Obtaining the supplementary protection certificate on the medicinal/phytopharmaceutical product

The service is intended for patent owners whose subject-matters are medicinal substances and who wish to extend their exclusive rights by a maximum of 5 years. 

The owner of a patent with effects in the Republic of Moldova, the subject-matter of which is a medicinal product or a phytopharmaceutical product (basic patent) for which an authorization for marketing the product has been granted, shall avail himself, in accordance with the requirements of this law and the Regulations, of a supplementary protection certificate, hereinafter certificate, for those parts of the primary patent which correspond to the authorization. The certificate shall take effect upon expiry of the legal protection term of the basic patent, for a period equal to the period covered between the date of filing of the patent application and the date of issuance of the first authorization, minus 5 years. Without prejudice to the aforesaid, the duration of the certificate may not exceed 5 years from the expiration date of the legal protection term in respect of the basic patent, subject to payment of the prescribed fee for maintenance of the certificate.

   In the case of a patent whose subject-matter is a medicinal product for which pediatric studies have been conducted, and the results of those studies are reflected in the information on the product for which an authorization for marketing has been issued, the periods specified above shall be extended by 6 months, while the period referred may be extended once. Within the limits of the protection conferred by the basic patent, the protection conferred by the certificate shall only extend to the product which forms the subject-matter of the authorization and any use of such product as a medicinal or phytopharmaceutical product, which was authorized prior to the expiration of the certificate. The provisions of this law relating to patents shall apply mutatis mutandis to supplementary protection certificates in the absence of any provisions to the contrary and with the exception of the opposition proceedings under CHAPTER IV Section 2. 

The application for the grant of a certificate shall be filed with AGEPI within 6 months following the date of issuance of the authorization. If the authorization has been issued prior to the grant of the primary patent, the application shall be filed within 6 months from the date of grant of the patent. The application shall not be deemed filed until after the prescribed fees have been paid. The application for the grant of a certificate must satisfy the requirements laid down in the Regulations.

The standard application form can be found at - https://www.agepi.gov.md/ro/formulare/inventions, F-01-BI-012-E-02-0220

      Conditions for Grant of a Certificate

A certificate shall be granted where an application is filed and where the following requirements are satisfied at the date of filing of that application:

a) the product is protected by a basic patent valid in the Republic of Moldova;

b) the product was granted an effective authorization for marketing as a medicinal or phytopharmaceutical product and is within the limits of the claims in the patent for invention;

c) the product is not yet a subject-matter of a certificate in the Republic of Moldova;

d) the authorization referred to in letter b) is the first authorization for marketing in the Republic of Moldova of the respective product as a medicinal or phytopharmaceutical product.

(2) If the requirements referred above are met, the AGEPI shall take the decision to grant a supplementary protection certificate and enter the particulars of the certificate in the National Register of Patents for Invention. Mention of the decision to grant a certificate shall be published in BOPI.

(3) The owner of more than one patent which relates to the same product may not obtain more than one certificate for that product. However, where two or more applications which relate to the same product are under examination and were submitted by two or more owners of different patents, each of such owners may obtain a certificate for that product.