后TRIPS時代的藥品專利保護:趨勢、影響與因應——以發展中國家的立場為視角

"The Protection of Pharmaceutical Patent in the Post-TRIPS Era:Tendency,Impacts and Countermeasures——From the Perspective of Developing Countries"

新冠疫情的爆發引發了全球對藥品可及性議題的高度關注。進入后TRIPS時代，發達國家正通過賦予藥品試驗數據以獨占權保護、延長對藥品專利保護的期限、鏈接仿制藥上市許可與藥品專利保護以及將藥品專利保護與投資議題掛鉤的方式迂回地推動藥品專利的強保護發展。這種強保護趨勢潛在地推動了原研藥品的''常青化''保護，限制了發展中國家知識產權立法的靈活性進而加劇了發展中國家的藥品可及性困境。應對藥品專利的強保護趨勢，首先，發展中國家應根據本國國情主動內化藥品專利保護的新制度以適應藥品專利的強保護趨勢。其次，發展中國家可考慮持續積極采用橫向場域轉移策略以實現自身的利益訴求。最后，在維護《TRIPS協定》核心地位的基礎上，發展中國家應積極參與到投資與知識產權議題的談判中去。

"The outbreak of the COVID-19 epidemic has aroused global attention to the issue of ''access to medicines''.In the post-TRIPS era,developed countries are promoting strong protection of pharmaceutical patents in a roundabout way by granting exclusive rights to pharmaceutical trial data,extending the patent term for drugs,linking the marketing authorizations of generic medicines to pharmaceutical patents,and linking pharmaceutical patents to investment issues. This tendency towards strong protection potentially promotes ''evergreening '' of Original medicines,limits the flexibility of IPRlegislation in developing countries,and exacerbates the ''access to medicines''dilemma in developing countries.In response to the tendency of strong protection of pharmaceutical patents,firstly,developing countries should internalize the new system of pharmaceutical patent protection according to their own national conditions in order to adapt to the tendency of strong protection of pharmaceutical patents.Secondly,developing countries may consider continuing to actively adopt forum shifting strategies to achieve their own interests.Finally,on the basis of maintaining the core position of the TRIPS Agreement,developing countries should actively participate in negotiations on investment and intellectual property issues."