KLRI : KOREA LEGISLATION RESEARCH INSTITUTE

Ⅰ. Backgrounds and Purpose

▶ Background and Purpose of Research

○ Our patent review practice takes an attitude of denying patentability, citing the flaws in the "industrial availability" of Article 29 paragraph 1 of the Patent Law.

○ This is due to the ethical aspect that recognizing a patent on a medical method hinders the health of mankind by restricting medical services to humans, or that patients' right to life is not sufficiently protected.

○ This attitude is vulnerable to promoting research motivation and promoting the development of medical technology through compensation for inventors.

○ This study will seek an optimal point of contact between the two propositions of promoting the development of medical technology and ensuring public health of the people.

▶ Contents and scope of research

○ This study is intended to examine the eligibility of 'medical methods' and will research the recognition of patent eligibility of medical method invention.

○ The main purpose is to discuss the limitations of existing discussions and to analyze overseas legislative cases.

 

Ⅱ. Major Content

▶ The patentability of medical methods and medical activities

○ The Practical Standards of Patent denied the possibility of industrial use for the invention of surgery, treatment, or diagnosis of human body as an essential element.

○ The 2018 criteria defined clinical judgment as "psychological activity to determine a disease or health condition based on medical instructions or experience“

○ However, in order to clarify the subject of clinical judgment through the revision of the criteria in 2019, 'medical person' was specified as the subject, and the current standard states that the medical person is the subject for the general medical practice.

○ These amendments would be based on the institutional environment in which patents can be established by 'artificial intelligence'.

○ Therefore, only clinical judgment or invention of medical methods by medical person will deny industrial availability.

▶ Necessity of re-examine existing discussions

○ Industrial development and health promotion are not necessarily mutually exclusive values, it denies the patent eligibility of medical activities by prioritizing health promotiont, but it is not believed that defining diagnosis using artificial intelligence as an exception does not only promote the development of related technologies and retreat the promotion of health promotion.

○ First, the development of diagnostic technology incorporating artificial intelligence can improve medical standards by reducing misdiagnosis rates, and the difficulty of clinical decision making is that reasonable judgments should be made from limited information.

○ Second, since diagnostic technology using artificial intelligence has less time and place limitations, it can increase the availability of medical care and the accessibility of patients to medical care.

▶ Comparative Legal Implications

○ The patent eligibility of medical method inventions is in principle negated in most countries except the United States.

○ However, the method varies from country to country, but in the case of Korea and Japan, it distinguishes between the invention of medical methods that can be patented through patent screening standards and those that are not, although they are not legally patent reasons, but deny industrial availability.

○ On the other hand, the EU defines the invention of the medical method as an unpatented reason through the law (EPC), and the U.S. allows it in principle, but the medical practice of medical workers does not have the effect of patent rights, imposing certain restrictions on the public interest.

○ There has been a recent revision of the patent review criteria for the recognition of patentability in diagnostic methods, and if the diagnostic activity does not include clinical judgment, patentability can be recognized unless it includes steps that are direct and temporary to the human body.

○ For example, "How to Detect Albumin in Urine for Diagnosis of Kidney Diseases" is a conventional practical diagnostic activity that negates industrial availability, but is now patentable through the revision of the screening criteria in 2008.

○ Furthermore, there was one more revision of the patent screening criteria for exceptional reasons to recognize the patentability of such diagnostic actions in 2019.

○ While artificial intelligence technology has been rapidly developing and expanding its use, especially in the field of diagnosis, it was unclear whether such convergence technology constitutes an act of diagnosis that could be recognized for its industrial availability.

▶ Exploring alternative legislative measures

○ This attitude is because medical technology or methods such as surgery, treatment and diagnosis are not persuasive in many respects to conclude that they are not available in industry because there is room for medical practice.

○ Although the dosage or dosage of medicines that can be seen as part of the treatment method for patients is considered a component of the use invention, it is also inappropriate not to apply to other general treatment or diagnostic activities.

○ In addition, a change in the current system will be necessary considering the current state of legislation worldwide, the trend of granting patents to recent medical practices, and the times in which the importance of the bio-industry is emphasized.

 

Ⅲ Expected Effects

○ In order to determine at what level the patent eligibility of medical practice should be recognized, it is necessary to first gather opinions from various fields, including the medical community, the pharmaceutical industry, consumer organizations, academia, legal circles, and patent industries, to derive a social consensus.

○ If the direction of patent protection is determined through social consensus, it is expected that the patent review standards can be revised or the patent law revised based on this.