의약품 특허보호 관련 TRIPS-Plus협정의 법적 쟁점 및 시사점

The TRIPS-Plus Agreement refers to Free Trade Agreements having provisions that restrict flexibilities under the TRIPS Agreement (hereinafter “TRIPS”) or that provides more protection than the requirement of the TRIPS. While the main function of patent system is to compensate innovation, fully functioning patent increases the price of pharmaceuticals so from the perspectives of public health, it may potentially influence on the access to medicine especially in developing countries which cannot afford. TRIPS-Plus Agreement includes patent term extension, compulsory licensing, data exclusivity, linkage between approval and patent, parallel imports. It could be easily found in the FTAs lead by the United States. In terms of the access to medicine, if the parties to the FTAs adopting TRIPS-Plus standards restrict compulsory licensing, parallel imports and extend patent term, then the availability of generic drugs which are low price compared to the original drugs is prevented. The requirement of data exclusivity and linkage of approval and patent have a possibility of making it impossible for manufacturers of generic drugs to get approval even in case of compulsory licensing or preparation phrase for the entry on the expiration of patent. Patent linkage which does not exist in the TRIPS create an obligation for the regulatory authorities to prevent possible infringement of patent which is private right or at least to decide possibility of infringement. Given the original function of the authorities and limited resource, it may be a significant burden for the authorities concerned. In terms of the international law, the relationship between the TRIPS-Plus and the TRIPS can be understood as modification of multilateral treaties between certain of the parties only in the context of Article 41 of the Vienna Convention on the Law of Treaties. Such modification should not prohibited by the treaty and should not affect the enjoyment by the other parties and should not be incompatible of the object and purpose of the treaty as a whole. There may be a controversy whether the TRIPS-Plus Agreement affect potentially the benefits of other WTO Members under the TRIPS Agreement. To avoid a possible conflict, some FTAs include side letters or understanding mentioning that the TRIPS-Plus agreement does not prevent the ability of the parties to take measures for the public health under the TRIPS Agreement but those documents have a limited value of interpretation. It does not mean that it is applied overriding the TRIPS-Plus Agreement. In conclusion, although developing countries retain some flexibilities under the TRIPS to take measures to protect public health pursuant to their social and economic priority, the TRIPS-Plus Agreement may be erode or limit significantly the protection of public health and the access to medicine if it becomes a general trend of increasing the required protection.