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Supplementary Protection Certificates
Supplementary Protection Certificates offer extended protection for authorised active ingredient/s of a medicinal product or for plant protection products that are covered by a patent (the underlying patent). Since medicinal products are not permitted to be sold without authorisation, the aim is to compensate patent holders for commercial disadvantages arising from the lengthy process to obtain authorisation.
The protection certificate comes into effect upon expiry of the maximum term (20 years) of the underlying patent. The term of the protection certificate is equal to the elapsed period between filing of the patent application and granting of the first marketing authorisation in the EEA, less five years. The maximum term of the protection certificate is five years dating from the time of coming into effect.
Extension by a further 6 months is possible if the application is supported by studies carried out in line with a paediatric investigation plan.
In order to submit an application, you must be the patent holder and/or authorisation holder of an underlying patent for the authorised active ingredient/s of a medicinal product or for plant protection products.
Procedure
If your application for a supplementary protection certificate does not comply with the regulations, you will be notified of the deficiencies. You may rectify the indicated deficiencies within the deadline stated (usually two months). If you fail to do so, your application will be rejected.
When issuing the protection certificate, no check is made of whether a certificate has already been issued by the Austrian Patent Office for the product and of whether the submitted authorisation is in fact the first marketing authorisation in Austria.
The identity of the protection certificate applicant or patent holder is checked. A check is also carried out to determine whether the underlying patent is valid and whether the product is covered by the protective scope of the underlying patent.
Register / publication
The Austrian Patent Office maintains a register of the bibliographic data of protection certificates and the extension of such certificates. The register of protection certificates is public. It is possible to obtain certified extracts from the register. Bibliographic data concerning the application and issue of supplementary protection certificates (and extension of such certificates) are also published in the Austrian Patent Gazette (II Part A).
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