我国药品专利补偿期限制度的研究
Research on the Compensation Period System of Drug Patent in China

药品专利期限补偿制度是美国、日本与欧盟等发达国家为缓解因严格药品上市审批制度而导致的创新药保护困境而制定的延长新药专利实质保护期的规定。因药品上市经过临床试验和上市审批时间过长，导致药品专利权期限被侵占进一步影响个人利益以及社会公共利益。当前2023年我国国家知识产权局所发布的《专利法》解释与《专利法》(2023年新修)对其规定较为粗略，且身为下位法的《专利法实施细则》本身没有对于药品专利期限补偿制度具体如何实施做出解答。同时我国药品专利期限补偿制度没有正式付诸实践，仍旧存在相应困境，有必要进行系统梳理和分析，结合域外法律实践经验、我国基本国情与医药行业现状，对上述现实困境予以回应。
The drug patent term compensation system is a provision formulated by developed countries such as the United States, the Japan and the European Union to alleviate the dilemma of innovative drug protection caused by the strict drug marketing approval system. Due to the long time for the drug to be marketed after clinical trials and marketing approval, the term of the drug patent right is encroached upon, which further affects the personal interests and the public interest. At present, the provisions of the Patent Law issued by the State Intellectual Property Office of China in 2023 and the Patent Law (newly revised in 2023) are relatively rough, and the Detailed Rules for the Implementation of the Patent Law, which is a subordinate law, does not provide an answer to the specific implementation of the drug patent term compensation system. At the same time, China’s drug patent term compensation system has not been formally put into practice, and there are still corresponding difficulties, so it is necessary to systematically sort out and analyze, and respond to the above practical difficulties in combination with foreign practical experience and the current situation of China’s pharmaceutical industry.