# C_2013086EN.01001001.xml

| 23.3.2013 | EN | Official Journal of the European Union | C 86/10 |
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23.3.2013

EN

Official Journal of the European Union

C 86/10

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Reference for a preliminary ruling from High Court of Justice (Chancery Division) Patents Court (United Kingdom) made on 18 December 2012 — Astrazeneca AB v Comptroller-General of Patents

(Case C-617/12)

2013/C 86/15

Language of the case: English

Referring court

Referring court

High Court of Justice (Chancery Division) Patents Court

Parties to the main proceedings

Parties to the main proceedings

Applicant: Astrazeneca AB

Applicant:

Defendant: Comptroller-General of Patents

Defendant:

Questions referred

Questions referred

| 1. | Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC (1), but automatically recognised by Liechtenstein, capable of constituting the ‘first authorisation to place the product on the market’ for the purposes of Article 13(1) of Regulation 469/2009/EC (2)? |
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1.

Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC (1), but automatically recognised by Liechtenstein, capable of constituting the ‘first authorisation to place the product on the market’ for the purposes of Article 13(1) of Regulation 469/2009/EC (2)?

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| 2. | Does it make a difference to the answer to the first question if:






  (a) | the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC (3); and/or |
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2.

Does it make a difference to the answer to the first question if:

(a)

the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC (3); and/or

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| (b) | the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data? |
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(b)

the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?

| 3. | If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009? |
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3.

If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?

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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

1

OJ L 311, p. 67

(2)  Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products

2

OJ L 152, p. 1

(3)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

3

OJ L 136, p. 1

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