Calculation of SPC term – more favourable for SPC holders?

September 2015

When it comes to SPCs – every day counts – both for SPC owners as well as their competitors wishing to enter the market. 

In the case of Seattle Genetics Inc (Case C-471-14), Seattle Genetics sought clarification from the CJEU as to whether the date of the first authorisation to place a product on the market in the European Community should be determined according to Community law under the law of the Member State in question?  And, if Community law applies, which date must be taken into account — the date of authorisation or the date of notification? 

The AG’s Opinion is that the SPC Regulation (No 469/2009) must receive “uniform and autonomous interpretation” taken from EU law rather than from the law of individual Member States. 

On turning to interpretation of the term "date of the first [marketing authorization] in the Community”, this differed depending on language versions.  In the specific case for Seattle Genetic, the Austrian Patent Office used the authorisation date for a product date to calculate SPC term, whereas the notified date would have afforded 5 extra days protection.

The AG noted the aim of the Regulation was to “restore a sufficient period of effective protection of the basic patent entitling its holder to enjoy an additional period of exclusivity on the expiry of that patent, for to compensate, at least partially, the delay in the commercial exploitation of his invention because of the time that has elapsed between the date of filing the patent application and the obtaining of the first [marketing authorization ] in the EU”.  Therefore the "date of the first [marketing authorization] in the Community" within the meaning of the SPC Regulation should be regarded as corresponding to the date on which the decision is notified to the recipient and therefore effective.   If the date of authorisation, rather than notification, was to be used, this would reduce the period of validity of SPCs in a manner that is not consistent with the fundamental objectives of the SPC Regulation. 

The full judgment will be given in due course, but is usually expected to follow the Opinion of the AG, and will likely mean that SPC holders could benefit from extra days of SPC protection.

Interestingly, back in 2013, the UKIPO changed its own practice for the calculation of the duration of certain SPCs (BL O/418/13 Genzyme Corporation) concluding that the calculation of the duration of an SPC based upon a European marketing authorisation should take account of the date of notification of the decision by the European Commission to grant the relevant marketing authorisation and not the date of the decision itself. 

Once the full judgement is given, SPC owners should prepare to seek correction of the SPC term for SPCs in which the term was calculated on the basis of the date of the decision rather than the date of notification.  Although the more favourable calculation has been available for some time in the UK, it has not in many other EU countries.  HGF has already successfully sought correction of the SPC term in the UK for a number of our client’s SPCs.

 This update was prepared by Mike Nelson, Partner and Andy Camenisch Senior Patent Attorney in our Leeds office.

If you would like further advice on this or any other matter please contact Mike or Andy or your usual HGF representative or visit our Contact page to get in touch with your nearest HGF office.