연구진흥

창의적인 신지식 창출과 산업계와의 협력적 네트워크 구축

금주의 우수논문

SSCI Article
Perceived impact of the patent linkage system on pharmaceutical market from the viewpoint of the domestic manufacturers in South Korea
손경복
  1. 성명
    손경복
  2. 소속
    약학대학 약학과
  3. 캠퍼스
  4. 우수선정주
    2022년 05월 2째주
Author
손경복 (Coll Pharm) corresponding author;
Corresponding Author Info
Son, KB(해당 저자), Hanyang Univ, Coll Pharm, Ansan, Gyeonggi Do, South Korea.; Son, KB(해당 저자), Natl Canc Ctr, Goyang, Gyeonggi Do, South Korea.
E-mail
이메일sonkyungbok@hanyang.ac.kr
Document Type
Article
Source
GLOBALIZATION AND HEALTH Volume:18 Issue:1 Pages:- Published:2022
Times Cited
0
External Information
http://dx.doi.org/10.1186/s12992-022-00829-1
Abstract
Background The United States requires a patent linkage system in other countries as part of free trade agreements. However, introducing a patent linkage system could be a significant barrier to the timely approval of generic drugs. This study aimed to evaluate the perceived impact of the patent linkage system in South Korea held by domestic manufacturers and analyze variations in evaluating the system according to the characteristics of domestic manufacturers. Methods In 2020, we conducted a questionnaire survey of 39 domestic manufacturers. The survey consisted of perceptions of the system, factors affecting patent challenges, and the perceived impact of the system. A 5-point Likert scale was used to rate each item. Domestic manufacturers were categorized into three groups based on their experience of listing a patent and acquiring first generic exclusivity. Results More than half of the manufacturers surveyed had experience of listing a patent. The patent linkage system could protect the involved patents. However, manufacturers perceived that they could successfully challenge the validity of the involved patents and then obtained market approval for generic drugs. Manufacturers responded that market size, expectations for succeeding in litigation, and expectations for manufacturing the drug were the most relevant factors when they initiated patent challenges. Manufacturers reported that the system, in particular the first generic exclusivity, enhanced the research and development capability of generic manufacturers, increased their domestic sales, and improved access to generic drugs. Conclusions The perceived impact of the patent linkage system was limited to the domestic market and generic drugs. In narrowing the impact to the effects on the domestic industry, the system had positive impacts of the system on generic manufacturers. The first generic drug exclusivity lies at the center of this positive perception. However, manufacturers perceived that the current system did not provide enough incentives for domestic manufacturers to be granted first generic drug exclusivity through patent challenges.
Web of Science Categories
Public, Environmental & Occupational Health
Funding
Ministry of Food and Drug SafetyMinistry of Food & Drug Safety (MFDS)
Language
English
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