# C_2011063EN.01002301.xml

| 26.2.2011 | EN | Official Journal of the European Union | C 63/23 |
| --- | --- | --- | --- |

26.2.2011

EN

Official Journal of the European Union

C 63/23

---

Reference for a preliminary ruling from High Court of Justice (Chancery Division) (United Kingdom) made on 5 January 2011 — Daiichi Sankyo Company v Comptroller-General of Patents

(Case C-6/11)

2011/C 63/42

Language of the case: English

Referring court

Referring court

High Court of Justice (Chancery Division)

Parties to the main proceedings

Parties to the main proceedings

Applicant: Daiichi Sankyo Company

Applicant:

Defendant: Comptroller-General of Patents

Defendant:

Questions referred

Questions referred

| 1. | Regulation 469/2009 (the Regulation) (1) recognises amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation by ‘the product is protected by a basic patent in force’ and what are the criteria for deciding this? |
| --- | --- |

1.

Regulation 469/2009 (the Regulation) (1) recognises amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation by ‘the product is protected by a basic patent in force’ and what are the criteria for deciding this?

1

| 2. | In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not ‘the product is protected by a basic patent’ according to Art 3(a) of the Regulation and, if so, what are those further or different criteria? |
| --- | --- |

2.

In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not ‘the product is protected by a basic patent’ according to Art 3(a) of the Regulation and, if so, what are those further or different criteria?

| 3. | In order for a combination of active ingredients cited in an authorisation for placing a medicinal product on the market to be the subject of an SPC, and having regard to the wording to Article 4 of the Regulation, is the condition that the product be ‘protected by a basic patent’ within the meaning of Articles 1 and 3 of the Regulation satisfied if the product infringes the basic patent under national law? |
| --- | --- |

3.

In order for a combination of active ingredients cited in an authorisation for placing a medicinal product on the market to be the subject of an SPC, and having regard to the wording to Article 4 of the Regulation, is the condition that the product be ‘protected by a basic patent’ within the meaning of Articles 1 and 3 of the Regulation satisfied if the product infringes the basic patent under national law?

| 4. | In order for a combination of active ingredients cited in an authorisation for placing a medicinal product on the market to be the subject of an SPC, and having regard to the wording to Article 4 of the Regulation, does satisfaction of the condition that the product be ‘protected by a basic patent’ within the meaning of Articles 1 and 3 of the Regulation depend upon whether the basic patent contains one (or more) claims which specifically mention a combination of (1) a class of compounds which includes one of the active ingredients in the said product and (2) a class of further active ingredients which may be unspecified but which includes the other active ingredient in the said product; or is it sufficient that the basic patent contains one (or more) claims which (1) claim a class of compounds which includes one of the active ingredients in the said product and (2) use specific language which as a matter of national law extends the scope of protection to include the presence of further other unspecified active ingredients including the other active ingredient in the said product? |
| --- | --- |

4.

In order for a combination of active ingredients cited in an authorisation for placing a medicinal product on the market to be the subject of an SPC, and having regard to the wording to Article 4 of the Regulation, does satisfaction of the condition that the product be ‘protected by a basic patent’ within the meaning of Articles 1 and 3 of the Regulation depend upon whether the basic patent contains one (or more) claims which specifically mention a combination of (1) a class of compounds which includes one of the active ingredients in the said product and (2) a class of further active ingredients which may be unspecified but which includes the other active ingredient in the said product; or is it sufficient that the basic patent contains one (or more) claims which (1) claim a class of compounds which includes one of the active ingredients in the said product and (2) use specific language which as a matter of national law extends the scope of protection to include the presence of further other unspecified active ingredients including the other active ingredient in the said product?

---

(1)  OJ L 152, p. 1

1

---