Supplementary protection certificates (SPC) for medicines and phytopharmaceutical products
Medicines are generally tested for years before being placed on the market, usually after receiving patent protection. In general, a patented medicine requires 12 years before receiving market authorisation (MA). As patents do not last a long time and investments in the field of pharmaceutical research are expensive, the effective duration of protection of the medicine (after which time the medicine may be marketed) may not be long enough to absorb the costs of developing the medicine.
Community Regulation 1769/92 on the supplementary protection certificate for medicines compensates these negative consequences for the pharmaceutical industry.
Community Regulation 1610/96 does the same thing for phytopharmaceutical products.
These regulations stipulate that a patent holder may introduce a request for a supplementary protection certificate within 6 months after the medicine or phytopharmaceutical product receives market authorisation. If the patent is not issued at the time of market authorisation, this request must be filed within 6 months after the patent is issued.
This supplementary protection certificate extends the duration of patent protection of the medicine or phytopharmaceutical product. The same exclusive rights and limitations are applicable to the patent during this period.
This supplementary protection only applies to medicines and phytopharmaceutical products for which market authorisation must be obtained. If the chemical molecule protected by the patent has another application (other than medicinal or phytopharmaceutical), this application may not benefit from the extended period of protection accorded by the certificate.
The supplementary protection certificate is valid after the expiration of the patent for a period of time equal to the period of time between the date on which the patent request was filed and the date of the first market authorisation in the Community, reduced by a period of 5 years. The maximum duration of the supplementary protection certificate is 5 years.
The supplementary protection certificate may be extended by 6 months for medicines for paediatric use. This extension is a result of Community Regulation 1901/2006 on paediatric medicines whose goal is to encourage testing of paediatric medicines.
How to obtain the certificate?
To obtain a supplementary protection certificate for a phytopharmaceutical product, a request form (DOC, 125.5 Kb) must be filed with the Office for Intellectual Property. More information on this form (PDF, 88.1 Kb).
The request may be filed in French, Dutch or German.
Content of the request
The request file must contain:
- The request form for a SPC addressed to the relevant Minister (2 copies);
- A copy of the market authorisation (MA) issued in Belgium which identifies the product, the number and the date of the authorisation as well as a summary of the product characteristics as of the date on which the SPC request was filed;
- If the MA was issued in Belgium prior to another market authorisation in the European Union, information on the identity of the product for which authorisation was issued and the legal basis of this authorisation as well as a copy of the publication of the authorisation in the Official Journal;
- Where applicable, the proxy authorisation given to a representative of the requesting party (accredited patent agent, attorney, employee etc.).
Most of the data listed above may be provided after the request is filed. However, a filing date for the request may not be attributed unless the following minimum data and documents have been provided:
- A declaration of the request for a certificate;
- Information on the requesting party’s identity;
- Information on the basic patent.
Official taxes must be paid for an SPC request and for its continuance.
Granting and publication
Once all the administrative formalities have been carried out, the certificate is issued as quickly as possible. This certificate enters into force on the day the patent expires. The SPC file is also made public except for documents regarding the MA and other documents which the patent holder prefers to keep confidential. The delivery of the certificate is mentioned in the Compendium and in the Patent Register. Any change to the certificate, such as a transfer or a license, must be submitted to the Office for Intellectual Property and mentioned in the Register.
- Règlement (CE) n° 469/2009 du Parlement Européen et du Conseil du 6 mai 2009 concernant le certificat complémentaire de protection pour les médicaments (Journal Officiel de l'Union Européenne L 152 du 16/06/2009).
- Règlement (CE) n° 1610/96 concernant la création d’un certificat complémentaire de protection pour les produits phytopharmaceutiques (Journal Officiel de l'Union Européenne L 198/30 du 08/08/1996).
- Loi du 29 juillet 1994 sur le certificat complémentaire de protection pour les médicaments (MB 06/09/1994).
- Loi du 5 juillet 1998 sur le certificat complémentaire de protection pour les produits phytopharmaceutiques (MB 28/08/1998).
- Arrêté royal du 5 janvier 1993 relatif à la demande et à la délivrance de certificats complémentaires de protection pour les médicaments (MB 06/02/1993)
- Arrêté royal du 8 novembre 1998 relatif à la demande et à la délivrance de certificats complémentaires de protection pour les produits phytopharmaceutiques (Moniteur belge 09/01/1999)