《专利法》修改:药品专利期限补偿条款的解读与分析

“Patent Law”Revised:Research and Analysis on the Compensation Clauses of Drug Patent Term

新修订的《专利法》第42条确立了我国的药品专利期限补偿制度。补偿范围、适用条件、补偿年限、补偿期的计算方式等具体问题由《专利法实施细则修改建议(征求意见稿)》予以明确。与域外其他国家相比,我国药品专利期限补偿制度采取了谨慎的立法态度,在申请条件、补偿期的双重限制和减法计算方式等方面更加严格,一定程度上对国内药企、仿制药企发展形成阻碍。当然,新《专利法》第42条建立的药品专利期限补偿制度对于鼓励药企创新、促进市场竞争、引进进口药具有十分积极的意义,但未来在法律规则细化,药企创新能力提升和保障药品可及性方面仍需进一步加强。

Article 42 of the newly revised“Patent Law”establishes Chinese drug patent term compensation system.Specific issues such as the scope of compensation,applicable conditions,compensation period,and calculation method of compensation period are clarified by the“Proposals for Amendments to the Implementation Rules of the Patent Law(Draft for Comment)”.Compared with other countries,Chinese drug patent term compensation system adopts a cautious legislative attitude.It is more stringent in terms of application conditions,double restrictions on the compensation period,and subtraction calculation methods,which may hinder the development of domestic pharmaceutical companies and generic drug companies.Of course,the establishment of a drug patent term compensation system under Article 42 of the new“Patent Law”has a very positive significance for encouraging pharmaceutical companies to innovate,promote market competition,and introduce imported drugs.In the future,it is still necessary to actively respond to the refinement of legal rules,enhance the innovation capabilities of pharmaceutical companies,and ensure the availability of drugs.