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초록

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This article is related to scope of protection of pharmaceutical use invention including dosage regimen According to Korean Patent Examination Guideline, medical activities such as methods for treatment of the human body by surgery, therapy or diagnosis is being regarded as industrially inapplicable inventions, therefore, cannot be patented even though they satisfy the requirements of novelty, inventive step and so on. Meanwhile, Korean supreme court usually held that new dosage regimen, correspond to a medical activity, is not a constitutional element of pharmaceutical use invention. As a result, in Korea, there was no need to discuss as to scope of protection of dosage regimen. However, recently there was a Supreme Court en banc decision ruling that in cases where the administration and dosage are added on top of the target disease or efficacy of a medicine as an invention of a product, such administration and dosage should be viewed not so much as a medical practice itself, as an expression of those features through which a medicine may fully realize its efficacy, thereby constituting an element of invention that attaches an entirely new significance to the medicine as a product. A new patent may be granted to a medicine meeting the patentability requirements, including novelty and nonobviousness, by virtue of the addition of administration and dosage. Under these circumstances, it is urgent to establish the scope of protection of pharmaceutical use invention including dosage regimen and this article suggested the reasonable protection range.

목차

I. 들어가며
 II. 의료관련발명의 특허법에 의한 보호
  1. 보호와 활용의 균형의 필요성
  2. 의료관련기술의 보호형태
 III. 투여용법ㆍ용량을 포함하는 의약용도발명의 보호범위해석과 침해책임
  1. 의약용도발명은 물건발명인가? 방법발명인가?
  2. 직접침해
  3. 간접침해
  4. 금지청구권이 미치는 범위
  5. 의사의 진료행위 및 약사의 복약지시행위에 대한 예외
 V. 결론
 참고문헌
 

키워드

권리범위 의약 용법 용량 제약산업 의약용도발명 Scope of protection Medicine Administration method Dosage Pharmaceutical industry Medical use invention

저자

• 신혜은 [ Shin, Hye-Eun | 충북대학교 법학전문대학원 부교수. ]

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