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The European Bolar Exemption From Infringement – Patent



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Under the so-called ‘Bolar’ exemption, clinical
trials for generics and biosimilars are exempt from infringement.
In some European countries, including the UK, the exemption even
extends to innovative products.

Introduction

In order to market a medicinal product, a manufacturer must
first obtain regulatory approval by conducting clinical tests and
trials to prove that the product is safe and effective. However,
when the medicinal product is a generic (1) or biosimilar (2)
product, a company can avoid having to carry out full trials by
relying on at least some of the data submitted by the original
applicant for marketing authorisation in connection with the
original (reference) medicinal product. To use this so-called
abridged procedure for obtaining marketing authorisation, however,
it is necessary to demonstrate that the generic/ biosimilar version
is bioequivalent to the approved reference medicine.

If the medicinal reference product is patent protected, then
there is a real risk that acts relating to that product infringe
the patent. Historically, this risk of patent infringement
potentially deterred generics manufacturers from carrying out the
tests required to obtain marketing authorisation until after patent
expiry, resulting in a delay of market entry of generics.

In an attempt to harmonise the position in Europe and to speed
up the entry of generic products onto the market after patent
expiry, the so called “Bolar exemption” was introduced
by the European Union (EU) to exempt from patent infringement the
tests and trials necessary to use the abridged procedure for
obtaining marketing authorisation.

EU Directive

The Bolar exemption is governed by European Directive 2001/83/EC
on the Community Code relating to medicinal products for human use,
as amended by European Directive 2004/27/EC, particularly Article
10 thereof.

Article 10 (6) excludes from infringement of patent rights or
supplementary protection certificates (SPCs): “Conducting the
necessary studies and trials with a view to the application of
paragraphs 1, 2, 3 and 4”. Paragraphs 1-4, i.e. Articles 10
(1)-(4) of the Directive, concern the provision of data during the
marketing approval process.

Implementation

Although the Directive was aimed at harmonising the position in
the EU member states, the implementation of the Directive into
national law has not been uniform, resulting in significant
differences between the member states.

Thus, whilst some countries, notably the UK, have adopted an
exemption that is limited to generic or biosimilar medicinal
products, others, including Germany and France, have adopted an
exemption that is not so limited, extending also to innovative
medicinal products.

Exempt acts

The Directive does not provide any guidance as to which acts are
exempt from infringement, referring merely to “conducting the
necessary studies and trials”. It is widely accepted that
actual trials testing the safety or efficacy of the medicinal
products would fall within the scope of this exemption, but there
has been uncertainty regarding other acts, such as the manufacture,
supply or import of the medicinal product.

A particularly contentious issue is whether a third party is
free to supply the medicinal product to the party carrying out the
trials necessary to obtain marketing authorisation. This question
was referred to the Court of Justice of the EU by a German court,
but the case was subsequently closed without any guidance being
issued.

Data exclusivity and market exclusivity

It is recognised that allowing the producer of a generic or
biosimilar medicinal product to use an abridged marketing
authorisation gives the producer of the generic or biosimilar an
advantage. To redress the balance and reward innovators, the
Directive sets a period of “data exclusivity”, during
which the data submitted in connection with an innovative drug may
not be used by third parties.

In addition, a further period of “market
exclusivity” runs from the end of the data exclusivity period
and prevents manufacturers of generic/biosimilar medicinal products
from placing their products onto the market. The combined period of
data exclusivity and market exclusivity is about 10 years in
Europe.

Detailed further information regarding these forms of
exclusivity, as well as regarding the requirements for obtaining
marketing authorisation for generics and biosimilars may be found
on the website of the European Medicines Agency.

Experimental use exemptions

In addition to the Bolar exemption, many EU member states have
an “experimental use exemption” which exempts certain
experimental activities from patent infringement. Again, the scope
of these provisions varies widely among the member states. Thus,
whilst in some countries, notably Germany, the experimental use
exemption has been interpreted by the courts to exempt all
experimental uses aimed at gaining knowledge, in others the
exemption has been interpreted much more narrowly.

The scope of the UK’s experimental use exemption used to
be particularly narrow, but in 2014 the UK adopted a much broader
experimental use exemption.

Under the new UK law “anything done in or for the purposes
of a medicinal product assessment which would otherwise constitute
an infringement of a patent for an invention is to be regarded as
done for experimental purposes relating to the subject-matter of
the invention”(3).

A “medicinal product” is defined in this context as
“a medicinal product for human use or a veterinary medicinal
product”. Thus, whilst there is no explicit reference to
innovative products, there seems to be no restriction placed on the
types of medicinal products covered, so it is widely accepted that
this provision exempts from infringement trials relating to
innovative drugs. A “medicinal product assessment” is
defined as “any testing, course of testing or other
activity” undertaken with a view to providing data for
obtaining marketing authorisation. It remains to be seen precisely
which acts are exempt under this provision.

Outlook

The Unitary Patent (UP) and the Unified Patent Court (UPC) are
expected to come into effect in 2018.

The Agreement on the UPC contains a narrow Bolar exemption,
which refers to the European Directives mentioned above and will
therefore be limited to generic or biosimilar medicinal products.
There have been suggestions, however, that the EU may in due course
issue a new Bolar directive that would provide a wider exemption
akin to the scope of the German Bolar exemption.

The Agreement on the UPC also contains an experimental use
exemption, but no guidance on the scope of this exemption has been
issued.

It remains to be seen how any differences between the national
exemptions and the exemptions under the Agreement on the UPC will
be reconciled.

(1) The term “generic medicinal product” is defined
in Article 10 (2) of Directive 2004/27/EC. (2) Article 10(4) of
Directive 2004/27/EC refers to biological medicinal products that
are “similar” to a reference product, but does not
provide a definition of “biosimilars”. (3) Section
60(6)(D-F) of the UK Patents Act 1977 as amended.

Originally published 15 June 2022

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.



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