제약산업의 기술혁신에서 특허와 의약품 안전규제기관의 규제가 미치는 영향과 한국의 방향 - 한국 제약산업의 특징과 생물학적 제제를 중심으로 -

Role of patent in facilitating innovations is considered most positively in the pharmaceutical industry than any other industries. However, patent works differently in even traditional small molecule drugs by countries such as the U.S, India, and Israel. Specifically, drug safety regulation agency(hereafter “regulation agency”) plays more roles in countries where generic drug companies are seen as important. Korea's pharmaceutical industry has continued to grow and innovate centering around generic drug companies while having started as a substitute industry for import and gone through turning points which provided the pharmaceutical market for the environment in which regulation agency exerts more influence than patent does. Besides, Korea's patent practices have limited patent's role in the pharmaceutical industry through the interpretation of non-obviousness and novelty. The role of regulation agency in innovations has emerged to the surface and gained more importance recently such as providing market exclusivity to the generic drug company which successfully challenges the patent as a first mover. The comparative role of regulation agency is more important in biologics which are mainly using recombinant DNA technology. Attaining approval of regulation agency in biological similarity is more difficult in Biosimilars which are generic drugs of biologics. To achieve technological innovations in Korea's pharmaceutical industry, more efforts should be focused on roles and reforms of safety regulation agency than patent.