Medicines are generally tested for years before being placed on the market - those tests often continue after the patent has been granted. It is estimated that it takes an average of 12 years to obtain a marketing authorisation (MA) for a patented drug. As the patent term is quite short and investments in pharmaceutical research are considerable, the term of protection of the useful drug, i.e. after the drug can be marketed, may not be sufficient to amortise the investments for the development of the drug.
The Regulation (EC) No. 469/2009 (former Regulation 1769/92) on the supplementary protection certificate (SPC) for medicines counteracts these negative consequences for the pharmaceutical industry.
The Regulation (EC) No. 1610/96 does the same for crop protection products.
These regulations allow the patent holder to apply for a supplementary protection certificate within 6 months of the date on which the product, as a medicinal product or plant protection product, obtained marketing authorisation. If the patent has not yet been granted at the time of the marketing authorisation, this application must be submitted within 6 months of the granting of the patent.
This supplementary protection certificate extends the duration of protection of the medicinal product or plant protection product by the patent. The certificate gives the same exclusive rights as the basic patent gives and the same restrictions and exceptions apply during this period. An additional exception also applies to supplementary protection certificates for medicinal products, the so-called “manufacturing waiver”.
This additional protection applies only to medicinal products and plant protection products for which marketing authorisation must be obtained. If the chemical molecule protected by the patent has an application other than pharmaceutical or plant protection related, this application may not benefit from the extended term of protection granted by the certificate.
The supplementary protection certificate is valid from the date of expiry of the patent for a period equal to the period between the date of filing of the patent application and the date of the first marketing authorisation in the Community, reduced by a period of 5 years. The maximum duration of the supplementary certificate is also 5 years. A circular dated 08/03/2018 (PDF, 165.48 KB) (French version – Dutch version of the circular dated 08/03/2018 (PDF, 166.27 KB)) sets out the rules applicable before the Office for Intellectual Property for determining the date of marketing authorisation for a medicinal product or plant protection product.
As regards SPCs for medicinal products, Regulation (EC) 1901/2006 on medicinal products for paediatric use introduced a reward system in the form of a six-month extension of the SPC ('paediatric' extension). This reward is granted for products for which paediatric data must be presented, if the following conditions are met:
- all measures identified in an approved pediatric investigation plan must be in place,
- the product must be authorized in all member states of the European Union and
- the relevant data about the research results must be included in the product information.
Procedure
How do you obtain the certificate or the “pediatric” extension of the certificate for medicines?
To obtain a supplementaryprotection certificate for a medicinal product (including the "paediatric" extension), an application form (DOC, 128 KB) (French version – Dutch version) must be submitted to the Intellectual Property Office Belgium. More information can be found in the explanatory note (PDF, 21.2 KB) (French version – Dutch version of the explanatory note (PDF, 21.08 KB)) accompanying this form.
To obtain a supplementary protection certificate for a plant protection product, an application form ( (DOC, 125.5 KB)French version – Dutch version of the application form (DOC, 136 KB)) must be submitted to the Intellectual Property Office Belgium. More information can be found in the explanatory note (PDF, 20.79 KB) (French version – Dutch version of the explanatory note (PDF, 21.14 KB)) accompanying this form.
To obtain an extension of the supplementary protection certificate for a medicinal product (the "paediatric" extension) following the application for SPC, an application form (DOC, 119 KB) (French version – Dutch version of the application form (DOC, 127 KB)) must be submitted to the Intellectual Property Office Belgium.
The application must be submitted in one of the national languages.
Content of the application
The application for a supplementary protection certificate must contain:
- the request form for the grant of an SPC addressed to the competent Minister;
- a copy of the marketing authorisation (MA) issued in Belgium which contains a product identification, the number and date of the authorisation, as well as a summary of the product characteristics, at the date of submission of the SPC application;
- if the marketing authorisation issued in Belgium is later than another marketing authorisation in the European Union, an indication of the identity of the product for which the authorisation was issued and the legal provision on which the authorisation is based, as well as a copy of the publication of the authorisation in the Official Journal;
A request for a 'paediatric' extension must also contain:
- a copy of the declaration of compliance with an approved and completed paediatric investigation plan;
- where applicable, in addition to the copy of the MA mentioned in point 3 above, a copy of the MA in all other Member States of the European Union, as well as Norway and Iceland.
Most of the details indicated above can be provided after the application has been submitted, via a regularisation. However, an application filing date can only be assigned, if at least, the following details and documents are filed:
- a declaration that a certificate or an extension of the certificate has been requested;
- information to identify and contact the applicant;
- information for determining the basic patent (application for a SPC) or the basic certificate (application for a 'paediatric' extension).
Costs
Official fees must be paid when applying for a SPC or a paediatric extension, and for the SPC to remain in effect.
Granting and publication
When the Office for Intellectual Property deems that all formalities have been completed, the certificate is issued. This certificate enters into force on the day of expiry of the patent.
The SPC application is also made public, except for documents relating to the MA and other documents that the patent holder wishes to keep confidential if he instructs the Office to this end. The application and the issue of the certificate are listed in the Bulletin and in the Register of Patents. Any change in the certificate, such as a transfer or license, must be communicated to the Office for Intellectual Property and entered in the Register.
The same provisions apply in the event of a paediatric extension.
