# C_2014129EN.01000702.xml

| 28.4.2014 | EN | Official Journal of the European Union | C 129/7 |
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28.4.2014

EN

Official Journal of the European Union

C 129/7

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Request for a preliminary ruling from the Oberlandesgericht Düsseldorf (Germany) lodged on 13 December 2013 — Astellas Pharma Inc. v Polpharma SA Pharmaceutical Works

(Case C-661/13)

(2014/C 129/09)

Language of the case: German

Referring court

Oberlandesgericht Düsseldorf

Parties to the main proceedings

Applicant: Astellas Pharma Inc.

Defendant: Polpharma SA Pharmaceutical Works

Questions referred

| 1. | Is Article 10(6) of Directive 2001/83/EC (1) to be interpreted as meaning that the exclusion from patent protection also applies to acts of provision by which a third party for purely commercial reasons offers or supplies to a manufacturer of generic medicinal products a patent-protected active substance which that generic pharmaceutical undertaking has planned to use for conducting studies or trials for a marketing authorisation under medicinal product law as provided for in Article 10(6)? |
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1.

Is Article 10(6) of Directive 2001/83/EC (1) to be interpreted as meaning that the exclusion from patent protection also applies to acts of provision by which a third party for purely commercial reasons offers or supplies to a manufacturer of generic medicinal products a patent-protected active substance which that generic pharmaceutical undertaking has planned to use for conducting studies or trials for a marketing authorisation under medicinal product law as provided for in Article 10(6)?

| 2. | If the first question is to be answered in the affirmative:






  (a) | Does the third party’s enjoyment of the exemption depend on the manufacturer of generic medicinal products who is supplied by him actually using the provided active substance for exempted studies or trials under Article 10(6) of Directive 2001/83/EC? Does the exclusion from patent protection apply in such a case even where the third party has no knowledge of the intentions of his customer to use the active substance for purposes covered by the exemption and has also not satisfied himself in this regard?
  Or, in order for the third party to enjoy the exemption, does it matter only that at the time of his act of provision he can legitimately assume on the basis of all the circumstances (for example, the focus of the undertaking supplied, the small quantity of the active substance provided, the imminent expiry of the patent protection for the active substance in question, experiences as to the customer’s reliability) that the generic pharmaceutical undertaking supplied will use the active substance provided exclusively for exempted trials or studies in the context of a marketing authorisation? |
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2.

If the first question is to be answered in the affirmative:

(a)

Does the third party’s enjoyment of the exemption depend on the manufacturer of generic medicinal products who is supplied by him actually using the provided active substance for exempted studies or trials under Article 10(6) of Directive 2001/83/EC? Does the exclusion from patent protection apply in such a case even where the third party has no knowledge of the intentions of his customer to use the active substance for purposes covered by the exemption and has also not satisfied himself in this regard?

Or, in order for the third party to enjoy the exemption, does it matter only that at the time of his act of provision he can legitimately assume on the basis of all the circumstances (for example, the focus of the undertaking supplied, the small quantity of the active substance provided, the imminent expiry of the patent protection for the active substance in question, experiences as to the customer’s reliability) that the generic pharmaceutical undertaking supplied will use the active substance provided exclusively for exempted trials or studies in the context of a marketing authorisation?

| (b) | Must the third party, in connection with performance of his act of provision, take measures of his own to ensure that the active substance is actually used by his customer only for exempted trials or studies and do the measures to be taken by him differ according to whether the patent-protected active substance is only offered or also supplied? |
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(b)

Must the third party, in connection with performance of his act of provision, take measures of his own to ensure that the active substance is actually used by his customer only for exempted trials or studies and do the measures to be taken by him differ according to whether the patent-protected active substance is only offered or also supplied?

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(1)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2011 L 311, p. 67), as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ 2004 L 136, p. 34).

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