专利链接制度中拟制侵权之认定

Artificial Infringement in Pharmaceutical Patent Link System

第四次专利法修改引入了药品专利链接制度,规定专利权人可以就仿制药生产者申请上市审批的药品相关技术方案是否落入其药品专利权保护范围提起诉讼,为高效解决原研药专利权人与仿制药生产者之间的专利纠纷提供了途径。但从侵权法角度来看,专利挑战行为的侵权定性尚不明确,不具备传统的侵权构成要件。如果提起诉讼,需要构建以拟制侵权为核心的药品专利诉讼制度,将专利挑战行为拟制为侵权,并限定其使用范围,明确其赋予管辖权的功能,进一步完善专利链接制度。

The fourth revision of the Patent Law introduced the drug patent link system, which stipulates that the patentee can file a lawsuit on whether the drug-related technical solution applied by the generic drug manufacturer for marketing approval falls within the scope of protection of the drug patent right, in order to efficiently resolve the patent right of the original research drug. Patent disputes between people and generic drug producers provide avenues. However, from the perspective of tort law, the characterization of the infringement of patent challenge is not clear, and it does not have the traditional elements of infringement. If a lawsuit is filed, it is necessary to build a drug patent litigation system with fictitious infringement as the core, make the patent challenge act as an infringement, limit its scope of use, clarify its function of conferring jurisdiction, and further improve the patent link system.