korean drug approval-patent linkage

8/2/2019 Korean Drug Approval-patent Linkage

1/3

Central International Law Firm

March 2012

Drug Approval-Patent Linkage in Korea

The recently revised Korean Pharmaceutical Affairs Act (KPAA) stipulates a Patent List (so-

called Green List), which corresponds to the Orange Book of the US and on which patent

information relevant to an original drug (OD) may be listed. The KPAA also stipulates a

generic drug marketers duty to notify the OD marketing approval holder and OD patent

holder of the fact that he has filed an application for marketing approval of a generic drug

(GD). Details of the Korean drug approval-patent linkage system are given below.

1. Listing of Patent Information by OD Marketers

1) Who can request the KFDA to list patent information?

A person who obtains the marketing approval for an OD may request the Korea Food andDrug Administration (KFDA) to list patent information relating to the OD in the Patent List of

the KFDA (see Article 31ter(1) of the KPAA).

That is, an OD marketing approval holder, who may be a patentee or a licensee of the

patent, may request the KFDA to register patent information in the Patent List.

2) When to request entry into the Patent List

For an original drug whose marketing will be approved on or later than March 15, 2012, a

request for registration in the Patent List must be filed within thirty (30) days from the

marketing approval date (see Article 30bis(1) of the Enforcement Regulation of the KPAA).

One thing to note is that the patent linkage system also applies to drugs whose marketing

was approved before March 15, 2012. For those drugs, the deadline for making a listing

request is June 14, 2012 (three (3) months from March 15, 2012).

3) Patents eligible for listing

For the listing of patent information on the Patent List, the following criteria must be met (see

Article 30bis(3) of the Regulation):

The patent is directed to one of the following:

- substance,

- formulation,

- composition, and

- medicinal use

The patent is directly relevant to the main ingredient and its standard, ingredients and

their amounts, formulation, efficacy/effect, and method of use/dosage of the approved

drug;

The patent is directly relevant to the safety, efficacy, and quality as recognized by theCommissioner of the KFDA at the time of approving the drug based on submitted

1


2/3


March 2012

materials;

The patent differs from the patents already listed in the Patent List in the aspects of

safety, efficacy, and quality;

The patent has not yet expired and is valid; and

The drug approval is valid.

4) Information to be entered in the Patent List

The information subject to listing on the Patent List includes (see Article 30bis (2) of the

Regulation):

The name of the drug which received marketing approval and the identity of the

approval holder;

Information about the patentee (or about its agent having an address or businessplace in Korea if the patentee has neither an address nor a business place in Korea);

The registration date and the expiry date of the patent;

The patent number; and

Information about the relevant claims of the patent.

In the above, the information about the relevant claims should include a detailed description

of how each claim is relevant to the approved drug.

2. Notification by GD Marketers

1) Notification obligation

If a person applies for marketing approval of a GD and uses safety and efficacy data of an

OD listed on the Patent List, he must notify both the OD marketing approval holder and the

OD patentee except in some exceptional circumstances.

Such a notification must be made within seven (7) days from the date on which the GD

marketer applies for drug approval (see Article 30ter(1) of the Regulation).

2) Contents of the notification

A notification to the OD holder must contain the following (see Article 30ter(1) of the

Regulation):

The application date for GD approval;

The fact that the application for GD approval was made by submitting bioequivalence

test data based on the safety and efficacy data of the OD, for the purpose of selling

the GD by commercially manufacturing or importing it before the patent expires; and

Reasons for believing that the patent is invalid or that the GD does not infringe the

patent.

2


3/3


March 2012

3) Exemption from the notification obligation

A GD marketer is exempted from the notification obligation in the following cases (see Article

31quater(1) of the KPAA):

(i) Where the patent term has expired;

(ii) Where the GD marketing approval is requested on the condition that the GD will

be sold only after the patent has expired;

(iii) Where the patentee and the OD holder agree that they do not require such

notification;

(iv) Where the Intellectual Property Tribunal or a court rendered a decision that the

patent is invalid or a decision that the GD does not infringe the patent; or

(v) Under circumstances which are similar to above subparagraphs (i) to (iv) and are

provided by the Ministerial Decree of the Ministry of Health and Welfare.

3. Suspension of GD Approval

The KORUS FTA gives Korea a grace period for which Korea may postpone the

implementation of measures for suspending the GD approval process. The grace period is

three (3) years from the effectuation date of the KORUS FTA.

Accordingly, the revised KPAA does not contain provisions for staying marketing approval

proceedings of generic GDs. The KPAA is expected to be amended sooner or later to set up

a system that stays the proceeding for approving a GD when the holder of an OD patent files

a patent infringement action against the GD marketer.

As for how long a GD approval proceeding will be stayed when a patentee brings a patent

infringement action against a GD marketer, currently, the Korean government seems to

consider staying the drug approval proceeding until the issuance of a court judgment

confirming non-infringement or for twelve (12) months from the filing date of the infringement

action if no court judgment is rendered within the twelve months.

3

korean drug approval-patent linkage

Documents