Abstract
ObjectivesThe 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.MethodsWe 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.FindingsOnly 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.ConclusionSome 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.
Highlights
Patent challenges reflect conflict and competition [1]
Since the Hatch-Waxman Act, generic manufacturers in the United States can submit dossiers related to market approval for generics to the Food and Drug Administration (FDA) prior to expiration of the patent for the corresponding brand-name drug [3]
Patent challenges initiated by generic manufacturers for selectively targeted drugs with large sales volumes have been observed in the United States
Summary
Patent challenges reflect conflict and competition [1]. Changes in the regulatory processes for generic drugs have made patent challenges more critical in the pharmaceutical sector [2]. Since the Hatch-Waxman Act, generic manufacturers in the United States can submit dossiers related to market approval for generics to the Food and Drug Administration (FDA) prior to expiration of the patent for the corresponding brand-name drug [3]. These generic manufacturers can assert that one or more brand-name drug patents are invalid and/ or not infringed by their generic drugs. Researchers describe this marketing strategy employed by generic drug manufacturers as “prospecting” [7, 8]. The debates about “evergreening” of brand-name manufacturers and “prospecting” of generic manufacturers have received a great deal of policy attention in the United States and have been empirically investigated by many researchers [4, 6,7,8,9,10]
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