# C_2011179EN.01000702.xml

| 18.6.2011 | EN | Official Journal of the European Union | C 179/7 |
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18.6.2011

EN

Official Journal of the European Union

C 179/7

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Reference for a preliminary ruling from Court of Appeal (England & Wales) (Civil Division) (United Kingdom) made on 16 March 2011 — Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents

(Case C-130/11)

2011/C 179/11

Language of the case: English

Referring court

Referring court

Court of Appeal (England & Wales) (Civil Division)

Parties to the main proceedings

Parties to the main proceedings

Applicant: Neurim Pharmaceuticals (1991) Ltd

Applicant:

Defendant: Comptroller-General of Patents

Defendant:

Questions referred

Questions referred

| 1. | In interpreting Article 3 of Regulation EEC No. 1768/92 (1) [now Regulation (BC) No. 469/2009 (2)] (‘the SPC Regulation’), when a marketing authorisation (A) has been granted for a medicinal product comprising an active ingredient, is Article 3(d) to be construed as precluding the grant of an SPC based on a later marketing authorisation (B) which is for a different medicinal product comprising the same active ingredient where the limits of the protection conferred by the basic patent do not extend to placing the product the subject of the earlier MA on the market within the meaning of Article 4? |
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1.

In interpreting Article 3 of Regulation EEC No. 1768/92 (1) [now Regulation (BC) No. 469/2009 (2)] (‘the SPC Regulation’), when a marketing authorisation (A) has been granted for a medicinal product comprising an active ingredient, is Article 3(d) to be construed as precluding the grant of an SPC based on a later marketing authorisation (B) which is for a different medicinal product comprising the same active ingredient where the limits of the protection conferred by the basic patent do not extend to placing the product the subject of the earlier MA on the market within the meaning of Article 4?

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| 2. | If the grant of the SPC is not precluded, does it follow that in interpreting Article 13(1) of the SPC Regulation, ‘the first authorisation to place the product on the market in the Community’ needs to be an authorisation to place a medicinal product on the market within the limits of the protection conferred by the basic patent within the meaning of Article 4? |
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2.

If the grant of the SPC is not precluded, does it follow that in interpreting Article 13(1) of the SPC Regulation, ‘the first authorisation to place the product on the market in the Community’ needs to be an authorisation to place a medicinal product on the market within the limits of the protection conferred by the basic patent within the meaning of Article 4?

| 3. | Are the answers to the above questions different if the earlier marketing authorisation has been granted for a veterinary medicinal product for a particular indication and the later marketing authorisation has been granted for a medicinal product for human use for a different indication? |
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3.

Are the answers to the above questions different if the earlier marketing authorisation has been granted for a veterinary medicinal product for a particular indication and the later marketing authorisation has been granted for a medicinal product for human use for a different indication?

| 4. | Are the answers to the above questions different if the later marketing authorisation required a full application for marketing approval in accordance with Article 8(3) of Directive 2001/83/EC (3) (formerly a full application under Article 4 of Directive 65/65/EEC (4))? |
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4.

Are the answers to the above questions different if the later marketing authorisation required a full application for marketing approval in accordance with Article 8(3) of Directive 2001/83/EC (3) (formerly a full application under Article 4 of Directive 65/65/EEC (4))?

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| 5. | Are the answers to the above questions different if the product covered by authorisation (A) to place the corresponding medicinal product on the market is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant? |
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5.

Are the answers to the above questions different if the product covered by authorisation (A) to place the corresponding medicinal product on the market is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant?

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(1)  Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, OJ L 182, p. 1

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(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, OJ L 152, p. 1

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(3)  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 L311, p. 67

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(4)  Council Directive 65/65/EEC OF 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products, OJ 22, p. 369 (English special edition: Series I Chapter 1965-1966, p. 24)

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