특허실무상 의료행위에 관한 연구: 임상적 판단과 의료인을 중심으로

Since human life is the basis of the dignity stipulated in Article 10 of the Constitution, and medical activity is directly connected to such life, the value of industrial development must step back in front of the need for health promotion. In this regard, most countries are taking a similar position, and our patent practice also denies the patentability of medical activity from a humanitarian perspective. However, diagnostic methods not involving clinical decision making can be patented as an exception from 2008. With the rapid development of AI(Artificial Intelligence) technology in the field of diagnosis in recent years, it is unclear in patent examination guidelines whether such convergence technology falls under the above exceptions. Accordingly, two major revisions were made to our patent examination guidelines in 2019. First, it has been clarified that the subject of clinical decision making is medical practitioner. This is to create an institutional environment in which industrial applicability can be recognized when performed by AI, and to protect and promote the innovative technologies that lead the so-called 4th industrial revolution. In addition, the advancement of AI-based diagnostic technology through the granting of patents will ultimately reduce the false diagnosis rate and improve the medical level, and will be consistent with the health economy by avoiding unnecessary surgery or treatment. Furthermore, AI-based diagnostic technology can increase the availability of medical care and accessibility of patients because there are few restrictions on time and place. It will be beneficial not only to increase medical demand due to the recent aging of the population, but also to respond to a large number of medical demands in a short period of time caused by an increase in infectious diseases. In short, health promotion and industrial development in the medical field are not necessarily mutually contradictory values. Second, according to the revision of clinical decision making, the definition of medical activity was consistently reorganized. In detail, while clarifying the subject of medical activity, the scope was expanded from doctors to medical practitioners. In the past patent examination guidelines, medical activity did not include practices that should be denied industrial availability from a humanitarian point of view. This amendment would be reasonable in that it resolved this. But, it is questionable that the cause of the act based on medical knowledge was newly added to the concept of medical activity. This is because medical knowledge is no longer monopolistic domain of humans, and the use of vast MI(Medical Information) is better utilized by AI, so it is not conducive to the original purpose of the revision to separate AI and medical practitioner. Furthermore, as this is an internal driver, the judgment is ambiguous, and the responsibility for proving industrial applicability belongs to the applicant, so the disadvantages of such ambiguity may lead to an excessive burden on the individual. Therefore, it is necessary to consider deleting the expression or changing it to the mental activity of medical practitioner so that it can be distinguished from information processing performed on a computer such as AI. Although these patent examination guidelines have no legal effect, they are a powerful criteria of patentability, and in particular, since we rely on patent examination guidelines for a large part of the patentability of medical practices, it has a large impact in practice. Therefore the importance of patent examination guidelines should not be underestimated, and it needs to be discussed continuously.