我国“Bolar例外规则”的学理解构与制度重建

Interpretation and Reconstruction of Bolar Exception Rule in China

我国"Bolar例外规则"规定于《专利法》第69条第(5)项,系为维护公共健康而对医药专利权所作的限制,通过对该条文的解读发现,其在制度构架和价值选择上有重新构建之必要。医药专利牵涉多方主体之利益,需要我们坚持公共利益优位原则,合理区分正当仿制行为与医药专利侵权行为的界限,从仿制行为的主观意图、客观行为和举证责任等方面进行综合权衡和考量。具体而言,可引入"客观衡量标准"基础上的合理注意义务来认定"行政审批目的"与"生产经营目的"的主观意图,同时需对特定环节的仿制行为之法律性质加以明确化,并优化侵权抗辩举证责任的分配规则。从我国移植"Bolar例外规则"的立法初衷来讲,对医药专利权加以必要限制有助于缓解国内公共健康危机,保障公众对药品的可及性。

China’s Bolar Exceptional Rule stipulates in Article 69(5) of the Patent Law, which is a restriction on the patent right for the maintenance of public health. Through the interpretation of the article, there is a need to relocate on the selection about the institutional framework and value. Medical patents involve the interests of multiple parties. We need to adhere to the principle of public interest superiority, reasonably distinguish the boundaries between legitimate imitation behavior and pharmaceutical patent infringement, and make comprehensive trade-offs and considerations from the subjective intentions, objective behaviors and burden of proof of imitation behavior. Specifically, the reasonable attention obligation based on the "objective measurement standard" can be introduced to determine the subjective intention of "the purpose of administrative examination and approval" and "the purpose of production and operation", and at the same time, the legal nature of the copying behavior of a specific link needs to be clarified, and optimize the distribution rules for the burden of proof of infringement defense. In terms of the original intention of transplanting the Bolar Exceptional Rule in China, the necessary restrictions on the patent right of medicine will help alleviate the public health crisis in China and protect the public’s accessibility to medicines.