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Law No. 581 Of 14 December 2004 Concerning The Supplementary Protection Certificate For Medicinal And Plant Protection Products

Original Language Title:  LEGE nr. 581 din 14 decembrie 2004 privind certificatul suplimentar de protecţie pentru medicamente şi produse de uz fitosanitar

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LEGE no. 581 581 of 14 December 2004 on the supplementary protection certificate for medicinal products and plant protection products
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 1.233 1.233 of 21 December 2004



The Romanian Parliament adopts this law + Chapter I General provisions + Article 1 Within the meaning of the present law, the following terms and expressions have the following meanings: a) medicinal product-any substance or mixture of substances presented for the treatment or prevention of diseases in humans or animals, and any substance or mixture of substances that may be administered to humans or animals in order to establish a medical diagnosis or for restoration, correction or modification of physiological functions in humans or animals; b) plant protection product-any active substance or preparation containing one or more active substances in the form delivered to the user and intended for: 1. to protect plants or plant products against any harmful organisms or to prevent their action, as long as the substance or preparation is not otherwise defined; 2. to exercise an action on the vital processes of plants, provided that it is not the nutritional substance; 3. ensure the preservation of plant products, provided that the substance or product is not subject to special Community rules on conservation agents; 4. destroy harmful plants; or 5. destroy parts of plants, inhibit or prevent unwanted growth of plants; c) substances in the medicinal product-any matter, irrespective of its origin, which may be human, animal, plant or chemical; d) substances in the product of plant protection-chemical elements and their compounds, as they are present in the natural state or manufactured in the industry, including any impurity that inevitably results from the manufacturing process; e) active substances in the medicinal product-chemical substances as such or mixtures thereof, plants, plant parts or constituents of plants, animal organisms, parts or constituents of animal organisms, human or animal metabolic products, microorganisms, including viruses, as well as constituents or their metabolic products; f) active substances in the product of plant protection-substances or micro-organisms, including viruses, exerting a general or specific action on harmful organisms or plants, plant parts or plant products; g) preparations-mixtures or solutions composed of two or more substances, of which at least one of them is the active substance, intended to be used as plant protection products; h) plants-live plants and live parts of plants, including fresh fruit and seeds; i) plant products-products in unprocessed state, derived from plants, or which have undergone a simple processing, such as: grinding, drying or pressing, excluding plants, as defined in lett. h); j) harmful organisms-pests of plants or plant products, belonging to the animal or plant kingdom, including viruses, bacteria and microplasms and other pathogens; k) product-active substance or mixture of active substances of a medicinal product or of a plant protection product; l) basic patent-an invention patent that protects a product, as it is defined at lit. k), a product manufacturing process or the use of the product which has been chosen by the holder for the purpose of obtaining a certificate; m) certificate-additional certificate of protection; n) authorization-the first valid authorization, issued by the competent authority, for the placing on the market in Romania or in the European Community of the drug or of the plant protection product, for any use thereof as a medicinal product or as a plant protection product; o) OSIM-State Office for Inventions and Trademarks; p) BOPI-Official Industrial Property Bulletin-Inventions Section. + Article 2 OSIM grants the patent holder, under the conditions of this law, an additional protection certificate for drugs or phytosanitary products, valid on the territory of Romania. + Chapter II Protection conferred by the certificate + Article 3 (1) May be subject to the certificate provided in art. 1 lit. m), under the conditions of this law, any product protected on the territory of Romania by a patent in force and which, before placing on the market, was authorized as a drug or as a phytosanitary product. (2) Provisions of para. (1) applies also for European patents with extended effects in Romania, for European patents in force on the territory of Romania, as well as for valid patents in the country of origin and for which the Romanian state recognizes a transitional protection, according to law + Article 4 (. The protection granted by the certificate shall extend, within the limits of the protection conferred by the basic patent, only to the product subject to the marketing authorisation of the medicinal product or plant protection product concerned, namely for any use thereof as a medicinal product or a plant protection product authorised before the expiry of the certificate. (2) During the period of validity of the certificate it will be allowed to carry out by third parties the clinical research intended to authorise the marketing of essential products similar to the patented ones, their marketing can be made only after expiry of the additional protection for the product + Article 5 (1) The provisions of art. 4 4 para. ((1), the certificate confers the same rights as the basic patent and is subject to the same limitations and obligations. (2) If the basic patent protects an active substance and its derivatives, salts and esters, then the certificate confers the same protection. (3) The granting of a certificate for a product consisting of an active substance shall not prevent the granting of other certificates for its derivatives, salts and esters, in so far as these derivatives are the object of patents in which they were Specifically claimed. + Article 6 The right to grant the certificate belongs to the holder of the basic patent or its successor in rights. + Article 7 (1) The legal provisions concerning the licences and the actual guarantees applicable to the patents apply accordingly to the certificates. (2) The conditions and terms in which licences have been granted for the basic patent shall also extend to the certificate, if in the contract or, as the case may be, in the final and irrevocable court decision is not provided otherwise. + Chapter III Application for issue of certificate + Article 8 (1) The application for the issuance of the certificate must be submitted to OSIM within 6 months, starting from the date on which the product obtained the authorization provided for in art. 1 lit. n). (. If the authorization is issued before the granting of the basic patent, the application for the issuance of the certificate must be submitted within 6 months from the date of granting the patent. + Article 9 If the applicant for a certificate is other than the holder of the basic patent or his successor in rights, OSIM shall notify the holder or his successor of the application and ask him to make comments. + Article 10 (. The application for the issue of the certificate shall contain: a) the express request for issuing the certificate; b) name and address of the applicant c) the name and address of the trustee, d) the number of the basic patent or the transitional protection certificate, as the case may be; e) the title of the invention, according to the basic patent or the transitional protection certificate; f) the number and date of the first marketing authorization of the product in Romania. (2) If the authorization provided in par. ((1) lit. f) it is not the first authorisation for placing on the market of the product in the European Community as a medicinal product or as a product for plant protection, the application for the issue of the certificate must state the number and date of concerning the identity of the product thus authorised and the legal basis for authorisation. + Article 11 ((. The application for the issue of the certificate shall be accompanied by: a) an authenticated copy of the marketing authorization of the product in Romania, identifying the product and containing the number and date of the authorization, as well as a summary of the product characteristics; b) proof of payment of the registration fee and examination of the application for issuing the certificate; c) the proxy of representation of the applicant, as appropriate. (2) If the authorization provided in par. ((1) lit. a) it is not the first authorisation for placing on the market of the product in the European Community as a medicinal product or as a product for plant protection, the application for the issue of the certificate must also be accompanied by a copy of the official publication of the specialty or, in the absence of such publication, of any document certifying the issuance of the authorization, its date and the identity of the product thus authorized. + Chapter IV Conditions for granting the certificate + Article 12 The certificate is granted if the conditions laid down in art. 10 10 and 11 and if, at the time of application for the issue of the certificate, the following conditions are met a) the product is protected by a basic patent or transitory protection certificate, in force in Romania; b) the product has obtained a marketing authorisation as a medicinal product or as a product for plant protection; c) the product has not been protected by a certificate; d) the authorization provided in b) is the first authorization for placing on the market in Romania or in the European Community of the product as a medicine or as a product for plant protection. + Article 13 The holder of several patents referring to the same product may not obtain more certificates for this product. However, when two or more applications related to the same product under consideration come from two or more different patent holders, each of these holders may obtain a certificate for this product. + Chapter V Procedure for granting the certificate + Article 14 Within one month from the date of registration of the application for the issuance of the certificate, OSIM shall examine whether the conditions of the form referred to in Article 3 3, 10 and 11. If so, within 3 months from the date of registration of the application, OSIM publishes in BOPI-Section Inventions the following elements of the application for the issuance of the certificate: a) name and address of the applicant; b) the number of the basic patent or the transitional protection certificate in force; c) the title of the invention of the basic patent or the transitional protection certificate in force; d) the number and date of the first authorisation and the product which it identifies; e) where applicable, the number and date of the first marketing authorisation in the European Community. + Article 15 If the conditions laid down in art. 10 10 and 11, OSIM shall notify the applicant that, within two months from the date of notification, it shall remedy the deficiencies of the application or, as the case may be, pay the legal fee for registration and examination of the application. + Article 16 If the applicant fixes the deficiencies notified according to art. 15, within one month from the completion of the application or, as the case may be, from the payment of the tax, OSIM publishes in BOPI-Section Inventions the elements provided in art. 14. Otherwise, OSIM rejects the request. + Article 17 Within 6 months of the publication of the application, OSIM shall examine in substance the conditions laid down in art. 12 and shall decide, where appropriate, to grant the certificate or reject the application for the issue of + Article 18 (1) Within one month of taking the decision, OSIM shall publish in the BOPI-the Inventions Section the mention of the certificate granting, as well as the following data: a) name and address of the certificate holder; b) the number of the basic patent or the transitional protection certificate in force; c) the title of the invention, according to the basic patent or the transitional protection certificate in force; d) the number and date of the first marketing authorisation and the product which it identifies; e) where applicable, the number and date of the first marketing authorisation in the European Community; f) duration of the certificate ((2) In case of rejection of the application for the issuance of the certificate, OSIM shall publish, in compliance with the ((1), at least the information provided in art. 14. + Article 19 ((. Applications for the issue of the certificate and their decisions shall be entered in the National Register of supplementary protection certificates. (2) The register provided in par. ((1) shall be established and administered by OSIM. + Chapter VI Duration of protection + Article 20 (. The certificate shall take effect, from the date of expiry of the legal term of the basic patent, for a duration equal to the period between the date of the deposit of the patent application and the date of issue of the first marketing authorisation in the The European Community of the medicinal product or product for plant protection, reduced by a period of 5 years. (2) In the case of a patent for which the Romanian State recognizes a transitional protection, according to the law, the duration of the protection will be equal to the period between the date of filing of the patent application in the country of origin and the date of issue of the Placing on the market in the European Community, the duration from which a period of 5 years is decreased (3) However, the duration of the certificate may not exceed a period of 5 years, starting from the date of expiry of the legal term of the basic patent. + Article 21 For the calculation of the duration of the certificate, a provisional first marketing authorisation shall not be taken into account unless it is directly followed by a definitive authorisation of the same product. + Article 22 During the validity of the certificate the holder is obliged annually to pay the legal maintenance fees in force. + Article 23 (. The validity of the certificate shall cease in the following situations a) the expiry of the duration provided in 20 20; b) the waiver of the certificate holder; c) non-payment of the annual maintenance fee of the certificate; d) if, and as long as the medicinal product or plant protection product provided for in the certificate is no longer authorised to be placed on the market, following the withdrawal of the appropriate marketing authorisation or authorisations. ((2) OSIM shall be notified, ex officio or at the request of a third party, of the situations of termination of validity of the certificate, provided in par. ((1). + Chapter VII Defence of rights conferred by the certificate + Article 24 Any interested person may ask the Bucharest Tribunal to cancel the certificate for the duration of its validity, for any of the following reasons: a) the certificate was granted without complying with the conditions provided in art. 12 lit. a)-d); b) the validity of the basic patent ceased before the expiry of the legal protection period; c) if the basic patent is cancelled, in whole or in part, so that the product for which the certificate was granted is no longer protected by the claims of the basic patent, or if, after the end of the validity of the basic patent, reasons are found that would have justified the cancellation, in whole or in part, of it. + Article 25 Any interested person may make an action in the cancellation of a certificate in order to cancel the corresponding basic patent. + Article 26 If the validity of the certificate ceases in one of the situations provided in 23 or 24, OSIM publishes in the BOPI a mention of this cessation. + Article 27 ((1) The OSIM decisions concerning the granting of the certificate or the rejection of the application for the issuance of the certificate may be challenged by the holder or any person concerned, within 3 months of the communication or, as the case may be, from the publication in the BOPI, legal fee payment. (2) Appeals shall be settled by a review panel in the OSIM Department of Appeals. (3) The decision of the commission, motivated, shall be communicated to the parties within 15 days of the ruling and may be appealed to the Bucharest Court. (4) Within 15 days of communication, the decisions of the Bucharest Tribunal can be appealed with appeal to the Bucharest Court of Appeal. + Article 28 Decisions on the rectification of the duration of protection of the certificate, when the date of the first marketing authorisation in the European Community, contained in the application for the issue of the certificate in accordance with art. 10, is incorrect, are subject to the remedies provided in art. 27. + Article 29 The sentences of the Bucharest Court, delivered in the cases provided in art. 24, can be appealed to the Bucharest Court of Appeal, within 30 days of communication. + Article 30 At the request of the court, OSIM is obliged to submit to it the documents, documents and information necessary to judge the case with which it was invested. + Article 31 The legal provisions on charges in the field of industrial property protection and their regime of use are also applicable to the procedures provided for in this Law. + Chapter VIII Transitional and final provisions + Article 32 For any product which, on the date of entry into force of this Law, is protected by a basic patent in force or by a transitional protection certificate in force and for which a first marketing authorisation has been obtained in the Romania, as of 1 January 2000, as a medicinal product or product for phytosanitary use, the certificate may be granted provided that the application for the issue of the certificate is submitted within 6 months from the date of accession of Romania to the Union European. + Article 33 This law transposes Regulation no. 1.768/92 1.768/92 on the creation of an additional protection certificate for medicinal products, published in the Official Journal of the European Communities (JOCE) no. L 182 of 2 July 1992, and Regulation no. 1.610/96 1.610/96 on the application of an additional protection certificate for plant protection products, published in the Official Journal of the European Communities (JOCE) no. L 198 of 8 August 1996, in order to apply their provisions on the date of Romania's accession to the European Union + Article 34 This law takes effect on the date of Romania's accession to the European Union + Article 35 Within 90 days of the entry into force of this law, OSIM will issue rules that will be published in the Official Gazette of Romania, Part I. This law was adopted by the Romanian Parliament, in compliance with the provisions of art. 75 75 and art. 76 76 para. (2) of the Romanian Constitution, republished. CHAMBER OF DEPUTIES PRESIDENT VALER DORNEANU SENATE PRESIDENT NICOLAE VACAROIU Bucharest, December 14, 2004. No. 581. ------------