Shire International GmbH - 2009/040

Administrative Decision Number2009/040
Date23 August 2019
SectionPatents and SPC's
Decision in Respect of an Application by Shire International GmbH for
Reinstatement of the Deadline for Filing an Application for an Extension of
the Duration of Supplementary Protection Certificate (SPC) No. 2009/040
1. This case concerns an application for reinstatement of the deadline for filing an
extension of the duration of SPC No. 2009/040.
2. The primary legislation governing SPCs in Ireland is Council Regulation (EEC) No.
1768/92. This was transposed into Irish Law by Statutory Instrument (S.l.) No. 125/1993,
(European Communities (Supplementary Protection Certificate) Regulations, 1993). In
January 2007, Regulation (EC) No. 1901/2006 on medicinal products for paediatric use
came into force and aimed at promoting the development of medicinal products for use in
the paediatric population. Amongst the incentives for the pharmaceutical industry
introduced by this Regulation was that of a 6-month period of extension to the duration of
an existing SPC - commonly known as a “paediatric extension”. In 2009, the original 1992
Regulation was amended to provide for this further period of extension and was codified
as Regulation (EC) 469/2009 hereinafter the ‘SPC Regulation’.
3. On 21 December 2009, Movetis N.V. (‘Movetis’) submitted an SPC application No.
2009/040 for the product “Prucalopride or a pharmaceutically acceptable acid addition salt
thereof” (the active ingredient in the medicinal product RESOLOR) and the corresponding
certificate was granted on 1 April 2010 with an expiry date of 15 November 2020.
4. On 1 February 2019, the agent, FRKelly, filed an application for a paediatric
extension on behalf on Shire International GmbH (‘Shire), to whom the original SPC had
been assigned on 5 February 2019. The agent simultaneously submitted an application
for reinstatement of the deadline for the filing of this extension application. He explained
this was necessary because, under Article 7(4) of the SPC Regulation, the latest date for
lodging this application had already passed on 15 November 2018 (i.e. not later than two
years before the expiry of the original certificate).

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