미국의 특허 협상 공세가 국내 제약 산업에 미치는 영향에 관한 고찰

We will require a further thorough preparation for the United States’ dominant role play to maximize the profits of its own domestic pharmaceutical companies by strong patent protection for the new drug through the FTA and TPP. Especially our domestic generic pharmaceutical companies suffer from severe revenues decline by the introduction of the patent linkage system with a permission of medical and the market power of the blockbuster companies is likely to be further strengthened owing to blockbuster pharmaceutical companies’ effort trying to seek the strategy to extend the patent term of their blockbuster drugs. Most importantly, we should strive to build pharmaceutical companies's robust business base that can compete with multinational pharmaceutical capital through patents and R&D capacity building and awareness of the importance of IP. In particular, many generic pharmaceutical manufacturers must establish a patent invalidation strategy of the global drug developer's pioneer patents, or develop improved drugs about to patent expire by joint research with the global manufacturer for new drugs and it is necessary to seek strategic alliances with the global manufacturer for entering the foreign market. Our data exclusivity requires a higher level of protection compared to the US data exclusivity and relevant regulations of the FTA. By equalizing data exclusivity period for new drugs and improved drugs, does not obtain the original purpose of the system of recognition of the value of research and development and vice versa, it is necessary to modify the system because a possibility of adverse willing to lower the innovative drug development. In future the implementation of patent linkage system with a permission of medical will strengthen patentee’s rights protection and patent dispute and litigation for generic manufacturers are to increase significantly. Conversely, our domestic pharmaceutical manufacturers’ patent challenge for patent acquisition seems to be accelerating. Only if the patent holder submit patent information list to upload by patent linkage system with permission, she is able to prevent latecomer from entering the medicine market. Accordingly, the patent holder is going to create a lot of secondary patents or to stop the approval process of generics, or to induce a reverse payment settlement to delay the entering to market. Because it affects to delay release of a relatively less expensive generic and is more likely to have an adverse effect on the finances of the national health insurance, the Pharmaceutical Affairs Law revision is to be required along with government measures to eliminate these habitual evils.