Topics The "2023 Life Science Intellectual Property Forum" was held -Current Status, Prospects and Challenges of Digital Therapeutics (DTx)
On February 3, 2023, the "2023 Life Science Intellectual Property Forum" was held at the Ochanomizu Sola City Conference Center (Chiyoda-ku, Tokyo) under the sponsorship of the Pharmaceutical Manufacturers Association of Japan and the Bioindustry Association of Japan, with the title of "The Current Status, Prospects and Issues of Digital Therapeutics. This was the third year for the forum to be held at this venue. This was the first time in three years that the event was held at this venue, and it was the first time for the Corona Disaster Relief Foundation to hold a hybrid event with an online format. The event was a great success with more than 400 participants, including visitors. This report provides an overview of the lectures and panel discussions.
Panel Discussion
Introduction
The "2020 Life Science IP Forum" was held under the title of "How to Protect New Businesses that Use Digital Data as a Source of Value: Multifaceted Protection through IP and Contracts," and focused on introducing specific examples of new businesses of companies using digital data, data protection and utilization by such businesses, and the protection and handling of results resulting from such businesses. The presentation covered the protection and handling of data. Then, 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 implemented in society with economic backing (insurance coverage through regulatory approval), so to speak, and the "Digital Health in the World" report was published in the Journal of the Japanese Ministry of Health, Labour and Welfare. 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.
In response to the above, this forum will discuss the current status and prospects for social implementation of DTx, the latest development trends of DTx therapeutic applications in Japan and overseas, government initiatives for approval review of programmed medical devices, domestic and international intellectual property trends for DTx, and DTx initiatives as a pharmaceutical company and future issues from an intellectual property standpoint. The panelists representing industry, academia, and government gave lectures on the latest development trends of programmed medical device applications, government initiatives for approval review of programmed medical devices, domestic and international IP trends of DTx, and DTx initiatives by pharmaceutical companies and future issues from the IP perspective. In the panel discussion, there was a lively debate on issues related to DTx clinical trials, the actual status of domestic and international systems and regulations and their economic value, issues related to how intellectual property should be protected, differences from the conventional approach to IP strategy in pharmaceuticals, and prospects for solving these issues. The discussion was lively.
Lecture (1)
The Latest Trends in DTx (Digital Therapeutics)
Mr. Shuta Mitomo, Executive Officer, General Manager, Real And Virtual Transformation Division (RAViX), CMIC
Today, I would like to talk about DTx in general terms, focusing on treatment programs. In the Society 4.0 world we live in today, the challenge is how to structure information and collect data. In the medical field, we are moving toward Society 5.0 by accelerating the trend toward diversification, individualization, and subjectivity, and it will be important to aggregate such structured data and utilize it for DTx and other purposes.
DTx is characterized by improving symptoms through cognitive-behavioral therapy and behavior modification, and is being developed first for mental disorders and lifestyle-related diseases, but overseas, development is also underway in areas such as controlling the side effects of cancer.
As an overview of domestic trends, the development of therapeutic applications has begun in Japan, starting with the 2014 amendment to the Pharmaceuticals and Medical Devices Law (Pharmaceuticals and Medical Devices Law), which made it possible to obtain approval for programs on their own. As for regulations, the environment has been improving with the start of the prior confirmation system for change plans according to the characteristics of medical devices (IDATEN system) in 2020, and the issuance of the notice "Trial Implementation of Priority Review, etc. for Programmed Medical Devices" in 2022. Under such circumstances, Japan's first therapeutic program was approved in 2020, and as of January 2023, diagnostic programs have been added to the therapeutic programs, bringing the total number of approved items to 382. In a move to encourage development, early approval of medical applications has been called for at the 2020 Conference on Promoting Regulatory Reform. In December 2022, there is also a message to review regulations to promote social implementation, which is expected to be realized. It is said that the market will enter a period of market formation and development, with the number of products increasing toward 2030.
Meanwhile, looking at the situation overseas, the first diabetes treatment program was approved in the United States in 2010. In North America and Europe, diabetes, obesity, and cardiovascular diseases account for about half of all approved programs, followed by programs for mental health and gastrointestinal diseases. In terms of clinical trial enrollment, there is a significant difference from Europe and the U.S. In Japan, there are a total of two therapeutic programs, while overseas, there are about 60 approved programs in 2019 alone. As systems for expedited review overseas, the Pre-Cert program in the U.S. and the provisional approval system such as DiGA in Germany have characteristics that should be observed. In addition, as information for considering development items, the cost for prescriptions in Germany is a benchmark when considering development, and from examples of products overseas, the combination of wearable devices as well as applications is an important factor.
Lecture (2)
Government initiatives on approval review of programmed medical devices, etc.
Mr. Minoru Iijima, Director, Office of Programmed Medical Device Review and Management, Medical Device Review and Management Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare
Programmed medical devices are "medical devices that are programs or storage media on which such programs are recorded," and the 2013 revision of the Pharmaceutical Affairs Law clarified that they are included in the scope of stand-alone programmed medical devices. Medical devices under the Pharmaceutical Affairs Law are regulated according to risk: low-risk products (Class I) are notified to the Pharmaceuticals and Medical Devices Agency (PMDA); medium-risk products (Class II to part of Class III) are certified by a registered certification body; and high-risk products (Class III part of Class III, Class IV) are approved by the Minister of Health, Labour and Welfare through the PMDA's approval review. The regulations differ, such as approval by the Minister of Health, Labour and Welfare through PMDA's approval review. However, programs that are equivalent to Class I general medical devices, which pose the lowest risk to patients, are excluded from the scope of medical devices under the Pharmaceutical Affairs Law. Therefore, it is necessary to determine whether a program under development qualifies as a medical device, and we have issued "Guidelines for Medical Device Applicability of Programs" to clarify the criteria for determining whether a program qualifies as a medical device, as well as applicable and non-applicable cases. Currently, the guideline is being revised in the MHLW Research Institute of Health, Labor and Welfare. In addition, please refer to the Ministry of Health, Labour and Welfare's website for individual applicability consultation cases.
The number of programmed medical devices approved in a fiscal year was 39 in FY2021, and as of the end of September 2022, two behavior change apps had been approved or certified.
In November 2020, the Ministry of Health, Labour and Welfare (MHLW) published the "Package Strategy for the Promotion of Practical Application of Programmed Medical Devices (DASH for SaMD)" and is implementing measures to promote the practical application of programmed medical devices (SaMD) based on this strategy. For example, on June 9, 2022, the next-generation medical device evaluation index "Evaluation Index on Medical Device Program with Behavior Change For example, on June 9, 2022, the next-generation medical device evaluation index "Evaluation Index for Medical Device Programs with Behavioral Change" was released.
This evaluation index covers "medical device programs that promote behavioral change in patients, etc. by being used under the guidance of a physician and by providing information according to individual patients, etc." It is not binding on the content of the application, but is to be flexibly adapted to the characteristics of the product.
In the evaluation, the applicant is required to clarify the history of design and development, specifications of the item, principles of the developed device (including algorithms), target disease, intended use or effect, status of use of similar products in Japan and overseas, places of use, and methods of use. In "Target diseases, scope of intended users and their requirements," it is necessary to clarify the target diseases and their severity, whether the intended users are patients or medical professionals, requirements for users, and patients or medical professionals who are not suitable for use. In "purpose or effect of use," it should be clarified whether the product is for prevention or treatment, and in particular, if the product is intended for treatment, whether the product is intended to assist or support the physician's therapeutic action. Under "Clinical Positioning," clarify the nature of the app's intervention, the stage of intervention, the frequency of intervention, and whether it is to be used on top of existing therapies or as an adjunct, support, replacement, or novel therapeutic approach to existing therapies.
It should be clear whether the psychotherapy rationale provided by the behavior change app involves novel methods, is based on standard treatment or treatment guidelines, or has been shown to be effective in a validated clinical trial. In particular, the fact that the existing standard treatment or the treatment approach on which the app is based is positioned in treatment guidelines or evaluated in reimbursement will affect the decision to include the app in insurance coverage, so developers need to collaborate with relevant academic societies from the early development stage.
In the case of behavior change apps, it is difficult to evaluate efficacy and safety only in non-clinical trials, so there is a high need for data on clinical trial results.
The design of the clinical trial should appropriately determine whether the comparison group should be a standard treatment, an existing program, or a sham app, and provide evidence of clinical usefulness. The evaluation measure must have a clinically meaningful amount of change as a measure of efficacy.
When introducing a behavior change application approved overseas to Japan, it may be necessary to conduct clinical trials in Japan because cultural backgrounds such as racial differences and living environments may affect the effectiveness of the application, and it is not possible to confirm whether the application will function simply by translating it into Japanese. Since a low continuation rate of use of behavior change applications may affect clinical results, it is necessary to devise a design that enhances usability and ease of use, etc. It is recommended to utilize PMDA's consultation before starting a clinical trial to discuss this issue.
Regarding partial change approval applications and minor change notifications, updates or improvements to the platform OS or concomitant devices may be required, and the change procedure should be determined by referring to the notification.
The concept of determining the need for a partial change approval application is that a partial change approval application is required when there are changes that affect efficacy and safety. However, since matters affecting efficacy and safety vary from product to product, it is recommended that the PMDA be consulted as appropriate. If you envision post-marketing performance improvements and plan to make continuous, high-frequency improvements, you should also consider using the IDATEN system.
Since many companies developing programmed medical devices are start-ups and other small companies, a centralized consultation service for medical device applicability, regulatory development, and medical insurance was established at PMDA on April 1, 2021, and during the year of FY2021, 238 consultations, or about 1 consultation per business day, were The PMDA's Program Medical Device Review Office responds to these consultations free of charge, but because the content of the consultations affects the development policy of the consultants, it takes a reasonable amount of time to respond to them.
In addition to the ordinary approval, the application for marketing authorization for medical devices under the current system includes the pioneering medical device designation system, the designation system for medical devices for specific purposes, the conditional early approval system for medical devices (Type 1 and Type 2), the IDATEN system, the rebalancing notification, and the trial implementation of priority review, etc. for programmed medical devices, Various options are available.
The Rebalancing Notification clarifies the path to proceed with the development of medical devices on the premise of ensuring consistent safety and efficacy before and after marketing, and after consulting with the applicant to apply for approval without conducting a new clinical trial, etc. The Rebalancing Notification is intended to provide a clear path for the development of medical devices. Three cases are assumed to be covered: medical devices that require evaluation of differences in the medical environment in Japan and overseas, improved versions of types of medical devices with a sufficient track record of clinical use, and diagnostic devices used for physiological tests whose clinical usefulness is being explored.
The rebalancing notice "3. Consultation on diagnostic devices that measure physiological parameters that can be used as reference information for diagnosis" is expected to apply mainly to programmed medical devices for diagnostic systems. With the clinical results to date, test results on mechanical performance, etc., Phase I approval will be obtained for the purpose of use or effect in performance, and after clinical evidence is established with experience in clinical field use, partial change approval will be obtained to advocate clinical significance. There have been cases where Phase I approval was obtained for ordinary medical devices based on measurement performance.
Starting in FY2022, the "Project to Study Operational Improvement of the Pharmaceutical Affairs Approval System Based on the Characteristics of Programmed Medical Devices" will be implemented, with a view to introducing a two-step approval system for programmed medical devices. For the first stage of approval, the necessity of non-clinical and clinical studies in the evaluation and the scope of clinical significance that can be claimed will be examined, etc. For the second stage of approval, it is planned to examine whether clinical significance can be evaluated based on actual use.
The IDATEN system allows for the partial change of approved items within the scope of the plan to be notified after marketing, provided that the change plan is confirmed in advance during the approval review process, in cases where the performance, etc. is intended to be changed or improved, such as medical devices and programs utilizing artificial intelligence technology that are subject to repeated improvements or enhancements after marketing. In April 2022, an endoscopic image diagnosis support program received confirmation of the change plan as the first IDATEN for performance improvement of programmed medical devices utilizing AI.
Regarding innovative programmed medical devices, many of the therapeutic applications target lifestyle-related diseases, etc., and do not meet the requirements related to the seriousness of the target diseases under the existing pioneering medical device designation system. Therefore, designation requirements are set according to the characteristics of programmed medical devices, and if designated, the applicant will receive priority consultation, priority review, prior evaluation, concierge support, etc. The designation is scheduled to be announced after public solicitation, hearings, preliminary review, evaluation by PMDA, and deliberation by the Pharmaceutical Affairs and Food Sanitation Council of Japan for the items to be designated.
The Ministry of Health, Labour and Welfare (MHLW) is implementing the "Support Program for Consultation and Approval Applications for Innovative Medical Devices and Other Products. Under this program, 50 percent of the PMDA's consultation fees and examination and investigation fees are subsidized for venture companies and small and medium-sized enterprises (SMEs) for innovative medical devices originating in Japan, medical devices for rare diseases, need items, and items designated for priority review, etc. for programmed medical devices.
After obtaining approval/certification from the pharmaceutical affairs bodies, the applicant submits a request for insurance coverage of the programmed medical device, and the Central Social Insurance Medical Council (Chuikyo), an organization specializing in insured medical materials, evaluates whether the product is covered by the comprehensive technical fee or, if the product is more medically useful than the existing technical fee, whether the product is covered by the additional fee for medical management of programmed medical devices, etc. or the additional fee for specific insured medical materials, etc. In the case where the medical usefulness of the product is higher than the existing technical fee, the Specialized Organization for Medical Supplies and Materials will decide whether to evaluate the product under the comprehensive technical fee or under the additional fee for medical management of programmed medical devices or specified medical supplies. In addition, if a request for insurance coverage is not submitted after approval by the pharmaceutical affairs bodies, the product cannot be used in insured medical care.
In the 2022 revision of medical fees, products involving highly innovative technology among medical devices evaluated under the comprehensive technical fee system were also added to the scope of "challenge application." Therefore, it is possible to review the technical fee calculation requirements and technical fee points by challenge application even for programmed medical devices that have been covered by insurance. However, in principle, multiple Challenge Applications cannot be filed for the same product.
The "SaMD WG" was established under the Specialized Subcommittee for Insurance Medical Materials of the Central Council of Medical Examiners in order to study the way of specialized medical fees for programmed medical devices in preparation for the FY2024 revision of medical fees.
The MHLW is implementing the Medical Venture Total Support Program (MEDISO), which supports medical venture companies and academia, providing consultation services by experts, support according to growth stages from the research stage to the commercialization stage, IP strategy and exit strategy surveys, and human resource exchange programs.
Finally, the Pharmaceutical Industry Promotion and Medical Information Planning Division of the Medical Affairs Bureau (Sangyo-Joho Division) provides advance consultation on insurance coverage for programmed medical devices. For the consultation, you can apply for consultation items on the prescribed form and meet with us in a web conference or face-to-face format to discuss insurance strategies with an eye on the way out. In particular, with regard to therapeutic applications, there are issues to be discussed at the preliminary stage of considering clinical trials, such as what kind of product concept and intended use or effect should be developed, what kind of data showing clinical usefulness is required for insurance evaluation, and whether there is any gap between the direction of insurance application and the direction of development/approval application. Therefore, it is recommended that advice be obtained from the Industrial Information Division of the Medical Affairs Bureau at an early stage of development, as appropriate.
Lecture (3)
Domestic and international IP trends in digital therapeutics
Mr. Hiroshi Oshima, Vice President, Intellectual Property Group, Deloitte Tohmatsu Financial Advisory
The DTx market is growing rapidly, and IP strategies are becoming more sophisticated and complex. As we move forward in our business, it will be important to provide multifaceted protection for the entire DTx ecosystem and to reduce IP risks. Today, I would like to discuss these domestic and international IP trends in DTx.
First, an overall picture of the DTx market. The global market is growing rapidly at 29% per year and is projected to reach US$22.5 billion by 2028.
DTx solutions for diseases can be divided into five types: (1) physical and mental treatment by improving behavioral habits, (2) medication optimization, (3) brain and mental improvement through sensory stimulation, (4) information sharing with medical institutions through patient monitoring, and (5) physical stimulation. Among these, the behavioral habit improvement type is being actively developed by U.S. companies, and CureApp and SusMed, which have already received approval in Japan, have begun working on this type.
Patent applications in this area have increased dramatically since 2013, with many companies participating in applications related to improving behavioral habits. On the other hand, applications related to medication optimization, brain/neural effects, and patient monitoring appear to be an oligopoly of a few companies. We estimate that a DTx business of the current size is protected by 10-50 patents.
Corporate alliance activities are also active. In addition to alliances with pharmaceutical companies for the development and marketing of therapeutic applications, for example, joint development in new areas such as VR technology, and acquisitions of companies are also becoming more active. We believe that the movement to incorporate DTx companies' technologies will become increasingly active in the future.
Next, we will introduce the IP filing trends of each company (Welldoc, Click Therapeutics, CureApp, SasMed, Akili, and Propeller) in their case studies. The trends of each company indicate that DTx's IP strategy is to first patent the basic functions corresponding to the treatment concept, followed by the sequential patent protection of additional functions such as those that improve convenience for patients and medical institutions. The IP mix of icon design as the user interface of the application screen, protection of its functions, etc., and device protection will also need to be addressed in the future. When providing platforms, it is important to protect the areas to be opened with patents, while managing the invisible parts such as specifications, source code, and algorithms as know-how. In addition, we believe it is necessary to protect communication technology, VR technology, etc. with patents to reduce IP risks in anticipation of standardization and cross-licensing.
As an example of the IP risk that has emerged, a patent troll (Non-Practicing Entity, NPE) has already filed a lawsuit against a DTx company for patent infringement on a general-purpose technology patent in the U.S. (filed in December 2021). The risks related to licensing negotiations and litigation are worryingly increasing as the DTx market grows rapidly.
Finally, I would like to introduce some IP issues, particularly the perspective of IP due diligence (DD) for pharmaceutical companies when partnering and investing in DTx ventures and related companies.
First, it is necessary to make sure that the main functionality related to the treatment of the patient application as well as the functionality for each stakeholder is protected. The protection is not only through patents, but also through a mix of IP such as design protection of user interface icons, know-how of the invisible parts, copyright protection of the program, etc. Make sure that the protection is not only through patents, but also through the IP mix.
If the partner is also using other companies' technology (e.g., communication technology), it is also important to make sure that the partner company can guarantee the patents.
In addition, for technologies that should be opened up and widely used, it is necessary to check whether they have already been patented. It is a good idea to check whether or not the technology to be standardized is secured by patents and can be licensed out where necessary.
Another checkpoint is whether the company has a policy for securing IP in alliance agreements, an IP strategy, and an operational structure in place. Since IP risks increase with business growth, especially for general-purpose technologies, membership in defense organizations and readiness for cross-licensing are also checkpoints.
Lecture (4)
Digital Therapeutics Initiatives as a Pharmaceutical Company and Future Challenges from an IP Perspective
Mr. Hiroya Okumura, Chairman, Intellectual Property Committee, Pharmaceutical Manufacturers Association of Japan
I will first discuss the current status of DTx in the pharmaceutical industry, and then I will discuss three issues to consider in the DTx area from an IP perspective.
However, with the progress of Society 5.0 and the development of digital technology, the business domain of the pharmaceutical business is expanding to include prevention, diagnosis, treatment, and prognosis. Regarding digital transformation (DX) inside and outside of pharmaceutical companies, DX is being rapidly introduced within companies in areas such as R&D efficiency, manufacturing and production efficiency, and outside of companies in digital health products, customer management, and marketing. DTx, the subject of this issue, is a part of this trend. In this regard, I raised three issues from the viewpoint of pharmaceutical companies in terms of IP: first, diversity of business models; second, technical characteristics and licensing systems that are different from those of pharmaceutical companies; and third, development methods, collaborations, and alliances.
The first issue is the diversity of business models. The first issue is the diversity of business models. The business model for pharmaceuticals is based on the provision of goods such as medicines, but the business model for DTx is completely different in that it is based on the provision of "things" or "experiences. Also, within DTx, it is equally important to have a very wide range of technological diversity. When considering IP strategies for each DTx, one size fits for all is not possible, and the best must be considered on a case-by-case basis.
The second issue is the technical characteristics and licensing system, which are different from those of pharmaceuticals. First, looking at technical characteristics, for example, a patent for a nicotine treatment application is based on a completely different technology for those who are used to seeing pharmaceutical patents. Because of the challenge of having to incorporate this type of technology, there are three main differences in terms of intellectual property: First, the patents that form the core of protection are generally one basic patent that protects one product, whereas in the case of pharmaceuticals, one product is generally protected by one basic patent, and in DTx, one product is protected by many patents. The second difference is the continuous updating of patents. Third, DTx requires a multi-layered IP portfolio with active use of designs, trademarks, etc. Second, there is a need for knowledge of the licensing system. Since it is necessary to understand the licensing system and consider IP protection, we believe that deepening this knowledge is a very important issue. I understand that DTx will be exempted from data protection systems in major countries, but this is a major difference from the system design of pharmaceuticals, so it is important to keep this in mind. The third issue is the development method.
The third issue is development methods, collaboration, and alliances. and intellectual property issues, where alliances with startups and other companies are necessary, contracts with startups and other companies are important. In particular, the consideration of FTO indemnification clauses is an important issue. In addition, I believe that we are already in a situation where the alliances are overlapping and becoming more complex, and it is also important to determine the content of the partnership and in what ways we can leverage each other's strengths.
In summary, on the larger theme of thinking about the future pharmaceutical industry, I think DTx is about moving away from the current pharmaceutical supply business model to a different business model future using a completely different technology. We need to imagine the future we envision and think about what we need to do now, one of which is to secure resources, especially human resources, which is a major factor. Many people in the intellectual property departments of pharmaceutical companies have backgrounds in biology, chemistry, and pharmacy, but not many have backgrounds in digital technology. It is necessary to procure human resources from outside, but it is also necessary to secure human resources within the company, reskilling and raising the level of internal human resources.
Panel Discussion
Moderator: Mr. Hiroshi Oshima
Panelists Mr. Shuta Mitomo, Mr. Minoru Iijima, Mr. Hiroya Okumura Chairperson
1. challenges in Japan for DTx diffusion
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | I feel that decision making to enter the market is slow because they do not know how to monetize. How to think about monetization will be the key to future growth. It may be difficult to create a revenue model for the application alone, in which case synergies with the existing pipeline will be important. We also need to look at the health economic effects of introducing DTx before we can expand the market. The insurance system in the U.S. is too different to be of much help, but the German DiGA reimbursement system is closer to that of Japan, and we are watching it closely. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | The current business model of pharmaceutical companies is B to B, and it is difficult to grasp the real usage status of patients, but in the case of DTx, data is accumulated through daily use. The key is how to link this to synergies with existing businesses. Will it be an add-on to pharmaceuticals or will it be used to prevent serious illnesses? We need to carefully consider our strengths as a digital company, including whether or not to use it as a medical device, and then sort out where it fits in when combined with diseases. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | If we do not focus on revenue from the digital application part, it will be very different from the previous business model, but I recognize that it is socially necessary in terms of providing new options for patients and medical professionals. This is just my personal opinion, but I think we need to think about how to promote what is needed in the area of unwellness before treatment becomes necessary. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | For example, if insurance coverage is the exit point, it is important to consult with the Industrial Relations Division of the Medical Affairs Bureau to finalize the prospects for insurance coverage and measures for exit, and to formulate a clinical development plan at an early stage. If additional technical fees are to be sought, they must be demonstrated through clinical evidence. For example, if there is no technical fee that can be used as a reference for face-to-face cognitive behavioral therapy, strategies on how to add it must be considered in the early stages of development. Requests must be made through the relevant academic societies at the reimbursement revision. In addition, rather than aiming for insurance coverage for all SaMDs, OTC-SaMD-like products may be a possible target in the future. In fact, a smoking cessation application was approved for medical practitioners, but the supply of varenicline was halted, leading to a shift in strategy to market the product to health insurance associations. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | As for Japan's regulatory challenges compared to those overseas, we believe that the U.S. Food and Drug Administration's (FDA) trial Pre-Cert system, a digital health software pre-certification program, can be used as a reference. However, there are some issues, such as the fact that the program is not very popular due to the strict requirements imposed, and the number of participating companies is small. We have tried to consider arranging a slightly different system in Japan, but it has not progressed since the shortcomings of the system were pointed out. In the case of DiGA, only well-designed randomized controlled trials (RCTs) can be conducted because additional clinical data must be provided within one year after provisional approval (real-world data). Therefore, only well-designed randomized controlled trials (RCT trials) can be conducted (real world data (RWD) cannot be used), which has prevented widespread use. Japan's two-step approval system allows for the use of RWD and is different from other countries. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | In the case of applications, the general flow is to conduct clinical research to obtain basic data, and then conduct a single pivotal trial to obtain approval. The key factor is to narrow down what can be read from the RWD and what trials really need to be done. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | Regarding IP strategies for promoting DTx, there are many different ways to go about the DTx approval process, and we are still not quite sure what the key points are in terms of IP. We need to learn more about the process of obtaining intellectual property rights. The system is also in the process of being finalized. |
2. future efforts and involvement of pharmaceutical companies
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | In terms of how pharmaceutical companies are involved with DTx, first of all, when discussing preventive infringement searches (FTO searches), there are probably many patents related to this field, so I think it will be difficult for a start-up without a lot of dedicated IP staff to complete an FTO search. The survey results indicate that they need IP support, and pharmaceutical companies could support them in IP aspects. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | In terms of cross-licensing strategies, I think it is better to think of patents as tools for alliances with other companies for cross-licensing, etc. It is not possible to obtain strong patents such as substance patents for small molecule drugs, which are updated frequently and developed quickly. Under such circumstances, the same patent portfolio approach as for pharmaceuticals makes no sense. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | It was pointed out that the perspective of human resource development is also important. Major overseas pharmaceutical companies are taking measures such as hiring lawyers who are well versed in the field of digital technology. In addition, they are reskilling their current human resources in the pharmaceutical field. We are trying to catch up. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | As for administrative measures, the PMDA has established a Program Medical Device Review Office, which is staffed by a medical device reviewer and a clinical reviewer for pharmaceuticals. However, we are currently overloaded with numerous free consultations. How to increase the number of human resources has become a challenge. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | There is also an issue with our Quality Management System (QMS) system: DTx is similar to the management system for medical devices in some respects, but on the other hand, it has a direct effect on humans, so it is more like a drug than a medical device. If a start-up company were to market the product on its own, it would be difficult to establish a QMS system. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | Contracts with startups and ventures, etc., are also an important factor in whether or not they will be successful. The key points in the contract are how to handle FTOs, how to handle data, how to attribute deliverables, etc. In the case of DTx, I don't think it is appropriate for the pharmaceutical company to have the intellectual property. How to handle it is an issue to be discussed in the future. Startups, etc. will want to develop their deliverables horizontally. It will be necessary to organize them in a win-win situation, while determining what is necessary for themselves. |
3. future prospects
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | Considering the positioning of DTx with Society 5.0 in mind, I think it is possible to consider SaMD from RWD. Also, thinking from the patient's perspective, I believe that SaMD is used for maintenance therapy after a therapeutic intervention. It would be more natural to consider what the issues are that are being sought after in the target disease, and then draw a scenario in which DTx is the next step. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | I believe that rare diseases that require special treatment have a high affinity with DTx and will be an area of growth in the future. I also think that psychiatric fields, including dementia, are important from the perspective of reducing the burden on society. On the other hand, the area of lifestyle-related diseases has matured, and I think it will be difficult for new entrants to enter this field. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | There have been reports of symptoms being alleviated by games, mindfulness, etc. I think that these will emerge in 10 years, and it is possible that healthcare will be combined with VR, metaverse, etc. as a matter of course. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | DTx is one of the modalities that will provide new options for patients, and within the DTx modality, there will be sub-modalities such as VR. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | I think it would be very interesting to see DTx products that connect the unaffected, prevention, and treatment, and I think it would be a great contribution to society. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | As data is accumulated and DTx develops, there will also be intellectual property issues of how to protect the data and how to utilize it. Data itself is very important, but it is not easy to protect it well. We are always thinking about how to process data and protect intellectual property, but we believe that good measures are not easy to find. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | From the viewpoint of industry development, SaMD is supposed to be used for insurance treatment, but I hope that development will be promoted with an eye to the fact that there is another path, OTC. OTC has a large market and may be used for prevention. Simultaneous development would be burdensome, so we could obtain data for physicians, obtain approval, and then convert that to OTC, etc. This is an area that needs to be discussed further. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | I think DTx will grow from the behavioral change area. In addition, the creation of content such as games is a strength of Japan, and I believe it will grow in the future. In particular, I think the key will be how to combine this with virtual space. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | In terms of intellectual property, I believe that what has been happening in other industries will also happen in the DTx domain. The discussions that were happening in the smartphone industry have subsequently been taking place in the automotive industry, and then moving on to other industries. I think the next step will be in the DTx area. |
| The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations. | Technology is constantly advancing and becoming more sophisticated. I feel that this field is similarly promising. I expect that the field of intellectual property will expand accordingly. |
(Intellectual Property Forum Preparatory Committee)