EFTA over eerste EEA-handelsvergunning en reikwijdte ABC

EFTA Court 9 april 2015, IEFbe 1298, zaak E-16/14 (Pharmaq tegen Intervet)
Handelsvergunning. ABC. Diergeneesmiddel. Concept of eerste handelsvergunning in de EEA (European Economic Area). Een ABC is ongeldig wanneer het een bredere reikwijdte heeft dan in wordt voorzien door de relevante handelsvergunngin. EFTA antwoordt:

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.

Gestelde vragen:

1. Concerning Article 2 of the SPC Regulation, has a product been placed on the market as a medicinal product in the EEA before it has been granted marketing authorisation in accordance with the procedure for administrative authorisation laid down in Directive 81/851/EEC (or Directive 2001/82/EC) when delivery of the product has taken place in accordance with
(i) “special approval exemptions” granted by the State Medicines Agency to veterinarians and fish health biologists pursuant to Section 3-6 or 3-7 of the Norwegian Regulation of 22 December 1999, alternatively Sections 2-6 or 2-7 of the Norwegian Regulation of 18 December 2009, or
(ii) what are known as “AR 16 licences” granted by the Irish Department of Agriculture, Food and the Marine pursuant to the Irish Statutory Instrument No 144/2007 European Communities (Animal Remedies) Regulations 2007 part III “Exceptional authorisation”, point 16?
2. If question 1 is answered in the affirmative, is such a product outside the scope of the SPC Regulation and is an SPC granted on the basis of such a product therefore invalid?
3. Concerning the interpretation of Article 2 of the SPC Regulation, should a marketing authorisation granted for a veterinary medicinal product pursuant to Article 26(3) of Directive 2001/82 be deemed to constitute an administrative authorisation pursuant to Directive 81/851 (or Directive 2001/82) within the meaning of Article 2?
4. (a) Do special approval exemptions pursuant to Section 3-6 or 3-7
of the Norwegian Medicines Regulations of 1999 (FOR-199-12-22-1559) or Section 2-6 or 2-7 of the Norwegian Medicines Regulations of 2009 (FOR-2009-12-18-1839) constitute valid authorisation to place the product on the market as a medicinal product within the meaning of Article 3(b)?
(b) Do special approval exemptions pursuant to Section 3-6 or 3-7 of the Norwegian Medicines Regulations of 1999 (FOR-199-12-22-1559) or Section 2-6 or 2-7 of the Norwegian Medicines Regulations of 2009 (FOR-2009-12-18-1839) constitute a first authorisation to place the product on the market as a medicinal product in Norway within the meaning of Article 3(d)?
5. When the medicinal product is a virus vaccine, can the scope of protection under the SPC cover not only the specific strain of the virus that is included in the medicinal product and covered by the basic patent, but also other strains of the virus that are covered by the basic patent? In answering this question, is it of significance whether
(a) such other strains have an equivalent therapeutic effect to the virus strain included in the medicinal product or whether the therapeutic effect is not immediately equivalent?
(b) a medicinal product based on such other strain will have to be the subject of a separate marketing authorisation with requirements for documentation of safety and effect?
6. If an SPC has been granted with a product definition that is not strictly limited to the specific strain of the virus authorised to be placed on the market as a medicinal product,
(a) will such an SPC be valid, or
(b) will the SPC be valid; such, however, that the scope of protection pursuant to Article 4 does not extend beyond the specific virus strain authorised to be placed on the market as a medicinal product?