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 …

General Comment No. 25 and the Right to Science and Culture

Now, we got to have the final interpretation guideline for so-called ‘neglected human rights’, or the right to science and culture. On April 7, 2020, the Committee on Economic, Social and Cultural Rights (CESCR) published the General Comment No. 25 on the right to science of Art. 15 of ICESCR. The General Comment No. 25 is …

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 …

A task of copyright law for the protection of creative labor

Abstract If the paradoxical reality that copyright system which is supposed to protect individual creators serves to exploit creative labor is left unattended, the copyright system is hard to sustain. In order to alleviate the exploitation of creative labor, we need to revise the existing Copyright Act to codify measures warranting fairness rather than freedom …

Copyright L&E for nonprofit performance of music, found constitutional

The Constitutional Court of Korea upheld Art. 29(2) of the Copyright Act as constitutional (2016HunMa1115 & 2019HunGa18, November 28, 2019). The Art. 29(2) permits a public performance of commercial phonograms and audiovisual works if no profit is received in return from audience, excepting cases as prescribed by the Presidential Decree. This provision has long been …

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, …

Administrative enforcement of IP: Lessons of KORUS for RCEP

Border Measures KORUS grants a power to the customs authorities to suspend release of suspected counterfeit or pirated goods into free circulation when a right holder requests to do so with “adequate evidence”. The suspension should be applied to “all points of entry to its territory” and remain applicable for at least one year. While …