European Union: Harmonisation Of Bolar Exemptions Across Europe

The "Bolar exemption" is an exception to the exclusive right granted by a patent, permitting use of patented products in experiments for the purpose of obtaining regulatory approval for medicines.

UK implementation of the Bolar exemption

As included in the UK Patents Act prior to 1 October 2014, the allowed companies to carry out regulatory tests required for proving the equivalency between a generic drug and a patented drug. This meant that generic drug companies were allowed to do no more than obtain the necessary regulatory approval to launch their products prior to expiry of a patent protecting the original drug, so that when the patent expires, the marketing authorisation would be in place. Wider clinical or field trials were precluded. At the time, EU Directive 2001/83/EC relating to medicinal products for human use applied to the UK. In Germany¹ and France², however, corresponding provisions under the same European directive, were not (and still are not) limited to trials of generic or biosimilar medicinal products (see below).

Following extensive industry lobbying of the UK government to facilitate trials for existing drugs and for the development of new, non-generic drugs, e.g. trials of new drugs falling within the scope of a patent or requiring comparative studies with a known patented drug, the UK government extended, in 2014 ³, the "experimental use" exception of Section 60(5)(b) of the Patents Act 1977 by the addition of sections 60(6D) and 60(6E):

For the purposes of subsection (5)(b), 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, where "medicinal product assessment" includes:

• testing with a view to providing data for obtaining marketing authorisation and associated regulatory compliance anywhere in the world (by contrast, some corresponding provisions in certain EU countries only permit testing for purpose of obtaining marketing authorisation and regulatory compliance in the EU); and

• enabling anyone (government, public authority or any person real or legal, anywhere) who has the function of providing public health care (anywhere) or of providing advice about the provision of health care to such public authority to carry out an assessment of suitability (typically referred to as a "Health Technology Assessment" e.g. by the National Institute for Clinical Excellence) of a drug for purposes of determining whether to use it or recommend its use.

Differences of application in Europe

Also falling under the "broader" category are Iceland, Norway and Switzerland. Iceland and Norway are EEA states. Switzerland is neither an EU nor EEA member but is part of the single market.

This UK limitation on the scope of patent protection (or, if you like, extension of the "experimental use" exception) will encourage companies to carry out their research and clinical trials in the UK where those trials are required to obtain market authorisation for innovative drugs. This is expected to have a positive effect on the UK economy.

It was anticipated that the CJEU might give clarity on questions of whether, in the case of a generic company seeking to shelter under the Bolar exemption, a third party who supplies active ingredients to that company is also sheltered (C-661/13), but the patentee withdrew the complaint before any decision by the Court.

Draft EU Pharmaceutical Directive

A new draft Directive 2023/0132 has been published by the Commission to replace the existing Directive 2001/83/EC (and Directive 2009/35/EC relating to colouring matters which may be added to medicinal products).

The draft Directive proposed, among other matters, to harmonise Bolar exemptions across Europe in certain key respects. The exemption is intended (Recital 63) to be confined to conduct of studies and trials and other activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request. The exemption is to apply "even though this may require substantial amounts of test production to demonstrate reliable manufacturing". But during the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Thus, Article 85 of the draft Directive provides that Patent rights and supplementary protection certificates shall not be regarded as infringed when a reference medicinal product is used for the purposes of studies, trials and other activities conducted to generate data for an application, for:

1. a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;
2. health technology assessment as defined in Regulation (EU) 2021/2282;
3. pricing and reimbursement.

The draft Directive also applies itself to section 27(d) of the Unified Patent Court Agreement so as to apply the newly worded exemption to that agreement.

Comment

If the Bolar exemption were personal to the party carrying out the tests to obtain the marketing authorisation, the exemption would be severely limited. Generic companies wishing to carry out the tests would be forced to turn to suppliers outside the EU in countries where there is no patent protection. This is not in the interests of European industry for whom the exemption was enacted. On the other hand, permitting the stockpiling by generics suppliers of patented drugs within the EU for the uncertain purpose of supplying customers who may or may not use them for Bolar test purposes would represent an erosion of the traditional patent monopoly. The draft Directive seeks to expand the exemption to achieve a better balance.

Implementation of the Directive should also avoid a peculiar form of forum shopping that presently exists across Europe. As matters stand, patent applicants can choose their preferred Bolar exemption regime by applying for a European patent registered in the name of a company located in a member state (e.g. Belgium, Netherlands or Sweden) that has a narrower exemption, and declaring such a patent as having unitary effect.

Footnotes

1. § 11 Nr. 2 b PatG "The effects of the patent shall not extend to studies and trials and the resulting practical requirements necessary for obtaining a marketing authorisation [arzneimittelrechtlichen Genehmigung] to place a medicinal product on the market in the European Union or marketing approval [arzneimittelrechtlichen Zulassung] for a medicinal product in the Member States of the European Union or in third countries." (Translation.) Note that there is no intended difference between acts permitted for "authorisation" or "approval" inside or outside the EU. The former is merely the expression used for EU marketing approval and the latter is more generic.

2. Code de la propriété intellectuelle Article L613-5 d) "The rights conferred by the patent shall not extend to the tests required with a view to obtaining a marketing authorisation [une autorisation de mise sur le marché] for a medicine, as well as to the acts necessary for them to be carried out or the authorisation to be obtained." (Translation.) It is possible that "le marché" might mean the EU market, but commentators seem to be of the view that the term means the worldwide market.

3. The Legislative Reform (Patents) Order 2014 (S.I. 2014/1997)

4. Source – WIPO: http://www.wipo.int/wipo_magazine/en/2014/03/article_0004.html

5. Confirmed in Organon v. ARS Netherlands Supreme Court 23 June 1995, BIE 1997/41.