Grant of Supplementary Protection Certificates (SPC) for Medicaments and Plant Protection Products

Where applicable, the National Office shall grant supplementary protection certificates for substances protected on the territory of the Contracting State by the valid patent, if they are the active substances of the products which prior being placed on the market, are subject to the registration according to the special regulations.

The active substance shall mean:

• a chemically manufactured substance or
• a combination of substances,
• a micro-organism or
• a combination of micro-organisms,

which have general or specific therapeutic or preventive effects with regard to human or animal diseases

or

which may be administered to the human beings or animals in order to disease diagnosis, improvement or arrangement of their health condition

or

which are destined to the protection of plants or plant products.

The product referred to in first paragraph shall mean any active substance or a combination containing one or more active substances put up in the form for being placed on the market as a medicament or a plant protection product.

Application for a certificate

The application for a certificate shall be filed by the proprietor of the patent, whose subject-matter is a substance, except for the patent granted under special provisions, or a method for obtaining a substance or a use of a substance as a medicament or as a plant protection product, or his successor in title.

The application for a certificate shall be filed within 6 months from the date on which the decision on the registration of the product is issued according to special regulations. If the registration is made prior to the grant of the basic patent, the application for a certificate shall be filed within the period of 6 months from the date on which the patent is granted.

The application for a certificate shall contain:

a) a request for the grant of the certificate stating in particular:

1. the name and address of the applicant;

2. the name and address of the representative, if any;

3. the number of the basic patent and the title of the invention;

4. the number and date of the first registration of the product according to special regulations; 4d

b) a copy of the decision on the registration of the product issued according to special regulations, where the product is identified, including the product data summary, if it is a medicament;

c) chemical, generic or other terminology enabling to identify the substance protected by the basic patent with the registered product.

When filing the application for a certificate, the applicant shall pay the administrative fee according to the special regulations.

The National Office shall record the filing of the application for a certificate to the Patent Register and publish it in the Bulletin. The publication shall contain the name and address of the applicant, the number of the basic patent and the title of the invention protected by the patent, the number and the date of the registration, including of the mention of the product, putting on the market of which is authorised by means of this registration.

Conditions for obtaining a certificate

The National Office shall grant a certificate, if the following conditions are met on the date of filing the application:

a) the basic patent is valid on the territory of the Contracting State;

b) the product contains the active substance protected by the basic patent and is validly registered as a medicament or a plant protection product according to special regulations;

c) the certificate has not yet been granted to the substance;

d) the registration referred to in the letter b) is the first authorisation to place a medicament manufactured en masse in the Conrtacting State or the first authorisation to place a plant protection product on the market in the Contracting State.

Grant of the certificate

If the application for a certificate meets said conditions and the substance, for which the certificate is applied for, meets the conditions as well, the National Office shall grant the certificate and record it in the National Patent Register. The certificate shall contain:

a) the name and address of the proprietor of the certificate;

b) the number of the basic patent and the title of the invention;

c) the number and date of the first registration, the authority having issued the decision on the registration, and the mention of the product, placing on the market of which is authorised by means of this registration;

d) the duration of the certificate.

The Office shall publish the grant of the certificate in the National Bulletin.

If the application for a certificate does not meet conditions, the National Office shall invite the applicant to remedy the deficiencies within a set time limit. If the applicant fails to complete the application within the set time limit, the National Office shall terminate the procedure; the applicant shall be notified about this consequence.

If conditions for the grant of the certificate are not met the application a certificate shall be rejected.

Subject-matter and effects of the certificate

Within the limits of the protection conferred by the basic patent, the protection by the certificate shall extend to the chemical substance or a combination of substances, micro-organism or a combination of micro-organisms, which represent the active substance of the registered product, as well as to every use of the subject-matter of the patent as a medicament or plant protection product, which was authorised before the expiry of the certificate.

The certificate shall confer the same rights as conferred by the basic patent; the certificate shall be subject to the same limitations and the same obligations.

Duration of the certificate

The certificate shall take effect for a period equal to the period, which elapsed between the filing date of the basic patent application and the date of the first registration enabling to place the product on the market in the Contracting State as a medicament or plant protection product, reduced by 5 years, but at most 5 years from the date, on which the certificate takes effect.

The certificate shall take effect after the expiry of the lawful term of the basic patent.

For maintaining the certificate, the proprietor shall pay yearly administrative fees according to the special regulations.

Rights of third persons who started, after the lapse of time for payment of the fee for maintenance of a certificate in force, to use the invention in good faith or performed serious and effective preparations for such use, shall not be affected by payment of this fee within additional period of time.

Lapse of the certificate

The certificate shall lapse

a) by expiry of its duration period;

b) if its proprietor surrenders it;

c) if its proprietor does not pay administrative fees for maintaining the certificate in force;

d) if the product may no longer be placed on the market following the revocation or expiry of the registration;

e) by revocation of the certificate.

The Office shall record the lapse of the certificate to the National Patent Register and announce it in the National Bulletin.

Revocation of the certificate

The National Office shall revoke the certificate, if

a) the conditions for its grant have not been met;

b) the basic patent has lapsed before its duration term;

c) the basic patent has been revoked or limited to the extent that the substance, for which the certificate was granted, is no longer protected by the basic patent; it shall apply also in case of the basic patent revocation, which occurred after its lapse.

The request for revocation of the certificate may also be submitted after the lapse of the basic patent under, if the applicant proves his legal interest.