Information 2023 Life Science Intellectual Property Forum Digital Therapeutics (DTx): Current Status, Prospects and Challenges
The "2023 Life Science IP Forum" will be held on Friday, February 3, 2023 at 1:00 p.m. at Ochanomizu Sola City Conference Center (Chiyoda-ku, Tokyo).
In response to Society 5.0 proposed in the Japanese government's Fifth Science and Technology Basic Plan (January 2016), the "2020 Life Science IP Forum" will introduce specific examples of new businesses of companies utilizing digital data, and in such business models, the In addition to the protection and handling of the raw data of measurement results provided by users in such business models, the forum also discussed the secondary use of data and the protection and handling of results obtained as a result of such use, transcending the boundaries between industry, academia, and government, taking into account industrial policy aspects.
In December 2020, Digital Therapeutics for Nicotine Dependence (DTx), the world's first case of insurance coverage of a therapeutic application/digital therapy in the area of smoking cessation treatment, was approved by the pharmaceutical affairs bodies and included in insurance coverage, and is now being implemented in society with economic backing. Against this backdrop, the Japan Digital Health Alliance, a cross-industry organization that conducts research and makes policy recommendations on digital health-related technologies and legal systems, was established in March 2022 through the merger of the Pharmaceutical Digital Health Study Group and the Japan Digital Therapeutics Promotion Study Group.
DTx, which is classified as a medical device program for diagnosis, treatment, prevention, and palliation, is a solution that provides therapeutic intervention for diseases, and therefore, in addition to the evaluation of efficacy and safety to obtain manufacturing approval, there are said to be challenges in the evaluation of health economic potential, which is one of the indicators for calculating insurance reimbursement. In addition, the DTx business is also being protected. In terms of intellectual property, which is one of the foundations for protecting such DTx business, unlike the conventional model of protecting business by means of a central patent that protects the active ingredient of a drug, which was the mainstream in the pharmaceutical industry, various intellectual property rights such as trade secrets under the Unfair Competition Prevention Law, patents, designs, trademarks, and copyrights and contractual protection.
In light of these circumstances, this forum will feature lectures on the current status and prospects for social implementation of DTx by people active in the DTx industry, government, and law, and panel discussions on issues in DTx clinical trials, economic value evaluation, and how DTx should be protected by intellectual property rights. The panelists will discuss issues in DTx clinical trials, economic value assessment, and DTx intellectual property protection, as well as the prospects for resolving these issues.
