France SPC Calculation
The French Intellectual
Property Office previously did not accepted to adjust the expiration date of a
granted Supplementary Protection Certificate (SPCs) when it had been calculated
on the date of grant of the Marketing Authorization (MA), not on the date of
Notification of the MA, as decided by the CJEU. (Seattle Genetics Decision)
The French IPO has
changed its stance and now extends the expiration date of granted SPCs, in
compliance with the CJEU decisions. (Seattle Genetics and Incyte Corporation)
French SPC owners can
file requests before the French IPO to change expiration date of granted SPCs.
Translated Public statement issued by French IPO on January 15,
2018 (Click here to view Public Statement):
In a judgment of 6 October 2015 (case C-471/14, Seattle genetics
Inc.), the Court of Justice of the European Union considered that Article 13
(1) of Regulation No 469/2009, which governs duration of Supplementary
Protection Certificates (SPCs) for medicinal products, was to be interpreted as
meaning that 'the date of the first marketing authorization in the Union',
within the meaning of that provision, is that of the notification. the decision
granting the marketing authorization to the recipient 'and not the date of
granting.
In that case, the application for a CCP was based on a Community
marketing authorization (MA) issued by the Commission pursuant to a decision
taking effect, pursuant to the Treaty on the Functioning of the European Union,
the day notification to the addressee.
Thus, all CCPs issued by the INPI after the judgment of 6 October
2015, for medicinal products requested on the basis of a Community MA, have
their period of validity calculated taking into account the date of
notification of the AMM as published in the Official Journal.
The European Court of Justice issued a new judgment on 20 December
2017 (Case C-492/16 Incyte Corporation), which held that the CCPs issued prior
to the Seattle Genetics judgment, and whose duration validity had been
calculated taking into account the date of granting of the marketing
authorization, must be subject to rectification, the latter may be introduced
until the duration of the certificate has expired.
Pursuant to this case-law, it is now possible for CCP holders in
force, whose duration has been calculated taking into account the date of the
granting of a Community MA, to obtain the rectification of the term of their
CCP.
This rectification may be effected on a simple request from the
holder of the SPC entered in the National Patent Register, together with a copy
of the publication in the Official Journal of the date of notification of the
Community AMM concerned.
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