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Legislative Implementation of Flexibilities - North Macedonia

Title:Articles 97-98, 100, 102, 104,107-108 of the Law on Industrial Property No. 07-1006/1 of 12/02/2009
Field of IP:Patents
Type of flexibility:Compulsory licenses and government use
Summary table:PDF

Provisions of Law

Compulsory license
Article 97
(1) If the patent holder does not use the invention protected by a patent or uses it in a scope which is insufficient to the needs of the national market, and rejects to enter into a license agreement or sets unmarketable conditions for entering into that contract, the right to use the invention, by a compulsory license, may be assigned to another person, with the obligation to pay the fee to the patent holder.
(2) Compulsory license may also be issued if the utilisation of the invention protected by a patent is necessary due to emergency situations in the country, protection of public interest in the area of health, food, protection and promotion of the environment or if it is of particular interest to a certain industrial field or if it is necessary for implementing the judicial and administrative procedure related to protection of competition.
(3) The exemptions in granting compulsory license as referred to in paragraph (1) of this Article shall be possible in the situations referred to in paragraph (2) of this Article, for which the patent holder shall be notified as soon as possible.
(4) Request for a compulsory licence referred to in paragraph (1) of this Article may not be submitted prior to the expiry of a period of four years from the date of filing the patent application i.e. prior to the expiry of a period of three years from the date of the patent granting, in case this period expires later.
(5) A compulsory licence shall not be issued if the patent holder proves that there are legal constraints which justify the fact that invention protected by a patent has not been used or has been insufficiently used.
(6) In the cases referred to in paragraph (2) of this Article, the compulsory license may be issued even prior to the expiry of the period laid down in paragraph (4) of this Article.

Particularities of the compulsory license
Article 98
(1) A compulsory license may not be exclusive.
(2) The compulsory licence shall be valid as long as there is reason for which it has been issued.
(3) On the elaborated request of the interested person, the compulsory license shall be cancelled if there are no longer the reasons for which the license has been issued, and there is no possibility for those reasons to occur again, provided that the legitimate rights to the assignee of the compulsory licence are protected.
(4) The compulsory license may not be transferred, unless the transfer is done together with the production capacity i.e. with part of it that uses the invention for which the license has been issued.
(5) Compulsory license shall be issued for the needs of the national market, unless it is proved in the legal proceedings that this is contrary to the protection of competition on the market.

Compulsory licence for dependent patent
Article 100
(1) A compulsory licence may also be issued if the invention protected by a patent cannot be used as a whole or partially without using another invention protected by a former patent, whereby the later invention, representing a more significant technical improvement, is of particular importance to the economy or to fulfilling the general needs.
(2) If a compulsory license is issued in accordance with paragraph (1) of this Article, the holder of the previous patent may request a compulsory license to use the invention of the latter patent for a relevant fee.

Compulsory license for the needs of public health
Article 102
(1) Any person that has filed an application in compliance with the provisions of this Law may be issued, by the court, a compulsory patent license i.e. a supplementary protection certificate for the needs of production and sale of pharmaceutical products, where such a product is intended to be exported in the importing countries with problems in public health.
(2) When deciding upon issuing compulsory license, the court shall take into consideration the WTO General Council Decision of 30 August 2003 on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health of 14 November 2001, (hereinafter referred to as: “Decision”.
(3) The pharmaceutical product referred to in paragraph (1) of this Article shall be any product in the pharmaceutical industry, including the medications for human use, which include any substance or mixture of substances designed for treatment or prevention of human diseases including any substance or mixture of substances which may be applied to people in terms of renewal, improvement, or adjustment to their physiological functions by causing pharmaceutical, immunological, or metabolic effects or by giving the medical diagnosis, including active components and accessories to diagnose outside the alive human body.

Lawsuit to issue compulsory license for the needs of public health
Article 104
(1) The lawsuit that includes an application for issuing a compulsory license for the needs of the public health shall be submitted to the court in compliance with Article 101 of this Law if there is a patent or a supplementary protection certificate in the territory of the Republic of Macedonia that covers the works for production and sale for the purpose of exporting.
(2) The one submitting the lawsuit for compulsory license shall be bound to attach the following to the lawsuit:
1) applications for compulsory licenses in other countries for the same product, with data on the quantities and the importing countries;
2) the applicant for compulsory license, and in case there is an agent, data about the agent;
3) name of the pharmaceutical product i.e. not subject to protection, which the applicant plans to produce on the basis of compulsory license;
4) quantity of the pharmaceutical product that the applicant plans to produce on the basis of compulsory license;
5) data on the importing country;
6) evidence about the previous negotiations with the right holder in compliance with paragraph (5) of this Article; and
7) evidence about the application of the authorised agent of the importing country or the non-governmental organisation which operates with an authorisation from one or more importing countries or UN bodies or another international health organisation, which operates with an authorisation of one or more importing countries indicating the quantity of the required product.

Properties of the issuing compulsory license for the needs of public health
Article 107
(1) The compulsory license may not be exclusive.
(2) The duration and the scope of the compulsory license stated in the court decision regarding the license shall depend only from the duration of the reason due to which it had been issued.
(3) The quantity of products that may be produced on the basis of the compulsory license must not exceed the quantity which is necessary to respond to the needs of the importing countries i.e. the importing countries stated in the lawsuit, taking into consideration the quantity of products produced in other countries on the basis of the compulsory license.
(4) The compulsory license may be transferred only together with the production capacity i.e. with the part of it, in which the invention for which the compulsory license has been issued is used.

Requirements for issuing compulsory license for the needs of public health
Article 108
(1) The product which is produced or imported on the basis of a compulsory licence may not be offered for sale or placed on the market of a country i.e. not indicated in the application, except when the importing country, in compliance with item 6, subitem (i) of the Decision, imports in a country that has also signed the regional trade agreement and has the same problem in the field of health.
(2) The packing or any relevant text must contain a clear indication that the product is a subject to a compulsory license, the name of the court granting the license and the number of the subject, a clear indication that the product is intended exclusively for export and distribution in the importing country or the importing countries and detailed data regarding the product provided for customs authorities in the Republic of Macedonia.
(3) Compulsory license shall be issued for the needs of the local market, unless proved in the judicial procedure of issuing that this is contrary to the protection of competition on the market.
(4) If the product for which in the Republic of Macedonia a compulsory license has been issued, is patent granted in the import country indicated in the application, the product may be exported only if that country has issued a compulsory license for export, sale, and/or distribution of that product.
(5) The conditions under which the license is issued shall not affect the method of distribution in the importing country.

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