투여용량·용법에 특징이 있는 의약발명의 특허성

This article is related to patentability of medicinal invention characterized in which dosage and administration is specified. According to the practice of Korean Intellectual Property Office, medical procedure such as treatment method of human being is unpatentable for the reason that requirement of industrial applicability is not met, even though it satisfies the requirements of novelty, inventive step and so on. Meanwhile, a medicinal use invention, an invention of a product, can be patented. In accordance with exhaustion of new material, the importance of medicinal use invention is growing. Recently, there are a lot of applications for medicinal use inventions which are based on discovering of a new dosage and administration as well as based on discovering of a new medicinal use of a material itself. A new dosage and administration of a medicine may be considered as treatment method of human being even though it is claimed as an invention of a product. For that reason, European country and Japan did not give a patent to a medicinal invention characterized in which dosage and administration is specified. However, according to revised EPC 2000, any substance or composition for any specific use in a method for treatment of the human can be patented provided that such use is not comprised in the state of the art. In addition, according to revised version of Japanese Patent Examination Guideline, a medicinal invention characterized in which dosage and administration is specified is also patentable provided that it satisfies the requirements of novelty, inventive step and so on. Through comparative research this article suggests to revise Examination Guideline for medicinal use invention to permit patentability of medicinal invention characterized in which dosage and administration is specified.