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What are Paediatric Extensions and how do they work?

Will The Change In Filing Date Requirements For Paediatric Extensions Cause Applications To Be Rejected?

At present paediatric extension applications have to be filed not later than six months prior to the expiry of the SPC to which it is related. A number of companies generally tend to leave the filing to the last minute. How will applicants be able to cope with the change in the transitional period from six months to two years as from 27th January 2012? Also, will there be any confusion for potential paediatric extension on SPCs which are shorter than two years in duration?

However another far more serious anomaly exists in the wording of Regulation EC469/2009, under Article 7 paragraph 5 in which it would appear that for existing SPCs the six month transition period will only apply up to 27th January 2012. After that date, even on existing granted SPCs, the transition period will rise to two years. So, if a patentee is working on a paediatric extension using the six month transition, it must ensure that the application is filed before 27th January 2012. Failure to comply, even by one day, could mean the application for a paediatric extension will be rejected.

Call +44(0)1707 654 850 or send a message now for further information regarding the change in filing procedures affecting Paediatric Extensions or for any other pharma patent and intelligence queries you may have.

MPA's patent, SPC and paediatric extension review database covers major product/ preparation patents together with any related supplementary protection certificates (SPCs) and includes paediatric extension dates for all products on the European market, including all 27 EU countries plus Switzerland. Is your product's loss of exclusivity approaching?

 

Extensions to SPCs Arising From Paediatric Trials

On 26 January 2007, regulation (EC) No. 1901/2006 came into force. This Regulation sets out the new legislative framework to promote the development of medicinal products for use in the paediatric population. Amongst the incentives introduced by Regulation No. 1901/2006 is the possibility of an extension to the duration of a SPC covering a marketed medicinal product.

Supplementary Protection Certificates  (SPCs)

SPCs provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a marketing authorisation.

Extension of SPC Duration

Before Regulation (EC) No. 1901/2006 came into force, the maximum duration of an SPC was five years.

Now, under the provisions of the new Regulation, an SPC covering a product may be extended (beyond the term that it would otherwise be afforded) by a period of six months. This extension of term applies to all of the authorised indications for the product (including the non-paediatric indications).

The SPC duration extension may apply if the results of a Paediatric Investigation Plan (PIP) agreed with the European regulators (the EMEA) are included in an application for Marketing Authorisation for:

(a) a product not previously authorised (Articles 7 and 36(1); or

(b) a new indication (including paediatric indication), new pharmaceutical form of a new route of administration of a previously-authorised product (Article 8 and 36(1)).

The extension of duration may be available even if the data from the PIP fail to lead to the authorisation of a paediatric indication. However, in this situation, the results of the paediatric studies must at least be reflected in the Summary of Product Characteristics (SmPC) for the medicinal product concerned (Article 36(1)). There are also some particular circumstances in which the extension of duration is not available.

An application for extension of the duration of an SPC can be made:

(a) when applying for an SPC;

(b) when an SPC application is pending; or, at the latest

(c) two years prior to the expiry of an existing SPC.

However, prior to 26 January 2012, it has been be possible to file such an application for extension up to six months before the expiry of an existing SPC.

An extension of SPC duration may be based upon paediatric studies on a marketed product that have been completed by 26 January 2007 (not in accordance with an agreed Paediatric Investigation Plan "PIP"). However, the extension may only be granted if those studies are submitted by 26 January 2008 and additional significant studies contained in an agreed PIP are completed after 26 January 2007.

 
   
 
 
 
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