News

Timing matters: Belgium clarifies relevant marketing authorization date for calculating an SPC term of protection

Timing matters: Belgium clarifies relevant marketing authorization date for calculating an SPC term of protection

11 April 2018

Supplementary protection certificates (SPCs) aim to provide a uniform solution at the European Union level for obtaining a time extension for protection of medicinal products and plant protection products for which a marketing authorization (MA) is required, with a view to compensating applicants for any effective patent term loss due to regulatory approval procedures.  The regular patent term is 20 years as from the date of filing, while the combination of patent and SPC protection (wherein the SPC relates to the relevant product protected by the patent) will provide the patent and SPC holder with a maximum of 15 years of effective patent term exclusivity as from the date of the MA; hence this can exceed the regular patent term when the date of the MA is more than 5 years after the patent filing date. However, an SPC can never offer more than five years of additional protection above and beyond the regular patent term.

The relevant date for the calculation of the SPC term used to be dependent on the local practice of each national patent office; that changed partially in 2015 when the Court of Justice of the European Union (CJEU) issued a ruling on the SPC term calculation for a centralized MA (case C-471/14, Seattle Genetics). A centralized MA is one obtained via the procedure for the authorization of medicinal products according to EC Regulation 726/2004. The CJEU ruled that the relevant date is the notification date of the centralized MA, i.e. the date when the decision of the MA is notified to the MA holder, rather than the decision date, i.e. the date of the European Commission’s decision to grant the MA. This ruling was aligned with the standard practice in Belgium at that time, and the Belgian Patent Office (BPO) subsequently detailed its practice in a circular letter, dated April 2016.

In March 2018, the BPO issued an updated circular letter providing further details on its practice in relation to the relevant date of a MA, clarifying both the situation of a centralized MA as well as a national MA as follows:

The main principle applied by the BPO is that the relevant date of a MA for purposes of calculating the SPC term is the notification date. This main principle is valid for SPCs for medicinal products and for SPCs for plant protection products, and is applicable for both the determination of the due date for filing the SPC application (art. 7.1 EC 469/2009 – EC 1610/96) as well as for the calculation of the duration of the certificate (art. 13.1 EC 469/2009 – EC 1610/96).

For centralized MAs, in line with the C-471/14 ruling, the relevant date of the MA is the date of notification of the decision granting the marketing authorization, as published in the Official Journal of the European Union.

Where a national MA is the first authorization to place the product on the European market, the basic principle is the same as for centralized MA’s, i.e., if there is an official publication it will be the published date of notification of the decision to grant that first MA. In the absence of an official publication of the notification date, the BPO will consider the starting date of the period for which that first marketing authorization is valid as the date of the MA. However, if the applicant was notified later, he has the option to provide evidence of a later notification date.

In addition, the circular letter specifies that, should the holder of a certificate believe that in view of the CJEU rulings a different MA date is to be considered for his certificate, he can submit a written motivated request to correct the granted certificate accordingly.

We remain at your service for the latest up-to-date information or more case-specific questions with respect to this clarification and possible requests for correction of granted SPC certificates in Belgium.