UK Government Considers Broadening Bolar Exemption
When a generic pharmaceutical company seeks approval for a generic version of a reference product, they must necessarily perform certain tests on their product. If the product in question is patented, then obtaining the product (e.g. through importation or manufacture) in order to carry out those tests is technically an act of patent infringement.
Historically, therefore, generic companies were prevented from ‘day one’ launches immediately following patent expiry. This was because it was only possible to commence the tests necessary to secure approval following patent expiry, meaning that the dates of i) the application for generic approval being filed, ii) approval being obtained, and iii) launch were all pushed back.
To minimise or ideally eliminate the time lag between patent expiry and launch of generic pharmaceutical products, the EU introduced the so-called Bolar exemption into patent law. Very briefly, this provides a defence to patent infringement to those conducting tests for obtaining data to support applications for the approval of generic pharmaceutical products and also any consequential practical requirements (e.g. importing or manufacturing the pharmaceutical product to be used in those tests).
By relying on the Bolar defence, generic pharmaceutical companies could conduct the tests necessary to obtain approvals for their products prior to patent expiry. The approvals could then be secured and the product launched immediately following patent expiry.
One drawback with the wording of the Bolar exemption as implemented into UK law is that the nationality of the generic approval for which the data is being obtained is not specified. Plainly, if the otherwise infringing tests are being conducted to obtain data to support a UK application for generic approval, then the defence does apply.
However, the case is not so clear where the tests are being conducted in the UK to provide data to support an application outside of the UK and especially outside of the EU. Similarly, in a situation where the data may be used to support both a UK and a non-EU application for approval, confusion exists.
Additionally, the Bolar defence is only currently applicable if the approval which is to be sought is for a generic drug; it does not apply if the tests are being conducted to provide data to support an application for approval of an innovative drug. A second defence, available to those conducting research done for experimental purposes has been construed narrowly by the UK Court and also does not apply to clinical trials and test involving innovative drugs. This arguably puts those companies developing innovative drugs in a worse position to those developing generic products.
In order to improve clarity and also make the UK a more attractive jurisdiction for conducting clinical trials, the UK government are now working to reword those sections of the UK Patents Act which provide research-based defences such as the Bolar defence. It is envisaged that any changes that are made will come into force towards the end of 2013.
This is clearly an important development which will have significant effects on the ability of pharmaceutical companies to conduct tests and trials in the UK. We will report further, once the revised wording of the statute has been finalised.