# C_2015350EN.01000801.xml

| 22.10.2015 | EN | Official Journal of the European Union | C 350/8 |
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22.10.2015

EN

Official Journal of the European Union

C 350/8

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JUDGMENT OF THE COURT

of 9 April 2015

in Case E-16/14

Pharmaq AS v Intervet International BV

(Veterinary medicinal products — Supplementary protection certificate — Regulation (EEC) No 1768/92 — Concept of ‘first authorisation to place a product on the market’ in the European Economic Area — Active ingredient)

(2015/C 350/11)

In Case E-16/14, Pharmaq AS v Intervet International BV — REQUEST to the Court under Article 34 of the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice from Oslo tingrett (Oslo District Court) concerning the interpretation of Articles 2, 3 and 4 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, the Court, composed of Carl Baudenbacher, President, Per Christiansen and Páll Hreinsson (Judge-Rapporteur), Judges, gave judgment on 9 April 2015, the operative part of which is as follows:

Oslo District Court

| 1. | Under Regulation (EEC) No 1768/92, a supplementary protection certificate for a veterinary medicinal product may be granted in an EEA State on the basis of a marketing authorisation granted in that State pursuant to the administrative authorisation procedure set out in Title III of Directive 2001/82/EC, including the procedure for authorisation in exceptional circumstances under Article 26(3) of that directive. Such a marketing authorisation constitutes a valid authorisation and, where appropriate, may also constitute the first authorisation to place the product on the market as a veterinary medicinal product within the meaning of Article 3(b) and (d) of Regulation (EEC) No 1768/92.
  Permissions granted on the basis of the first paragraph of Article 8 of Directive 2001/82/EC do not constitute a marketing authorisation within the meaning of Regulation (EEC) No 1768/92. That derogating provision strictly limits the use of the measures permitted under it, stating that it applies only in the event of serious epizootic diseases, in the absence of suitable medicinal products and after informing the EFTA Surveillance Authority of the detailed conditions of use.
  The determination of whether ‘special approval exemptions’ or ‘AR 16 licences’, granted respectively by Norwegian and Irish authorities between 2003 and 2011, and the provisional marketing authorisation granted in the United Kingdom in 2005 were issued pursuant to national provisions implementing the first paragraph of Article 8 or Article 26(3) of Directive 2001/82/EC depends essentially on the assessment of the facts in the national proceedings, which is a matter for the national court. |
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1.

Under Regulation (EEC) No 1768/92, a supplementary protection certificate for a veterinary medicinal product may be granted in an EEA State on the basis of a marketing authorisation granted in that State pursuant to the administrative authorisation procedure set out in Title III of Directive 2001/82/EC, including the procedure for authorisation in exceptional circumstances under Article 26(3) of that directive. Such a marketing authorisation constitutes a valid authorisation and, where appropriate, may also constitute the first authorisation to place the product on the market as a veterinary medicinal product within the meaning of Article 3(b) and (d) of Regulation (EEC) No 1768/92.

Permissions granted on the basis of the first paragraph of Article 8 of Directive 2001/82/EC do not constitute a marketing authorisation within the meaning of Regulation (EEC) No 1768/92. That derogating provision strictly limits the use of the measures permitted under it, stating that it applies only in the event of serious epizootic diseases, in the absence of suitable medicinal products and after informing the EFTA Surveillance Authority of the detailed conditions of use.

The determination of whether ‘special approval exemptions’ or ‘AR 16 licences’, granted respectively by Norwegian and Irish authorities between 2003 and 2011, and the provisional marketing authorisation granted in the United Kingdom in 2005 were issued pursuant to national provisions implementing the first paragraph of Article 8 or Article 26(3) of Directive 2001/82/EC depends essentially on the assessment of the facts in the national proceedings, which is a matter for the national court.

| 2. | Pursuant to Article 4 of Regulation (EEC) No 1768/92, the scope of protection conferred by a supplementary protection certificate extends to a specific strain of a virus covered by the basic patent, but not referred to in the marketing authorisation for a virus vaccine relied on for the purposes of Article 3(b) of Regulation (EEC) No 1768/92, only if the specific strain constitutes the same active ingredient as the authorised medicinal product and has therapeutic effects falling within the therapeutic indications for which the marketing authorisation was granted. It is not relevant whether a medicinal product based on such other strain would require a separate marketing authorisation. The appreciation of such elements is a matter of fact which is to be determined by the national court.
  A supplementary protection certificate is invalid to the extent it is granted a wider scope than that set out in the relevant marketing authorisation. |
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2.

Pursuant to Article 4 of Regulation (EEC) No 1768/92, the scope of protection conferred by a supplementary protection certificate extends to a specific strain of a virus covered by the basic patent, but not referred to in the marketing authorisation for a virus vaccine relied on for the purposes of Article 3(b) of Regulation (EEC) No 1768/92, only if the specific strain constitutes the same active ingredient as the authorised medicinal product and has therapeutic effects falling within the therapeutic indications for which the marketing authorisation was granted. It is not relevant whether a medicinal product based on such other strain would require a separate marketing authorisation. The appreciation of such elements is a matter of fact which is to be determined by the national court.

A supplementary protection certificate is invalid to the extent it is granted a wider scope than that set out in the relevant marketing authorisation.

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