(1) Reasons for Proposal

This Partial Amendment aims to improve shortcomings in the implementation of the drug authorization-patent system introduced under the Free Trade Agreement between the Republic of Korea and the United States of America (“KORUS FTA”), protect drug-related patents more reasonably, encourage the development of competitive generic drugs, and operate the system more effectively.

(2) Major Provisions

A. Allow the registration of a patent if the patent is revised to meet registration requirements (Article 50-2 (2))

1) Currently, an application for the registration of a drug patent can be filed only within 30 days from the date of marketing approval or revised approval or from the date of registration of the patent, which makes it difficult to protect the patent as it is impossible to register the patent when the registration period expires while some part of the patent is being revised.

2) Allow the registration of a patent when the patent is revised to meet registration requirements through a trial for corrections under the Patent Act.

B. Link approved drug information with registered information, and simplify the change procedure (Articles 50-3 (3) and (4))

1) Currently, the same registered information as approved drug information is not linked in the drug patent list, which requires filing an application to change registered information in the patent list when an application to change approved drug information is filed.

2) Consider registered information in the patent list such as drug name and patent holder information to be changed if approved drug information is changed, skip a stakeholder hearing procedure for such changes, and simplify the change procedure for the patent list.

C. Allow an application for a sales ban only for drugs likely to infringe on any patent (Article 50-6 (1)) 

1) To apply for a sales ban on generic drugs, the patentee files a patent lawsuit against all the same drugs, which wastes human and financial resources, and this calls for action on the sales ban application system.

2) Allow an application for a sales ban only on generic drugs involved in a patent lawsuit and likely to infringe on any patent.

D. Overhaul exclusive marketing approval requirements (Article 50-8 (1)) 

1) One of the exclusive marketing approval requirements requires filing a petition for trial within 14 days from the filing date of the first trial or receiving a trial ruling or ruling for patent invalidity before the foregoing, which creates problems such as filing a petition for trial too early.

2) Remove the above requirement in exclusive marketing approval and allow exclusive marketing approval only if a patent-related petition for trial is fully prepared and filed before applying for drug marketing approval.

E. Overhaul requirements for unsold drugs after exclusive marketing approval (Article 50-10 (2) to (5))

1) Even if the exclusive marketing approval of some drugs that can be sold before others ceases to be effective, it is not possible to cancel or ban their sales, which allows them to be sold continuously, renders such cessation practically ineffective, and calls for addressing shortcomings with the system. 

2) Prepare requirements for the non-performance of obligations such as not selling such drugs within 2 months after exclusive marketing approval in an effort to ensure that the exclusive marketing approval system is practically effective.

F. Impose fines for non-compliance with the procedure under exclusive marketing approval (Article 98 (1))

1) There is no punitive action for non-compliance with the procedure such as proving whether a drug has been sold within 2 months after exclusive marketing approval, which makes it difficult to implement the exclusive marketing approval system effectively.

2) Impose fines of up to 1 million won for non-compliance with the procedure after exclusive marketing approval to facilitate the operation of the system.