"Bolar CJEU reference: Poles say no, Germans say yes" was the title of a PatLit
blogpost back on 11 December 2013 which brought news via katfriend Paul England (Taylor Wessing LLP) that the Düsseldorf Court of Appeal, Germany, had referred some questions to the Court of Justice of the European Union (CJEU) for a preliminary ruling as to whether and, if so, 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 authorization, is covered by the
Bolar exemption. Paul summarised the issue there as follows:
"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?
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?
Or does the privileged status of the third party merely depend on whether, at the time of the act of delivery, the third party can rightly assume that, judging all of the circumstances (i.e. profile of the supplied company, small amount of the provided active substance, imminent expiration of the patent protection of the relevant active substance, experience gained concerning the customer's reliability), the supplied manufacturer of generics will use the provided active substance for privileged trials and studies in the context of a marketing approval only?
(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?
The case itself is being fought out between Polish company Polpharma S.A. Pharmaceutical Works and Japanese company Astellas Pharma Inc; if you must know, the patent is for novel
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
