"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".The Düsseldorf trial court considered that such third party supply was only exempted by the Bolar provision under very restrictive conditions, where the supplier is co-organiser of the tests and studies carried out by its customer and which are allowed under the Bolar exemption. This being so there was no need to refer the question of third party supply to the CJEU. The Düsseldorf appellate court disagreed and has sent the following questions off to Luxembourg for a definitive ruling:
1. Must Art. 10(6) Directive 2001/83 [of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use] be interpreted as meaning that those acts of delivery are also excluded from patent protection by which a third party offers or delivers a patented active substance to a manufacturer of generic products for purely commercial reasons, which the manufacturer of generics intends to use for studies or trials in order to obtain a marketing authorisation or approval within the meaning of Art. 10(6) of Directive 2001/83?quinuclidine derivatives and pharmaceutical preparations. The decision of the referring court has been helpfully translated into English thanks to the much-appreciated efforts of two of Paul's German colleagues, Christoph de Coster and Julia Bödeker (whose case it is), who are both entitled to a well-deserved Katzenklaps [Merpel thinks this might be the right term for a katpat in German, but she's not too sure. Can any reader confirm?]. You can read it here or download it here
2. If this first question is to be answered in the affirmative:
(a) Does the privileged status of the third party depend on whether the manufacturer of generics supplied indeed uses the provided active substance in privileged studies or trials within the meaning of Art. 10(6) of Directive 2001/83? In such a case, does the exclusion from patent protection also apply if the third party is unaware of its customer's intended privileged use and has not ascertained whether this is the case?
(b) In the context of its act of delivery, is the third party obliged to take separate precautions to ensure that its customer will indeed use the active substance for privileged trials and studies only or do the precautionary measures of the third party differ, depending on whether the patented active substance is merely offered or actually delivered?