Patent challenges and factors associated with successful patent challengers under the patent linkage system: recent evidence from South Korea after the Korea United States free trade agreement

Objectives The patent linkage system upgraded patent challenges to an important factor in granting timely market approval for generic drugs. We aim to understand patent challenges and identify the factors that are associated with successful patent challengers under the patent linkage system in South Korea. Methods We constructed a novel dataset that combined information on manufacturers with detailed data about their patent challenges after introduction of the patent linkage system. Based on the number of successful patent challenges, manufacturers were categorized into non-challengers, passive challengers, and aggressive challengers. Then, two types of logistic models were applied to identify the factors associated with successful and aggressive challengers. Findings Only 39 active ingredients were challenged by 77 manufacturers from March 2015 to December 2019. Of 171 manufacturers, 94 (55 %) were non-challengers, 58 (34 %) were passive challengers who had succeeded in fewer than 4 patent challenges, and 19 (11 %) were aggressive challengers who had succeeded in 4 or more patent challenges. Higher sales, more employees, and a greater number of reimbursed drugs were associated with being a patent challenger, while a greater number of reimbursed drugs was associated with being an aggressive challenger. Conclusion Some manufacturers utilize patent challenges to strengthen their product portfolios in the market. However, under the patent linkage system, the frequency of patent challenges is limited in South Korea compared to the United States. In particular, patent challenges against drugs in injection form and biologics are very rare.

The Trans-Pacific Partnership’s patent linkage: Unfriending or befriending the right to biologics?

The World Trade Organization brought Intellectual Property Rights into the multilateral trading system. The adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which formed part of the Agreement Establishing the World Trade Organization, established a minimum level of protection with respect to various forms of Intellectual Property Rights. However, in the aftermath of its adoption, several Free Trade Agreements, which include Intellectual Property Rights provisions of different potency, have come into existence. These Free Trade Agreements have given rise to what is commonly known as TRIPS-plus IP provisions. The provisions may renege on States’ obligation to promote access to biologics, medicines which are derived from proteins through biotechnological process. In this light, one recent Free Trade Agreement is the Trans-Pacific Partnership Agreement, which requires its Parties to implement a number of TRIPS-plus obligations, including data exclusivity and patent linkage. Against the aforementioned backdrop, this article focuses on patent linkage and explores whether the provision allows the Trans-Pacific Partnership Parties to utilize TRIPS flexibilities to promote the right to biologics. In doing so, the article provides potential responses to the question, does patent linkage deter the realization of the right to biologic? With the purpose to do so, while the first section provides a concise introduction into the agreement, the second section discusses the TRIPS standard on patent. While the third part demonstrates the nature of obligations enshrined in the Trans-Pacific Partnership’s rule on patent linkage, the fourth section investigates the obligations’ implication on the right to biologics. The last section provides the conclusion.

Does the Patent Linkage System Prolong Effective Market Exclusivity? Recent Evidence From the Korea-U.S. Free Trade Agreement in Korea

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.