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 active pharmaceutical ingredient (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.Paul promises that Taylor Wessing will report further details of this reference as they are made public.
Decision of the Polish courts
The Polish Supreme Court recently confirmed decisions of its lower instance courts and decided that third 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, third party supply shall be allowed under certain conditions, namely if the supply is aimed at the privileged purposes.