ESTABLISHMENT OF A SUPPLEMENTARY INDUSTRIAL PROTECTION CERTIFICATE FOR MEDICINAL PRODUCTS

Definitions

The following definitions shall apply:
a) “medicinal product”: any substance or combination of substances presented as having properties for treating or preventing disease in human beings or animals, as well as any substance or combination of substances for administering to human beings or animals with a view to making a medical diagnosis or restoring, correcting or modifying organic functions in human beings or animals;
b) “product”: the active ingredient or composition of active ingredients of a medicinal product; 
c) “basic patent”: a patent that protects a product as such, a manufacturing process for a product or a use of a product and which is designated by its holder for the purposes of the procedure for issuing a certificate; 
d) “certificate”: the supplementary protection certificate.

Conditions for issuing the certificate

The certificate is issued for the Republic of San Marino, if on the date of the application: 
a) the product as such, a process for its manufacturing, is protected by a basic patent in force; 
b) a valid authorisation has been issued for the product as a medicinal product placing on the market in Italy or in the European Union;
c) the product has not already been the subject of a certificate;
d) the authorisation referred to in letter b) is the first authorisation to place the product on the market as a medicinal product.

Object of protection and effects 

Within the limits of the protection conferred by the basic patent, the protection conferred by the certificate concerns only the product which is the subject of the authorisation to place the corresponding medicinal product on the market, for any use of the product as a medicinal product, which was authorised before the expiry of the certificate.
The certificate confers the same rights as those conferred by the basic patent and is subject to the same limitations and the same obligations.

Right to the certificate

The right to the certificate belongs to the holder of the basic patent or to his/her successor in title. 
The certificate is issued only once for each product. 
If several holders of different patents concerning the same product submit an application for a certificate and a certificate has not yet been issued, each holder can obtain the certificate.

Application for a certificate

The application for a certificate must be filed within six months from the date on which the marketing authorization for the product, as a medicinal product, was issued. 
Without prejudice to the provisions of the previous paragraph, when the marketing authorization occurs before the basic patent is issued, the application for a certificate must be filed within six months from the date of issue of the patent. 
In the event of failure to comply with the deadline for the application for a certificate, the Patent and Trademark Office shall declare the application for a certificate inadmissible.

Content of the application for a certificate

The application for a certificate must contain: 
a) a request for the issue of a certificate that contains in particular:
i) the name and address of the applicant, and his contact details in the Republic of San Marino;
ii) the name and address of the agent;
iii) the number of the basic patent and the title of the invention;
iv) the number and date of the first marketing authorisation for the product and, if it is not the first marketing authorisation in the European Union, also the number and date of that authorisation;
b) a copy of the marketing authorisation, showing the identity of the product and containing, in particular, the number and date of the authorisation, as well as the summary of the characteristics of the product, as provided for by Article 11 of Directive 2001/83/EC or Article 14 of Directive 2001/82/EC;
c) if the authorization is not the first authorization ofplacing the product on the market in the European Union, as a medicinal product, the identity of the product thus authorised and the legal provision under which the authorisation procedure was carried out, as well as a copy of the publication of said authorisation in the Official Journal.
The application for a supplementary protection certificate must be accompanied by a receipt for payment of the application filing fee, the amount of which is determined by delegated decree.

Filing of the application for a certificate

The application for a certificate must be filed with the State Patent and Trademark Office.
The State Patent and Trademark Office examines whether the deadline for filing the application for a certificate has been respected and whether the conditions. 
If the certificate application does not satisfy the conditions set out in the previous paragraph, the Patent and Trademark Office shall inform the applicant that the application may be completed within a peremptory deadline of two months. 
If the certificate application is not completed within the aforementioned deadline, it shall be considered as never having been filed.

Issuance of the certificate

When the certificate application and the product for which it is the object satisfy the conditions set out in this law, the Patent and Trademark Office shall issue the certificate. 
The Patent and Trademark Office shall issue the certificate by registering it in the patent register.

Publication

Upon issuing the certificate, the Patent and Trademark State Office publishes in the bulletin: 
a) the name and address of the certificate holder; 
b) the name and address of the agent; 
c) the number of the basic patent; 
d) the date of the application; 
e) the title of the invention; 
f) the number and date of the marketing authorization referred to in Article 121-ter, letter b); 
g) the product covered by the authorization; 
h) the expiry date of the protection of the certificate. 
The rejection of the application for a certificate, early termination, and nullity are also subject to publication.

Fees

The certificate is subject to the payment of a filing fee and annual fees, the amount of which is determined by delegated decree. 
The annual fees must be paid in advance and in a single solution for the total duration of the certificate. 
The fees are not repeatable, even in the event of revocation of the marketing authorization occurring after the payment.

Duration of the certificate

The certificate is effective from the legal term of the basic patent for a duration equal to the period between the date of filing of the application for the basic patent and the date of the first authorization to place on the market in the European Union or in Italy, reduced by five years. 
Without prejudice to the provisions of the preceding paragraph, the duration of the certificate cannot exceed five years from the date on which the certificate becomes effective. 
The date of the first authorization to place on the market for the purpose of determining the period means the date of notification to the applicant of the authorization.

Expiration of the certificate

The certificate expires: 
a) at the end of the expected duration; 
b) by written renunciation of the holder; 
c) by failure to pay the annual fees established within the terms; 
d) if and for the entire period in which the product protected by the certificate can no longer be placed on the market, following the withdrawal of the corresponding marketing authorization(s), the Patent and Trademark State Office decides ex officio or at the request of a third party on the expiry of the certificate.

Nullity of the certificate 

The certificate is null: 
a) if was issued in violation of the provisions; 
b) if the basic patent expired before the expiry of the legal durationale; 
c) if the basic patent is declared invalid or is limited in such a way that the product for which the certificate was issued is no longer protected by the rights of the basic patent, or if after the lapse of the basic patent there are grounds for invalidity that would have justified the annulment or the limitation. 
Anyone may file an application or bring an action for the annulment of the certificate to annul the corresponding basic patent.

Publication of the indication of lapse or invalidity

If the certificate lapses accordingly, or if it is declared invalid accordingly, an indication to this effect is published by the State Patent Office and Trademarks. 

Appeals

The decisions of the State Patent and Trademark Office adopted are subject to the same appeals and actions provided for by Title III of Law 25 May 2005 n.79.