CJEU to provide guidance on the scope of the Bolar exemption

Is the supply of patent-protected products to a generics company which intends to use the product in tests necessary to obtain marketing authorisation exempt from patent infringement under the Bolar provisions in Europe? This issue has recently been referred to the Court of Justice of the EU and it is hoped that this will bring about some much-needed guidance on the scope of the Bolar exemptions.

Introduction
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  Directive 2004/27/EC, particularly Article 10 thereof.  In a nutshell, it exempts from patent infringement the necessary studies and trials with a view to generating the data required to obtain marketing authorisation for a generic or biosimilar medicinal product.  A more detailed discussion of the Bolar exemption can be found here.

Whilst it is undisputed that a party wishing to carry out trials necessary to obtain marketing authorisation for a generic medicine is free under the Bolar exemption to manufacture the required quantity of said product, there has been much debate over the issue of the manufacture and supply of such a product by a third party.

Polpharma S.A. Pharmaceutical Works vs Astellas Pharma Inc
The national courts of Poland and Germany were recently called upon to consider this issue in a dispute between Polpharma S.A. Pharmaceutical Works, a Polish manufacturer who manufactured solifenacin succinate and supplied this to generics companies, and Astellas Pharma Inc, a Japanese company which owns a European patent for a group of compounds including solifenacin succinate. 

Polpharma advertised solifenacin succinate for sale on its website as well as in various professional journals, which, not surprisingly, was held to represent an offer for sale outside of the scope of the Bolar exemption.

More contentious was the fact that Polpharma had also supplied a generics company based in Germany, Hexal AG, with solifenacin succinate.  Polpharma asserted that the supply had been made subject to the condition that Hexal AG uses the active substance for the sole purpose of conducting the studies required to obtain marketing authorisation.

The Düsseldorf trial court (German court of first instance) considered that third party supply is only exempted by the Bolar provision under very restrictive conditions: the supplier needs to be seen as a co-organiser of the tests and studies carried out by its customer and have an objectively clear interest in these studies and trials.  It held that these conditions were not met in the present case and that no referral to the CJEU was necessary.  The Polish court, which had to consider similar issues, came to the same conclusion.

However, on Appeal, the Dusseldorf Higher Regional Court (German court of second instance) felt that some clarification from the CJEU is required on this issue.  The following questions have thus been referred to the CJEU (a case number has not yet been allocated):

Questions referred to the CJEU
1. Must Art. 10(6) of Directive 2001/83 be interpreted as meaning that those acts of delivery are also excluded from patent protection by which a third party offers or delivers a patented active substance to a manufacturer of generic products for purely commercial reasons, which the manufacturer of generics intends to use for studies or trials in order to obtain a marketing authorisation or approval within the meaning of Art. 10(6) of Directive 2001/83?

2. If this first question is to be answered in the affirmative:

(a) Does the privileged status of the third party depend on whether the manufacturer of generics supplied indeed uses the provided active substance in privileged studies or trials within the meaning of Art. 10(6) of Directive 2001/83? In such a case, does the exclusion from patent protection also apply if the third party is unaware of its customer's intended privileged use and has not ascertained whether this is the case?

Or does the privileged status of the third party merely depend on whether, at the time of the act of delivery, the third party can rightly assume that, judging all of 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), the supplied manufacturer of generics will use the provided active substance for privileged trials and studies in the context of a marketing approval only?

(b) In the context of its act of delivery, is the third party obliged to take separate precautions to ensure that its customer will indeed use the active substance for privileged trials and studies only or do the precautionary measures of the third party differ, depending on whether the patented active substance is merely offered or actually delivered?

Outlook
It is hoped that the CJEU will provide some much-needed guidance on this issue. It remains to be seen, however, whether the guidance will be sufficiently broad to clarify the scope of the Bolar provisions.  In particular, the questions referred to the CJEU are couched in very narrow terms, referring, for example, only to generics, whereas the Bolar exemption also covers biosimilar medicinal products and, in some countries, even innovative medicinal products. 

Barbara Rigby, Associate