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 (extended 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.
Time limits for submitting an application
Special transitional time limits are valid for the five years following the entry into force of the revised Patents Act on 1 January 2019 (see Art. 149 of the revised Patents Act). After this period, the following time limits apply:
- The application for extending the term of protection of an SPC can be made at the earliest with the application for the grant of an SPC and at the latest two years before it expires.
- The application for the grant of a paediatric SPC can be made no later than two years before the expiry of the maximum term of the patent.
- 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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