Grounds of Nullity for a SPC in Austria

During a request for a declaration of partial nullity of a Supplementary Protection Certificate (SPC), the Nullity Department of the Austrian Patent Office had to decide the question, whether stating a wrong authorization to place the product on the market in the Community (EU / EEA) as a medicinal product would be a ground to declare partial nullity of a SPC insofar as the duration of the granted SPC exceeds the day calculated on basis of the correct first marketing authorization.

In the case to be decided when filing for the SPC the owner of the basis patent had stated an authorization from Luxemburg dated 21 March 1988 as the first authorization to place the product on the market in the Community. Due to this statement in the application, the end of the term of the SPC was calculated in the decision to grant with 24 August 2005. However, when the correct date of the first marketing authorization with 15 April 1987 in France would have been given, the end of the SPC would have been 18 September 2004.

Applying the decision of the European Court of Justice according to which the grounds of invalidity as set out in Article 15(1) of Regulation No 1768/92 are not exhaustive (Decision C-127/00 of 11. December 2003), the Nullity Department concluded that a corresponding nullity request of a third party aiming at a partial or full declaration of nullity by reducing the term of the SPC, also to zero, is possible. In particular the Nullity Department of the Austrian Patent Office decided under citation of preamble 17 and art. 17 para 2 of the Regulation No 1610/96, when a mistake has been committed regarding the date of the first marketing authorisation in the Community but that date is subsequent to the relevant date fixed in Article 19(1) of Regulation No 1768/92 for Austria, so that this article is not infringed, it is necessary only to rectify the date of expiry of the certificate.

In simple words, a wrong date of the first marketing authorisation in the Community does not destroy the whole SPC but only leads to a rectification of the date of expiry of the certificate, of course only as long as the correct date is subsequent to the cut-off date according to Article 19(1) of Regulation No 1768/92.

D.I. Peter Pawloy