Access to Medicine

South Korean President has to act as what he claimed at the WHA 73

The following statement was released on June 3, 2012 by tens of civil society organizations including Knowledge Commune. On May 29, 2020, the World Health Organization called governments, non-governmental organizations, scientists, researchers, and civil societies for a solidarity to action for equitable global access to COVID-19 health technologies. We endorse and welcome the WHO’s Solidarity …

Reforming proposals for the existing patent-approval linkage system

Abstract In order to implement the Korea-US FTA, the drug approval-patent linking system was introduced in the Pharmaceutical Affairs Act on March 15, 2015. Five-years implementation experience has provoked discussion for reforming the linkage system, and the government-led discussion focuses on procedural reform and the problems revealed in the operation of the system. However, since …

Are purposes of the patent-approval linkage system achieved?

The linkage between patent status and drug approval process consists of two elements: notification and prohibition. The notification element refers to a mechanism in which a patentee is notified of the application of marketing approval of a generic product. The prohibition element refers to a mechanism in which a marketing approval of a generic product …

Submission to the Supreme Court on olanzapine patent

Written submission on olanzapine patent was filed to the Korean Supreme Court, which was officially accepted by the Court on October 31, 2019. PDF documents of the submission are available at here and here (all in Korean). The submission was endorsed by five CSOs (Knowledge Commune, Commons Foundation, Center for Health and Social Change, Association …

Olanzapine patent dispute: Who is responsible for a price reduction made under the National Health Insurance System?

Eli Lilly’s patent on olanzapine product (Zyprexa) invoked a number of disputes with generic companies across the world. The main challenge of the generic companies is lack of novelty or inventiveness of the patent. Some jurisdictions found the patent valid, and others first decided in favor of generics (for instance, Germany and Korea). In Canada, …

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 …