Supplementary Protection Certificates

With a Supplementary Protection Certificate, the term of protection of a pharmaceutical patent can be extended, as pharmaceuticals may often only be sold after a very long approval procedure. However, the crux lies in the detail – there are often numerous cases pending with the European Court of Justice.

The Supplementary Protection Certificate is a property right granted by the government, which is registered with the Austrian Patent Office and protects a product for pharmaceuticals or pesticides. The Protection Certificate extends the protection of a product for pharmaceuticals or pesticides, which is protected by a basic patent. The background of this is that pharmaceuticals and pesticides must go through a long state marketing authorization procedure before they can be marketed, and only then can be placed on the market. Thus the term of the patent already begins before the rights holder can bring his invention on the market. In order to compensate for this, the Supplementary Protection Certificate gives the possibility to gain back the lost time of the protection period through a supplementary property right: this gives the simultaneous holder of a patent and a Supplementary Protection Certificate the possibility of a protection period of maximum 15 years from the initial approval (in the EU). For pharmaceuticals for children there is additionally the possibility of a paediatric extension of 6 months.

The Supplementary Protection Certificate is an unexamined intellectual property right: The Austrian Patent Office does not examine whether a Supplementary Protection Certificate already exists for this product, or whether the submitted approval for licensing really is the first approval for the marketing of the product in Austria.

In Austria, the relevant legal provisions can be found in the Supplementary Protection Certificates Act, which is very much linked to the EU-regulations.

What is remarkable in practice, is that licences, rights based on prior use as well as intervening rights on the basic patent are also valid for the Supplementary Protection Certificate, as long as no contrary agreement have been made or decisions made.

With regard to the rights and claims granted in case of breach, the same applies as for a patent.



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