[Ip-health] Patent expired, but no generic entry

Heesob Nam hurips at gmail.com
Fri Feb 21 03:52:07 PST 2020


On 22 January, 2020, the Ministry of Food and Drug Safety made open
useful data: Pharmaceutical products to which patent rights ceased to
exist but no generic competition.

The data was retrieved from the "Green List" for linkage patents in
Korea (FYI, EPO provides a guideline on how to search the Green List
in English, here). From 2013 to 2019, in total 2,629 patents have been
registered for 1,501 pharmaceutical products. Of these, 463 products
have lost their patents due to patent term expiry or invalidation.
However, more than half of them have faced no generic competition (239
products, 52%). These 239 products having no patent and no generic
shows interesting distribution: 147 small molecule chemical drugs
(61.5%); 85 biological drugs (15.0%); and 7 traditional (herbal)
medicine (2.93%). More biological drugs have no generic competition
even when patent barriers disappear (Comparing 35.6% of biological
drugs in Green List from 2013 to 2018).

The MFDS does not provide any explanation on the cause of no patent
and no generic. But I can say that there are three reasons. First,
some products still possess regulatory exclusivity such as a data
exclusivity. Second, a market size is small and little profitability.
Third, for some biological drugs, generic producers were not able to
enter the market not because of the patent but because of high cost in
producing and complex manufacturing processes.

Heesob Nam, PhD

Representative and chief researcher, Knowledge Commune
Director, Commons Foundation
T: +82 (0)2 796 1839
M: +82 (0)10 3925 2797
hurips at gmail.com, heesobnam at commons.foundation

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