biotechnology company “NPF DNA-Technology” are unable to patent developed her technique of genetic modification of human embryos. Earlier in registration methodology was rejected by the Rospatent, and now the intellectual property rights Court confirmed legitimacy of the decision. Claims of Rospatent to the methods boil down to the fact that the early editing leads to hereditary changes in the genome. The court’s decision published in the database “E-justice”.
In November 2019 Chinese scholar Cisangkuy Hae reported that the light appeared first genetically modified babies. It was two girls, whose genes team Ho using the method of CRISPR purposefully introduced a mutation that had to do with the twins is resistant to HIV. At this point in our country, too, was developed the method of “genetic prevention” of HIV: a group under the leadership of Denis Rebrikov of rnimu Pirogov learned to edit the same gene CCR5, which was aiming for Chinese scientists.
The performance of Hae have led to scandal, since the international scientific community has opposed the editing of embryos, and Chinese authorities said they knew nothing about these experiments. However, Denis Rebrikov said he was willing to continue the research he, but in our country, and more legally. In August 2019 on behalf of the company “NPF DNA-Technology” was applied for patenting this technique of editing. Denis Rebrikov was listed as one of the authors of the methodology, and the company as the copyright holder. However, Rospatent rejected the application.
The refusal of Rospatent motivated by the fact that, according to article 1349 of the Civil code of then Federation, the subject of patent rights cannot be a procedure based on the “modification of genetic integrity of cells of the embryonic line of a human”. The germ line is the group of cells that later develop germ cells of the embryo. Therefore, only the genes of these cells can be transmitted to offspring. Thus, has not provided for the patenting of potentially hereditary genetic changes.
The refusal of Rospatent was challenged in a specialised Arbitrazh court — the Court for intellectual property rights. The plaintiffs stated that the cells of the germ line are separated not earlier than 14 th day of development, and genetic modification he plans to conduct at the stage of a single cell at the moment of fertilization. Thus, he cannot break genetic integrity of cells of the germ line specific of the embryo, since at the time of modification of the embryo does not yet exist.
But the arguments of “DNA-Technology” the court is not persuaded. On the contrary, they concluded that, since all cells of the embryo to subsequently develop from the zygote, and edit the genome occurs at this stage, it “can not affect the cells of the germ line person is not available at this stage of development.”
Rebrikov of said N+1that he and his colleagues haven’t made a decision about next steps. “We are consulting with lawyers. We need to decide whether to file a lawsuit in the next court, or enough of this solution to try to change the rules of the Civil code,” — said the scientist.
The refusal of the court to the patenting of the methodology is not identical to the prohibition of experiments. It means that the authors of the method do not gain exclusive rights to the use of this technology in our country. However, in order to move from preclinical research to human experimentation, the scientist must obtain permission from the Ministry of health.
For this purpose, as he said earlier, he has to find volunteers who would agree to such an experiment, then develop a Protocol to work with them and get the approval of this specific Protocol. The scientist was looking for such couples not only to “genetic prevention” of HIV, but also for the treatment of hereditary deafness. However, until now, as far as we know, the experiment with a particular couple he could not run.
The decision of Rospatent and the Court for intellectual property rights in General follows the logic of the Ministry of health, which in October 2019, after a series of publications in the media about the initiatives Rebrikova start experimenting with editing the genes of human embryos , statedthat “on the clinical use of [technologies for genome editing of embryos] too early to say”, and “the existing normative-legal regulation in the sphere of health does not allow for the application of such technologies in providing medical care.”
The patents on the technology for genome editing in our country issue: the Broad Institute (Broad Institute), for example, claimsthat he already belongs to threen patents in this area.
About the debate that followed the statement of Czankra Hae, read our article “Fixed edition”. And the arguments for and against experiments Rebrikova we collected in another text “In edit mode”.