Supplementary Protection Certificate (SPC)

A supplementary protection certificate (SPC) provides extended protection for approved active pharmaceutical ingredients or plant protection products that are already covered by a patent (basic patent). Since pharmaceuticals may only be sold after receiving regulatory approval, the SPC serves to compensate for the economic disadvantages that patent holders face due to the often lengthy approval procedures.

The Austrian Patent Office also maintains a public register containing bibliographic data on supplementary protection certificates and publishes this information in the Austrian Patent Gazette (Part II, Section A).

The application must be filed no later than six months after the grant of the authorisation for placing the product on the market in Austria, or after the grant of the patent – whichever period expires later.

For extensions relating to paediatric medicines or rare diseases, the following applies: the application must be filed during the procedure, but no later than two years before the expiry of the supplementary protection certificate.

The SPC takes effect upon expiration of the maximum term of the basic patent (20 years). Its term of protection corresponds to the period between the patent application and the first marketing authorization in the European Economic Area, minus five years. The maximum term is five years from the date of entry into force. If confirmation of studies regarding suitability as a pediatric medicine is available, the certificate may be extended for an additional six months.

When applying for a supplementary protection certificate, the Austrian Patent Office examines:

• whether the applicant is identical to the patent holder
• whether the basic patent is still in force
• whether a valid authorization for the product has been granted
• whether the authorized product is covered by the scope of protection of the basic patent

It is not examined whether a supplementary protection certificate has already been issued for the product, or whether the authorization submitted is actually the first authorization for placing the product on the market in Austria.

If an application for an SPC does not comply with the regulations, the applicant is informed of the deficiencies and is generally given a two-month period to remedy them. If the deficiencies are not remedied, the application is rejected.

The filing fee for a supplementary protection certificate is €387 (including the document fee). An application for extension of the term costs €282.

Annual fees for a supplementary protection certificate increase over the term – from €2.611 in the first year to €4.282 in the fifth. For details, see here.