Pharmaceutical companies can extend the protection period of an authorised medicinal product by up to a further five years after the expiry of the patent with a supplementary protection certificate (SPC). In addition, they can extend protection for a further six months (where necessary) if they have carried out paediatric studies for a medicinal product (known as a paediatric extension).
The six-month extension can be obtained in one of two ways:
- either by extending an already granted conventional SPC, or if no conventional SPC exists...
- with a paediatric SPC, which is directly linked to the term of the patent.
Requirements for a requesting an extension:
- For a medicinal product to obtain marketing authorisation, clinical trials must be carried out on children in accordance with a paediatric investigation plan (PIP).
- The results of this PIP must be published in the product information of the medicinal product in question.
- The application for the marketing authorisation in Switzerland for a paediatric medicinal product must not be made later than six months after the application for marketing authorisation in the European Economic Area.
- Background information on the introduction of paediatric extensions
- Swissmedic, Swiss Agency for Therapeutic Products – medicines for children
- Patent Examination Guidelines in German
- Patent Examination Guidelines in French
- Application for the grant of a paediatric supplementary protection certificate (in German)
- Application for the grant of a paediatric supplementary protection certificate (in French)
- Application for the grant of a paediatric supplementary protection certificate (in Italian)
- Application for the extension of a supplementary protection certificate for medicinal products (in German)
- Application for the extension of a supplementary protection certificate for medicinal products (in French)
- Application for the extension of a supplementary protection certificate for medicinal products (in Italian)
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