Please see paragraph 4 of Article 3 (cited above). Until now, there are no cases applied in practice.

Yes, they are excluded. Please see paragraph 6 of Article 3 as cited above.

Yes, they are excluded. Please see paragraph 7 of Article 3 as cited above.

They are protected under the second part of paragraph 7, of Article 3 of the law (see above). We are preparing all the documents to ratify in the near future the Budapest Treaty for the protection of micro-organisms. The Ministry of Agriculture and Food has prepared a new law for the protection of new varieties of plants according to UPOV standards, which should enter into force probably by the end of this year.

In Article 27 of the law it is defined: 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.

Yes. It is according to Article 3, paragraph 1 of the law which states: "In order to be patentable, an invention shall be novel, shall involve an inventive step and shall be industrially applicable." Whereas Article 6 underlines: "An invention shall be considered industrially applicable if it can be made or used in any kind of industry. Industry shall be understood in its broadest sense and shall cover any productive activities and services."

According to Article 27, paragraph 2 of the law: 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.

Paragraph 1 of Article 13 of the law states: a) The application shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art. b) Where the application refers to biologically reproducible material which cannot be disclosed in the application in such a way as to enable the invention to be carried out by a person skilled in the art and such material is not available to the public, the application shall be supplemented by a deposit of such material with a recognized depositary institution.

Article 27, paragraph 3 of the law states: 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) (cited above) 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.

The granting of compulsory licences is regulated under Articles 39 and 40 of the Law on Industrial Property and Article 22 of the Law No. 8477 dated 22 April 1999 (General Provisions on Compulsory Licences): 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 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 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.

A compulsory licence will only be granted if the applicant has previously made efforts to obtain a contractual license from the patent holder on reasonable commercial terms and conditions and these efforts have not been successful within a reasonable period of time. The expression "reasonable period of time" has to be determined by the competent authority on a case-by-case basis, in accordance with the relevant circumstances. Concerning the use predominantly for the home market, as one of the conditions under which a compulsory license will be granted, Article 39 stipulates that it must be used within the territory of the Republic of Albania, which in conformity with Article 31(f) of the TRIPS Agreement.

Article 28, paragraph 5 of the law provides for additional protection only for pharmaceutical products. It states that the term of a patent for invention related to pharmaceutical products can be extended over 20 years, but no more than 5 years.

Our Law on Industrial Property does not provide additional protection based on the date of filing of the patent application. All patents are granted in conformity with the standards of protection specified in the TRIPS Agreement and the Albanian laws on industrial property.

Our law provides for such a principle according to Articles 41-42, where it is stated: 1) Subject to this Law, the performance of any act referred to in Article 27(1), (2) and (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), (2) and (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 the Civil Procedure Code also provide for the principle of the reversal of the burden of proof in a process patent litigation.

Law No. 8488, dated 13 May 1999 "On protection of topographies of integrated circuits" provides for protection as follows: Chapter I - Basic provisions; Chapter II - Subjects of protection; Chapter III - Common regulations for the procedure of protection; Chapter IV - Contents, terms and limitation of rights; Chapter V - Procedure for protection and registration; Chapter VI -Invalidation of the register; Chapter VII - Infringement of the right and compensation of the damage; Chapter VIII - Transitional and final provisions.

Article 9 of our law is in full compliance with Article 36 of the TRIPS Agreement: The holder of the protected topography shall be granted exclusive rights of commercial exploitation, including the right to authorize or prohibited any of the following acts: - reproduction of the topography by any means or in any form; - importation, sale or other form of distribution of the topography or products that include integrated circuit incorporating the respective topography. The exclusive rights referred to in Paragraph 1 shall not extend to any concept, process, system or technical embodied in the topography other than the topography itself.

With regard to Article 37 of the TRIPS Agreement, Article 16 of our law reads: "A person who commercially exploits an integrated circuit incorporating the protected topography, and does not know, or has no reasonable grounds to believe that the topography of the product is protected shall not be prevented from commercially exploiting that integrated circuit". Compensation, the amounts of which depends on the scope of commercial exploitation of protected topography, may be claimed from the person referred to in Paragraph 1, by the right holder of the protected topography from the date when the person referred to in Paragraph 1 has known, or has had reasonable grounds to believe that the topography is protected. The amount of compensation under Paragraph 2 shall be agreed upon between the right holder of the protected topography and the person referred to in Paragraph 1. If no agreement is achieved, the Court of Justice in Tirana shall decide on the amount of compensation. The provisions of Paragraph 2 shall apply also to the successors in title of the person referred to in Paragraph 2. The right of commercial exploitation is limited to importation, sale or distribution of the products of integrated circuits or other products incorporating the respective topography, and this right applies to a topography or products that were on hand at the time when the claim under Paragraph 2 was received.

According to the Article 10 of the law: The exclusive rights shall expire after 10 years from the earlier of the following dates: - the end of the calendar year in which the topography is first commercially exploited anywhere in the world; or - the end of the calendar year in which the application has been filed in due form. The exclusive rights shall expire before the period defined in Paragraph 3, if the respective fees are not paid or if the right holder of the protected topography renounces protections in writing. If a topography has not been commercially exploited, the exclusive rights shall expire after 15 years from its fixation or encoding.

Albanian Competition Law protects business secrets, including trade secrets. Article 49.1 of the law prohibits disclosing business or operative secrets of competitors in an illegal manner or encouraging the competitors' employees to do so. Article 49.2 forbids using or giving others business or operative secrets obtained in the course of employment or other confidential relations during the term of those relations in order to gain competitive advantage for oneself or a third party or to damage the owner of a commercial company. The obligation continues for a period of two years after the employment or confidential relationship is terminated if the owner of the business or operative secret has a justifiable interest and the obligation does not unreasonably restrict the business or professional activity of others. Albanian pharmaceutical legislation does not grant any defined period of time for the protection of undisclosed information. Neither the legislation on plant protection products.

The Regulation of the Commission of the Verification of Manufacturing Conditions of Pharmaceuticals and the Regulation for the Registration of Pharmaceuticals (amended) constitute the Albanian legislation dealing with undisclosed information in this field. Both regulations do not define explicitly what an undisclosed information is. But in both of them, it is defined what kind of information must be presented by manufacturers: all documents presented by the manufacturer to take the approval for the manufacturing of drugs and all documents which comprise the drug dossier for obtaining marketing authorization. The regulation defines that the documentation which is confidential is deposited in the National Center of Drugs Control and remains as exclusive property of Albanian authorities that are engaged in the drug registration procedure. (Regulation of the Commission of the Verification of manufacturing Conditions of Pharmaceuticals, point 12; Regulation for the Registration of Pharmaceuticals (amended), point 21) In the field of veterinary, Regulation No. 4, dated 30 December 1999 "On the registration of the veterinary drugs" based on Law No. 7674, dated 23 February 1996 "On the veterinary service and inspectorate", Article 14 points 2, 3 and 4 define clearly the procedure of registration of any medicine imported and locally produced. The registration is made in the state register - it is valid for 5 years and, when necessary, can be renewed in conformity with the procedure fixed by European Union directives on this problem. The registration is considered done after the issuing of the Minister Order. The document is conserved in the Commission of Drugs Registration in the Veterinary Division.