| Summary: | 碩士 === 國立政治大學 === 科技管理與智慧財產研究所 === 106 === CRISPR-Cas system is an acquired immune system of prokaryotic cells to defense foreign genetic elements. In a study published in 2012 by Emmanuelle Charpentier, a scientist at Umeå University, and Jennifer A. Doudna, a scientist at the University of California, Berkeley (UC), they performed genome editing in vitro by using a programmable CRISPR-Cas9 system. They filed a US and European patent application for their CRISPR-Cas9 system. In 2013, Zhang Feng, a scientist of The Broad Institute (BI) applied CRISPR-Cas9 system on multiplex genome editing in eukaryotic cells successfully and also filed several US and European patent applications limited to CRISPR-Cas9 systems in a eukaryotic environment after UC.
However, in April 2014, US Patent and Trademark Office (USPTO) approved BI’s patent application, which is earlier than UC. UC argued their invention, which is directed to CRISPR-Cas9 systems not restricted to any environment, is the same as BI’s invention and BI’s patent is obvious. In 2015, UC suggested both parties enter patent interference. In the decision made by Patent Trial and Appeal Board (PTAB) in February 2017, the board held BI’s claims are not the same invention as UC’s claims and the invention of CRISPR-Cas9 systems in eukaryotic cells would not have been obvious over the invention of CRISPR-Cas9 systems in any environment, the parties’ claims do not interfere.
On the other hand, European Patent Office (EPO) approved UC’s patent application for using the CRISPR-Cas9 system in both prokaryotic and eukaryotic environment in May 2017. Several CRISPR-related patents applied by BI is also approved by EPO lately.
This paper analyzes the decision made by PTAB and EPO’s office action during the examination of UC and BI’s patent application and found that the different opinion on the obviousness of the invention that CRISPR-Cas system limited in a eukaryotic environment invention between USPTO and EPO came from the different understanding of “reasonable expectation of success.” According to the comment Doudna made in magazine interviews after their study was published in 2012, that she said their team was not sure if CRISPR-Cas9 would work in eukaryotes, PTAB thus found that BI’s invention did not have a reasonable expectation of success. However, EPO believes that environmental differences between eukaryotic and prokaryotic cells do not render the CRISPR-Cas9 system incompatible under both conditions.
The different opinion between the USPTO and EPO on the obviousness will make it difficult for the future CRISPR related patent applicants. This study suggests that when applying for CRISPR related patents in the future, minor adjustments should be made to align to the examination standard of the specific region and their different opinions in “reasonable expectations for success” in order to maximize the applicants’ benefit. In addition, the inventor should also avoid publishing their personal opinions on the inventions or further research of the invention on any public occasion before the patents are granted.
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