Research and Study on the Way of Protection and Utilization of Intellectual Property forFormulation of Intellectual Property Strategy in Genomic Medicine Field (Summary)
Recent years, with advances and cost reduction of genome information decoding technology,
and development of data analysis technology, it has become possible to test genome information ofindividuals more simply, so that such efforts is advanced toward realizing "genomic medicine" thatenables more effective or efficient diagnosis, treatment and prevention of disease appropriate toconstitutions or medical conditions of individual patients by using such information.
In particular, with regard to “genomic medicine” targeting cancer, following that “cancer
genomic medicine” was explicitly stated as a priority issue in the “Basic Plan to Promote Cancer
Control Programs of Third Term” (Cabinet decision on March 9, 2018 (Heisei 30)) and so forth, incooperation with the government, research institutes, hospitals across the country and so on, theCancer Genomic Medicine Promotion Consortium has been formed, and the effort toward practicalapplications have been promoted.
A major feature of the effort is that genomic test is performed under the health insurance
treatment, so it is assumed that the patient's genomic and clinical information will be accumulated onan unprecedented scale. While the genome information and clinical information themselves arepotentially useful as intellectual property, besides by utilizing these primary genome information andso on, it is expected that a large amount of intellectual property useful in the fields of diagnosis,treatment, drug discovery and so on will be yielded. In order to timely protect such a large amount ofdata and intellectual property produced at an accelerated pace, it is necessary to set up a new
intellectual property strategy different from at the time of analyzing genes one by one and filing patentapplications one by one.
Besides, the genomic test is funded by the national expense or the health insurance payment
made by the general public, and the genome information is derived from the patient, so that the resultof the genomic test is appropriately protected as the intellectual property of the general public on theone hand, whereas it is also necessary to exploit it effectively and to give back widely to the generalpublic the obtained results (new diagnostic methods, treatments, drugs, etc.). Furthermore, in order forthe government, research institutes, hospitals, and secondary user organizations to be able toeffectively connect to their results achieving both protection and exploitation, it is urgently necessary
to consider the way of relationship between these organizations about intellectual property and toestablish the system for smooth implementation of genome medicine.

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Accordingly, in the research study, the situation of intellectual property protection andutilization in public sector projects or private sector of genome information or related fields (bioresources, medical related information) of Japan and foreign countries were researched. At the sametime, it was clarified what kind protection and utilization of intellectual property regarding related
technology are made through the research of intellectual property trends such as patents on genome
medicine related technology. Through these, it was aimed to produce basic materials for considerationof the future direction of intellectual property strategy and intellectual property structure in the fieldof genomic medicine.

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