Intellectual Property Provisions Relating to Drug Regulation in the TPP Agreement / 中国药学杂志

ABSTRACT

OBJECTIVE: To study the intellectual property provisions relating to drug regulation in the TPP agreement, analysize the interaction mechanism between drug regulation and intellectual property rights on the basis of information sharing, study the possible impact, and then discusses the references to China. METHODS: This article analysizes the TPP final text and relevant research literatures, study the interaction mechanism between drug regulation and intellectual property rights and the possible impact of, and then discuss the relevantlaw of China. RESULTS: The TPP agreement provides several intellectual property provisions relating to drug regulation, demanding the concordant relation between the registration of pharmaceutical and patent protection period, drug data protection and patent protection, which will establish the interaction mechanism based on information sharing. The intellectual property provisions relating to drug regulation are a summary of the experience of the TPP parties forming a coordinated and interactive mechanism between encouraging innovation and ensuring drug safety and an attempt to a wide range practice, which will have abroad impact on the biopharmaceutical industry. CONCLUSION: Refer to the relevant experience in TPP agreement, China can amend the Pharmaceutical Administration Law and the Patent Law in the process of revision by improving the information sharing mechanism to achieve a higher level of institutional interaction.