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<< Patent Intelligence Briefings / << Paediatric Extensions / Patent Cover vs. Data & Marketing Exclusivity >>

European Union Data and Marketing Exclusivity

Data and marketing exclusivity in the Europe Union (EU) provides originators of medicines a degree of marketing protection.

Outside of the defined period of exclusivity, applicants are able to refer to the originator’s documentation and file for an abridged licence, citing the originators work and having to prove that their product is the same as that of the originator. The costs and complexity associated with filing an abridged application for a marketing authorisation are significantly lower than those for a full application.

When considering the issue of data exclusivity, it should be remembered that where there is patent cover in place within a given state, this would in any case prevent marketing of the product. However, the reverse also applies, in that if patent cover has expired or has never existed, there may still be a period of data exclusivity that applies, preventing an abridged application from being filed.
  

How To Calculate Data and Marketing Exclusivity 

Directive 2001/83/EC

Under Directive 2001/83/EC, EU Data Exclusivity laws guaranteed marketing protection, against use of the data for filing an abridged licence, for the originator of medicines for either 6 or 10 years. This Directive applied in respect of first EU authorisations up to and including 31st October 2005.

The first EU marketing authorisation date is the earliest date that a marketing authorisation was granted in an EU member state. Such authorisation may have been obtained via a national or centralised EU procedure.

For products subject to central authorisation, 10 years data exclusivity is granted. 

When filing for a marketing authorisation in the following states on a product that was first authorised via a national authorisation, data exclusivity applies for a period of six years from the first EU marketing authorisation date:

Austria, Denmark, Finland, Greece, Ireland, Portugal, Spain, Norway and Iceland.
This is also the period adopted by the 12 new member states during their negotiations for EU accession.

When filing for a marketing authorisation in the following states on a product that was first authorised via a national authorisation, data exclusivity applies for a period of ten years from the first EU marketing authorisation date:

Belgium, Germany, France, Italy, Luxembourg, The Netherlands, Sweden and UK

 

Directive 2004/27/EC

The new EU Pharmaceutical Legislation, Directive 2004/27/EC amending Directive 2001/83/EC adopted in 2004 created a harmonised EU eight year data exclusivity provision with an additional two years market exclusivity provision. This effective ten year market exclusivity can be extended by an additional one year for new therapeutic indications.

This 8 + 2 + 1 formula applies to new chemical entities (NCEs) in all procedures to all Member States, for first EU marketing authorisations dates of 1st November 2005 onwards.

In reality this means that a generic application for marketing authorisation can be submitted after 8 years citing the originators authorisations and work, but the product cannot be marketed until after 10 years or 11 years where there has been a therapeutic indications authorised after the original application.

The additional one year exclusivity is possible if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.

 

MPA’s databases provide the first EU authorisation dates that define data exclusivity periods, in addition to showing relevant patent cover. Call +44(0)1707 654 850 or send a message now, to discuss any queries you may have and to arrange a free demonstration of our services.

 

* This guide's information obtained with the assistance of the EGA

 
   
 
 
 
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