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.
WIPO FOR OFFICIAL USE ONLY
Na podlagi prvega in sedmega odstavka 21. člena Zakona o Vladi Republike Slovenije (Uradni list RS, št. 24/05 – uradno prečiščeno besedilo) in tretjega odstavka 22. člena Zakona o industrijski lastnini (Uradni list RS, št. 102/04 – uradno prečiščeno besedilo) izdaja Vlada Republike Slovenije
U R E D B O o izvajanju uredb Sveta (ES) o uvedbi dodatnega varstvenega certifikata za
zdravila in za fitofarmacevtska sredstva
1. člen (vsebina)
(1) S to uredbo se določa postopek za izvajanje Uredbe Sveta (ES) št. 1768/92 z dne 18. junija 1992 o uvedbi dodatnega varstvenega certifikata za zdravila (UL L, št. 182/1992, str. 0078), s spremembami (v nadaljnjem besedilu: Uredba 1768/92/ES), in Uredbe Evropskega parlamenta in Sveta (ES) št. 1610/96 z dne 23. julija 1996 o uvedbi dodatnega varstvenega certifikata za fitofarmacevtska sredstva (UL L, št. 198/1996, str. 0030), s spremembami (v nadaljnjem besedilu: Uredba 1610/96/ES), v Republiki Sloveniji. (2) Če z Uredbo 1768/92/ES oziroma Uredbo 1610/96/ES ali s to uredbo ni drugače določeno, se za dodatni varstveni certifikat za zdravila oziroma za fitofarmacevtska sredstva (v nadaljnjem besedilu: certifikat) smiselno uporabljajo določbe o patentu zakona, ki ureja pridobitev in varstvo pravic industrijske lastnine.
2. člen (vložitev prijave za certifikat)
Prijava za certifikat se vloži pri Uradu Republike Slovenije za intelektualno lastnino (v nadaljnjem besedilu: urad). Kot datum vložitve prijave se šteje datum, ko je urad prejel prijavo za certifikat.
3. člen (vsebina prijave za certifikat)
Prijava za certifikat mora poleg sestavin, določenih v prvem odstavku 8. člena Uredbe 1768/92/ES oziroma v prvem odstavku 8. člena Uredbe 1610/96/ES, vsebovati še naziv proizvoda oziroma sredstva, za katero se zahteva podelitev certifikata.
4. člen (pristojbine)
(1) Za vložitev prijave za certifikat in za vzdrževanje certifikata se plačujejo pristojbine v naslednji višini: 1. prijavna pristojbina: 100.000 tolarjev; 2. pristojbine za vzdrževanje: – 1. leto: 400.000 tolarjev, – 2. leto: 500.000 tolarjev, – 3. leto: 600.000 tolarjev, – 4. leto: 700.000 tolarjev, – 5. leto: 800.000 tolarjev. (2) Pristojbine iz tega člena se plačujejo na račun št. 01100-1000307004 pri Upravi Republike Slovenije za javna plačila v Ljubljani ali pri blagajni urada. (3) Če se pristojbina plača na račun iz prejšnjega odstavka, se kot datum plačila šteje datum, ko je celotni znesek pristojbine knjižen na ta račun. (4) Če se pristojbina plača pri blagajni urada, se kot datum plačila pristojbine šteje datum plačila pri blagajni urada.
5. člen (odločanje)
(1) Če prijava za certifikat in proizvod oziroma sredstvo, na katero se prijava nanaša, izpolnjujeta pogoje Uredbe 1768/92/ES oziroma Uredbe 1610/96/ES in te uredbe, urad certifikat podeli. Urad v postopku podelitve certifikata ne preverja, ali so izpolnjeni pogoji, določeni v točkah c) in d) 3. člena Uredbe 1768/92/ES oziroma v točkah c) in d) prvega odstavka 3. člena Uredbe 1610/96/ES. (2) Če prijava za certifikat ne izpolnjuje pogojev iz 8. člena Uredbe 1768/92/ES oziroma iz 8. člena Uredbe 1610/96/ES ali 3. člena te uredbe ali če ni plačana prijavna pristojbina v skladu s 4. členom te uredbe, urad pozove prijavitelja, da v določenem roku odpravi nepravilnosti.
WIPO FOR OFFICIAL USE ONLY
(3) Urad ob upoštevanju prejšnjega odstavka zavrže prijavo za certifikat, če ta ali proizvod oziroma sredstvo, na katero se nanaša, ne izpolnjuje pogojev Uredbe 1768/92/ES oziroma Uredbe 1610/96/ES ali te uredbe.
6. člen (objava)
Urad objavi v svojem uradnem glasilu naslednje podatke o prijavah za certifikat in o certifikatih: a) številko in datum prijave za certifikat oziroma številko certifikata; b) številko in datum sklepa, s katerim se je končal postopek, če certifikat ni bil podeljen; c) podatke o prijavitelju oziroma imetniku: priimek, ime in naslov, če gre za fizično osebo, oziroma firmo in sedež, če gre za pravno osebo; d) podatke o morebitnem zastopniku, če zastopnik to želi: priimek, ime in naslov oziroma firmo in sedež; e) številko osnovnega patenta; f) naziv izuma; g) številko in datum prve odobritve, da se da proizvod oziroma sredstvo na trg kot zdravilo oziroma fitofarmacevtsko sredstvo v Republiki Sloveniji oziroma v Evropski skupnosti (v nadaljnjem besedilu: Skupnost) in navedbo države, če odobritve ni izdal pristojni organ Skupnosti po centraliziranem postopku; h) naziv proizvoda oziroma sredstva; i) trajanje certifikata oziroma datum, do vključno katerega velja certifikat.
7. člen (obravnava že vloženih prijav)
Prijave za certifikat, ki so bile vložene pred uveljavitvijo te uredbe in o katerih urad še ni odločil, se obravnavajo po določbah te uredbe.
8. člen (prenehanje veljavnosti)
Z dnem uveljavitve te uredbe prenehata veljati Uredba o izvajanju Uredbe Sveta (ES) o uvedbi dodatnega varstvenega certifikata za zdravila (Uradni list RS, št. 42/04) in Uredba o izvajanju Uredbe Sveta (ES) o uvedbi dodatnega varstvenega certifikata za fitofarmacevtska sredstva (Uradni list RS, št. 42/04).
9. člen (začetek veljavnosti)
Ta uredba začne veljati petnajsti dan po objavi v Uradnem listu Republike Slovenije. Št. 00713-15/2005/5 Ljubljana, dne 2. junija 2005. EVA 2005-2111-0075
Vlada Republike Slovenije
Janez Janša l. r. Predsednik