Bolar exemption and third-party supply referred to CJEU

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By Christoph de Coster and Julia Bödeker

Last month the Düsseldorf Court of Appeal referred questions to the Court of Justice of the European Union (CJEU) on whether and under what conditions the supply of patent-protected substances by a third party to a generic company, which intends to use the substance for obtaining a marketing authorisation, is covered by the Bolar exemption. The decision of the German court and the referred questions are now available in English.

While it is undisputed that generics themselves are allowed to manufacture the patent-protected substance for marketing authorisation purposes under the Bolar exemption, it was unclear whether API suppliers may sell a protected substance to generics for Bolar purposes. The question is crucial for the API suppliers and the generic industry in Europe. If a supply in the development phase is not possible under the Bolar exemption, European API suppliers will be forced out of Europe and the supply sources for generic companies and their ability to enter the market immediately after patent expiry will be seriously limited. The objectives of the Bolar exemption to strengthen the generic industry in Europe and allow immediate market entry of generic products after patent expiry would be at risk…

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