14 years ago

Korea Moves to Implement an “Orange Book”-Type Registration System for Patents Covering Approved Pharmaceuticals

Action is currently underway in Korea to establish a patent registration system for pharmaceutical drugs that have received market approval.  The registration scheme when implemented will be similar to that of the procedure in the U.S., which provides for patents covering FDA-approved drugs to be listed in a centralized listing known as the Orange Book.

The provisions being advanced for enactment in the Korean Pharmaceutical Affairs Act (“KPAA”) will also include provisions similar to those under current Paragraph IV notification practice in the U.S.  In the Korean version, a party applying for marketing approval from the Korea FDA, based on safety/efficacy data of an existing drug whose patent is listed in the Korean registration list, must notify the patent owner of the application to the Korea FDA for market approval. 

This notification requirement is subject to some exceptions, but is generally applicable when the patent at issue is/will be in force at the time of the applicant’s marketing of the follow-on product and there is no authorization from the patent owner and no judicial or governmental action precluding patent enforcement.

The text of the proposed amendment is set out below.

Korean Pharmaceutical Affairs Act>

Article 31(ii) (protection of drug patents)

(1)   The Commissioner of the Korea Food & Drug Administration shall register patent information such as the patentee of a drug for which a marketing approval is obtained, the person who obtains the marketing approval (“patentee et al.”), and the patent term, in a drug patent list (“patent list”), and publish such drug patent list, according to Article 31(2) or 31(3).

(2)   The person who applies for a marketing approval of a drug based on safety or efficacy data of the drug registered in the patent list shall notify the patentee et al. of such application, according to Article 31(2) or 31(3), except for cases falling under the following subparagraphs:

(i)                 Where the patent term has expired;

(ii)               Where the marketing approval is applied under the condition that the drug would be sold after the patent has expired;

(iii)             Where there is a consent of the patentee et al. or an equivalent thereof;

(iv)             Where the Intellectual Property Tribunal or the Court rendered a decision that the drug patent registered in the patent list is invalid, or the drug for which the marketing approval is applied does not fall within the scope of the registered patent, prior to the application for a marketing approval; or

(v)               Where there is an acknowledgement by the Ministerial Decree from the Ministry of Health and Welfare for the reasons corresponding to subparagraphs (i) to (iv) of this section.

(3)   Proceedings according to sections (1) and (2), including subjects to be registered in or deleted from the patent list, procedure/method, the contents of the notification of the application for marketing approval, and the deadline therefor, shall be prescribed by the Ministerial Decree of the Ministry of Health and Welfare.

Upon enactment of the legislation, patent owners will need to coordinate registration of Korean drug patents with the Korea FDA to obtain the notification safeguards of the statute, and generic manufacturers will need to carefully review the strength and scope of claims in Korean drug patents on the Korea FDA register and give proper notice to the owners of patents covering the brand products for which they seek generic approvals.

Steven J. Hultquist

March 18, 2011