한미FTA 속의 TRIPs-Plus

Pharmaceuticals serve two roles: One as a cure for disease and the other as a product. As a cure for disease, a drug's value cannot be quantified because it saves lives. As a product, profit analysis shapes every step of a drug's progression to market. With the creation of the World Trade Organization(WTO), the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) established a comprehensive IP regime that imposed minimum IP requirements on all member states. Currently 152 member states are under the umbrella of TRIPs with exception of least-developed countries. In addition to the global TRIPs agreement conducted under the auspices of the WTO, U.S are increasingly entering bilateral free trade agreements (FTAs). There is a trend in U.S's FTAs to establish IP protections that are in excess of those provided by the TRIPs agreement. These provisions are known as “TRIPs-plus”conditions. One is marketing data exclusivity and the other is patent linkage. The purpose of these provisions is to delay generic drug manufacturers in getting approval to market their product, thus keeping the market free from competition-even when a patent term has expired. In addition, two provisions may impact the ability of a government to issue a compulsory license, which is considered a valuable mechanism for reducing drug prices. The patent infringement exemption are termed the Roche-Bolar provisions(or Bolar provisions). After the 1984 U.S. case of Roche products. Inc. v. Bolar Pharmaceutical Companies are introduced into U.S. legislation as part of the 1984 Hatch-Waxman Act. The provisions allow generic manufacturers to compete in the post-patent market almost immediately following patent expiry because it allows for the use of a patented invention, before the expiration of the patent, in order to prepare a generic version of the drug to be ready for the production and distribution once the patent has expired. In 2007. October 31, Korean Intellectual Property Tribunal handed down a decision using and stockpiling of the patented invention before the expiration of the patent is infringement of the patent. This ruling is against trend encouraging R&D of generic pharmaceuticals heading back to the past. Art. 31. 1 of the constitution guarantees the right to health. If the government blocks citizen's right to have cheap medicine, what obligation do they fulfilling under the constitutions? legislative act and Judicial act must be done considering nation's unique environment they are living in .