1 College of Pharmacy, Ewha Womans University, Seoul, South Korea.
2 Institute of Health and Environment, Seoul National University, Seoul, South Korea.
Int J Health Serv. 2019 Apr;49(2):306-321. doi: 10.1177/0020731418822237. Epub 2019 Jan 9.
This study evaluated the effect of the patent linkage system, fully introduced by the Korea-U.S. Free Trade Agreement in 2015, on patent challenges and the effective market exclusivity of new medicines in Korea. We used pharmaceutical approval data and pharmaceutical litigation data to detect new medicines and their counterparts, to collect patent challenges against new medicines, and to calculate effective market exclusivity for new medicines. Then, a nonparametric event history model was applied to statistically explain the duration of the market exclusivity of new medicines. Between 2007 and 2011, a total of 94 new medicines, consisting of 82 new chemical entities and 12 new biologics, were approved. The patent linkage system encouraged patent litigations to occur sooner, with a race to challenge the patents by various generic applicants. However, it was difficult to conclude that patent challenges had a significant impact on the prolongation of effective market exclusivity. The patent linkage system had a neutral effect on the effective market exclusivity of new medicines and encouraged patent challenges without abbreviating effective market exclusivity. In addition, this study highlights an important issue regarding biologics that has not been the subject of market competition, even for patent challenges.
本研究评估了专利链接制度的效果，该制度于 2015 年由韩国-美国自由贸易协定全面引入，对韩国的专利挑战和新药的有效市场独占权产生了影响。我们使用药品批准数据和药品诉讼数据来检测新药及其对应药物，收集针对新药的专利挑战，并计算新药的有效市场独占期。然后，应用非参数事件历史模型来从统计学上解释新药市场独占期的持续时间。2007 年至 2011 年期间，共批准了 94 种新药，其中 82 种为新化学实体，12 种为新生物制品。专利链接制度鼓励专利诉讼更早发生，各种仿制药申请人竞相对专利提出质疑。然而，很难得出专利挑战对延长有效市场独占期有重大影响的结论。专利链接制度对新药的有效市场独占期没有产生显著影响，鼓励了专利挑战，但没有缩短有效市场独占期。此外，本研究强调了一个重要问题，即生物制品即使面临专利挑战，也没有成为市场竞争的对象。
