# C_2014061EN.01000401.xml

| 1.3.2014 | EN | Official Journal of the European Union | C 61/4 |
| -------- | -- | -------------------------------------- | ------ |

---

Request for a preliminary ruling from the Oberster Patent- und Markensenat (Austria) lodged on 2 December 2013 — Arne Forsgren

(Case C-631/13)

2014/C 61/06

Language of the case: German

Referring court

Oberster Patent- und Markensenat

Parties to the main proceedings

Applicant: Arne Forsgren

Defendant: Österreichisches Patentamt

Questions referred

| 1. | Under Article 1(b) and Article 3(a) and (b) of 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,( 1 ) provided that the other conditions are met, may a protection certificate be granted for an active ingredient protected by a basic patent (in this case, Protein D) where that active ingredient is contained in the medicinal product (in this case, Synflorix) as part of a covalent (molecular) bond with other active ingredients but none the less retains its own effect? |
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

| 2. | If Question 1 is answered in the affirmative:
2.1
Under Article 3(a) and (b) of Regulation (EC) No 469/2009, may a protection certificate be granted for the substance protected by the basic patent (in this case, Protein D) where that substance has a therapeutic effect of its own (in this case, as a vaccine against Haemophilus influenzae bacteria) but the authorisation of the medicinal product does not relate to that effect? 2.2
Under Article 3(a) and (b) of Regulation (EC) No 469/2009, may a protection certificate be granted for the substance protected by the basic patent (in this case, Protein D) where the authorisation describes that substance as a ‘carrier’ for the actual active ingredients (in this case, Pneumococcal polysaccharides), the carrier, as an adjuvant, enhances the effect of those substances, but that effect is not expressly mentioned in the authorisation of the medicinal product? | 2.1 | Under Article 3(a) and (b) of Regulation (EC) No 469/2009, may a protection certificate be granted for the substance protected by the basic patent (in this case, Protein D) where that substance has a therapeutic effect of its own (in this case, as a vaccine against Haemophilus influenzae bacteria) but the authorisation of the medicinal product does not relate to that effect? | 2.2 | Under Article 3(a) and (b) of Regulation (EC) No 469/2009, may a protection certificate be granted for the substance protected by the basic patent (in this case, Protein D) where the authorisation describes that substance as a ‘carrier’ for the actual active ingredients (in this case, Pneumococcal polysaccharides), the carrier, as an adjuvant, enhances the effect of those substances, but that effect is not expressly mentioned in the authorisation of the medicinal product? |
| --- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 2.1 | Under Article 3(a) and (b) of Regulation (EC) No 469/2009, may a protection certificate be granted for the substance protected by the basic patent (in this case, Protein D) where that substance has a therapeutic effect of its own (in this case, as a vaccine against Haemophilus influenzae bacteria) but the authorisation of the medicinal product does not relate to that effect? | | | | |
| 2.2 | Under Article 3(a) and (b) of Regulation (EC) No 469/2009, may a protection certificate be granted for the substance protected by the basic patent (in this case, Protein D) where the authorisation describes that substance as a ‘carrier’ for the actual active ingredients (in this case, Pneumococcal polysaccharides), the carrier, as an adjuvant, enhances the effect of those substances, but that effect is not expressly mentioned in the authorisation of the medicinal product? | | | | |

---

( 1 )  OJ 2009 L 152, p. 1.

---