# C_2017318EN.01000801.xml

| 25.9.2017 | EN | Official Journal of the European Union | C 318/8 |
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25.9.2017

EN

Official Journal of the European Union

C 318/8

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Request for a preliminary ruling from the Gerechtshof Den Haag (Netherlands) lodged on 13 July 2017 — Staat der Nederlanden v Warner-Lambert Company LLC

(Case C-423/17)

(2017/C 318/13)

Language of the case: Dutch

Referring court

Referring court

Gerechtshof Den Haag

Parties to the main proceedings

Parties to the main proceedings

Applicant: Staat der Nederlanden

Applicant:

Defendant: Warner-Lambert Company LLC

Defendant:

Questions referred

Questions referred

| 1. | Must Article 11 of Directive 2001/83 (1) or any other provision of European Union law be interpreted as meaning that a communication whereby the marketing authorisation applicant or holder for a generic medicine, within the meaning of Article 10 of Directive 2001/83, notifies the authority that he is not including in the Summary of Product Characteristics and the package leaflet those parts of the Summary of Product Characteristics for the reference medicine which refer to indications or dosage forms covered by the patent right of a third party, should be considered as a request to limit the marketing authorisation which must result in the marketing authorisation not applying, or no longer applying, to the patented indications or dosage forms? |
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1.

Must Article 11 of Directive 2001/83 (1) or any other provision of European Union law be interpreted as meaning that a communication whereby the marketing authorisation applicant or holder for a generic medicine, within the meaning of Article 10 of Directive 2001/83, notifies the authority that he is not including in the Summary of Product Characteristics and the package leaflet those parts of the Summary of Product Characteristics for the reference medicine which refer to indications or dosage forms covered by the patent right of a third party, should be considered as a request to limit the marketing authorisation which must result in the marketing authorisation not applying, or no longer applying, to the patented indications or dosage forms?

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| 2. | If the answer to question 1 is in the negative, do Articles 11 and 21(3) of Directive 2001/83 or any other provisions of EU law preclude the competent authority from making public, by means of an authorisation granted under Article 6 in conjunction with Article 10 of Directive 2001/83, the Summary of Product Characteristics and the package leaflet, including those parts which refer to indications or dosage forms which fall under the patent rights of a third party, in a situation where the marketing authorisation applicant or holder has notified the authority that he is not including in the Summary of Product Characteristics and the package leaflet those parts of the Summary of Product Characteristics for the reference medicine which refer to indications or dosage forms covered by the patent right of a third party? |
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2.

If the answer to question 1 is in the negative, do Articles 11 and 21(3) of Directive 2001/83 or any other provisions of EU law preclude the competent authority from making public, by means of an authorisation granted under Article 6 in conjunction with Article 10 of Directive 2001/83, the Summary of Product Characteristics and the package leaflet, including those parts which refer to indications or dosage forms which fall under the patent rights of a third party, in a situation where the marketing authorisation applicant or holder has notified the authority that he is not including in the Summary of Product Characteristics and the package leaflet those parts of the Summary of Product Characteristics for the reference medicine which refer to indications or dosage forms covered by the patent right of a third party?

| 3. | Does it make any difference to the answer to question 2 that the competent authority requires the authorisation holder to include in the package leaflet which the authorisation holder must insert in the packaging of the medicine a reference to the authority’s website on which the Summary of Product Characteristics is published, including the parts which refer to indications or dosage forms covered by the patent rights of a third party, whereas those parts, pursuant to Article 11 of Directive 2001/83, are not included in the package leaflet? |
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3.

Does it make any difference to the answer to question 2 that the competent authority requires the authorisation holder to include in the package leaflet which the authorisation holder must insert in the packaging of the medicine a reference to the authority’s website on which the Summary of Product Characteristics is published, including the parts which refer to indications or dosage forms covered by the patent rights of a third party, whereas those parts, pursuant to Article 11 of Directive 2001/83, are not included in the package leaflet?

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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 2001 L 311, p. 67).

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