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<< Patent Intelligence Briefings / << Data and Marketing Exclusivity / The Specific Mechanism >>

Pharma Patent Cover vs Data & Marketing Exclusivity

How exclusivity works...

Data and marketing exclusivity prevents an originator's documentation being cited and used to file an abridged product licence application.The relative costs of an abridged over a full application, thereby makes generic compeition unlikely where there is still exclusivity.

For 1st EU authorisation dates before 1st November 2005:

Exclusivity applied for a 6 year period following 1st EU Authorisation in:

  • 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.

In the following states the exclusivity applied for a 10 year period following 1st EU Authorisation:

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

For 1st EU authorisation dates of 1st November 2005 onwards:

Data exclusivity applies for 8 years, followed by a 2 year marketing exclusivity plus the possibility of one extra year's marketing exclusivity for new therapeutic indications authorised after the initial authorisation.

This leads to the so-called 8+2+1 rule, exclusivity of:

  • 8 years for data, 2 years for marketing and 1 additional year for new therapeutic indications.

Compare this with patent expiry.....

The normal patent duration is the filing date + 20 years. This can be extended by a SPC whereby the overall life of the patent effectively becomes the lower of:

  • The filing date + 25 years; and
  • The EU First Authorisation + 15 years.

Thereby allowing for a maximum SPC length of 5 years, in a situation where the EU first authorisation is 10 years or more after the filing date.

It is then also possible to extend the life of the SPC by a further 6 months via a paediatric extension.

So Which Is More Significant: Exclusivity or Patent Cover?

It is important to appreciate that patent cover and exclusivity are two sides of the same coin, since they both seek to grant IP rights holders protection.

Regardless, considering the above calcuations, in most cases, it would normally be expected that the patent/spc/paediatric cover will exceed that of exclusivity as determined by EU regulations; Since patent cover cover can be the equivalent of EU 1st authorisation date + 15 years (giving up to 25 years of patent cover) + 6 months vs. Data/marketing exclusivity cover typically amounting to the EU 1st authorisation date +8 +2 +1 years as described above.

The reverse situation, of exclusivity exceeding patent cover, is more unusual but can nevertheless happen, particularly where there is no patent or SPC and therefore no paediatric extension, since paediatric extensions are against the SPC.

In a situation of there being no SPC, then the patent runs for 20 years. If the 1st EU authorisation is over 9 years after the filing date, then marketing exclusivity could exceed patent cover duration. Thereby meaning that although patent cover has expired, there can still be exclusivity.

There is also the theoretical possibility of the data and marketing exclusivity exceeding the SPC life, where the 1st EU authorisation date is more than 14 years after the filing date, however this really is an extremely unusual situation.

Examples: 

Assume the following scenarios:

Patent Filing Date
1st EU Authorisation
Patent Expiry SPC Expiry Data/Marketing Exclusivity *
Conclusion
2000 2008 2020 2023 2019 D/M exclusivity irrelevant as SPC supercedes it
2000 2014 2020 2025 2025 If 1st EU authorisation over 14 years after filing, d/m exclusivity supercedes it
2000 2009 2020 no SPC 2020 If no SPC and EU authorisation over 9 years after filing, d/m exclusivity supercedes it
no patent 2008 - - 2019 If no patent, d/m exclusivity still relevant

* Assuming the 8 +2 +1 year rule is being applied

Conclusions - Why It Is Important To Be Aware of Both Patent and Exclusivity

It is essential for market participants to be aware of both patent and exclusivity issues, in order to determine whether generic activity may be possible and whether this may be made unfeasible by the presence of data and marketing exclusivity.

Moreover, whilst the above situations of exclusivity exceeding patent cover are quite rare, exclusivity does become critical where there is no patent cover at all. Here, even though there may be little or no patent cover, potential market entrants can be deterred by the presence of data and marketing exclusivity, which thereby precludes the possiblity of making an abridged licence application.

Further reading:

Data & Marketing Exclusivity >
Calculating and the implications of data and marketing exclusivity in the EU.

Supplementary Protection Certificates (SPCs) >
A guide to supplementary protection certificates, including explanation of duration.

 
   
 
 
 
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