Patent Linkage and its Reform

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 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.

The governmental plan is distinguished from civil societies’ reform model, which includes: 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.

Experiences of other jurisdictions on linkage system such as Canada, Mexico, Australia, Hong Kong, Taiwan, Singapore, China, Philippines and so on would be helpful in improving the civil societies’ model: 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 the generic exclusivity recently.

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 litigation 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 MFDS’s website or here.