[Ip-health] Patent linkage and its reform

Heesob Nam hurips at gmail.com
Fri Apr 19 07:22:52 PDT 2019


The US has disseminated TRIPS-plus rules through FTAs. One of them is
a so-called drug approval and patent linkage system. South Korea
imported the linkage system in 2012, and the Korean model was fully
implemented from March 15, 2015.

After four-year experience, the Korean government, specifically the
Ministry of Food and Drug Safety, tries to revise the linkage system.
Still we don’t know details of the revision plan. But I know that MFDS
has consulted pharmaceutical industries for more than one year and the
revision aims at ensuring a patent protection by prohibition of
marketing approval of generic products and improving the effectiveness
of generic exclusivity.

So we, Korean civil societies, are trying to push our own reform
model. This may include: measures to prevent misuse of linkage system
or evergreening; introduction of a public body to review validity of
listed patents and control the price of patented medicines like PMPRB
of Canada; and repeal of first generic exclusivity.

I’d like to have your experiences on linkage system in Canada, Mexico,
Australia, Hong Kong, Taiwan, Singapore, China, Philippines and so on.
Especially on how the linkage has an impact on public expenditure on
medicines and generic entry, which are little observed in Korean
model, and why some countries do not allow the generic exclusivity and
why China and Taiwan introduced it recently. Further, it would be
great to know if there is any discussion on reform.

Overview of Korean linkage system

Of various linkage models, the Korean model is closer to the US one.
Differences are shorter period of automatic stay, 9-month, and a
unique generic exclusivity. The period of generic exclusivity is the
same as the automatic stay period. And unlike the Hatch-Waxman model
of the US, the Korean linkage model permits 14 days for the
eligibility of the ‘first’ generic. In other words, if a generic
applicant challenges the listed patent within 14 days from the date
when the ‘true’ first challenge was initiated by another generic
applicant. Due to this 14-day window, multiple generic applicants are
involved in a single patent challenge, resulting in a large number in
both patent litigations and owners of generic exclusivity.

For more on the Korean linkage model, refer to Guide to Drug Approval
System in Korea (April 2017), Chapter IV, Section 6 “Patent-approval
linkage system” (available at
https://www.mfds.go.kr/eng/brd/m_52/view.do?seq=71608 or
https://bit.ly/2Glu5Fw)

Best,
Heesob



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