Dr. Hans Weickmann

Change in practice for calculation of term of supplementary protection certificates

28.10.2015

Art. 13(1) of Regulation (EC) No. 469/2009 is to be interpreted as meaning that the “date of the first authorisation to place the product on the market in the [Community]” within the meaning of that provision is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision (ECJ, C-471/14). The German Patent and Trademark Office has previously regarded the (earlier) date of the decision granting marketing authorisation as the relevant date for calculating the term of the supplementary protection certificate. According to the German Patent and Trademark Office, an extension of the term of granted supplementary protection certificates is possible upon request.

Under certain conditions, the supplementary protection certificate gives the proprietor of a patent directed to plant protection, human or veterinary medicinal products an extension of the term of protection of such patent by a maximum of 5.5 years. The supplementary protection certificate therefore provides a compensation for the time-consuming authorisation procedures that are required by law for plant protection or medicinal products.

According to Art. 13(1) of Regulation (EC) 469/2009, the certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years.

With the recent decision C-471/14 (Seattle Genetics Inc.) of the European Court of Justice of 6 October 2015, it was now clarified whether the date of authorisation or the date of notification of the authorisation is to be taken into account according to Art. 13(1) of Regulation No. 469/2009.

In the case underlying the decision, Seattle Genetics Inc. requested the grant of a certificate on the basis of a basic patent at the Austrian Patent Office. The Austrian Patent Office considered the date of the Commission's decision granting marketing authorisation to be relevant for the calculation of the term of the supplementary protection certificate. Seattle Genetics Inc. filed a suit against the Austrian Patent Office’s decision and requested that the term of the certificate be extended, since the relevant date for calculating was not the date on which marketing authorisation was granted, but the date on which notification of the decision granting marketing authorisation was given to the plaintiff.

The questions of the Oberlandesgericht Wien for preliminary ruling were answered by the 8th Chamber of the European Court of Justice as follows:

1) Art. 13(1) of Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that the “date of the first authorisation to place the product on the market in the [European Union]” is determined by EU law.

2) Art. 13(1) of Regulation (EC) No. 469/2009 is to be interpreted as meaning that the “date of the first authorisation to place the product on the market in the [Union]’ within the meaning of that provision is the date on which notification of the decision granting marketing authorisation is given to the addressee of the decision.

The German Patent and Trademark Office generally used the date on which marketing authorisation was granted, but not the date of notification for calculating the term of a supplementary protection certificate. According to the information given by the German Patent and Trademark Office, in view of the new case law, it is now possible to have the term of granted supplementary protection certificates adjusted upon request. A respective communication will be published on the homepage of the German Patent and Trademark Office.

The date of the decision granting marketing authorisation as well as the date of its notification are published in the Official Journal of the European Union according to Art. 13(2) of Regulation No. 726/2004. Since there usually are at least two days between the date of the decision and the date of notification, a request for an adjustment of the term is in any case advisable.

Weickmann & Weickmann will gladly assist you with any questions regarding supplementary protection certificates.

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