Perceived impact of the patent linkage system on pharmaceutical market from the viewpoint of the domestic manufacturers in South Korea
- Title
- Perceived impact of the patent linkage system on pharmaceutical market from the viewpoint of the domestic manufacturers in South Korea
- Author
- 손경복
- Keywords
- Patent linkage; Perception; Manufacturer; Policy evaluation; South Korea; Public aspects of medicine; RA1-1270
- Issue Date
- 2022-03
- Publisher
- BMC
- Citation
- Globalization and Health, Vol 18, Iss 1, Pp 1-8 (2022)
- Abstract
- Background: The United States requires a patent linkage system in other countries as part of free trade agree‑
ments. However, introducing a patent linkage system could be a signifcant 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 afecting 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 frst 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 frst
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 efects on the domestic industry, the system had positive impacts of the system
on generic manufacturers. The frst 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 frst generic drug exclusivity through patent challenges.
- URI
- https://www.proquest.com/docview/2652175362?accountid=11283https://repository.hanyang.ac.kr/handle/20.500.11754/170793
- ISSN
- 1744-8603
- DOI
- 10.1186/s12992-022-00829-1
- Appears in Collections:
- COLLEGE OF PHARMACY[E](약학대학) > PHARMACY(약학과) > Articles
- Files in This Item:
There are no files associated with this item.
- Export
- RIS (EndNote)
- XLS (Excel)
- XML