Just as everyone, we heard the news on the first genetically engineered babies in mankind’s history. We took a closer look this morning into our patent data to check if there’s any published details already available. Indeed, the Chinese patent office publishes its data earlier than the other countries, sometimes as early as 3 months after the filing, so if the babies are born now, there’s a good chance that the Chinese patent data is already available.
In the past 4 years, we have manually searched, reviewed, classified and categorized more than 3200 CRISPR patent families published worldwide (including Chinese patents, most of which are only domestic). We did not have in mind any specific Chinese team positioning in the area of HIV “genetic vaccine”, although there is a significant cluster of several dozens of patent families claiming around the CCR5 (C-C chemokine receptor type 5) gene or protein in the IPStudies patent landscape, both by academic and industrial players, from worldwide research teams.
Interestingly, in our CRISPR database the sole patent application published so far by Jiankui He and a couple of co-inventors is not directly on the CRISPR biotechnology, but rather on bioinformatics, in other words on the “dry lab” side of personalized medicine. This patent application was filed on November 21st, 2017 at the Chinese patent office by the Southern University of Science and Technology of China. It may thus have been filed internationally last week according to international patent laws, but this will only be visible in patent data registers such as the WIPO, the EPO and the USPTO by mid 2019 (stay tuned to our data!).
This patent application (automated translation here) discloses a dedicated bioinformatics workflow to screen off-target mutations such as indels, by aligning and comparing whole-genome sequencing (WGS) data of a progeny gene sample and a parental gene sample. The comparison itself is not automated, but rather manual, using the conventional IGV viewer tool that is widely used in the bioinformatics community. The patent application does not mention any specifics on the sample origin, thus it may apply indifferently to animals or human embryos. Moreover, it only discloses the detection step, not any decision or automation step further down the gene engineering system, thus it looks more like a quality control method.
Clearly, the know-how behind Jiankui He announcement must be much broader than this single disclosure:
- Some of his know-how also certainly comes from the very early CRISPR research works at the Rice University – indeed, he was one of the very few scientists worldwide who were already working on CRISPR there as early as in 2010, 2 years before the genetic engineering capability discoveries. No evidence found of patent publications out of this work.
- Some of the embryo egg manipulation know-how is very manual and even “bare-handed” as presented by his team’s embryologist in the youtube video package they released yesterday.
- Last but not least, the technology to enable whole genome sequencing at early embryo development stage, where each dividing cell is so precious and promising, is probably key here. The patent portfolios of Jiankui He’s Chinese companies highlight their significant IP filings on third generation sequencing at the single molecule level. Those patent publications are primarily from the Chinese patent office, but it will be interesting to keep on monitoring for international extensions as we spotted some 2016 evidence of Jiankui He looking for IP advice by a large US patent law firm.
A few weeks ago, Shobita Parthasarathy published in Nature a comment arguing for the use of the patent system to regulate gene editing. However, this assumes that there are patents applicable in the first place and that it is possible to enforce them. There are more than 100 Chinese patents granted in the CRISPR patent landscape, including the University of California CRISPR-Cas9 patent. Which CRISPR-Cas9 plasmids were used by Jiankui He’s team and was the human genome editing use licensed for them in China?
A number of those questions will certainly be debated at the second International Summit on Human Genome Editing in Hong-Kong, where Jiankui He will be presenting “The Roadmap towards Developing Standards for Safety and Efficacy for Human Germline Gene Editing and Moral Principles” in a few hours.