Shire International GmbH - 2009/040

• Administrative Decision Number: 2009/040
• Year: 2019
• Date: 23 August 2019
• Section: Patents 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

INTRODUCTION

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).