Duration of the supplementary protection certificate

The duration of the supplementary protection certificate compensates for the time taken by trials and the administrative authorisation procedure. Article 13 of Regulation (EC) No 469/2009 sets it as follows: the certificate takes effect at the end of the lawful term of the basic patent and lasts for a period equal to the time elapsed between the filing date of the application for the basic patent and the date of the first marketing authorisation in the Union, reduced by five years, up to a maximum of five years.

Calculating the duration of the certificate

Two dates determine the result: the filing date of the application for the basic patent and the date of the first marketing authorisation in the Union, which is not necessarily the French authorisation. In Seattle Genetics of 6 October 2015 (Case C-471/14), the Court of Justice of the European Union held that the relevant date is the date of notification of the authorisation decision, not the date of its adoption. A few days' difference represents, for a reference medicinal product, a considerable commercial stake.

The paediatric extension

The duration of the certificate may be extended by six months where the results of a paediatric investigation plan have been submitted, under Regulation (EC) No 1901/2006. The extension requires that the certificate has been granted and that the requirements of the plan have been met for all presentations of the medicinal product. The entry on paediatric extension of an SPC sets out the conditions.

Practical effects

The duration of the certificate sets the earliest date on which generics may enter the market, which explains the intensity of litigation over its calculation as well as over the validity of the title. A certificate whose duration was wrongly determined can be rectified, and national grant decisions sometimes diverge for the same product, in the absence of a central office. The manufacturing waiver also allows production in Europe during the protection period, for export or stockpiling.

Key points

The duration of the certificate is checked by calculation, not by reading the register. Both dates relied on and the computation method should be verified when the application is filed, because errors are usually discovered as expiry approaches, when the stakes are highest.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats litigates patent disputes before the Paris Judicial Court, the Paris Court of Appeal and the Unified Patent Court. Where the question arises in a real case, the useful moment is almost always before proceedings are issued.

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