生物药专利链接与管制性排他权的冲突与制度协调

The Conflict and Institutional Coordination of the Patent Linkage of Biological Drugs and the Right of Regulatory Exclusivity

美国根据《药品价格竞争与专利期补偿法》与《生物制剂价格竞争与创新法案》的要求,分别设计了针对化学小分子药品与生物大分子药品的药品专利链接制度,以达到药品创新激励与仿制药获取之间的利益平衡。然而,《生物制剂价格竞争与创新法案》所赋予的管制性排他权极大地阻碍了仿制药的获取,美国生物药专利链接制度凸显的一系列问题提示我们在建立药品专利链接制度时需要重新考量药物创新激励与管制性排他权的衔接问题,从而建立实现以创新为基石,促进高质量仿制药发展为目的的药品专利链接制度。

Through the Drug Price Competition and Patent Restoration Act and the Biologics Price Competition and In⁃novation Act,the United States designed two sets of different drug patent linkage systems for chemical small molecule drugs and biological macromolecule drugs respectively,so as to achieve the balance of benefits between promoting drug innovation incentives and obtaining generic drugs.However,the regulatory exclusivity right granted by the Biologics Price Competition and Innovation Act greatly obstructs access to generic drugs.A series of problems highlighted by the biological medicine patent linkage system in the United States suggest that we need to reconsider the connection between the drug patent linkage system and the right of regulatory exclusivity,so as to develop the drug patent linkage system with innovation as the cornerstone for promoting the development of high-quality generic drugs.