On the basis of the first and seventh paragraph of Article 21 of the Government of the Republic of Slovenia Act (Official Gazette of the Republic of Slovenia, No 24/05) and the third paragraph of Article 22 of the Industrial Property Act (Official Gazette of the Republic of Slovenia, No 102/04), the Government of the Republic of Slovenia hereby issues the following
DECREE IMPLEMENTING COUNCIL REGULATIONS (EC) CONCERNING THE CREATION
OF A SUPPLEMENTARY PROTECTION CERTIFICATE FOR MEDICINAL PRODUCTS AND FOR PLANT PROTECTION PRODUCTS
Article 1 Scope of the Decree
(1) This Decree prescribes the procedures for implementing Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ L 182/1992, p. 0078), as amended, hereinafter referred to as “Regulation No 1768/92/EEC”, and Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (OJ L 198/1996, p. 0030), as amended, hereinafter referred to as “Regulation No 1610/96/EC”, in the Republic of Slovenia.
(2) The provisions on patents of the Act governing acquisition and protection of industrial property rights shall apply mutatis mutandis for supplementary protection certificate for medicinal products or plant protection products, hereinafter referred to as “certificate”, unless otherwise provided by Regulation No 1768/92/EEC or Regulation No 1610/96/EC or this Decree. .
Article 2 Application for a certificate
The application for a certificate shall be filed with the Slovenian Intellectual Property Office, hereinafter referred to as “the Office”. The date of filing of an application shall be the date on which the Office has received the application.
Article 3 Content of the application for a certificate
Beside items listed in Article 8(1) of Regulation No 1768/92/EEC or Article 8(1) of Regulation No 1610/96/EC, the application for a certificate shall contain also the title of the product for which the certificate has been requested.
Article 4 Fees
(1) The filing of the application and the maintenance of the certificate shall be subject to fees, as follows:
Filing fee 100,000 Slovenian Tolars
Maintenance fees 1st year 400,000 Slovenian Tolars 2nd year 500,000 Slovenian Tolars 3rd year 600,000 Slovenian Tolars 4th year 700,000 Slovenian Tolars 5th year 800,000 Slovenian Tolars
(2) The fees referred to in this Article shall be paid to the account No 01100- 1000307004 with the Uprava RS za javna plačila in Ljubljana, or at the Office’s cashier’s desk.
(3) Where the fee is paid to the account referred to in paragraph (2), the date on which the payment shall be considered to have been made shall be the date on which the whole amount is actually entered in that account.
(4) Where the fee is paid at the Office’s cashier’s desk, the date on which the payment shall be considered to have been made shall be the date on which the amount is paid at the cashier’s desk.
Article 5 Decision-making
(1) Where the application for a certificate and the product to which it relates meet the conditions laid down in Regulation No 1768/92/EEC or Regulation No 1610/96/EC and this Decree, the Office shall grant the certificate. The Office does not verify whether the conditions laid down in Article 3(c) and (d) of Regulation No 1768/92/EEC or Article 3(1)(c) and (d) of Regulation No 1610/96/EC are met.
(2) Where the application for a certificate does not meet the conditions laid down in Article 8 of Regulation No 1768/92/EEC or Article 8 of Regulation No 1610/96/EC or Article 3 of this Decree, or where the filing fee is not paid according to Article 4 of this Decree, the Office shall invite the applicant to rectify the irregularity within the prescribed time limit.
(3) The Office shall, subject to paragraph (2), reject the application for a certificate if the application or the product to which it relates does not meet the conditions laid down in Regulation No 1768/92/EEC or Regulation No 1610/96/EC or this Decree.
Article 6 Publication
(1) The Office shall publish in its Official Journal the following information on applications and certificates:
(a) the number and date of the application or the number of the certificate;
(b) the number and date of the decision terminating the proceedings, if the certificate has not been granted;
(c) information concerning the applicant or holder of a certificate: surname, first name and address in the case of natural persons, and business name and registered office in the case of legal persons;
(d) information concerning the representative, if any and if he so wishes: surname, first name and address, or business name and registered office;
(e) the number of the basic patent;
(f) the title of the invention;
(g) the number and date of the first authorization to place the product on the market in the Republic of Slovenia or on the Community market as a medicinal product or plant protection product, and indication of the sate, if the authorization has not been issued by a competent Community authority under a centralised procedure;
(h) the title of the product;
(i) the duration of the certificate or date on which the certificate expires.
Article 7 Treatment of applications
Applications for the grant of a supplementary protection certificate which were filed before the date of entry into force of this Decree and on which the Office has not yet taken a decision shall be treated in accordance with the provisions of this Decree.
Article 8 Termination of validity
On the date of entry into force of this Decree, the Decree implementing Council Regulation (EEC) concerning the creation of a supplementary protection certificate for medicinal products (Official Gazette of the Republic of Slovenia, No 42/04) and Decree implementing Regulation (EC) of the European Parliament and of the Council concerning the creation of a supplementary protection certificate for plant protection products (Official Gazette of the Republic of Slovenia, No 42/04) shall cease to apply.
Article 9 Entry into force
This Decree shall enter into force on the fifteenth day following its publication in the Official Gazette of the Republic of Slovenia.