10 Points on Regulatory Data Exclusivity (RDE)

This is based on the second half of a talk given by Neil Jenkins at the CIPA Life Sciences Conference on 14 November 2013.  The first part about UK Pharma Patent Cases in 2013 can be accessed here.

1.  Regulatory data exclusivity relates to marketing authorisations for pharmaceutical products. When applying for marketing authorisation to release a pharmaceutical product on to the market the relevant company needs to file a regulatory dossier application which provides clinical trial data to the relevant regulatory authority.  Such data is expensive to produce and therefore a company would want to keep it confidential.  However there is a public policy to cut down on unnecessary experiments.  In addition governments wish to encourage competition to drive down health costs.  Thus third parties can rely in part on existing applications for marketing authorisations when trying to obtain authorisations (by filing ‘bridged’ applications), and RDE is a way of dealing with the competing interests in this situation.

2.  RDE is essentially a quasi IP right which gives a company a period of exclusivity in a market in respect of competitor products which have referred to the company’s regulatory dossier application when applying for their own marketing authorisation.   TRIPS mentions RDE and says that companies shall be protected against unfair commercial uses of their data.  The right exists in many territories, though the periods vary tremendously.  In the US it links to the patent system through the orange book.  Whilst patents protect inventions, RDE protects the investment made in generating data and is an automatic right which comes into being as soon as an application for marketing authorisation is filed.

3.  In Europe RDE is governed by Directive 2001/83 as amended in 2004 and a Regulation which issued in 2004. The Directive sets out the framework for RDE whilst the regulation deals with RDE obtained via the European Medicines Agency (EMA).  Marketing authorisations can be obtained from a single national authority or from a number of countries using an ‘EPO-type’ procedure in a single application where national authorities will coordinate.  In addition marketing authorisations can be obtained centrally from the EMA.

4.  Before 2004 under the old law there were a series of cases before the ECJ which concerned line extensions of the right.  The question was if subsequent data became available for new pharmaceutical forms of the active substance would these new forms have their own RDE period?  The ECJ decided ‘no’.  The overhaul of the law in 2004 concerned 3 concepts listed below and discussed in points 5 to 7 below:

– the definition of the generic medicinal product

– the global marketing authorisation concept

– the 8+2+1 rule (8 years of data exclusivity, 2 years of market exclusivity and 1 additional year of market exclusivity for new therapeutic indications).

5.  The definition of the medicinal product was broadened to include salts and derivatives, such as immediate release forms.

6.  It was made clear that for a ‘global marketing authorisation’ where additional data is filed for new indications the new data does not have its own RDE period.  As a consequence present litigation is mainly to do with the scope of global marketing authorisations.

7.  A bridged application that refers to an earlier application can only be filed 8 years after the earlier application, and marketing authorisation will not be granted until 10 years from the earlier application, which is extended to 11 years where the earlier application refers to new indications.

8.  Enantiomers will normally be seen as derivatives of the original product and so covered by the same global marketing authorisation.  However in the case of escitalopram it was not included in the original authorisation because its ‘profile’ was sufficiently different from the original substance.  The issue was also raised in the Sepracor case.  The EMA has published a paper on this saying it essentially depends on whether the enantiomers show different properties.

9.  Combination products are dealt with in Article 10 of the Directive.  Essentially new data is needed for the combination and one cannot rely on data for the individual substances.  Whilst it was assumed that a combination would not form part of the earlier global marketing authorisation (and thus would have its own period), this has been challenged in the pending case Teva v EMA.

10.  Crossover is possible between the centralised EMA route and national routes.  The centralised route is restricted and normally needs a new active substance for a full regulatory dossier and a bridged application is only possible if the original case was EMA authorised.  There is uncertainty over the RDE period for a centralised authorisation if there have been previous national authorisations.  Is it part of the same global marketing authorisation?  This issue is pending in Novartis v Commission.

In conclusion RDE is powerful tool, giving an automatic right which has a long duration.  However there are still uncertainties as to scope of a global marketing authorisation.

You may also wish to see related articles 10 Points About Data in Patent Applications and Patent Advice for Research Companies.


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