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The supplementary protection certificates (SPC) in Belgium There are two community regulations applicable in this case:

• The Community Regulation no. 1768/92 concerning the SPC's for medicines;
• The Community Regulation no. 1610/96 concerning the SPC's for phytopharmaceutical products.

What is a SPC?

1. Aim of the Regulation

The aim of the Community Regulations is to extend the duration of effective protection for inventions in the pharmaceutical or phytopharmaceutical field taking into account the fact that the period that elapses between the filing of a patent application for a new medicine or phytopharmaceutical product and the authorisation to put it on the market makes the period of effective protection conferred by the patent insufficient to cover the investment put into research.

2. Subject Matter of the Protection

Within the limits of protection conferred by the basic patent, the protection conferred by a SPC shall only extend to the products covered by the authorisation to put the corresponding medicine or phytopharmaceutical product on the market and for any use of the product as a medicine or phytopharmaceutical product that has been authorised before the expiry of the certificate.

3. Effects of a SPC

Considering what has been mentioned under 2., the SPC shall confer the same rights as those that are conferred by the basic patent and shall be subject to the same limitations and obligations.
It should be noted that in Belgium the basic patent could be either a Belgian patent or a European patent validated in Belgium.

4. Duration of a SPC

The SPC shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date of filing an application for a basic patent and the date of the first authorisation to put the product on the market in the EC, reduced by a period of five years.
The maximum duration of the SPC is five years from the date it takes effect.

5. Procedure to obtain a SPC in Belgium

5.1. Conditions:

A SPC will only be available in Belgium if at the date of filing the SPC in Belgium :

• the product is protected by a (Belgian or European) patent in force in Belgium;
• there is a valid market authorisation in Belgium and this authorisation is the first in Belgium;
• the first authorisation in the EC was issued after January 1, 1982 (for medicines) or after January 1, 1985 (for phytopharmaceutical products).

5.2.Filing:

The application for a SPC has to be filed at the Belgian Patent Office by the holder of the basic patent or his successor in title. If the name and/or the address of the basic patent holder have been modified and if these changes have not yet been registered in Belgium, it will be necessary to do so in order to have the SPC granted at the new name (or at the new address).

The application has to be filed within 6 months after the grant of the market authorisation in Belgium.

If the authorisation is granted before the basic patent is granted, the application of the SPC has to be filed within 6 months after the grant of the patent.

Regarding the market authorisations that must be mentioned in the filing, it should be noted that:

• The Belgian Patent Office requires the "active principles" as mentioned in the Belgian market authorisation to be mentioned on the request.
• It is possible that the first authorisation in Belgium and the first authorisation in the Community are the same if it is a Community authorisation granted by the European Commission.
• The copy of the first market authorisation in Belgium must be certified. For a Belgian market authorisation, the certification can take place before a Public Notary or the city Administration, or (and this is mostly the case) directly at the Ministry of Public Health. In general the Belgian branch of the filing company (often the holder of the market authorisation in Belgium) is charged of producing that certified copy. Concerning community market authorisations, it should be noted that the Commission does not grant any certified copies. However the Belgian Patent Office requires a certified copy. Consequently, this certification can take place before a Public Notary or simply in the juridical service of the filing company On the other hand, the copy of the first market authorisation in the Community (if it differs from the authorisation in Belgium) must not be certified.
• The applicant may ask in the request that the product composition remains secret.

The grant of a SPC

As for patents, the SPC will remain in force if annual fees are paid.

As for a Belgian patent, it is not possible to oppose to the grant of a SPC in Belgium. Thus it is necessary to act before the Courts in order to have a SPC cancelled and, as for patents, there is no deadline to do so. As for patents, it is the Court of First Instance as mentioned in Article 73 of the Belgian patent law that is the relevant court in this matter.

Furthermore, it is impossible for a third party to provide the Belgian Patent Office with any remarks concerning a SPC request during or after the grant procedure.