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Experimental Use Defence to Patent Infringement - Bolar Exemption

Experimental Use Defence to Patent Infringement - Bolar Exemption

28/04/06

Background

An integral part of obtaining a marketing authorisation for pharmaceutical compositions is the detailed testing of those compositions.

 

Traditionally, where pharmaceutical compositions were patented, the producers of generic drugs had to wait until the expiry of the relevant patents before carrying out the experiments necessary to seek marketing authorisations since such experimentation was considered to be an infringement of the patent.

 

This had the effect that by the time the marketing authorisation was obtained to allow the sale of generic drugs, the patent had been expired for some time.  Thus the patentee was able to enjoy a monopoly for his pharmaceutical composition extending beyond the life of the patent.

 

 

Bolar Exemption

The provisions of EC Directive 2001/82/EC which provides a defence from patent infringement in the UK for such experimental use and which is known as the Bolar Exemption were implemented into the UK Patents Act on 30 October 2005.

 

This exemption has the effect that experimentation on patented pharmaceutical compositions which is done for the purpose of obtaining a marketing authorisation does not constitute patent infringement.  As a result, the manufacturers of generic drugs can obtain marketing authorisations as from the date of expiry of the relevant patents.

 

 

Effects

Although there is no case law as the change in the law has only recently occurred, one of the key points which would appear to determine whether actions are exempted is whether they constitute experimentation ON patented subject matter (i.e. the patented composition is the subject of the experimentation) rather than experimentation WITH or USING patented subject matter (where the patented product is used as a tool).

 

In addition, it is expected that for the Bolar exemption to apply to an activity, that activity will:

-           Need not be non-commercial, i.e. the exemption is not limited to 'non-commercial research' as with the defence from infringement provided by section 60(5)(a) of the UK Patents Act.

 

-           Cover preliminary work such as whether one can actually perform the invention or improve on it.

 

-           Cover bioequivalence and stability testing, but not comparative studies on new drugs (as the experimentation will be performed USING the patented composition, not ON the patented composition).