투여용량 내지 투여용법을 구성요소로 하는 의약용도발명의 특허대상 여부 - 대법원 2015.5.21.선고 2014후768 판결을 중심으로 -

Pharmaceutical inventions are typically claimed as the following types: substance, composition, dosage form, dosage regimen and method thereof. Out of these types of pharmaceutical inventions, there is no clear guidance as to whether inventions relating to dosage regimen are eligible for patent or not. The problems with the patent protection of new dosage regimen stem from the fact that therapeutic methods are excluded from patent protection in Korea. Even though examination practice does not allow claims like dosage regimen, the Supreme Court in 2014Hu768 clearly opined that dosage regimen is also the subject matter eligible for patent protection and any element directed to dosage regimen in pharmaceutical inventions should be regarded as the subject matter to meet the same basic requirements of patentability as any other inventions. In the aftermath of this decision, as pharmaceutical inventions as to dosage regimen are patentable, there would be a legal loophole that therapeutic methods are also protected as patent since medical use of the patented dosage regimen is a type of therapeutic activities. To fix this loophole, it is suggested to amend the Patent Act introducing the Doctor Infringement Immunity, and to regard therapeutic methods also susceptible of industrial application for patent protection.