Abstract

The implementation of the pharmaceutical patent term compensation system can greatly stimulate the research and development enthusiasm of pharmaceutical enterprises, enhance the accessibility of medicines and promote the national health level. However, the system is still in the preliminary stage of implementation, and there are still a lot of inconsistencies with the real contradictions and the national situation. Through the study, it is found that the following problems exist in the implementation of China's pharmaceutical patent term compensation system: the details of the legislative provisions have not yet been perfected, the approval process cannot exclude the malicious opposition, the interests of creation and imitation are not yet balanced, and the opposition procedure is difficult to implement. Based on this, a systematic study of the legal framework and practice of pharmaceutical patent term compensation system in other countries is conducted, and corresponding solutions to the problems are proposed, i.e., improving the legislative framework and specific provisions, optimizing the examination and approval process and regulatory mechanism, balancing the incentives for innovation and the public interest, and establishing an opposition procedure to prevent abuse of rights, with a view to contributing to the improvement of the system.

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