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Pharmaceutical Patent - Extension of Term Provisions

Patent Term
20 years from date of filing

Pharmaceutical Patent Extension?
Yes. Article 89 Korean Patent Act.

If a patented invention is not able to be worked for more than two (2) years from grant as a result of completing tests necessary to gain permission under the Pharmaceutical Affairs Act a patent term extension is available on application.

The extension is limited to the period during which the patented invention could not be worked because of a marketing authorization still had to be obtained, i.e. the period between patent grant and grant of regulatory approval (Article 91(1) Korean Patent Act).

Upon filing of an application for extension, the term is deemed extended (Article 90(4) Korean Patent Act).

Bolar Provision
Yes.

Article 96(1) of the Korean Patents Act provides that the effects of the patent right shall not extend to the “working of the patent right for the purposes of experiment or research”.

There are no specific exemptions under Korean law to allow pre-patent expiry development work and there is no case law on this issue.

Since the patent law system of Korea is very similar to that of Japan, it is likely that the Korean courts will follow the decision of the Japanese Supreme Court in Ono Pharmaceutical v. Malco Pharmaceutical K.K (1999) which allows for generic drug manufacturers to experiment with a patented drug to obtain regulatory approval.

References
Korean Patent Act - hosted on the Korean Intellectual Property Office website

Prepared for IP Organisers by Dr Grace Chan, David Tadgell and Virginia Beniac-Brooks, Phillips Ormonde & Fitzpatrick - November 2007.