Points of View Characteristics of Intellectual Property Surrounding Digital Health -Based on Global Trends and Analysis of Japanese and U.S. DTx Firms

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Junya Tsujii, Senior Researcher, National Institute of Biomedical Innovation Policy

1. Introduction

For R&D-oriented companies, intellectual property, including patents, is an effective means of securing the right to license their technologies and preventing the emergence of counterfeit products. In particular, the importance of intellectual property in the pharmaceutical industry has been discussed in many places, and appropriate measures to deal with intellectual property are required in order to continue the cycle of recovering large R&D expenditures, said to be in the tens to hundreds of billions of yen, and investing in new R&D. Intellectual property in the pharmaceutical industry is unique. In most cases, there is only one basic patent (one basic patent for one substance) for a product (drug), which can be exclusively protected by a substance patent or a use patent. In addition, the industry is characterized by the fact that it aims for stronger protection through the acquisition of rights to peripheral patents, such as formulation and manufacturing methods. On the other hand, in industries such as the automobile and IT industries, where numerous parts and technologies are integrated to create a single product, products are generally protected comprehensively by multiple intellectual properties (and confidentiality as know-how). In addition, an "open strategy," in which the company strategically grants a license to its patents to competitors for the purpose of product diffusion, etc., is combined with a strategy to simultaneously secure competitiveness through its own patents (core technology) and to create and expand new markets. As described above, there are various ways to approach intellectual property depending on the characteristics of the industry and product.

In recent years, "digital health " ¹⁾, new solutions utilizing digital technology, have been emerging one after another in the medical and healthcare fields. This wave has had no small impact on the state of the pharmaceutical industry, with the pharmaceutical industry collaborating with other industries with unique strengths, such as the IT industry, and focusing on digital health, such as medication management applications and digital therapeutics ("DTx"), which are expected to have synergy with pharmaceuticals. However, while multiple elemental technologies are expected to be involved in this area, the speed of technological evolution in each of these technologies is rapid, and given the background that continuous product updates are required even after the product is launched, a different approach is expected to be required from that of intellectual property considered for pharmaceuticals.

As the pharmaceutical industry is expected to enter the digital health field more actively in the future, it is important for the industry to know how other industries, which could be co-creators or competitors of the pharmaceutical industry, approach intellectual property. While the Pharmaceutical Industry Policy Institute has previously reported on the characteristics of DTx intellectual property based on case studies of various ^companies2), this paper will delve deeper into the characteristics through a quantitative analysis of intellectual property related to digital health. Specifically, first, from a broad perspective, we will overview the global patent application trends in digital health (Survey 1). Next, we will focus on DTx, which is closely related to the pharmaceutical industry, and analyze patent (Survey 2-1) and design (Survey 2-2) application trends from the perspective of DTx companies in Japan and the US.

Survey Methodology

For the patent search, we used PATENTSCOPE, a patent database search system provided by the World Intellectual Property Organization (WIPO) ³⁾.

3) In the search1, for each of the terms "digital health," "digital medicine," and "digital therapeutics (DTx)," patents that met the conditions shown in Note 4) were ^extracted4). In cases where there were multiple applicants for the same patent, the number of patents per applicant was divided equally by the number of applicants in order to calculate the applicant attributes and nationalities. (For example, if the applicant attribute is one company and one individual, the number of patents for the company is counted as 0.5 and the number of patents for the individual is counted as 0.5.5 ^.5). Patents that contained two or more search terms were counted separately as patents related to each search term.

In Survey 2-1, based on the company names of DTx companies in Japan and the U.S., the patents applied for by each company were extracted according to the conditions shown in Note 6) ^.6) In addition, in Survey 2-2, the patents that were applied for by each company were counted separately. In Surveys 1 and 2-1, in order to ascertain the number of patented technologies actually invented, we used the "Single Family Member" function of WIPO PATENTSCOPE and counted patents by patent ^family7) (patents based on the same technology were counted as one patent). However, in order to analyze the geographical impact of the patents on the countries of application and transition, all patents (excluding duplicate patents), including related patents in the patent family, were included in the total number of patents.

For Survey 2-2 (design search), the "Patent Full-Text and Image Database" of the U.S. Patent and Trademark Office (USPTO), the "Patent Information Platform (J-PlatPat)" of the National Institute of Industrial Property Information and Training (INPIT), and the "eSearch plus" of the European Union Intellectual Property Office (EUIPO) were used. (EUIPO), and a design search was conducted using the names of Japanese and U.S. DTx companies according to the conditions described in Note 8) ^.8) The scope of data for Survey 1 was 2022 design designs, and the scope of data for Survey 2 was 2022 designs.

The scope of data was all information available as of August 12, 2022 for Survey 1, and as of August 17, 2022 for Surveys 2-1 and 2-2. Please note that the search was based on specific search terms, and it may not be possible to extract all the relevant patents and designs exactly.

3. survey results

Survey 1: Trends in Digital Health-related Patents

The number of patents related to "digital health," "digital medicine," and "DTx" extracted by the search criteria were 943, 102, and 249, respectively. When these are summarized by patent application year, there is a slight difference in the timing of the start-up of patent applications, but all of them showed an increase in the number of patent applications from the mid to late 2010s (Figure 1a)). Considering that, in principle, there is a lag of one year and six months between the filing of a patent application and its publication, it can be inferred that the number of patent applications will further increase from 2021 onward. Since this survey is based on a search using English words and phrases, patents in non-English-speaking countries that are not written in English may be omitted from the selection, but if the invention in question is also applied for in English-speaking countries, this will not affect the number of patents per patent family.

Next, around 70% of the applicant attributes were companies, and about 10% of the applications were filed by academia (Figure 1b)). The details of the patents are omitted, but in digital health, in addition to electrical/IT/communication equipment companies such as Sony (Japan), Nokia Technologies (Finland), and Huawei Technologies (China), Eccrine In the digital medicine field, Ginger.io (U.S.) and Ping An Technology (China), which develop mental health apps, were notable filers. (U.S.), which develops software to treat eye diseases, as well as applications from the University of Miami (U.S.). (U.S.) were also seen.

In addition, a survey of the nationalities of applicants, excluding individuals, showed that the U.S. was the prominent country in both digital health, digital medicine, and DTx, accounting for approximately 60-70% of the total (Figure 1c)). Among the other countries, applicants from China, Korea, Japan, and the UK stood out. It should be noted, however, that due to the nature of the survey based on specific words and phrases, digital health-related patents that do not include such words and phrases are not extracted.

In addition, looking at the year of establishment of the companies that became applicants, the largest number of applicants were established in 2011 or later (Figure 1d)). Furthermore, when the number of companies that were established after 2000 was expanded to include those established after 2000, more than 70% of the companies in "Digital Health" and "Digital Medicine" and more than 80% in "DTx" were established after 2000. In Policy Research Institute News No. 66, the author noted that start-ups (defined as companies established after ²⁰⁰⁰⁹ ) play a major role in the development of digital medicine, based on the global trend of clinical trials for digital ^medicine10). 10) However, in the upstream patent applications, it can be said that many startups are the starting point of inventions.

Furthermore, Figure 2 shows the relationship between the nationality of the applicant (excluding individuals) and the country of application and transition for each patent. In Figure 2, the top 50 pathways and the pathways with a minimum frequency of 2 or more are indicated. However, in cases where multiple applicants are listed in the same patent, the application/transitioning country is tabulated for each applicant based on the assumption that each applicant is equally entitled to the patent. It should be noted that this report does not distinguish between direct applications and national transitions through the Patent Cooperation Treaty (PCT) for patent applications filed outside the applicant's home country. Figure 2 shows that, in the fields of digital health and digital medicine, U.S. applicants tend to file mainly in the U.S., while those in Europe, China, Japan, and other countries file and prosecute patent applications in a wide range of countries. In addition, non-US applicants also filed applications and transfers to multiple countries including the U.S. In DTx, a similar trend was observed, but it is characteristic that China is currently filing applications only in its own country. However, since China's patents are new ones filed after 2020, there is a possibility that there will be more activity in the future in obtaining rights in other countries.

3-2. Survey 2-1: Patent Application Trends by Japanese and U.S. DTx Companies

In section 3-1, we looked at the global trend of digital health-related patents from a broad perspective. From this section, we focused on DTx, which is closely related to the pharmaceutical industry, and investigated patent application trends of DTx companies in the U.S. and Japan, which have a large number of approved/approved products.

The companies covered in this study are listed in Table 1. In the U.S., companies with products approved by the U.S. Food and Drug Administration (FDA) (20 companies, hereinafter referred to as "U.S. DTx companies") were selected from the product ^library11) and other public information released by the Digital Therapeutics Alliance (DTA). In Japan, the current status of regulatory approval is not yet clear. In Japan, since there are currently only two DTx products (one company) that have obtained regulatory approval, we selected the target companies (8 companies, hereafter referred to as "Japanese DTx companies"), including companies with development information. Since the development status of the surveyed companies differs between the U.S. and Japan, the purpose of this survey is to understand the trends in each country, and does not refer to differences or goodness or badness between the countries.

To begin, we looked at the number of patent applications (number of patent families). The total number was 167 in the U.S. and 62 in Japan, and the average (8) and median (5) number of patent applications for each company was the same for both Japan and the U.S. (Figure 3a). Among these patents, for products that had obtained approval/approval from the regulatory authorities in Japan or the U.S. (including one product under regulatory application in Japan), we extracted patents that contained words related to the indicated disease in the patent specification (product-related patents) (Figure 3b), showing the total number of Japanese and U.S. DTx companies combined). As a result, the average number of related patents per approved/approved product was 7, and the median was 5, suggesting that multiple product-related patents are filed for one product.

Welldoc, the developer of "BlueStar," the world's first DTx application approved by the FDA in 2010 for the treatment of diabetes, filed a patent application in 2008 for "Systems and methods for disease control and BlueStar's core functions are "disease management support based on blood glucose, diet, and other data, as well as individual patient management support based on treatment data and machine learning. The core function of BlueStar is "support for self-management of diabetes by providing disease management support based on data such as blood glucose levels, diet, etc., and customized treatment guidance and advice to individual patients based on treatment data and machine learning". ¹²⁾ We assume that this patent protects a part of the core function of BlueStar. In addition to this, "Adaptive analytical behavioral and health assistant system and related method of use" (U.S. Patent No. 8,838,513, a pattern recognition algorithm learned from behavioral and clinical information of patients (U.S. Patent No. 8,838,513, "Systems and methods for managing medication adherence" (U.S. Patent No. 9,536,053, "Systems and methods for planning and presenting intervention methods to prevent/promote events and to support the decision-making process") and "Systems and methods for managing medication adherence" (U.S. Patent No. 9,536,053, "Systems and methods for managing medication adherence") Systems and methods for managing medication adherence" (U.S. Patent 9,536,053, Systems and methods for managing medication adherence), "Systems and methods for creating and selecting models for predicting medical conditions" (U.S. Patent 9,824,190, Machine learning models based on patient data are created and selected. (U.S. Patent No. 9,824,190, a system and method for creating and selecting machine learning models based on patient data to predict medical conditions), and several other patents that would cover some of the core functionality. More interestingly, some of these patents originated from the same invention (with the same priority date) and renewed their scope of rights every few years with similar invention names, while adding complementary technologies, even after obtaining FDA approval/clearance. It is apparent that patents are continuously updated in anticipation of changes in product performance due to technological evolution.

In Japan, CureApp's nicotine dependence treatment application and CO checker received regulatory approval in 2020 as the first DTx in Japan. Patents protecting the core functionality of this DTx would be Patent No. 6116769 and Patent No. 6339298 (both of which are entitled "Program, Apparatus, System and Method for Smoking Cessation Patients"). The former is "a program for providing information (messages, etc.) to correct errors based on interpretation information about matters related to smoking by a patient," and the latter is "a consistency determination between information on smoking status entered by a patient and concentration of biological indicators representing smoking status (exhaled carbon monoxide concentration with time stamps, etc.) The latter is a patent for "a program for providing information on smoking cessation treatment to be implemented by a patient based on the These have been transferred to the United States, Europe, and China. In addition, in its "Business Plan and Growth Potential Matters" published in December 2021, SusMed, which submitted an application for manufacturing and marketing approval of an application for insomnia treatment in 2022, listed four patents as key technologies for the insomnia treatment application (insomnia-related: 3 patents, treatment-related application management system and management server device : 1) ^patents13). Among these patents, for example, "Insomnia Treatment Support Device and Program for Insomnia Treatment Support" (Patent No. 6245781) has been transferred to the U.S., Europe, China, Korea, etc., and international rights acquisition is being directed.

In DTx, there may be cases where a single key patent (in this paper, patents related to the core functions of a product are referred to as "key patents" for convenience) is used to protect a product, but as in the above example, the combination of multiple key patents for a single product to provide comprehensive protection is a characteristic of DTx patents. Furthermore, we believe that the patents listed above include many "programs, systems (combinations of programs and devices), and methods necessary for the performance of specific functions," and that even in DTx, which is easily affected by differences in language and cultural backgrounds, the influence of such differences is minimal, and that the patents should be able to be executed globally and in a common manner. We infer that there is a tendency to grant rights in multiple countries to programs and system-related technologies, etc. that are less susceptible to the effects of DTx, which are easily influenced by differences in language and cultural backgrounds, and can be commonly executed globally, as part of major patents.

Next, the annual trend of patent applications shows that the number of patent applications in both Japan and the U.S. increased from around the late 2010s (Figure 4a). In addition, the number of years between the establishment of each company and the filing of a patent application is shown in Figure 4b). Since the majority of the surveyed companies are start-ups, it is not appropriate to discuss the peak of the number of years from establishment to patent application at this point, but it can be said that both Japan and the U.S. are characterized by a rapid start-up of patent applications. In Policy Research Institute News No. 66, the author mentioned that innovative technologies originating from academia play an important role in the establishment of DTx companies. ¹⁰⁾ It can be inferred that these companies are aiming to obtain patent rights soon after their establishment, based on basic research conducted in academia and other fields.

Figures 5 and 6 show trends in patent applications and countries where patents have been filed and transferred. U.S. DTx firms mainly applied for and transferred patents to the U.S., where they had already obtained approval/licensing, accounting for more than 80% (84%) of the total number of patent families (167 inventions) (Fig. 5a)). However, there are some WO patents that have not yet been transferred to other countries and some patents that have not yet been filed in the U.S., so not all inventions have been filed or transferred to the U.S. In addition, Europe (EP) and Canada were at the top of the list of countries other than the U.S. in terms of patent applications/transfers, and Japan had the largest number (22% as a percentage of the number of patent families) when limited to Asia. Although this is a simple average, when the ratios to the number of patent families (number of inventions) for each country excluding WO patents are added up, the total is 253%, which means that each invention is filed or transferred to approximately 2.5 countries. Looking at annual trends in the number of countries to which applications are filed or transferred, Europe, Canada, and China were the main destinations for applications outside the U.S. in the early 2010s, but since 2015, the number of countries to which applications are filed or transferred has been diversifying, including Japan, Australia, and South Korea (Figure 5b). It may be said that U.S. DTx companies are accelerating patenting with an eye toward product development in global markets, including Japan.

Among Japanese DTx firms, the majority of patent applications were filed and transferred to Japan, accounting for about 90% (89%) of the total number of patent families (number of inventions, 62) (Fig. 6a)). The total of the ratios to the number of patent families (number of inventions) in each country excluding WO patents is 147%, which is approximately 1.5 countries per invention, indicating that applications and transfers outside the home country are also taken into consideration. On the other hand, looking at annual trends in the number of countries to which applications are filed or transferred, no significant trends were observed (Fig. 6b). However, since applications to countries other than Japan are basically based on PCT applications, and there are several patents that have not yet been transferred to other countries, as is the case with U.S. DTx companies, it is expected that further multinational development will continue in the future.

Each patent is assigned an internationally unified classification symbol called the International Patent Classification (IPC) based on its technical content. ¹⁴⁾ The IPC is classified into sections, classes, subclasses, and groups (main and subclasses) starting from the highest level. The IPC is classified into sections, classes, subclasses, and groups (main and subclasses) from the highest level. In this survey, we organized the technical contents of patent applications filed by Japanese and U.S. DTx companies based on the classification symbols up to subclasses that can roughly identify the technical fields. As a result of the survey, G16H (healthcare informatics, i.e., information and communication technology [ICT] specifically adapted to the handling or processing of medical or health care data) and A61B (diagnosis; surgery; personal identification) accounted for more than half of all patent applications in both Japan and the US. Among them, G06N (computational devices based on specific computational models), so-called AI technology patents such as computational devices based on machine learning and other learning models, were actively applied for as a characteristic of the U.S. (Figure 7a)). In Japan, on the other hand, the percentage of G06Q (data processing systems or methods especially adapted to administrative, commercial, financial, managerial, supervisory, or forecasting purposes) was high (Figure 7b)). They refer to inventions related to business methods realized using ICT (Information and Communication Technology) ^.15) In addition, the ^percentage of patents granted with G06Q is also called "business-related inventions. In addition, a small number of applications for G16Y (information and communication technology specifically adapted to the Internet of Things [IoT]), an IoT (Internet of Things)-related technology, were also granted.

In addition, in order to understand the trend of patent applications, we analyzed the words and phrases used in the patent titles of Japanese and U.S. DTx companies using a co-occurrence network (number of patents covered: 229 patents, total of patents from Japanese and U.S. DTx companies). A co-occurrence network is a method for extracting and visualizing the frequency of words appearing in sentences and the strength of connections between words. As a result of the analysis, "system" and "method" were the most frequently appearing words from the technology viewpoint, indicating that many patents related to systems and methods that combine multiple elemental technologies such as programs and devices were applied for (Figure 8, dashed line box). In addition, co-occurrence relations to machine learning/modeling and remote monitoring were also extracted. However, looking at the patent specifications, many of the "machine learning" patents were filed as "systems incorporating machine learning-based disease prediction models," etc., rather than patents related to the composition of learned models or algorithms themselves. When organized from the disease/target perspective, co-occurrence relationships were found for diabetes, asthma, health care, and neuromodulation (Figure 8, solid line box).

Survey 2-2: Design Application Trend of Japanese and U.S. DTx Companies

In DTx, which are mainly provided in the form of apps, games, VR, etc., the displayed images may play an important role in demonstrating the product function (effectiveness, continuity, etc.). In Japan, with the revision of the Design Law in 2022 (enforced on April 1, 2020), in addition to the conventional "designs that include an image as part of an article or other item" (e.g., the operation display of a copier), "images that are independent from the article itself" (images that are not recorded on the article or projected on a location other than the article) are now protected under image design ^.18) In other words, the image itself, which is not recorded on the article itself, is not protected. In other words, images that are not recorded on the article itself, but displayed through the cloud or network, are also considered to be subject to design ^{protection19)}. In the U.S., the GUI (graphical user interface) itself must be a part of the surface ornamentation of a display medium as a partial ^design20).

A survey of design applications filed by U.S. and Japanese DTx firms in Japan, the U.S., and Europe revealed that 84 applications were filed by U.S. DTx firms and 4 applications were filed by Japanese DTx firms (Figure 9a). However, the number of companies filing applications was skewed: 7/20 for U.S. DTx companies (including companies filing design applications for device designs such as inhalers) and 1/8 for Japanese DTx companies. On the other hand, the annual trend of applications did not show an increasing trend over time (Figure 9a)). In addition, the results of organizing the technical field of each design based on the Locarno Classification (Locarno Classification, 13th Edition) showed that 14-04 (screen displays and icons) was the most common, with design applications filed mainly in the US and Europe (Fig. 9b), c)). ²¹⁾ In Europe, which is particularly active in protecting image designs, it is possible to register a design for a GUI alone, and multiple designs in the same Locarno Classification can be covered by a single application (of the 29 EU designs classified under 14-04, 26 (22 and 4) are identical applications for multiple GUIs filed by two different companies). This is thought to be a factor that encourages the registration of image designs. On the other hand, the Japanese DTx company filed four applications for image designs (GUIs) from the same company, but the rights were obtained as conventional "designs that include an image in a part of an article, etc." (partial designs), which were classified as 14-03 (telecommunication equipment, radio remote control equipment and radio amplifiers) or 14-04 (screen Display and Icons). However, since the design application was filed before the amendment of the Design Law in 2021, it is possible that more design applications for "an image independent of an article" will be filed in Japan in the future. In addition, as of April 1, 2021, it became possible to file multiple design applications in a single application, as is the case in Europe and other ^countries22), and various legal amendments are underway to encourage the acquisition of image design rights in Japan.

Note that the largest number of applications in Category 24 (24-02, etc.) are for designs related to "medical and laboratory apparatus," and the survey results include a certain number of designs for blood glucose monitors, drug inhalers, and other such devices.

4. characteristics of intellectual property in digital health

Based on the survey results in section 3, the following are the characteristics of intellectual property (patents and designs) in the digital health field as considered by the author.

In Survey 1, an overview of global digital health-related patent application trends showed that the number of patent applications has been on the rise in recent years. The majority of applicants were start-ups established after 2000, and this was especially true for DTx. In digital health, where health-related solutions (non-medical devices) distributed to the general public are the main focus, applications by companies in the electrical/IT/telecommunications equipment field stood out, while in DTx, which requires specific know-how such as applying for approval and conducting clinical trials based on pharmaceutical regulations, start-ups specializing in DTx development were In DTx, which requires specific know-how in such areas as applying for approval and conducting clinical trials in accordance with drug regulations, the involvement of start-ups specializing in DTx development in many patents is a distinctive feature. However, it should be noted that this survey was a search using terms such as "Digital Health," and the definition of the term is still under research. For example, "Digital Health" was first used by the World Health Organization (WHO) in 2005, when it described "digitized products, systems, and services for health" as ^eHealth23), and in 2018, eHealth and mHealth (patients supporting medical and public health Digital Health" as a concept that encompasses eHealth and mHealth (mobile devices such as patient monitoring devices that support medical care and public health) ²⁴⁾. Digital Medicine" was first coined by Dr. David Williamson Shaffer and colleagues in ^200225), and a more rigorous definition was published by Dr. Eric Elenko and colleagues in ^201526). Digital Therapeutics" was also a concept first mentioned by Dr. Cameron Sepah and colleagues in a peer-reviewed journal in ^201527), and in 2019, the Digital Therapeutics Alliance, a non-profit organization including DTx development companies ( (launched in 2017), a non-profit organization including DTx development companies, published definitions for Digital Health, Digital Medicine, and Digital Therapeutics, ^{respectively28)}. As mentioned above, research on definitions has been progressing in recent years, but it is a research challenge that the definitions of the terms may differ slightly depending on the timing of the patent application.

Survey 2-1 summarizes patent application trends from the perspective of Japanese and U.S. DTx firms. A large number of these patents were filed early on in the company's establishment, and we believe that this is due to the rapid evolution of digital technology. In other words, in the DTx field, where innovative digital technologies are constantly emerging and the risk of technological obsolescence is high, it is necessary to file patent applications as early as possible to ensure that the company secures its own license. In the DTx area, where the R&D period is said to be several years, it is considered a good idea to obtain patent protection as early as possible. On the other hand, another characteristic of DTx is the need for a continuous approach to intellectual property based on the assumption that product updates will be made after the product is launched. In addition, as mentioned previously, startups are at the center of development in the DTx area, and not only securing their own licenses, but also collaborating with large companies, etc. and externally demonstrating their technological capabilities (strengths) that lead to increased corporate value may be another factor that encourages patent applications at an early stage of ^{establishment29)}.

In addition, in recent years, the number of countries in which patent applications are filed and transferred has been diversifying, especially among U.S. DTx firms, and the granting of rights outside the home country with a view to developing in the global market is accelerating.

Within the scope of this study, we also found that multiple product-related patents were filed for one product (one indication) (mean: 7; median: 5). In addition, several companies were found to be working toward comprehensive protection of their products by combining several patents related to the core function of the product (key patents). In DTx, which consists of a combination of various elemental technologies, it is not easy to secure product exclusivity with a single patent, and we assume that companies are aiming for multifaceted protection through multiple patents (in particular, patents related to programs and systems that are less affected by differences in language and cultural backgrounds and can be executed globally in common). The DTx-related patents are not easy to be protected.

In the technical fields of DTx-related patents, AI-related technologies (G06N), business-related inventions (G06Q), and IoT-related technologies (G16Y) were cited as distinctive items. In terms of specific technical content, system and method-related technologies were the main subjects of applications. As the industrial structure is shifting from "things" to "services" against the backdrop of the evolution of digital technology, it can be said that in the DTx area, patents related to AI and IoT technologies as well as business-related inventions utilizing these technologies are being sought for (Figure 10). In particular, in recent years, the number of applications for business-related inventions in Japan, the number of patents granted, and the rate at which patents are granted have been on the ^rise30). These inventions are a different concept from pharmaceuticals, which are mainly patents tied to "things." In order to obtain rights to systems that have no form, business models via IoT, etc., it is necessary to incorporate new thinking that goes beyond the conventional framework. It can be said that the pharmaceutical companies of the future will be required to transform themselves into "mono-koto" companies that can flexibly handle both "mono" and "koto" intellectual property.

In Survey 2-2, we summarized the trends of design applications for DTx. Compared to patents, there were not many designs filed by Japanese and US DTx companies, but we were able to identify several image designs, especially for therapeutic applications and games. According to Article 2, Paragraph 1 of the Design Law, a design is applicable to "something that causes a sense of beauty through the sense of sight ^.) Therefore, it can be said that it is possible to obtain rights for images, etc. that do not necessarily fall under " ^{inventions31).} The use of designs to supplement elements that are difficult to be patented (e.g., images that are considered to have an impact on the functionality of the product) and to strengthen the intellectual property rights of the product from multiple perspectives is an intellectual property approach that is characteristic of the DTx area, or more specifically, the digital health area.

Pharmaceutical Industry's Involvement in Digital Health Intellectual Property

So far, we have discussed the characteristics of intellectual property surrounding digital health. In Policy Research Institute News No. 64, the author reported that digital technology-related alliances involving pharmaceutical companies in Japan, the U.S., and Europe have been on the rise in recent ^years32), and would like to examine how the pharmaceutical industry is involved in digital health development from the perspective of intellectual property, particularly patents.

Based on the results of Survey 1 and Survey 2-1, Table 2 shows representative examples of patents in which pharmaceutical companies are involved. Patent applications involving collaboration between digital health companies and pharmaceutical companies include, for example, Novartis and Pear Therapeutics initiated joint development of DTx for the treatment of multiple sclerosis and schizophrenia in ^201833), and several patents have been jointly filed as a result of this collaboration (this (Three patent families were extracted in this survey). In addition, Otsuka America and Click Therapeutics signed a global license agreement in 2019 for the development and commercialization of DTx for major ^{depression34)}, and in 2022, Otsuka America will file a patent application for a system and method for treating depression via digital therapy ⁽ patent title: Systems and Methods for Treating Depression via In 2022, they jointly applied for a patent (title of invention: Systems and methods for treating depression using a digital therapeutic). In addition, several patents extracted in the search against digital health and digital medicine were also found to involve pharmaceutical companies, such as "medical device system and method for evaluating motor symptoms in Parkinson's disease patients" and "system and method for improving treatment adherence".

However, the percentage of patents with pharmaceutical companies as applicants was not high, at 3% for all of the patents identified in Survey 1, and the percentage of pharmaceutical companies to all companies as applicants was 7%, even for DTx, which had the highest percentage of pharmaceutical companies as applicants. However, with the accumulation of R&D cases, including DTx, and the expected increase in collaboration between pharmaceutical companies and digital health-related companies in the future, it can be inferred that pharmaceutical companies will become more actively involved in intellectual property.

6. conclusion

In this paper, we examine the characteristics of intellectual property in digital health (including digital medicine and DTx) through a quantitative analysis of patents and designs surrounding digital health. The digital health domain (especially the DTx domain) is unique in that there are several major patents related to the core functions of the products, and the product protection is oriented through multilayered intellectual property rights that combine peripheral patents and designs as well. In addition, although not discussed in detail in this paper, some of the intellectual property includes "trademarks. For example, CureApp has applied for and registered a number of trademarks, such as "treatment app," "app prescription," and "smoking cessation treatment app," and is promoting multifaceted rights by utilizing trademarks in addition to patents and designs (Table 3).

In addition, we mentioned that the number of digital health-related patent applications has been on the rise in recent years, and the acceleration of technological innovation in the years to come will further boost this momentum. In this trend, leading companies will be required not only to protect their own products through the creation of various types of intellectual property, but also to formulate and expand their own markets in the budding digital health field through intellectual property.

In the DTx area, we have shown the multi-layered protection by multiple intellectual properties and the characteristic technical fields. At present, it can be said that these intellectual property initiatives by leading companies are raising the barriers to entry for follow-on companies. However, for companies with no previous experience in the medical/healthcare field, the unique know-how related to clinical trials and regulatory approval, compliance with pharmaceutical regulations, and development costs that are estimated to be several hundred million to several billion yen are also considered to be major barriers to entry. We believe that this is also a major barrier to entry. However, as more development and approval cases are accumulated in the future, the R&D barriers will become lower, and the importance of protecting one's own products (ensuring exclusivity and one's own superiority) through intellectual property will increase in relative terms. In DTx, in particular, it is important not only to obtain intellectual property rights at the R&D stage, but also to deal with intellectual property over the long term in anticipation of changes in performance due to data accumulation and additional AI learning after the product is released to the market.

What kind of approach should the pharmaceutical industry take to intellectual property in the digital health field with these characteristics? Whether the pharmaceutical industry is entering the digital health field on its own or collaborating with other industries, the first thing it needs to do is to fully understand the characteristics of intellectual property in the digital health field. Again, in the digital health field, where multiple elemental technologies are combined and the risk of obsolescence of each technology is high, it is essential to build a multi-layered intellectual property portfolio combining multiple patents, designs, and trademarks for each product. In addition, it is also important to manage intellectual property from a long-term perspective, taking into account continuous changes in performance after the product is launched. In addition, as in the automotive and IT industries, in order to maximize the value of one's own products and technologies, it will be necessary to appropriately distinguish between a "closed strategy" (i.e., which technologies should be protected by rights and which should be kept secret as know-how) and an "open strategy" (i.e., licensing one's own technologies through cross-licenses, etc.), including both in Japan and abroad. In the future, the pharmaceutical industry itself will have to decide how far it is willing to go. The important thing is to identify the elemental technologies that will be the basis of product protection (the company's strength), and to appropriately build a system, network, and human resources to deal with intellectual property in digital health in order to ensure the competitiveness of the company's products, making full use of both open and closed strategies. The company should also appropriately build and nurture a system, network, human resources, etc. that can handle digital health intellectual property in order to ensure the competitiveness of its products using open and closed strategies. It will be necessary to construct appropriate intellectual property strategies for pharmaceuticals and digital health by backcasting from the future that should be aimed for.

Against the backdrop of the advancement of digital technology, the way of medical care is changing from the traditional "treatment-centered" to "the entire life course from prevention, diagnosis, and prognosis," and from "uniform medical care" to "individualized and stratified medical care. In this context, digital health, which can intervene in individual health in all aspects of daily life, including prevention, treatment, and prognosis, will become even more important in the future. As the center of gravity of the medical/healthcare industry expands from "manufacturing" to "making things," the pharmaceutical industry needs to understand the characteristics of this new industry and adopt a timely and flexible approach to intellectual property thinking. We hope that this report will help in this regard.

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