Last month the Düsseldorf Court of Appeal has referred questions to the CJEU on whether and under what conditions the supply of patent protected substances by a 3rd party to a generic company, which intends to use the substance for obtaining a marketing authorization, 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 authorization 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.
Decision of the Polish 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 Court also refused to refer the case to the CJEU.
Decision of the German courts
The district court 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 and allowed under the Bolar exemption. The district court of Düsseldorf refused to refer the question of third party supply to the CJEU.
The Düsseldorf Court of Appeal has now disagreed with the first instance decision and referred the question to the CJEU. According to the Düsseldorf Court of Appeal, 3rd party supply shall be allowed under certain conditions, namely if the supply is aimed at the privileged purposes.