The so-called Bolar exemption, which allows third parties to test patented drugs and agricultural products, has long produced uncertainty in the life sciences sector, owing to the disparate understanding of EU member states of its scope and a lack of clarity over which acts are exempt from infringement. The question of whether third parties supplying patented substances to generics companies for use in obtaining marketing authorisation are covered by the Bolar exemption is one such case in point. However, following a recent referral to the Court of Justice of the European Union (CJEU) by the Düsseldorf Court of Appeal, it is hoped that this issue will be resolved shortly.
The Bolar exemption, broadly speaking, exempts from patent infringement activities that are conducted with the intention of obtaining regulatory approval for generic drugs. To obtain marketing approval for a generic drug, an abridged procedure can be employed, which involves comparing a generic drug to an approved innovative drug and demonstrating that the two are bioequivalent. This comparison necessarily involves use of the innovative drug, which can result in patent infringement if a patent on the innovative drug is in force. The Bolar exemption provides exemption from patent infringement in this situation, and aims to reduce any delays associated with the market entry of generics, once the patent on the innovative drug has expired.
The EU Bolar exemption is governed by Article 10(6) of European Directive 2004/27/EC, which amends European Directive 2001/83, on the Community Code relating to medicinal products for human use. The aim of the Directive was to harmonise the position of EU member states on exemptions regarding “experimental use” and to reduce legal uncertainty in the life sciences sector. However, the Directive has been implemented and interpreted differently by national courts in the EU member states. The UK has implemented Article 10 of the Directive as Section 60(5)(i) of the Patents Act 1977, and only activities relating to obtaining marketing authorisation for generic drugs would be exempt from infringement. However in France and Germany, for example, this exemption is not limited to use of an abridged procedure for obtaining marketing authorisation for generic drugs. While there is a lack of UK case law on the scope of the exemption, it is nevertheless expected that the scope will be broadened in the UK in response to a recent consultation by the UK Intellectual Property Office (IPO). More information on this can be found in our article from February 2013.
A recent case heard in the German and Polish national courts has raised some important questions with regard to the scope of the Bolar exemption. In particular, it is unclear whether, or under what circumstances, a third party may sell a patent-protected substance to a generics company in connection with that company seeking to obtain marketing authorisation under the Bolar exemption. The case in question concerns the Polish company, Polpharma S.A. Pharmaceutical Works, which manufactures and sells medicinal products and generic active pharmaceutical ingredients (APIs), and the Japanese pharmaceutical company, Astellas Pharma Inc. Specifically, in the present case, Polpharma advertised and sold solifenacin succinate, an API protected by a European patent owned by Astellas Pharma Inc. The contentious issue is that Polpharma sold the solifenacin succinate to a manufacturer of generics, Hexal AG, which is based in Germany. While the advertisement of the patent protected substance was held to fall outside of the scope of the Bolar exemption, the Düsseldorf Court of Appeal in Germany felt that guidance was needed on the question of supply by a third party of an API to a generics company for the purposes of obtaining a marketing authorisation.
The Düsseldorf Court of Appeal has therefore referred a number of questions to the CJEU for a preliminary ruling (C-661/13), and the UK IPO has until 8 April 2014 to submit observations to the CJEU. More details can be found on the UK IPO website.
With the existing lack of UK case law on the scope of the Bolar exemption, it is hoped that the CJEU will provide some important guidance on this subject, both within the UK and across EU member states. This in turn may help to reduce uncertainty in the life sciences sector in Europe, particularly for API suppliers and the generics industry.
However, further debate and uncertainty may be on the horizon with the introduction of the Unified Patent Court (UPC) as there are unresolved issues regarding exactly how the Bolar exemption will be applied under the provisions of the UPC. Individual member states have implemented the Bolar Directive inconsistently, and it currently appears that the UPC intends to adopt a narrow approach to interpretation of the Directive, although the final wording has yet to be settled.