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. In Germany[1] and France[2], however, corresponding provisions under the same European directive, 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 the "experimental use" exception of Section 60(5)(b) of the Patents Act 1977 by the addition of section 60(6D):

 

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.

 

The new directive

 

The new subsection 6E defines what is meant by "medicinal product assessment". Notably, it 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 other 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

 

Accordingly, we have various flavours of Bolar exemption in Europe, which can be categorised by (a) acts exempted, (b) whether the testing is for marketing authorisation in the EU or beyond and (c) whether the testing can also be for Heath Technology Assessment. The following table summarises the differences:

 

 

 

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 new 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. But note that this intention of the legislature is circumvented by applying for a European patent registered in the name of a company located in a member state (e.g. Belgium, Cyprus, Netherlands or Sweden) that has a narrower exemption, and declaring such a patent as having unitary effect.

 

For further exploration of the Bolar exemption, please read: UK Government to Expand Bolar Exemption 

 

 

CJEU to consider scope of Bolar exemption

 

The Düsseldorf Court of Appeal has referred certain questions to the CJEU for a preliminary ruling as to 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).

 

Japanese pharmaceutical company Astellas Pharma Inc is suing Polish company Polpharma S.A. Pharmaceutical Works for supply of patented derivatives of quinuclidine to customers in Germany who are using the patented compounds for purposes of testing and obtaining marketing approval for equivalent or related compounds. Polpharma had been advertising the product (among others) for sale in Poland and on its website with a caveat that it was offered solely for experimental purposes or for use falling within the limits of the Bolar exemption. The Düsseldorf district court had ruled that the supplier would need to be a co-organiser of the tests or studies in order to benefit from the Bolar exemption.

 

The questions being asked of the CJEU relate to whether Art. 10(6) of Directive 2001/83 means that offering and delivering a patented active substance to a manufacturer of generic products are acts excluded from patent protection, where the generics manufacturer intends to use the substance for studies or trials in order to obtain a marketing authorisation or approval, even though the offering and delivering are for purely commercial reasons.

 

The court also poses questions aimed at the supplier's state of knowledge of its customer's use or intended use:

 

• Does it matter whether the customer actually uses the provided substance in privileged studies or trials?

 

• Does it matter whether the party offering or delivering is aware of or has ascertained its customer's intended privileged use?

 

• Or is it enough that, at the time of the act of delivery, the supplier can rightly assume from the circumstances (i.e. profile of the supplied company, small amount of the provided active substance, imminent expiration of the patent protection of the relevant active substance, experience gained concerning the customer's reliability), that the customer will use the provided active substance only for privileged trials and studies in the context of a marketing approval?

 

• Must the supplier take active precautions to ensure that its customer will indeed use the active substance for privileged trials and studies only?

 

• Does it matter whether the patented active substance is merely offered or actually delivered?

 

The Supreme Court of Poland had previously ruled in favour of the patentee, Astellas Pharma, holding that marketing of a patent pharmaceutical product irrespective of its purpose is not covered by the Bolar exemption and therefore constitutes patent infringement.

 

Comment

 

If the Bolar exemption is personal to the party carrying out the tests to obtain the marketing authorisation, the exemption is severely limited. Generic companies wishing to carry out the tests will 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.

 

For further information on the topics discussed here, please contact a member of our Life Sciences team

 

[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 authorization [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 "authorization" 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 authorization [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 authorization 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] Source – WIPO: http://www.wipo.int/wipo_magazine/en/2014/03/article_0004.html

 

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