디지털 치료제의 특허성에 관한 연구 - 출원 실무상 주의사항을 중심으로 -

Information Technology is developing so rapidly that it is difficult to find a field in our lives where it is not being utilized. Furthermore, digital therapeutics are expected to be a next generation therapeutic medicine that can overcome the constraints of medical services, such as location and time, and the shortage of medical practitioners. The accuracy of Information Technology used in the medical field has already been proven, and if safety is secured based on clinical evidence, it is not impossible to solve. In particular, the market size of digital therapeutics is growing rapidly due to the recent increase in medical demand caused by the aging population and the global spread of infectious diseases. In response to this, many related studies and investments are being concentrated, and many patent applications are being filed in order to obtain exclusive and monopolistic status as compensation. However, since digital therapeutics are a new paradigm technology that combines medical technology and information technology, which includes various issues under the Patent Act, there are some areas that require caution in patent application. First of all, in terms of therapeutics, the following points need to be considered. First, digital therapeutics have both process and product characteristics, but when describing the scope of claims, it should be noted that they should not be described in the form of processes. In addition, even if claimed as a product invention, if some of the components include medical practitioners’ actions, the industrial applicability as a whole may be denied. Furthermore, it is no different even if it is optional. Second, it is necessary to be careful because it is possible to misunderstand the requirements of industrial applicability and clarity when directly stating foreign expressions in the research field in the claims without legal filtering. And I think it is more desirable to use therapeutic apparatus, therapeutic device, or therapeutic system as expressions in the claims are more desirable as expressions of claims instead of digital therapeutics. Whenever a new paradigm technology emerges, the question of how to handle and express the technology inevitably follows. It is necessary to explore expressions that minimize confusion in the research field while not undermining the stability of patent rights. Next, the following matters need to be considered in terms of digital technology. First, with regard to patentability, the claims must clearly state that information processing by software is specifically implemented using hardware. In addition, caution must be taken because patentability may be denied if any of the steps that constitute a digital therapeutic involve the intervention of a human doctor rather than software. Second, in relation to public health, digital therapeutics need to be strict in some ways because they are a treatment method targeting humans, but since the safety required as a treatment method is mainly regulated by other laws that require clinical evidence, and since the benefits and risks need to be compared and balanced, it is not appropriate to apply article 32 of the patent act, unless there is a clear concern about harm to public health. Third, in relation to inventive step, it is desirable to describe the scope of claims centered on the flow of information through software and hardware, not the sequence of treatment methods, and it is necessary for a server that receives patient input values to ​​ produce recombined information using a specific algorithm, and in the process, it is necessary to utilize parameters that are differentiated from prior art. On the other hand, if a non-common device and its associated software are added, or a new index showing a correlation with a specific disease is presented as an input value or learning data to the software, it is helpful in non-obviousness. Finally, when describing the beneficial effects of an invention, it is more advantageous to specify the beneficial effects of software implemented in hardware than the effects of cognitive behavioral therapy methods in order to secure inventive step. Registering a stable patent plays a very important role in minimizing invalidity disputes and providing motivation for continuous research and investment. Therefore, it cannot be emphasized enough that meticulous attention should be paid to the description of the scope of claims in patent application. Accordingly, it is expected that the patent law will contribute to the development of related industries by securing stable rights to digital therapeutics. In addition, since medical treatment fundamentally pursues egalitarianism, digital therapeutics can greatly contribute to reducing the medical gap and ultimately improving public health.