When a generic
pharmaceutical company seeks approval for a generic version of a reference
product, it must necessarily perform certain tests on its 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.  WP Thompson will report further, once the
revised wording of the statute has been finalised.

This report
comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London
UK.  Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.