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本文对美国的知识产权法律法规以及药品市场准入中涉及的知识产权制度进行深入研究,并在总结分析国外品牌制药公司的专利保护策略以及仿制药公司在欧美市场中成功推出仿制药的案例基础上,提出了中国仿制药进入欧美市场的知识产权应对方法和策略,包括:(1)全面了解中欧美知识产权法律法规及市场准入中涉及的知识产权制度,是进行知识产权风险评估的基础;(2)全面分析研究对象的知识产权保护现状是进行知识产权风险评估的关键;(3)借鉴国外制药公司的经验是提高应对知识产权风险能力的有效途径;(4)选择合理有效的应对策略是仿制药顺利进入欧美市场的保障。本文提出的方法和策略对中国制药企业进入欧美仿制药市场具有一定参考和借鉴意义。
This article deeply studies the IPR laws and regulations in the United States and the intellectual property system involved in the drug market access. Based on a summary of the patent protection strategies of foreign branded pharmaceutical companies and the successful case studies of generic drug companies in the European and American markets (1) A comprehensive understanding of the IPR laws and regulations and the intellectual property systems involved in market access in Central, European countries and the United States is the basis for conducting IPR risk assessment ; (2) a comprehensive analysis of the status quo of IPR protection is the key to IPR risk assessment; (3) drawing on the experience of foreign pharmaceutical companies is an effective way to improve the ability to deal with IPR risks; (4) choosing a reasonable and effective response Strategy is a generic drug smoothly into the European and American markets. The methods and strategies proposed in this paper have certain reference and reference significance for Chinese pharmaceutical companies to enter the generic drug market in Europe and the United States.