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.

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").

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.

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.

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.

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.

The three following intellectual property rights-related laws provide for measures aimed at preventing violation of intellectual property rights: - the 1992 Trade Marks Law No.37 in its Chapter VI on Penalty (Articles 37-43); - the 1992 Copyright Law in its Chapter VIII (Articles 38-44) on Penalty; - the 1992 Patent and Design Law in its Chapter V on Preventive Measures, Offences and Penalty (Articles 58-61) lay down measures to prevent any infringement unlawful act which violate the owner right of intellectual property. These laws also provide for remedy measures like preventive seizure, confiscation, destruction of products and equipment as well as removing of the effects of the illegal acts and compensation. Damages compensation for the holder of rights The 1992 Trade Marks Law, Articles 40 and 43, and Patent Law, Article 61, provide for compensation. The Civil Transactional Law also provides for compensation. Other remedies The 1992 Trade Marks Law, Articles 41-43, provides for measures to remove goods outside the channels of commerce through the seizure and confiscation procedures. The removal of trademark and the product and equipment if needed. The 1992 Patent Law, Articles 58-61, provides for the same provisions. The 1992 Copyrights Law, Article 43, provides for confiscation measures and the closing of the institution violating copyright. The draft amendment will provide more detailed measures to enforce copyrights as reflected in the TRIPS Agreement. Right of information Article 41 of the Trade Marks Law provides that the court could order, within the procedure of seizure, to provide information on the third persons involved in the production and distribution of the infringing products. Judicial appeal The 1992 Trade Marks Law, Article 40, provides for the possibility for the owner of a trademark to access to the judicial procedures in order to enforce its rights. The Civil Transactions Law Article 282 provide the owner with the right of appeal through the judicial system in order to enforce its rights. The Evidence Law provides for an equitable and fair access to judicial procedures. The balance of the rights and obligations of both parties' claims and the opposing party is ensured. The basic principle of this law is that the claimant must provide evidence to substantiate his claim and the evidence must be relevant to the action. The court can order the evidence be produced if it is under control of the opposing party. The court can also call on the party to question him regarding the changes or alterations made to the element of evidence. Compensation for the opposing party The Civil Transactional Law provides for compensation for the opposing party who has been subject to abusive procedures relating to enforcement. Preventive customs procedures Customs Departments are allowed to take measures at the borders to prevent any violation of intellectual property rights in accordance with the above-mentioned laws as well as under Customs regulations. These measures could be taken either following the demand of the right holder or the judicial order.

The 1992 Copyrights Law, Articles 37-44, provides for preventive measures and penalty including confiscation, the closing of the institution violating copyright and prison measures and compensation. The draft amendment will provide more detailed measures to enforce copyrights as referred to in the TRIPS Agreement. The obligations arising from Article 9 of the TRIPS Agreement (Berne Convention, Articles 1-21 except Article 6bis) will be met through the extension of the scope in terms of the various categories and subjects of copyright as well as the nature of the protection. Computer programs are protected by the 1992 Copyright Law No. 40. Article 2 of this law mentions computer programs under the scope of protection. The draft amendment will introduce under the above-mentioned scope computer programs applications as well as compilations of data. The rental right is available under the existing law through the right of free exploitation provided for in the Article 14 of the 1992 Copyright Law. The draft amendment will introduce clearly the exclusive rights to exploit, under the rental right, literary works, including computer programs and cinematography work. The term of protection of copyright other than photography work is determined by the period of life of the owner and 25 years after his death. The draft amendment will extend this period to 50 years.

The 1992 Copyrights and Neighbouring Rights law No. 40 stipulates in its Article 4 that the copyrights shall be registered in the Ministry of Information and Culture and non-deposit of the work does not prejudice any of the protection aspects of the rights decided by the law. Article 33 stipulates that the Ministry of Information and Culture establishes a system for registration of copyrights and any actions that will occur on them. The bylaw of the 1992 Copyrights Law indicates the administrative procedures to be followed by the owners in pursuing depositing or registering actions.

The 1992 Copyrights Law No. 40 determines in its Article 14, as follows, the actions allowed without the consent of the owner of copyright: - the personal use of the work through copying or translating it. - The use of the work in the educational system with the purpose of the clarification through copies, programmes and reproductions for educational, cultural and religious purposes. The use must be in the necessary limit, provided that this will not seek any monetary profit and the name of the author and the origin of the work be indicated. - Quotation of paragraphs with the purpose of clarification, explanation and criticism and to the extent usually observed and necessary to reach the set objective, provided that the name of the author and the origin of the work be indicated. - Copying information and political, economic, social, cultural and religious press articles related to current events and their publication by newspapers as well as broadcasting works of like nature provided that the origin be mentioned. - Copying any audio or visual work relating to current events presented in broadcasting news and publishing it in the limit of the set objective and with the mention of the name of the author. - Public libraries, non-commercial documentation centers, educational and cultural and scientific institutes may copy protected works in the limit of the necessary needs, provided that this will not prejudice the author’s rights. - Newspapers and other news agencies may publish presentations made during judicial procedures and other similar works presented to the public, provided that the name of the author be mentioned. The amendments of the 1992 Copyrights law envisage reorganizing these provisions to cope with the TRIPS Agreement. The envisaged amendments are presented as follows: Without prejudice to literary rights of the author stipulated in the mentioned law, the author after the publication of his work must not prohibit a third person to perform one of the following acts: - To make a sole copy from the work for the merely non-commercial or professional but personal use, except the works of the fine and applied arts unless were located in public place. The works of architecture are also excepted. - To make a sole copy of computer programme with acknowledgement of its legitimate acquisitor who has a unit to derive from, provided that such act occurs in the limits of the licensed purpose or the purpose to retain or substitute at the time of losing the original, been damaged or became invalid to use. - Copying protected works to use them in judicial procedures or analogous to them within the limits required by such procedures provided that the source and the author name be mentioned. - Taking a sole copy of the work with acknowledgement of records house or archives, libraries, or documentation centers who do not seek direct or indirect profit all in the following two cases: (i) copying must be for the purpose of preservation of the original, or to exchange it for a lost, destroyed unsuitable to use or unobtainable copy against reasonable conditions; (ii) the purpose for copying must be in reply to application by a natural person to use it for research or study provided that it must be granted for one time or for interrupted periods of time provided that obtaining a license became impossible in accordance with the provisions of the law. - Quotation of short paragraphs, derivation or reasonable analysis of the work for the purpose of criticism, discussion, or information provided mentioning the source and the author’s name. - Performing the work in family meetings or by students in an educational institute against no direct or indirect remuneration. - Presenting the fine arts, applied and plastic arts works or architectural works in broadcasting programmes, if such works are permanently present in far places. - Reproduction of written, sound or audio-visual short excerpts for cultural, religious, educational or vocational training purposes provided that copying be in reasonable limits of its purpose and that the name of the author and the title of the work be mentioned wherever is possible and that the copying authority does not aim at direct or indirect profit and that license for copying was unobtainable in accordance with the provision of the law. Also under the same amendments, the author has no right to prohibit the copying made by newspapers, periodicals, broadcasting organizations within the limits justified by the aimed purpose to publish any of the following: - Excerpts of his available works to the public in a legal manner. This applies also on communicating excerpts from audio or visual works during current events, broadcasting or communicating them to the public by any other medium. The source and author’s name must be mentioned. - The published essays relating to discussion of issue preoccupying the public opinion in certain time, as long as no notification of prohibition was served at the time of publication provided that the source and author’s name must be mentioned. - Addresses, lectures, speeches recited in open sessions of parliamentary or judicial councils and public meetings as long as such lectures and speeches are addressed to the public and copied within the limits of copying the current news. All these restrictions on the economic rights of the authors are applied on the holders of neighbouring rights.

In addition to specific laws related to the protection of public health and nutrition, including the Anti-fraud and Defraud Law, Civil Law, the 1992 Patent and Design Law No. 44 in Section one on Patents and Utility Certificates (Article 6) stipulates that neither a patent nor a utility certificate shall be granted for the following: - plant or animal research, or biological processes for the production of plants or animals, with the exception of microbiological processes and products thereof, - chemical inventions related to foodstuffs, drugs or pharmaceuticals, unless such products are made by means of special chemical process, in which case protection shall extend only to the process and not to the products of the processes, - scientific principles and discoveries, - inventions related to national defense, - inventions, which, if disclosed or exploited, would be contrary to public policy and morality. It is to be noted however that, in order to be consistent with the provisions of the TRIPS Agreement, the draft amendment of the 1992 Patent and Design Law No. 44 will introduce new elements by eliminating the mention of the second above-mentioned sub-paragraph (ii) as exception from granting patent. In addition, the amendment will introduce diagnostic, therapeutic and surgical methods for the treatment of humans or animals among exceptions from granting patent as provided for in Article 27 of the TRIPS Agreement. Furthermore, Section two of the 1992 Patent Law provides for compulsory licences and the reasons of obtaining them in addition to the procedure stipulated in Article 29 under which they are granted. These provisions are also amended to bring the above-mentioned Law in conformity with Articles 30 and 31 of the TRIPS Agreement and to facilitate reading and understanding thereof. The new elements introduced through the amendment are mainly related to the non-exclusivity of compulsory licenses, their restriction to the local market, and the fair compensation for the patent owner. The efforts to be exerted within reasonable period of time for obtaining voluntary license, the prohibition to transfer compulsory licenses and other conditions are also introduced through the amendment to conform to the TRIPS provisions. The public emergency, the public interest and non-commercial uses are also mentioned as grounds of granting compulsory licences.

The 1992 Copyrights Law No. 40 lays down provisions to protect the exclusive rights of authors in relation with their literary and artistic works and determine the scope of the protection. The 1992 Copyrights Law, Articles 37-44, provides for preventive measures and penalty including confiscation, the closing of the institution violating copyright and prison and compensation. The draft amendment will provide additional measures to allow enforcement of copyrights as referred to in the TRIPS Agreement. The obligations contained in Article 9 of the TRIPS Agreement (Berne Convention Articles 1-21 except Article 6bis) will be met through the extension of the scope of copyright in terms of categories and subjects covered as well as the nature of the protection.

The 1992 Copyrights Law No. 40 protects computer programs. Article 2 of this law mentions computer programs under the scope of protection. As mentioned in the answer to question no. 2, Articles 37-44 provide for preventive measures and penalty in order to enforce and protect the owner rights, including computer programs. The draft amendment will bring computer programs applications as well as databases into the scope of copyright protection. It will introduce in clear terms the exclusive rights to exploit literary works, including computer programs, databases and compilation of data.

The rental right is available under the existing law through the right of free exploitation provided for in Article 14 of the 1992 Copyright Law. The rental right applies to all copyrights except for the computer program if the program does not constitute itself the main subject of the rental. It does not apply also to cinematography works unless the rental right is affecting their normal exploitation.

The 1992 Copyright Law includes the rights of producers of phonograms and broadcasting organisations under the protection of copyrights. However, the broadcasting of normal news and events do not fall under the umbrella of the protection unless they are assembled an innovative way or were subject to a personal effort that deserves protection.

The protection doesn’t cover just ideas, procedures, methods of work or function, concepts, principles, inventions and information as such even when they are expressed or explained or clarified or included a copyright. The protection does not cover also official documents regardless of their original language or the language to which is translated. The broadcasting of normal news and events does not benefit from the protection unless they are assembled in an innovative manner or subject to a personal effort that deserves such a protection as mentioned above.

The term of protection of copyrights and neighbouring rights is determined as follows: - As regards the author rights, the term of protection is determined by the period of life of the owner and 25 years after his death. The draft amendment will extend this period to 50 years as referred to in the TRIPS Agreement. - The term of protection of the rights of the joint authors is determined by their period of life and 50 years begin from the date of the death of the last surviving author. - The term of protection of the authors of collective works except the authors of applied arts is 50 years begin from the date of the first publication. - The term of protection of the rights of the authors of the applied artwork is 25 years from the date of their publication. - The term of protection of the rights of the performers is 50 years from the date of the Accomplishment of the work performed. If the performance was fixed in a phonogram the period would be calculated from the end of the year in which the fixation was made. - The term of protection of the rights of the producers of phonograms is 50 years from the date of publication or fixation if it was not published. - The term of protection of the rights of the broadcasting organisations is 20 years from the next year to the year in which the first transmission of the program was made.

The 1992 Copyrights Law Articles 38-44 provides for preventive measures and penalty including confiscation, the closing of the institution violating copyright and prison measures and compensation. The draft amendment will provide more detailed measures to enforce copyrights as referred to in the TRIPS Agreement. The obligations arising from Article 9 of the TRIPS Agreement (Berne Convention Articles 1-21 except Article 6bis) will be met through the extension of the scope in terms of the various categories and subjects of copyright as well as the nature of the protection. Furthermore, the amendment envisages to state that in case of conflict of laws the provisions of the law shall apply on the works, performances, phonograms, broadcasting programs related to foreigners on conditions of reciprocity, and without prejudice to the provisions of the international agreements to which the UAE is party.

The 1992 Trademarks Law No. 37 defines in its Article 1 a sign as a drawing which can be seen and which constitutes one element. Article 2 of the same law considers as trademark, among others, signs, which take a particular form if they are used to distinguish goods, products or services, or to indicate that the products, goods or services are the properties of the owner of the mark.

The 1992 Trademarks Law provides for protection of services-related trademarks in the same conditions of the protection of goods-related trademarks. The sign is protected if it constitutes a trademark as explained in the answer to question no. 9. The sound constitutes an element of the trademark if it accompanies the trademark.