Examen de la legislación de aplicación del Acuerdo sobre los ADPIC - Búsqueda

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En el párrafo 2 del artículo 63 del Acuerdo sobre los ADPIC, se exige a los Miembros que notifiquen al Consejo de los ADPIC las leyes y los reglamentos hechos efectivos por el Miembro en cuestión y referentes a la materia del Acuerdo, con el fin de ayudar al Consejo en su examen de la aplicación del Acuerdo.

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IP/Q/ARE/1, IP/Q2/ARE/1, IP/Q3/ARE/1, IP/Q4/ARE/1 Emiratos Árabes Unidos Unión Europea 54. Please quote what provisions of your legislation authorize judges to indemnify a defendant in the event of abuse by the plaintiff.
Article 59 of the Patent and Designs Law states that the applicant of the precautionary seizure should deposit a bail evaluated by the court prior to issuing its order for seizure and the seizer should file the relevant action within eight days as from the date of the issuance of the court’s order otherwise the matter shall be deemed null and void. Moreover, it is permissible for the attached person to file an action for compensation within sixty days as from the date of the termination of the previous term or from the date of issuing the final decision of refusing the relevant action, which the seizor preferred. Furthermore, it isn’t permissible to cash the bail referred thereto except after the issuance of a final decision in the seizor’s action or the claim of compensation which the attached person filed. Also the Trademarks Law provides in its Article 43 for provision aimed at indemnifying the defendant through a judicial decision.
02/02/2004
IP/Q/ARE/1, IP/Q2/ARE/1, IP/Q3/ARE/1, IP/Q4/ARE/1 Emiratos Árabes Unidos Unión Europea 55. Please explain how your legislation implements Article 50 of the TRIPS Agreement.
Article 58 of Patent Law provides that the owner of the patent may request the competent court, either before or during the civil or criminal proceeding, to issue a writ of attachment on the invention or industrial design, or on the establishment or the part of establishment using or exploiting a patent, in relation to which an infringement or an unlawful act has been committed. Temporary and rapid measures against any violation of intellectual property rights are provided in the other laws. Customs department is allowed to take measures at the borders to prevent any violation of intellectual property rights in accordance the above-mentioned laws as well as under Customs regulations. These measures are taken either following the demand of the right holder or on the basis of judicial order.
02/02/2004
IP/Q/ARE/1, IP/Q2/ARE/1, IP/Q3/ARE/1, IP/Q4/ARE/1 Emiratos Árabes Unidos Unión Europea 56. Please identify the competent authorities in your jurisdiction who receive requests from right holders for an application to suspend the release of counterfeit goods by the customs authorities.
The competent court is responsible to decide on preventive seizure. Customs are also responsible for suspension of customs release for a fixed period in response to an application by the rights holder or the public prosecution or by its own initiative.
02/02/2004
IP/Q/ARE/1, IP/Q2/ARE/1, IP/Q3/ARE/1, IP/Q4/ARE/1 Emiratos Árabes Unidos Unión Europea 57. Please indicate whether or not procedures are available to suspend the exporting of counterfeit goods.
The same rules mentioned in the answer the question no. 56 are applied to this question.
02/02/2004
IP/Q/ARE/1, IP/Q2/ARE/1, IP/Q3/ARE/1, IP/Q4/ARE/1 Emiratos Árabes Unidos Unión Europea 58. Please quote what provisions of your legislation authorize the competent authorities to order the destruction or disposal of infringing goods.
The Patent Law Article 61 allows the court to order the destruction of the equipment used in committing the act of imitation and remove the effects of any illegal act. The Copyright Law provides for the same measures. The Trademarks Law Article 43 provides for the destruction of the illegal marks and the products and packaging and tools of packaging and other articles bearing in the illegal marks.
02/02/2004
IP/Q/ARE/1, IP/Q2/ARE/1, IP/Q3/ARE/1, IP/Q4/ARE/1 Emiratos Árabes Unidos Unión Europea 59. Please indicate whether or not your legislation provides for a de minimis imports exception.
There is no indication in the three intellectual property federal laws of the de minimis imports exception.
02/02/2004
IP/Q/ARE/1, IP/Q2/ARE/1, IP/Q3/ARE/1, IP/Q4/ARE/1 Emiratos Árabes Unidos Unión Europea 60. Please explain how your legislation implements Article 61 of the TRIPS Agreement.
Punishment related to illegal acts that affect intellectual property rights are provided in the three intellectual property rights laws. Imprisonment and a fine are provided as sanctions in Article 37 of the 1992 Trademarks Law No. 37, Article 60 of the 1992 Patent Law No. 44 and in the 1992 Copyright Law Article 37.
02/02/2004
IP/Q/ALB/1, IP/Q2/ALB/1, IP/Q3/ALB/1, IP/Q4/ALB/1 Albania Canadá 1. What recourse do right holders have in respect of wilful trademark counterfeiting or copyright piracy on a commercial scale, as required by Article 61 of the TRIPS Agreement and throughout?
Article 83 of the "Law on Industrial Property" (1994) provides the right to the owner of a trademark. According to this article: The owner of a registered mark shall have the right to prevent a third party from using, without his authorization, in the course of trade, as a mark or as a trade name, an identical or similar sign for goods or services which are identical or similar to those in respect of which the mark is registered , where such use would result in a likelihood of confusion. Where the use relates to an identical sign for identical goods or services, the likelihood of confusion shall be assumed. The owner of a registered mark shall have the right to prevent a third party from using, without authorization, in the course of trade as a mark or as a trade name, an identical or similar sign for goods or services which are neither identical nor similar to those in respect of which the mark is registered, where the mark has become highly reputed and the use is detrimental to the distinctive character or reputation of the mark. Notwithstanding paragraph 1 of this Article, the owner of the registered mark shall not have the right referred to in that paragraph in respect of goods which have been put in the territory of the Republic of Albania or in any other territory determined in an bilateral or multilateral agreement of the Republic of Albania, by the owner of registered mark, or with his consent, provided that neither the goods nor the manner in which the mark is applied to the goods are altered. The holder of a trademark which is considered to be well-known in the Republic of Albania, even if it is not registered under this Law, shall have the right to prevent third parties from using in commerce without his authorization, any sign which constitutes a reproduction, an imitation or a translation of the trademark. The concept of a well-known trademark shall be established by the Patent and Trademark Office. Right holders of trademarks enjoy the option provided under articles 89 and 101 of the "Law on Industrial Property" (1994) and articles 11 and 19 of the Law "Some changes and supplements on the 'Law on Industrial Property'" (1999) in compliance with article 61 of the TRIPS Agreement. According to these Articles: The owner of the registered mark shall have the right to institute proceedings in the Court against any person who has infringed or is infringing his rights under the conditions of Article 83 of the Law. The owner shall have the same right against any person who has performed acts or is performing acts, which make it likely that such infringement will occur (imminent infringement). If the owner of the registered mark proves that an infringement has been committed or is being committed, the Court shall award compensation. In these compensations will be included the profit of the person who has performed the infringement, the damage which has incurred the owner of the mark except the one is included in the profit of the breaker and the expenses including the law costs. The Court shall grant an injunction to prevent further infringement and any other remedy provided in the general law. If the owner of the registered mark proves imminent infringement, the Court shall grant an injunction to prevent further infringement and any other remedy provided in this Law and in the Code of Civil Procedure. In addition to the measures specified in the previous paragraphs, the Court may re-establish the situation that existed before the infringement and to stop infringing actions, to proceed with an effective seizure of the goods and, when necessary, to destroy illegally used marks, tools that could be used to manufacture the goods and the goods themselves in absence of possibility to remove any illegally mark from such goods. The judicial authorities shall have the authority to order prompt and effective provisional measures: - to prevent an infringement of any intellectual property right from occurring and in particular to prevent the entry into channels of commerce in their jurisdiction of goods, including imported goods immediately after customs clearance; - to preserve relevant evidence in regard to the alleged infringement. The new Article 89/3 of the Law on Industrial Property states: In addition to the measures specified in paragraph 2(a) of this Article, the Court may re-establish the situation that existed before the infringement and to stop infringing actions, to proceed with an effective seizure of the goods and, when necessary, to destroy illegally used marks, tools that could be used to manufacture the goods and the goods themselves in absence of possibility to remove any illegally mark from such goods. Any natural or legal person who performs an act which he knows constitutes an infringement of the patent, mark or design shall commit an offence and shall be punishable from the Court by a fine between lek 20,000 and 100,000. Article 50 of Copyright Law as amended by the Law No. 8594 dated 6 April 2000 underlines that the translation, adaptation, sound or visual recording, reproduction, the transmission of an artistic work without the authorization of its author, which conflicts with the provisions of this law or the international conventions ratified by the Republic of Albania, when the author's moral and economic rights have been infringed, constitutes a criminal work and is penalized by fine or imprisonment up to one year. Whereas the Penal Code, as amended by the Law 7883 dated 24 January 2001, under Articles 147-149 underlines fines and imprisonment by up to four years for misappropriation of property through fraudulence by introducing a work of art and culture as the original or by changing the authenticity of the authorship; and fines and imprisonment by up to two years for partially or completely plagiarizing somebody else's work or for unauthorized reproduction of somebody's work. According to Article 82.4 of the Customs Code, the customs authorities upon request of the holder of a trademark or patent of production or other neighbouring rights specified in the Implementing Provisions of this Code, may prohibit their release in free circulation, the exportation, the re-exportation and their placing, under the suspensive procedure of the goods that are recognized to be counterfeited or pirated goods, according to the procedure provided for in the Implementing Provisions of this Code. And the Implementing Provisions on Customs Code, Article 120/1, states that the General Directorate of Customs may suspend the release of the goods or seize the goods depending on the situation. The Code of Civil Procedure authorizes judges to order the payment of monetary damages adequate to compensate for the injury done. Article 68 of this Code states: "When a sum of money or a removable thing is requested the value is determined on the basis of the amount indicated or of the value declared by the plaintiff. In the absence of indication or of declaration, it is accepted that the determination of the value is a competence of the court". And any person has the right to claim compensation of costs and damages caused by the infringer. Under Article 106 it is stated among others: "In its final decision, the court charges the party whose lawsuit has been dropped, to pay the judicial expenses in conforming with article 102 of this Code including, the payment for one advocate." Article 67 of the Law on Competition authorizes courts to impose fines not less than lek 10,000 and not more than lek 200,000 to any person or company who does not respect business secrets.
28/04/2003
IP/Q/ALB/1, IP/Q2/ALB/1, IP/Q3/ALB/1, IP/Q4/ALB/1 Albania Canadá 2. What protection does your Copyright legislation afford to "foreign works"?
Article 51 of the Copyright Law as changed by the Law No. 7564 dated 19 May 1992 stipulates that the provisions of this law shall apply not only to works the author of which has Albanian citizenship or lives permanently in the Republic of Albania, regardless of the country where they were published for the first time, but also to works published for the first time in Albania or in a country that is a member of an international Copyright treaty or convention to which Albania is also a signatory as well as to works published for the first time in a country that is not a member of an international Copyright treaty or convention, to which Albania is a signatory, when the works are published simultaneously in the territory of this country and in the Republic of Albania or in another country which is a signatory to the international Copyright treaty or convention.
28/04/2003
IP/Q/ALB/1, IP/Q2/ALB/1, IP/Q3/ALB/1, IP/Q4/ALB/1 Albania Japón 1. Please explain exceptions or exemptions of the national treatment and most-favoured-nation treatment under the Copyright and Neighbouring Rights Law, if any, as permitted in Articles 3 and 4 of the TRIPS Agreement.
The Albanian Copyright Law does not contain any provision on the exceptions provided for in Articles 3 and 4 of the TRIPS Agreement relating to national treatment and most-favoured-nation treatment.
28/04/2003
IP/Q/ALB/1, IP/Q2/ALB/1, IP/Q3/ALB/1, IP/Q4/ALB/1 Albania Suiza 1. Please explain in detail how your legislation provides protection for geographical indications.
Protection of geographical indications (appellation of origin) is provided by Articles 93 of the "Law on Industrial Property" (1994) and Articles 13 and 14 of the "Law on some changes and supplements on the "Law on industrial property" (1999) as follows: The appellation of origin is used to mark the natural, agricultural products, the industrial and handicrafts products. The appellations of origin protect: (a) geographical names of products, whose distinctive properties are mainly due to the location or region where they are produced, if such properties are a natural consequence of either the climate or soil or of established manufacturing procedures or processes; (b) the name of a product which has become generally known through long-term use in the course of trade as an indication that the product originates from a certain location or region. Geographical names which have become generally known through long-term use in the course of trade as designations for certain kinds of products may not be protected by appellations of origin. The Patent Office shall grant the right to use the appellation of origin after obtaining the expert opinion of the competent authorities, which must include: (a) products which may be marked under that appellation of origin; (b) locations or regions in which products marked under the appellation of origin originate; (c) production requirements a product must fulfill in order to be marked under the appellation of origin; (d) the required marking of products and further detailed requirements for grant of the right to use the appellations of origin. An appellation of origin shall be established: (a) by entering the geographical name and kind of product to which the name relates in the register of appellations of origin; (b) on behalf of a foreign person, on the basis of an international agreement on reciprocal protection of appellation of origin concluded by the Republic of Albania. An appellation of origin is a collective right and may be used as such only by those who produce or market the product for which an appellation of origin has been established. Persons not authorized to use an appellation of origin may not use such appellation even they add the words "type", "style", "fashion", "produced as" or similar words. The protection of the appellation of origin shall be applicable against a geographical indication which, although literally true as to the territory, region or locality in which the goods originate, falsely represents to the public that the goods originate in another territory.
28/04/2003
IP/Q/ALB/1, IP/Q2/ALB/1, IP/Q3/ALB/1, IP/Q4/ALB/1 Albania Suiza 2. Does your legislation grant patent protection to all categories of products or are there any exceptions? If so, please explain in detail what kind of exceptions exist and how they comply with Article 27 of the TRIPS Agreement.
According to Article 3 of the "Law on Industrial Property" (1994): (1) In order to be patentable, an invention shall be novel, shall involve an inventive step and shall be industrially applicable. (2) The following, in particular, shall not be regarded as inventions within the meaning of paragraph (1): (a) discoveries, scientific theories and mathematical methods; (b) aesthetic creations; (c) schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers; (d) presentations of information. (3) The provisions of paragraph (2) shall exclude patentability of the subject-matter or activities referred to in that provision only to the extent to which a patent application or patent relates to such subject-matter or activities as such. (4) A patent shall not be granted in respect of an invention the publication or exploitation of which would be contrary to public order or morality. (5) No patents shall be granted for substances obtained through internal nuclear transformations for military purposes. (6) No patents shall be granted for inventions of surgical, diagnostic or therapeutical methods practised on the human or animal body, as they shall be regarded as inventions which are not susceptible of industrial application within the meaning of paragraph (1). This provision shall not apply to inventions relating to substances and devices for use in any of these methods. (7) No patents shall be granted in respect of plant or animal varieties or essentially biological processes for the production of plants or animals this provision does not apply to microbiological processes or the products thereof.
28/04/2003
IP/Q/ALB/1, IP/Q2/ALB/1, IP/Q3/ALB/1, IP/Q4/ALB/1 Albania Suiza 3. Does your legislation, in accordance with Article 27.1 in combination with Article 31 of the TRIPS Agreement, consider importation as "working" a patent (and therefore preclude compulsory licensing, if a product is being imported)?
According to Article 27 of the 'Law on Industrial Property" (1994): (1) Where the patent concerns a product, the owner of the patent shall have the right to prevent third parties from performing, without his authorization, the following acts: (a) the making of a product incorporating the protected invention; (b) the offering or the putting on the market of a product incorporating the protected invention, the using of such a product, or the importing or stocking of such a product for such offering or putting on the market; (c) the inducing of other parties to perform any of the above acts. (2) Where the patent concerns a process, the owner of the patent shall have the right to prevent third parties from performing, without his authorization, the following acts: (a) the using of a process which is the subject matter of the patent; (b) in respect of any product directly obtained by such process, any of the acts referred to in paragraph (1)(b), even where a patent cannot be obtained for the said product; (c) the inducing of other parties to perform any of the above acts. (3) The owner of a patent shall have no right to prevent third parties from performing, without his authorization, the acts referred to in paragraphs (1) and (2) in the following circumstances: (a) where the act concerns a product covered by the patent after it has been put on the market by the owner of the patent, or with his express consent, in the Republic of Albania or in any territory specified in the bilateral or multilateral agreements which have been acceded to by Republic of Albania; (b) where the act is done privately and for non-commercial purposes, provided that it does not significantly prejudice the economic interests of the owner of the patent; (c) where the act is done for purely experimental purposes or for scientific research; (d) where the act consists of the extemporaneous preparation for individual cases, in a pharmacy or by a medical doctor, of a medicine in accordance with a medical prescription or acts concerning the medicine so prepared. (4) A patent shall also confer on its owner the right to prevent third parties from supplying or offering to supply a person, other than a party entitled to exploit the patented invention, with means, relating to an element of that invention, for carrying it out, when the third party knows, or it is obvious in the circumstances, that those means are suitable and intended for carrying out that invention. This provision shall not apply when the means are staple commercial products and the circumstances of the supply of such products do not constitute inducement to infringe the patent.
28/04/2003
IP/Q/ALB/1, IP/Q2/ALB/1, IP/Q3/ALB/1, IP/Q4/ALB/1 Albania Suiza Follow-up question: Please confirm whether your law, in accordance with Article 27.1 of the TRIPS Agreement in combination with Article 31 of the TRIPS Agreement, considers importation as "working/utilising" a patent (and therefore precludes compulsory licensing, if a product is imported).
According to Article 27 of the Law on Industrial Property (1994), paragraph 1(b): "(2) Where the patent concerns a product, the owner of the patent shall have the right to prevent third parties from performing, without his authorization, the following acts: (a) the making of a product incorporating the protected invention; (b) the offering or the putting on the market of a product incorporating the protected invention, the using of such a product, or the importing or stocking of such a product for such offering or putting on the market". In such cases, it is considered as working patent; so, no compulsory licence can be granted.
28/04/2003
IP/Q/ALB/1, IP/Q2/ALB/1, IP/Q3/ALB/1, IP/Q4/ALB/1 Albania Suiza 4. Does your legislation make the granting of a compulsory licence subject to all the conditions enumerated in Article 31 of the TRIPS Agreement? Please cite the relevant provisions of law.
The granting of compulsory licences is regulated under Articles 39 and 40 of the Law and general provisions adopted by government (temporary) for granting a compulsory licence: (1) On the request of any person who proves his ability to work the patented invention in the Republic of Albania, made after the expiration of a period of four years from the filing date of the application for the patent or three years from the grant of the patent, whichever is later, the Patent Office may grant a non-exclusive, non-voluntary licence if the patented invention is not worked or is insufficiently worked in the Republic of Albania. The grant of the non-voluntary licence shall be subject to the payment of equitable remuneration to the owner of the patent. (2) A non-voluntary licence shall not be granted if the Patent Office is convinced that circumstances exist which justify the non-working or insufficient working of the patented invention in the Republic of Albania. (3) In deciding whether to grant a non-voluntary licence, the Patent Office shall give both the owner of the patent and the person requesting the non-voluntary licence an adequate opportunity to present arguments. (4) Any non-voluntary licence shall be revoked when the circumstances which led to its granting cease to exist, taking into account the legitimate interests of the patent owner and of the licensee. The continued existence of these circumstances shall be reviewed upon request of the patent owner. Where the national security or public safety so requires, the Prime Minister may authorize, even without the agreement of the owner of the patent or of the applicant, by notice published in the Official Journal, a government agency or a person designated in the said notice to make, use or sell an invention to which a patent or a patent application for a patent relates, subject to payment of equitable remuneration to the owner of the patent or the applicant. The decision of the Prime Minister may be the subject of an appeal to the Court. 1. An applicant for a compulsory licence shall be required to prove that the requirements for a compulsory licence have been complied with, and further that a) the patentee was unwilling to grant a voluntary licence to exploit the patent under appropriate conditions and within a reasonable period of time; b) he is able to exploit the invention to the required extent. 2. The scope and duration of a compulsory licence shall be established by the court, taking into account the purpose of the exploitation authorized by the compulsory licence; a compulsory licence may be granted with or without limitation. Unless relinquished or cancelled, a compulsory licence shall have effect until expiration of the term of validity fixed by the court or until the lapse of patent protection. Compulsory licences shall be recorded in the Patent Register. 3. The patentee shall receive adequate compensation for the compulsory licence, which shall be fixed, failing agreement between the parties, by the court. The compensation shall take into adequate account the economic value of the compulsory licence. In particular, it shall be commensurate with the royalty the holder of the compulsory licence would have paid on the basis of an exploitation contract concluded with the patentee, taking into account the licensing conditions in the technical field of the invention. 4. The holder of a compulsory licence shall have the same rights as the patentee in regard to the maintenance of the patent and exercise of the rights deriving from protection. 5. A compulsory licence may not be assigned or transferred to any other person. Compulsory licences are non-exclusive and non-transferable, even in the form of sublicence, except with that part of the enterprise or goodwill which exploits such licence. The holder of the compulsory licence may not grant a licence of exploitation. 6. The holder of a compulsory licence may relinquish his compulsory licence at any time. If the holder does not begin exploitation within one year from the definitive grant of the compulsory licence, the patentee may claim modification or cancellation of the compulsory licence. 7. The patentee may request modification or cancellation of a compulsory licence if the circumstances on which it was based cease to exist and are unlikely to occur again. Modification or cancellation shall take a form that does not prejudice the legitimate interests of the holder of the compulsory licence.
28/04/2003
IP/Q/ALB/1, IP/Q2/ALB/1, IP/Q3/ALB/1, IP/Q4/ALB/1 Albania Suiza Follow-up question: Does your legislation provide for the granting of compulsory license to allow the exploitation of a patent ("second patent") which cannot be exploited without infringing another patent ("the first patent") as mentioned in Article 31 (l) of the TRIPS Agreement? If so, which conditions shall apply for the granting of such licences in your legislation?
Our legislation does not provide (until now) for the granting of compulsory licence to allow the exploitation of a patent ("second patent") which cannot be exploited without infringing another patent ("the first patent").
28/04/2003
IP/Q/ALB/1, IP/Q2/ALB/1, IP/Q3/ALB/1, IP/Q4/ALB/1 Albania Suiza 5. Does your legislation provide for the principle of the reversal of burden of proof in a process patent litigation? Please cite the relevant provisions of law.
Our law provides for such a principle in its Articles 41-42: (1) Subject to this Law, the performance of any act referred to in Article 27(1), 27(2) and 27(4) in Albania by a person other than the owner of the patent, and without the consent of the latter, in relation to a product or process falling within the scope of protection of the patent shall constitute an infringement of the patent. (2) Subject to this Law, the performance of any act referred to in Article 27(1), 27(2) and 27(4) in Albania by a person other than the applicant, and without the consent of the applicant, in relation to a product or process falling within the scope of provisional protection conferred on a published patent application under Article 20(3) shall constitute an infringement of that provisional protection. (1) The owner of a patent and the applicant for a patent shall have the right to institute proceedings in the Court against any person who has infringed or is infringing the patent or the provisional protection conferred on a published patent application. The owner of the patent and the applicant shall have the same rights against any person who has performed acts or is performing acts which make it likely that such infringement will occur ("imminent infringement"). The proceedings may not be instituted after five years from the act of infringement. (2)(a) If the owner of the patent proves that an infringement has been committed or is being committed, the Court shall award damages and shall grant an injunction to prevent further infringement and any other remedy provided in the general law. (b) If the owner of the patent proves imminent infringement, the Court shall grant an injunction to prevent infringement and any other remedy provided in the general law. (3)(a) Unless the licence contract provides otherwise, any licensee may request the owner of the patent to institute Court proceedings for any infringement indicated by the licensee, who must specify the relief desired. (b) Such licensee may, if he proves that the owner of the patent received the request but refuses or fails to institute the proceedings within three months from the receipt of the request, institute the proceedings in his own name, after notifying the owner of the patent of his intention. The owner of the patent shall have the right to join in the proceedings. (c) Even before the end of the three-month period referred to in subparagraph (3)(b), the Court shall, on the request of the licensee, grant an appropriate injunction to prevent infringement or to prohibit its continuation, if the licensee proves that immediate action is necessary to avoid substantial damage. (4) Where the subject matter of the patent is a process for obtaining a product, the burden of establishing that a product was not made by the process shall be on the alleged infringer if either of the following conditions is fulfilled: (a) the product is new; or (b) a substantial likelihood exists that the product was made by the process and the owner of the patent has been unable through reasonable efforts to determine the process actually used. Articles 12, 14 and 17 of Civil Procedure Code provide also the principle of burden of proof in a process patent litigation.
28/04/2003
IP/Q/ALB/1, IP/Q2/ALB/1, IP/Q3/ALB/1, IP/Q4/ALB/1 Albania Suiza 6. Please explain in detail if your legislation ensures that undisclosed test or other data submitted by an applicant to the responsible State agency in the procedure for market authorisation of a pharmaceutical or of an agricultural chemical product is protected against disclosure and against unfair commercial use by a competitor, for example by prohibiting a second applicant from relying on, or from referring to the original data of the first applicant, when applying subsequently for market authorization for his own product. Does your legislation provide for exceptions to this? If yes, under what conditions would such exceptions apply? Does your legislation set a specific term of protection for undisclosed test or other data of the first applicant?
Protection of undisclosed test or other data submitted by an applicant in the procedure for market authorization of a pharmaceutical is provided under the "Regulation of the Commission for the Verification of Manufacturing Conditions on Pharmaceutical" point 12 and under the Regulation "On a supplement and a change on the regulation No. 393 dated 20 January 1998 - On the Registration of Drugs in the Republic of Albania" point 2. In both of them it is defined that this information is confidential and, after the verification by the Commission, the documentation is deposited in the National Center of Drugs Control together with a copy of the marketing authorisation and is exclusive property of the Albanian authorities. The time period during which Albania protects data submitted to obtain marketing approval for pharmaceuticals is not defined (normally, it can't be less than the period of the working of the factory or the validity of the marketing authorization). Each pharmaceutical company submits the dossier for any drugs to get marketing authorization along with the bioequivalent study, when required. All this information is protected and other applicants or third persons are not allowed to consult it. The legislation does not provide for exceptions to this. Concerning agricultural chemical products, data submitted by companies in order to obtain marketing authorization is protected by the Decision of the Council of Ministers No. 72 dated 15 February 2001 "On the Approval of the regulation of Plant Protection Products". In Article 6 of this regulation it is defined the protection of data is ensured upon request of the applicant and no time limit is foreseen for this.
28/04/2003
IP/Q/ALB/1, IP/Q2/ALB/1, IP/Q3/ALB/1, IP/Q4/ALB/1 Albania Suiza 7. Please indicate remedies provided by your legislation, which constitute effective deterrents to infringements of intellectual property rights.
According to the "Law on Industrial Property" (1994) (articles 83, 89 and 101) and Article 19 of the Law "Some changes and supplements on the Law on industrial property" (1999) constitute effective deterrents to infringement of industrial property rights. The owner of the registered mark shall have the right to institute proceedings in the Court against any person who has infringed or is infringing his rights under the conditions of Article 83 of the Law. The owner shall have the same right against any person who has performed acts or is performing acts which make it likely that such infringement will occur ("imminent infringement"). If the owner of the registered mark proves that an infringement has been committed or is being committed, the Court shall award compensation. In these compensations will be included the profit of the person who has performed the infringement, the damage which has incurred the owner of the mark except the one is included in the profit of the breaker and the expenses including the law costs. The Court shall grant an injunction to prevent further infringement and any other remedy provided in the general law. If the owner of the registered mark proves imminent infringement, the Court shall grant an injunction to prevent further infringement and any other remedy provided in this Law and in the Code of Civil Procedure. In addition to the measures specified in the previous paragraphs, the Court may re-establish the situation that existed before the infringement and to stop infringing actions, to proceed with an effective seizure of the goods and, when necessary, to destroy illegally used marks, tools that could be used to manufacture the goods and the goods themselves in absence of possibility to remove any illegally mark from such goods. The judicial authorities shall have the authority to order prompt and effective provisional measures: - to prevent an infringement of any intellectual property right from occurring, and in particular to prevent the entry into channels of commerce in their jurisdiction of goods, including imported goods immediately after customs clearance; - to preserve relevant evidence in regard to the alleged infringement. The new Article 89(3) of the Law on Industrial Property states: In addition to the measures specified in paragraph 2(a) of this Article, the Court may re-establish the situation that existed before the infringement and to stop infringing actions, to proceed with an effective seizure of the goods and, when necessary, to destroy illegally used marks, tools that could be used to manufacture the goods and the goods themselves in absence of possibility to remove any illegally used mark from such goods. Any natural or legal person who performs an act which he knows constitutes an infringement of the patent, mark or design shall commit an offence and shall be punishable from the Court by a fine between lek 20,000 and 100,000. The Penal Code, as amended by the Law 7883 dated 24 January 2001, under Article 288(a) states that the unlawful production and distribution on commercial scale of industrial and nutritive articles and goods constitutes a criminal infringement and is punishable with fine or imprisonment up to 2 years. This offence, when committed in collaboration with other persons, more than once, orwhen it has caused serious consequences, is punishable with imprisonment from 3 to 10 years. Article 50 of Copyright Law as amended by the Law No. 8594 dated 6 April 2000 underlines that the translation, adaptation, sound or visual recording, reproduction, the transmission of an artistic work without the authorization of its author, which conflicts with the provisions of this law or the international conventions ratified by the Republic of Albania, when the author's moral and economic rights have been infringed, constitutes a criminal work and is penalized by fine or imprisonment up to one year. Whereas the Penal Code, as amended by the Law 7883 dated 24 January 2001, under Articles 147-149 underlines fines and imprisonment by up to four years for misappropriation of property through fraudulence by introducing a work of art and culture as the original or by changing the authenticity of the authorship; and fines and imprisonment by up to two years for partially or completely plagiarizing somebody else's work or for unauthorized reproduction of somebody's work. According to Article 82(4) of the Customs Code, the customs authorities upon request of the holder of a trademark or patent of production or other neighbouring rights specified in the Implementing Provisions of this Code, may prohibit their release in free circulation, the exportation, the re-exportation and their placing under the suspensive procedure of the goods that are recognized to be counterfeited or pirated goods, according to the procedure provided for in the Implementing Provisions of this Code. And the Implementing Provisions on Customs Code, Article 120(1) state that the General Directorate of Customs may suspend the release of the goods or seize the goods depending on the situation. The Code of Civil Procedure authorizes judges to order the payment of monetary damages adequate to compensate for the injury done. Article 68 of this Code states: "When a sum of money or a removable thing is requested the value is determined on the basis of the amount indicated or of the value declared by the plaintiff. In the absence of indication or of declaration, it is accepted that the determination of the value is a competence of the court". And any person has the right to claim compensation of costs and damages caused by the infringer. Under Article 106 it is stated among others: "In its final decision, the court charges the party whose lawsuit has been dropped, to pay the judicial expenses in conformity with article 102 of this Code including the payment for one advocate." Article 67 of the Law on Competition authorizes courts to impose fines not less than lek 10,000 and not more than lek 200,000 to any person or company who does not respect business secrets.
28/04/2003
IP/Q/ALB/1, IP/Q2/ALB/1, IP/Q3/ALB/1, IP/Q4/ALB/1 Albania Suiza 8. Please describe any new initiatives that are planned to improve enforcement of intellectual property rights in your country, particularly initiatives related to criminal enforcement.
According to Article 348 of the Code Civil Procedure, all the cases of the infringement of the industrial property rights will be tried by the commercial section of the District Court of Tirana. In respect of this several seminars and training of judges and prosecutors are being planned in cooperation with WIPO and EPO.
28/04/2003

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