The Feasibility of the Connection between the Drug Patents Examination and the New Drug Registration / 中国药学杂志

ABSTRACT

OBJECTIVE: To improve the feasibility of the connection between the drug patents examination and the new drug registration and design the connecting pattern between them, which will enhance the appearance on the market for the patent drugs, eventually increase the drug choice for the public. METHODS: To find the connecting space between drug patents examination and the evaluation standards for drug registration by comparing the "novelty", "inventiveness", "practical applicability" standards for a patent with the "safety", "efficacy" and "quality" standards for drug registration. RESULTS AND CONCLUSION: A large connecting space between the practical applicability standard for a patent and the evaluation standards for drug registration is found in this paper. The practical applicability standard for a patent can be adjusted dynamically according to the evaluation standards for drug registration based on the development level of the pharmaceutical industry, interests of patent holders and the public, etc.