바이오특허연구회

□ 용법으로 특정된 의약발명, 진단 확인을 위하여 인체로부터 각종 자료를 수집하는 방법발명에 대한 심사가이드라인의 구체례 등이 부가되었음 □ 개정안의 내용 (1) Regarding Part II, Chapter 1 "Industrially Applicable Inventions" (i) The methods for gathering data from the human body is made not considered to be "the diagnostic methods practiced on the human body," as long as it does not contain the surgical or therapeutic steps or the steps of judging the condition of diseases etc. of human for medical purposes. (ii) The examples of the inventions related to the combinations of products (combination of physical means and biochemical means, combination of tissue-derived materials and scaffolding materials, and combination of tissue-derived materials and medicine etc.) are added. (iii) It is made clear that the methods for cellular differentiation and induction etc. are not "methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body," and the examples of the inventions of related arts are added. (iv) The examples of the inventions of arts related to assisting devices are added. (2) Regarding Part VII, Chapter 3 "Medicinal Inventions" (i) In medicinal inventions, the invention is novel when there is difference between the invention and the conventional medicine in medicinal use of applying to a specific disease with a specific dosage and administration. (ii) The examples of the inventions characterized in the medicinal use of tissue-derived materials (cells etc.) are added. (iii) The examples of the inventions characterized in the medicinal use of cells specified by manufacturing process are added. □ 첨부 : 심사가이드라인 revision draft 1. Draft Revision of Examination Guidelines for "Medicinal Inventions"(영문) 2. Draft Revision of Examination Guidelines for "Industrially Applicable Inventions"(영문)