The Dusseldorf Court of Appeal has referred questions to the Court of Justice of the European Union (CJ) concerning the applicability of the so-called European ‘Bolar’ exemption to a third party manufacturer of a patented active substance.
The European Bolar provision is provided by Article 10(6) of European Directive 2001/83/EC and principally provides that conducting the necessary studies and trials with a view to obtaining a marketing authorisation for a generic medicinal product and the consequent practical requirements, shall not be regarded as contrary to patent rights or to supplementary protection certificates (SPCs) for medical products.
Polpharma SA Pharmaceutical Works v Astellas Pharma Inc
Polpharma SA Pharmaceutical Works is a Polish company which produces and sells its medical products as well as generic active pharmaceutical ingredients (API) worldwide.
Polpharma advertised the active substance solifenacin succinate in the professional journals SCRIP and Generics Bulletin, as well as on its website. Polpharma supplied 30.5kg of solifenacin succinate at a sales price of EUR 127,000 to Hexal AG, a German manufacturer of generics.
Astellas Pharma Inc, a Japanese company, sued Polpharma in Poland and Germany for infringement of its European patent 0 801 067 directed to solifenacin succinate.
Polpharma denied infringement. Its defence was that when concluding the business transactions, it was in agreement with Hexal that the product would only be used in studies and trials whose aim is to produce a solifenacin-based generic drug and to obtain a corresponding marketing authorisation. Whether or not Polpharma’s defence is correct therefore depends on the interpretation of the European Bolar provision.
Polish Supreme Court
In Poland, the Supreme Court rejected Polpharma’s defence stating that the Bolar exemption does not cover its sales of the patented API, even if made for the benefit of a party developing a generic product.
Düsseldorf Court of Appeal
In Germany the matter has been referred to the CJ to determine whether the Bolar exemption does indeed extend to third party supply to a generic manufacturer of a patent-protected active substance which that generic manufacturer plans to use for obtaining a marketing authorisation.
The questions referred to the CJ are translated here:
C-661/13 ASTELLAS PHARMA
Questions referred for a preliminary ruling
- Must Art. 10 para. 6 of Directive 2001/83/EC 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 para. 6 of Directive 2001/83/EC?
- If this first question is to be answered in the affirmative:
- 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 para. 6 of Directive 2001/83/EC? 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?
- 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 CJ’s guidance, when issued, is likely to have a major impact on API manufacture in Europe.