The recent U.S. ruling regarding the patent dispute over the original technology of Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) might be advantageous for ToolGen, Korea’s genome editing company, experts said here Thursday.
In the interference proceeding – which decides whether to nullify patents through judgment based on the first-to-invent rule – filed by UC Berkeley against Broad Institute of MIT and Harvard in February, the U.S. Property and Trademark Office (USPTO) raised the hand of Broad Institute.
USPTO said there was no reason for interference proceeding because the invention of Broad Institute was entirely different from that of UC Berkeley. In April, the university then brought the case to a federal appellate court.
A research team led by Professor Jennifer Doudna at UC Berkeley applied for the first technology patent to edit virus DNA using CRISPR in May 2012. In October and December that year, ToolGen and Broad Institute applied for the technology patent to edit DNA in animal cells and in eukaryotic cells, respectively, using CRISPR.
On the other hand, European Union Intellectual Property Office (EUIPO) approved the CRISPR patent of the UC Berkeley in March and broadly recognized it as being related to the treatment of various diseases, including cancer, HIV/AIDS, and various hereditary diseases. Accordingly, companies developing anticancer therapies using CRISPR in Europe should pay royalties to Professor Doudna.
Korean bio companies planning to develop products using the technology expressed concerns that the conflicting rulings by the U.S. and European officials could cause uncertainty for their businesses and increase commercializing costs.
But some industry watchers predict Broad Institute’s winning can prove to be advantageous for ToolGen툴젠. Not only does the USPTO adopt the first-to-file rule -- which gives patent rights to inventors who apply for IPO first regardless of when they invented it -- since 2003, but also the ruling reflects USPTO’s view that patents could differ depending on the kinds of cell.
"As ToolGen applied for the patent of CRISPR used in animal cells ahead of Broad Institute, the ruling would be advantageous to ToolGen,” said Biotech Policy Research Center(BPRC) 생명공학정책연구센터 in its recent report. “And ToolGen can take an advantageous position in patent disputes occurring in countries that apply the first to file system."
According to the report, ToolGen applied for the technology patent in the U.S., Korea, China, Japan, EU, and Australia, and registered two patents in Korea last year. Currently, patent examinations are ongoing in nine countries, including the U.S.
As of 2014, the global market for the CRISPR technology was $200 million and is estimated to grow 36.2 percent a year on average to $2.3 billion in 2022.
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