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ISSUE 1 2014 MASCHIO & SOAMES IP LTD
Germany – Referral to CJEU Regarding Scope of the Bolar Exemption
The Düsseldorf Court of Appeal in the case of Polpharma S.A. v. Astellas Pharma Inc. has referred to the CJEU the question of whether the Directives allow chemical suppliers to sell a protected substance to a generics company for use in the testing allowed by the Bolar exemption. The question is crucial for chemical suppliers and the generics industry in Europe. If a supply in the development phase is not possible under the Bolar exemption, then supply sources for generic companies and their ability to enter the market immediately after patent expiry will be seriously limited.
The referral has arisen because of conflicting decisions of the Polish and German courts. The Polish Supreme Court recently confirmed decisions of its lower instance courts and decided that 3rd party supply is not covered by the Polish implementation of the Bolar exemption. The district court in Düsseldorf decided that such a third party supply is only exempted by the Bolar provision under very restrictive conditions, namely if the supplier is co-organiser of the tests and studies carried out by its customer that are allowed under the Bolar exemption. The Düsseldorf Court of Appeal has now disagreed with the first instance decision and referred the question to the CJEU.
We shall advise on the outcome of this referral. In the meantime, we note that at least the new UK law that will come into force on 1st October 2014 seems to be clear in this regard. By exempting “anything done in or for the purposes of a medicinal product assessment”, it appears to exempt the supply of products for use in regulatory testing, as well as the testing itself, within the UK.
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