September 21, 2004
Underlying Procedure for the Grant of a Compulsory License:
The proposed legislation provides for the applicant to seek the
granting of a compulsory license through the established patent court
system. The court of first instance is the Intellectual Property
Tribunal of the Korea Intellectual Property Office. An appeal of the
decision of the Intellectual Property Tribunal rendered by a trial board
consisting of three trial examiners may be lodged with the Patent Court
(High court) and then the Supreme Court of Korea.
Applicant and Pharmaceutical Product:
Anyone who intends to export pharmaceutical products to an Importing
Country (as defined below) may request for the granting of a compulsory
license. The term "Importing Country" shall mean (A) an LDC designated
by the UN; (B) a non-LDC WTO member; or (C) a non WTO member.
The same definition for the term "pharmaceutical products" adopted by
WTO General Counsel's decision is adopted.
The right to seek a compulsory license described above applies to all
products within the scope of the term "pharmaceutical products" without
exception.
Contents of Application and Documents to be Submitted by the Applicant:
The applicant shall set out in the application form: (A) the name and
quantity of the pharmaceutical product; (B) list of the Importing
Countries; (C) the name of the patentee and the patent number; and (D)
compensation to be paid to the patentee. The Presiding Trial Examiner
can request the patentee to submit additional information if there are
any further patents or patent applications related to the product not
initially specified by the applicant.
The applicant has to submit documents showing: (A) that the Importing
Country has insufficient or no capacity for the production of the
pharmaceutical product in case the Importing Country is not an LDC;
(B-1) that the Importing Country has submitted a notification to the
Council for TRIPS under Paragraph 2(a) of the Decision of General
Council of 30 August 2003; (B-2) that the Importing Country submitted a
notification to the Minister of Foreign Affair in the prescribed form;
(C) the specific packaging or labeling of the product; (D) the address
of the website at which the contents of the compulsory license will be
posted; and (E) that the applicant had, at least thirty days before
filing the application, sought from the patentee a license to
manufacture and sell the pharmaceutical product for export to the
Importing Country and that such efforts had not been successful. The
applicant can supplement the documents set forth in above (A) to (E)
even after the application has been filed. The requirement of
negotiating with the patentee set forth in (E) above is deemed to have
been met if the Importing Country has notified that it will permit the
use of the concerned patent (i) due to national emergency or other
circumstances of extreme urgency, (ii) for public non-commercial use, or
(iii) to remedy a practice determined after judicial or administrative
process to be anti-competitive.
Trial Decision:
A decision will be rendered within thirty (30) days after the
applicant has submitted all of the required documents.
The decision shall set out: (A) the name and quantity of the
pharmaceutical product; (B) the list of the Importing Countries; (C) the
patent number; (D) the consideration to be paid to the patentee and the
method of payment; (E) specific packaging or labeling of the product;
and (F) a the address of the website at which the contents of the
compulsory license will be posted.
Compensation:
The compensation to be paid by the licensee to the patentee is
determined by the following formula: (sales quantity) x (price per unit)
x (contribution rate) x (basic rate) where sales quantity refers to the
aggregate quantity of the pharmaceutical product exported each year to
the Importing Country, price per unit is the average price of the
pharmaceutical product in the Importing Country calculated each year,
contribution rate is the ratio of the patent used in the manufacture of
the product, and basic rate is 4%. The basic rate may be adjusted within
plus or minus 2% in consideration of the innovative nature of the patent
and economic value in the Importing Country. When the compensation
cannot be determined by the formula, the Trial Board can determine the
appropriate compensation to be paid based on its consideration of the
economic value of the patent, prices of the Importing Country and the
international humanitarian interest. However, the compensation cannot
exceed 6% of net price of the product in the Importing Country.
Even if a patentee does not agree to the compensation, the patentee
cannot appeal the grant of a compulsory license based on such compensation.
Obligations of the Licensee and Cancellation of the Compulsory License:
The licensee shall: (A) not export the product in excess of the
quantity set forth in the trial decision; (B) not export the product to
any countries other than as set forth in the trial decision; (C) not use
different packaging and labeling of the product set forth in the trial
decision; (D) post the information set forth in the trial decision on
the web site set forth in the trial decision; and (E) not ship the
product when a compulsory license, if required in the Importing Country,
was not granted.
The Commissioner may cancel the compulsory license upon request from
the patentee or /ex officio/in case that: (1) the licensee fails to
fulfill in good faith any of the obligations set out above (A) to (E);
(2) the Importing Country notifies that the circumstances which led to
the compulsory license cease to exist; and (3) any other circumstances
which led to the compulsory license cease to exist.
Coming into Effect of the Compulsory License:
The grant of a compulsory license becomes effective only after the
Commissioner has recorded the contents of the trial decision on the
Patent Register.
The licensee may from time to time request the Commissioner to make
changes in the Patent Register as to the quantity, the packaging or
labeling of the product when such a change occurs after the grant of the
compulsory license.
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