MARKET EXCLUSIVITY PERIODS AND PATENT CHALLENGES IN PHARMACEUTICALS IN SOUTH KOREA
Author(s)
Park H1, Lee T2
1Ministry of Food and Drug Safety, Cheongju-si, South Korea, 2Seoul National University, Seoul, South Korea
OBJECTIVES: According to the Free Trade Agreement between South Korea and the US, patent linkage in pharmaceuticals came into force in March, 2012. The patent linkage is expected to influence the dynamics of pharmaceutical market. This study aims to analyze brand-name and generic drug competition in South Korea. METHODS: We gathered and analyzed the information on marketing approval of pharmaceutical products and patent rights of drugs on the Green List (drug-patent list). Among 1,088 drugs on the Green List, 130 brand-name drugs which have had their generic drugs approved and 160 patents which have been challenged by their generics were included in this study. Market exclusivity period was defined as the period between market approval of a brand-name drug and market approval of its first generic. The period between patent application of a brand-name drug and the first patent challenge was calculated. The factors that affect market exclusivity periods and the period up to the first patent challenge were also identified using multiple regression models. RESULTS: The average market exclusivity period was 7.2 years and showed a declining trend. The market exclusivity period tended to decrease if the brand-name drug of interest is for diabetes and when the number of its generic is large while it tended to increase if the drug of interest is a new one. Meanwhile, patent challenge has increased drastically in recent years. The average period up to the first patent challenge was 11.4 years. It tended to increase if the patent includes substance patent while it decreased in the case of biopharmaceutical products. CONCLUSIONS: As a result from brand-name and generic drug competition, market exclusivity periods were shortened and the patent challenge became more frequent in South Korea. Further studies are warranted to analyze the effect of implementing patent linkage in a full scale.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PHP27
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
Multiple Diseases