between the Broad Institute's patents and those from a separate application made by researchers at the University of California (UC), Berkeley.
In May 2015, UC Berkeley applied for an interference proceeding to strike out ten patents issued to Professor Feng Zhang at the Broad Institute the previous year (see BioNews 802). It argued that the patents overlapped with a separate patent application made by Professor Jennifer Doudna at UC Berkeley, who along with Professor Emmanuelle Charpentier was the first to invent the technology, as they described in a 2012 paper (see BioNews 881).
The Broad, on the other hand, claimed that its patents were concerned specifically with the use of CRISPR/Cas9 in eukaryotic cells and, as such, were distinct from the broader application made by UC Berkeley. It said the move from Professor Doudna's work altering the DNA of bacteria to the use of CRISPR/Cas9 in more complex, eukaryotic cells in plants, animals and humans was not 'obvious', as UC Berkeley had argued.
The USPTO agreed that the Broad's invention was distinct and upheld its patents, thereby also moving the UC Berkeley patents closer to being issued.
In a statement, the Broad Institute welcomed the judgment: 'We agree with the decision by the patent office, which confirms that the patents and applications of Broad Institute and UC Berkeley are about different subjects and do not interfere with each other.'
UC Berkeley was more ambivalent, commending the decision in so far as it increased the likelihood that the patents for Professor Doudna's technology would be accepted – which UC Berkeley believes will cover not just the use of CRISPR/Cas 9 in bacteria, but also its use in plants, animals and humans. As Professor Doudna explained, 'They [the Broad Institute] have a patent on green tennis balls; we will have a patent on all tennis balls.'
Following the ruling, shares in Editas Medicine, which holds licences to the Broad patents, increased by 29 percent, reports The New York Times. In contrast, licensees of Professor Doudna's intellectual property fared less well, with Intellia Therapeutics and Crispr Therapeutics each falling by almost 10 percent.
These companies may now have to pay to access the Broad Institute's patents. Alternatively, biotech companies may be required to pay both the Broad Institute and Doudna for access to their intellectual property.
Speaking to Nature News, Kevin Noonan, partner at McDonnell, Boehnen Hulbert & Berghoff, said that the judgment could create problems for those working in the field. 'Everybody [got] to keep their patents,' he said. 'This is maximum uncertainty for people because you don't know if you have to get licences from both sides.'
It is also not yet clear if UC Berkeley intends to appeal the ruling. A spokesman for UC Berkeley confirmed that it believes that the technologies were still not distinct, and reaffirmed the university's commitment to 'carefully consider all possible legal options', although its lawyer, Lynn Pasahow, said that UC Berkeley has yet to make a decision. It has two months in which to decide whether to appeal.
Nature News also points out that European patents over CRISPR/Cas-9 are still not settled and that the European Patent Office might choose to take a different view from the USPTO.
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