Patent

Critical study on patent infringements and presumption of negligence

Abstract Presumption of negligence in finding liability of patent infringements was introduced in the Korea Patent Act of 1974 by imitating the Japanese Patent Act amendment of 1959. Interestingly, the Japanese amendment was motivated by the UK Patent Act of 1949 which exempted the monetary liability of an innocent infringer. This was a misunderstanding of …

The Supreme Court ruled in supportive of public health policy in olanzapine patent dispute

In Olanzapine patent disputes, the Supreme Court ruled as we claimed. See, decision in Lilly Korea v. Hanmi and decision in Lilly Korea v. Myung-In (all in Korean). The Court did not recognize that generic companies are liable for the reduction of upper price limit of patented product, Zyprexa (Olanzapine) even when the reduction was …

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 the 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 …

US Ambassador confirmed patent linkage under FTA includes biologics

One of the controversies in implementing the KorUS FTA is whether biological products are subject to the patent linkage obligation of the KorUS FTA. The debate was provoked by the Korean government’s proposal which applies the patent linkage to biologics. But it is unclear if the FTA text imposes such an obligation.  Chapter 18 (IPRs) has no definition …