药品专利期限补偿制度国际化及我国应对之策

The Internationalization of Drug Patent Term Extension System and China’s Responses

药品专利期限补偿制度呈现出国际化的趋势。全球制药产业竞争是药品专利期限补偿制度国际化的推动力量。药品专利与药品价格之间的关系则是国际社会争论的焦点问题。药品专利期限补偿制度国际化进程中出现了由隐形向协同、由形式主义到实质主义、由选择性义务向强制性义务的范式转化趋势。我国应当在未来的自由贸易协定谈判中纳入药品专利期限补偿议题。在具体条款设计方面,应当在形成统一范本的前提下,区分不同谈判对象,灵活选用不同的内容范式,并且采用协同范式以规制其制度风险。

The drug patent term extension system presents an international trend.Global pharmaceutical industry competition is the driving force for the internationalization of drug patent term extension system,and the relationship between drug patents and drug prices is the focus of international debate.In the process of internationalization of the drug patent term extension system,the paradigm changes from stealth to synergy,from formalism to substance,and from selective obligation to compulsory obligation.China should include the issue of drug patent term extension in future FTA negotiation.In terms of specific provisions,under the premise of forming a unified model,different negotiating objects should be distinguished,different content paradigms should be used flexibly,and a collaborative paradigm should be used to regulate institutional risks.