About Intellectual Property IP Training IP Outreach IP for… IP and... IP in... Patent & Technology Information Trademark Information Industrial Design Information Geographical Indication Information Plant Variety Information (UPOV) IP Laws, Treaties & Judgements IP Resources IP Reports Patent Protection Trademark Protection Industrial Design Protection Geographical Indication Protection Plant Variety Protection (UPOV) IP Dispute Resolution IP Office Business Solutions Paying for IP Services Negotiation & Decision-Making Development Cooperation Innovation Support Public-Private Partnerships The Organization Working with WIPO Accountability Patents Trademarks Industrial Designs Geographical Indications Copyright Trade Secrets WIPO Academy Workshops & Seminars World IP Day WIPO Magazine Raising Awareness Case Studies & Success Stories IP News WIPO Awards Business Universities Indigenous Peoples Judiciaries Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions Economics Gender Equality Global Health Climate Change Competition Policy Sustainable Development Goals Enforcement Frontier Technologies Mobile Applications Sports Tourism PATENTSCOPE Patent Analytics International Patent Classification ARDI – Research for Innovation ASPI – Specialized Patent Information Global Brand Database Madrid Monitor Article 6ter Express Database Nice Classification Vienna Classification Global Design Database International Designs Bulletin Hague Express Database Locarno Classification Lisbon Express Database Global Brand Database for GIs PLUTO Plant Variety Database GENIE Database WIPO-Administered Treaties WIPO Lex - IP Laws, Treaties & Judgments WIPO Standards IP Statistics WIPO Pearl (Terminology) WIPO Publications Country IP Profiles WIPO Knowledge Center WIPO Technology Trends Global Innovation Index World Intellectual Property Report PCT – The International Patent System ePCT Budapest – The International Microorganism Deposit System Madrid – The International Trademark System eMadrid Article 6ter (armorial bearings, flags, state emblems) Hague – The International Design System eHague Lisbon – The International System of Appellations of Origin and Geographical Indications eLisbon UPOV PRISMA Mediation Arbitration Expert Determination Domain Name Disputes Centralized Access to Search and Examination (CASE) Digital Access Service (DAS) WIPO Pay Current Account at WIPO WIPO Assemblies Standing Committees Calendar of Meetings WIPO Official Documents Development Agenda Technical Assistance IP Training Institutions COVID-19 Support National IP Strategies Policy & Legislative Advice Cooperation Hub Technology and Innovation Support Centers (TISC) Technology Transfer Inventor Assistance Program WIPO GREEN WIPO's Pat-INFORMED Accessible Books Consortium WIPO for Creators WIPO ALERT Member States Observers Director General Activities by Unit External Offices Job Vacancies Procurement Results & Budget Financial Reporting Oversight

Legislative Implementation of Flexibilities - Croatia

Title:Articles 68-69b of the Patents Law No. 173/2003 as last amended by Act No. 76/2007
Field of IP:Patents
Type of flexibility:Compulsory licenses and government use
Summary table:PDF

Provisions of Law

Article 68 - Grant of a compulsory licence

(1) The competent court in the Republic of Croatia may grant a compulsory license for lack or insufficiency of exploitation of a patent to any person filing a request for the grant of a compulsory license, or to the Government of the Republic of Croatia, if the patent owner has not exploited the invention protected by a patent in the territory of the Republic of Croatia on reasonable terms or has not made effective and serious preparations for its exploitation.

(2) A request for the grant of a compulsory license based on paragraph (1) of this Article can be filed after the expiration of a period of four years from the filing date of a patent application, or after the expiration of three years from the date the patent was granted.

(3) A compulsory license cannot be granted if the patent owner provides legitimate reasons to justify non-exploitation or insufficiency of exploitation of the protected invention.

(4) Upon a reasoned request, the court may grant a compulsory license in respect of a first patent to the owner of a patent or to the owner of a plant variety right who cannot use his patent (second patent) or his plant variety right without infringing the first patent, provided that the invention claimed in the second patent or a protected plant variety involves an important technical advance of considerable economic significance in relation to the invention claimed in the first patent. The competent court may take any measure it regards as useful to verify the existence of such a situation.

(5) In the case of a compulsory license as provided in paragraph (4) of this Article, the owner of the first patent shall be entitled to a cross license on reasonable terms to use the

invention protected by the second patent or protected plant variety.

(6) The court may grant a compulsory license if the exploitation of the patented invention is necessary in situations of extreme urgency (national security, public interest protection in the field of health, food supply, environmental protection and improvement, specific commercial interest) or when it is necessary to remedy a practice determined by a judicial or administrative process to be anti-competitive.

(7) In the case of semi-conductor technology, a compulsory license may be granted only in the cases set out in paragraph 6 of this Article.

(8) A compulsory license may be granted only if the person filing the request has made efforts to obtain authorization from the patent owner on reasonable commercial terms and conditions and if such efforts have not been successful within a reasonable period of time. The court may derogate from these conditions in the situations set out in paragraph (6) of this Article. The right holder shall be informed of the granting of a compulsory license as soon as is reasonably possible.

Article 69 - Conditions applicable to the grant of a compulsory license

(1) A compulsory license shall be non-exclusive, and its scope and duration shall be exclusively limited to the purpose for which it was authorized.

(2) A compulsory license shall be transferred only with the production plant or the part thereof respectively, in which the invention it is granted for has been exploited.

(3) A compulsory license shall be granted predominantly for the purposes of supplying the domestic market unless it is necessary to correct a practice determined by judicial or administrative process to be anti-competitive.

(4) The competent authority shall, upon reasoned request by an interested person, cancel a compulsory license, subject to adequate protection of the legitimate interests of the persons so authorized, if and when the circumstances which led to its authorization cease to exist and are unlikely to recur.

(5) The patent owner has the right to remuneration, taking into account the economic value of the authorization and need to correct anti-competitive practice.

(6) A compulsory license according to Article 68 paragraph (4) of this Act shall be non- transferable except with a transfer of the second patent or the protected plant variety.

3. Compulsory licences for patents relating to the manufacture of pharmaceutical products intended for export to countries having public health problems", and headings and Articles 69a to 69h are added to read:

Article 69a - Granting of a compulsory license

(1) The court may grant to any person filing an application pursuant to the provisions of this Act, a compulsory licence for a patent and/or issue a Supplementary Protection Certificate required for the manufacture and sale of pharmaceutical products, when such products are intended for export to importing countries having public health problems. When deciding on the grant of a compulsory licence the court shall take into consideration in particular, the need to implement the Decision adopted by the WTO General Council on 30 August 2003 on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (hereinafter: the Decision) of 14 November 2001.

(2) The pharmaceutical product referred to in paragraph (1) of this Article shall be any product of the pharmaceutical industry, including medicinal products for human use, comprising any substance or combination of substances intended for treating or preventing disease in human beings, and any substance or combination of substances, which may be administered to human beings with a view to restoring, correcting or modifying physiological functions in humans, by exerting a pharmacological, immunological or metabolic action, or to making a medicinal diagnosis, including active ingredients and diagnostic kits ex vivo.

(3) The importing country referred to in paragraph (1) of this Article shall be any country to which the pharmaceutical product is to be exported. The importing country may be:

(a) any least-developed country appearing as such in the United Nations list;

(b) any member of the WTO, other than the least-developed country members referred to in item (a) of this paragraph that has made a notification to the Council for TRIPS of its intention to use the system as an importer, including whether it will use the system in whole or in a limited way;

(c) any country that is not a member of the WTO, but is listed in the OECD Development Assistance Committee's list of low-income countries with a gross national product per capita of less than USD 745, and has made a notification to the Office of its intention to use the system as an importer, including whether it will use the system in whole or in a limited way.

(4) Any WTO member that has made a declaration that it will not use the system as an importing WTO member is not an eligible importing country.

(5) Importing countries, which are not WTO members, and are least developed or developing countries, eligible under paragraph (3) of this Article shall comply with additional requirements:

(a) the importing country shall make the notification pursuant to the Decision directly to the Office;

(b) the importing country shall state in the notification that it will use the system to address public health problems, and not as an instrument to pursue industrial or commercial policy objectives, and that it will adopt the measures referred to in paragraph 4 of the Decision;

(c) the court may, upon a legal action instituted by a right holder or by the Office, terminate a compulsory license, if the importing country has failed to comply with its obligations referred to in item (b).

(6) A legal action containing an application for the grant of a compulsory license shall be instituted before the court pursuant to the provisions of Article 67a of this Act, if in the territory of the Republic of Croatia there is a patent or a Supplementary Protection Certificate the effects of which cover the intended manufacturing and sale activity for export purposes.

(7) A legal action shall contain:

(a) information concerning the applications for compulsory licences filed in other countries for the same product with details of the quantities and importing countries concerned;

(b) information concerning the applicant for a compulsory licence and of her/his representative, if any;

(c) the non-proprietary name of the pharmaceutical product, which the applicant intends to manufacture under the compulsory licence;

(d) the quantity of the pharmaceutical product, which the applicant intends to manufacture under the compulsory licence;

(e) the importing country;

(f) evidence of prior negotiations with the right holder pursuant to the provisions of paragraph (10) of this Article;

(g) evidence of a specific request from an authorized representative of the importing country, or a non-governmental organization acting with the formal authorization of one or more importing countries, or UN bodies or other international health organization acting with the formal authorization of one or more importing countries, indicating the quantity of the product required.

(8) When deciding on an application for the grant of a compulsory license, the court shall verify in particular the following:

(a) whether each importing country cited in the application, which is a WTO member, has made a notification to the WTO pursuant to the Decision, or whether each importing country cited in the application, which is not a WTO member, has made a notification to the Office pursuant to the provisions of this Article in respect of each of the products covered by the application. This shall be without prejudice to the possibility, which the least-developed countries have pursuant to the Decision of the TRIPS Council of 27 July 2002;

(b) that the quantity of the product cited in the application does not exceed that notified to the WTO and the Office, respectively, by an importing country, which is a WTO member;

(c) that, taking into account other compulsory licenses granted elsewhere, the total amount of the product authorized to be produced for any importing country does not significantly exceed the amount notified by that country to the WTO, and the Office, respectively.

(9) The information referred to in paragraph (8) of this Article shall be provided and presented in a legal action by the applicant for the grant of a compulsory licence.

(10) A compulsory license may be granted only if the applicant has made efforts to obtain authorization from the patent owner for the exploitation of the protected invention on reasonable commercial terms and conditions, and if such efforts have not been successful within thirty days prior to a legal action. This provision shall not apply in situations of national emergency or other circumstances of extreme urgency, or in cases of public non-commercial use, pursuant to Article 31, item (b) of the TRIPS Agreement.

Article 69b

(1) A compulsory license shall be granted as a non-exclusive license, and its scope and duration, which shall be cited in a decision on its grant, shall be exclusively limited to the purpose for which it has been granted. The quantity of products to be manufactured under such licence shall not exceed the quantity necessary to satisfy the needs of the importing country, or importing countries cited in a legal action, taking into account the quantity of the products manufactured under compulsory licenses granted elsewhere.

(2) A compulsory license shall be transferred only with the production plant in which the invention, it is granted for, has been exploited.

(3) In its decision the court shall specify the acts, which the applicant is entitled to perform, and which are necessary for the purpose of manufacturing the products intended for export and distribution in the country or countries cited in the application. No product made or imported under a compulsory license shall be offered for sale or put on the market in any country other than that cited in the application, except where an importing country avails itself of the possibilities under subparagraph 6(i) of the Decision to export to fellow members of a regional trade agreement that share the health problem in question.

(4) In its decision the court shall order that the products made under such license shall be clearly identified, through specific labeling or marking, as being produced under a compulsory licence. The products shall be distinguished from those made by the right holder through special packaging and/or special coloring or shaping, provided that such distinction is feasible, and does not have a significant impact on price. The packaging and any associated literature shall bear an indication that the product is subject to a compulsory license, giving the name of the competent court which granted it, the file number and specifying clearly that the product is intended exclusively for export to and distribution in the importing country or countries. Details of the product characteristics shall be made available to the customs authorities in the Republic of Croatia and the Member States of the European Union.

(5) In its decision the court shall order that before shipment to the importing country the licensee shall post on a web site, the address of which shall be communicated to the Office, the following information:

(a) the quantities of products being supplied under the licence to the importing countries;

(b) the distinguishing features of the product concerned.

(6) If a product covered by a compulsory licence granted in the Republic of Croatia, is patented in the importing country cited in the application, the product shall only be exported if those countries have issued a compulsory licence for the import, sale and/or distribution of the product concerned.

(7) In its decision the court shall order the applicant to pay remuneration to the right holder, as determined by the court as follows:

(a) in the cases of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use under Article 31 item (b) of the TRIPS Agreement, the remuneration shall be a maximum of 4% of the total price to be paid by the importing country or on its behalf;

(b) in all other cases, the remuneration shall be determined taking into account the economic value of the use authorized under the license to the importing country or countries concerned, as well as humanitarian or non-commercial circumstances relating to the issue of the license.

(8) When the court decision on the grant of a compulsory license has become final, the court may, upon a claim for the preservation of evidence filed by the right holder, inspect books and other records kept by the licensee, for the sole purpose of checking whether all the obligations contained in the court decision on the grant of a compulsory license, and in particular those relating to the final destination of the products, have been complied with. The books and records shall contain a proof of exportation of the product, in the form of a declaration of exportation certified by the customs authority, and a proof of importation.

(9) The license conditions shall be without prejudice to the method of distribution in the importing country.

https://www3.wipo.int/contact/en/area.jsp?area=development_agenda https://www.wipo.int/pressroom/en/ https://www.wipo.int/tools/en/disclaim.html https://www.wipo.int/en/web/privacy-policy/ https://www.wipo.int/en/web/accessibility/ https://www.wipo.int/tools/en/sitemap.html https://www3.wipo.int/newsletters/en/ https://www.wipo.int/podcasts/en/ https://www.wipo.int/news/en/