Source: http://www.dehns.com/site/information/industry_news_and_articles/cjeu_to_provide_guidance_on_scope_of_bolar_exemption.html
Timestamp: 2017-12-12 16:09:10
Document Index: 140787198

Matched Legal Cases: ['CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ']

CJEU to provide guidance on the scope of the Bolar exemption - London, Brighton, Oxford, Munich - Dehns
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.
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.
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):
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.