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Comparative Study on the Extended Patent Term to Restrain Patent Owners from Obtaining the Excessive Market Exclusivity Regarding Pharmaceuticals in Korea, the US, Japan, the UK, France, and Germany
Yakhak Hoeji 2022;66(6):350-363
Published online December 31, 2022
© 2022 The Pharmaceutical Society of Korea.

Sohee Kim*, Daesung Lee**, Hyungbin Choi*, and Kyenghee Kwon*,**,***,#

*Department of Industrial Pharmacy, Graduate school of Dongguk University
**College of Pharmacy, Graduate school of Dongguk University
***Department of Food & Medical Products Regulatory Policy, Graduate school of Dongguk University
Correspondence to: Kyenghee Kwon, College of Pharmacy, Dongguk University, Ilsandong-gu, Goyang-si, Gyenggi-do, Korea
Tel: +82-31-961-5201, Fax: +82-31-961-5206
E-mail: khkwon@dongguk.edu
Received October 31, 2022; Revised December 20, 2022; Accepted December 27, 2022.
Abstract
The extended patent term or exclusivity period from pharmaceuticals’ approval date is limited to 14 years in the US or 15 years in the EU. However there are no such restrictions in Korea, so the market exclusivity can be excessively extended. Therefore, the status of extension of patent term in Korea was analyzed and the patent term from the product’s approval date in Korea, the US, Japan, the UK, France, and Germany were compared. For that, the following information from NEDRUG or KIPRIS were collected and analyzed: the filing date of the patent, whether the patent term has been extended, the expiration date of the patent term, approval date, the products’ name, and representative claims. Alecensa, Xalkori, Biktarvy, and Champix were selected for the comparison. Among 597 patents in Korea, 90.1% (538) were extended and 17.1% (102) of patents exceeded 14 years from the approval date. There were 81 and 60 products that have patents whose term exceeds 14 and 15 years from the approval date, respectively. In the comparative cases of 4 products, the patent term from products’ approval date in Korea is longer than 14 or 15 years, whereas the US, the UK, France, and Germany comply with the regulated limitation. The excessive patent protection delays the market entry of lower-cost generics and leads to an increase in financial burden on healthcare cost. To address such problems, a proper limitation on the extension of the patent term from the product’s approval date needs to be established.
Keywords : Republic of Korea, Drug approval, Patent term extension, Market exclusivity, Patent life


December 2022, 66 (6)
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