투여용법․용량을 포함하는 의약용도발명의 권리범위

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.