药品专利信息登记反垄断问题研究

Research on the Antitrsut Issue of Drug Patent Information Registration

在药品专利纠纷早期解决机制中,药品上市许可持有人有义务保证所登记药品专利信息的完整性和准确性。药品上市许可持有人在具有市场优势地位情况下实施滥用药品专利信息登记权利的行为,有可能构成反垄断违法行为,需要进行反垄断规制。反垄断执法专门机构可以规范药品专利信息登记行为,仿制药企业可以提起反垄断民事诉讼,由此排除或者修正错误登记的药品专利信息。药品专利权人主观故意可以作为滥用垄断地位行为的构成要件,应当防止不适当地扩大药品专利信息登记的专利权范围。药品上市许可持有人应当在修改或者删除错误登记的药品专利信息以及对仿制药企业进行损害赔偿等方面承担法律责任。

In the early settlement mechanism for drug patent disputes,the holder of the drug marketing authorization is obliged to ensure the completeness and accuracy of the registered drug patent information.If the holder of the drug marketing authorization abuses the procedure of drug patent information registration in a dominant market position,it may constitute the violation of antitrsut law and needs to be regulated by antitrsut laws.The specialized agency for antitrsut law enforcement can regulate the registration of drug patent information,and the generic pharmaceutical company can initiate antitrust civil litigation to exclude or correct erroneous patent information.The subjective intention of the pharmaceutical patent holder can be an constitutive elements of an abuse of monopoly status,and it is necessary to prevent the improper expansion of the scope of the patent right for drug patent information registration.The holder of the drug marketing authorization shall bear legal responsibility for modifying or deleting the erroneously registered drug patent information,as well as for compensating damages to the generic pharmaceutical company.