MOLDOVA (MD) - Supplementary Protection of Pharmaceutical and Phytopharmaceutical Products (2004/07)

An Extract from the Patent Law of Moldova Kommentar in deutscher Sprache Article 20¹. Supplementary Protection of Pharmaceutical and Phytopharmaceutical Products (1) An owner of a patent for a pharmaceutical or phytopharmaceutical invention who has obtained a market authorisation for these products has a right to a supplementary protection of the invention that equals a term from the date of filing of a national application to the date of market authorisation but not more than 5 years. (2) The supplementary protection of pharmaceutical and phytopharmaceutical products shall be granted upon an application of the patent owner and shall be certified by a certificate granted by the Office. The certificate grants the same rights as the basic patent and has as a consequence the same rights and liabilities. During the validation of the certificate its owner must pay the annuity fees for the patent. (3) An application that includes information identifying the applicant, the patent number, the date and the number of the granted market authorisation for pharmaceutical and phytopharmaceutical products shall be filed with the Office within six months from the date of the market authorisation. If the market authorisation has been granted before the date of granting of the basic patent for the invention, the application shall be filed within six months from the date of granting of the patent. (4) The application shall contain: a) a copy of the market authorisation for pharmaceutical and phytopharmaceutical products; b) a document confirming the payment of fees. (5) The decision to grant the certificate shall be published in the Official Journal and registered in the National register of patents for inventions. The term of publication and the list of data for the publication shall be determined by the Office. (6) A certificate may be granted for any product that was protected by the basic patent valid in the Republic of Moldavia on December 14, 2000 and the first authorisation to place it on the market as a pharmaceutical and phytopharmaceutical product for which was granted after January 1, 1993. (7) Applications for granting of a certificate according to item (6) shall be lodged from January 1, 2003. [For the purposes of information: an extract from the old patent law of December 14, 2000 Article 20¹. Supplementary Protection of Pharmaceutical Products (1) An owner of a patent for a pharmaceutical invention who has obtained a market authorisation for these products has a right to a supplementary protection of the invention that equals a term from the date of filing of an application for the patent to the date of market authorisation but not more than 5 years. (2) The supplementary protection of pharmaceutical products shall be granted upon an application of the patent owner and shall be certified by a certificate granted by the Office. The certificate grants the same rights as the basic patent and has as a consequence the same rights and liabilities. During the validation of the certificate its owner must pay the annuity fees for the patent. (3) An application that includes information identifying the applicant, the patent number, the date and the number of the granted market authorisation for pharmaceutical products shall be filed with the Office within six months from the date of the market authorisation. If the market authorisation for pharmaceutical products has been granted before the date of granting of the basic patent for the invention, the application shall be filed within six months from the date of granting of the patent. (4) The application shall contain: a) a copy of the market authorisation for pharmaceutical products; b) a document confirming the payment of fees. (5) The decision to grant the certificate shall be published in the Official Journal and registered in the National register of patents for inventions. The term of publication and the list of data for the publication shall be determined by the Office.] Kommentar: Zusätzlicher Schutz von Arzneimitteln und phytopharmazeutischen Produkten. Das moldawische Patentgesetz vom 14. Dezember 2000 ist durch einen § 20¹ ergänzt worden. Er beinhaltet den Schutz von Arzneimitteln und phytopharmazeutischen Produkten (ab 31. Dezember 2002) über die Laufzeit eines erteilten Patentes hinaus. Hat der Inhaber eines Pharmapatents die Erlaubnis zur Vermarktung seiner Produkte in Moldawien erhalten, so kann er für den Zeitraum vom Anmeldetag bis zum Tag der Marktzulassung einen zusätzlichen Schutz für bis zu 5 Jahren erhalten. Das Patentamt stellt ein Zertifikat aus, das vom Basispatent abhängig ist und nur so lange gilt, so lange entsprechende Jahresgebühren bezahlt werden. Der Antrag auf Erteilung eines SPC muss innerhalb von 6 Monaten nach der Zulassung des Arzneimittels gestellt werden. Ist das Patent noch nicht erteilt, so laufen die 6 Monate vom Erteilungstag an. Das SPC kann für jedes Produkt erteilt werden, dass in der Moldawischen Republik ab dem 14. Dezember 2000 erteilt worden ist. Der Antrag kann seit dem 1. Januar 2003 gestellt werden.

[Germany][Russia][Albania][Mongolia][Ukraine][News][Archive][Links][home]