Background and legislation
The EFTA Court has jurisdiction with regard to the EFTA States which are also party to the EEA Agreement – namely, Iceland, Liechtenstein and Norway. The EFTA Court may issue non-binding Advisory Opinions on the interpretation of the EEA legislation, and in this instance – in Pharmaq AS v Intervet International BV (Case E-16/14) – they have provided an opinion on the interpretation of EU Regulation No 1768/92, relating to SPCs, which has been incorporated into the EEA Agreement.
In the EU, Regulation No 1768/92 has been repealed and replaced by Regulation (EC) No 469/2009, known as the “SPC Regulation”. Since the relevant provisions of the two regulations are essentially identical in this case, the EFTA Court’s opinion of the validity and scope of SPCs for veterinary medicinal products is nonetheless very useful. Further, as the provisions are essentially identical, for consistency we shall refer to the SPC Regulation below.
According to Article 2 of the SPC Regulation, any product protected by a patent in the territory of an EEA State and subject, prior to being placed on the market as a veterinary medicinal product, to an ‘administrative authorisation procedure’ as laid down in Directive 2001/82/EC (the “Veterinary Medicinal Code”), may be the subject of an SPC. When assessing the validity and duration of an SPC, it is critical to assess when the first valid authorisation was granted to place the veterinary medicinal product on the market.
Article 4 of the SPC Regulation states that an SPC shall extend only to the product covered by the MA. ‘Product’ is defined as the active ingredient or combinations of active ingredients of a medicinal product. It is therefore necessary to consider the scope of both the basic patent and the MA when assessing the validity of an SPC.
The EFTA Court considered whether: (i) the grant of an authorisation under exceptional circumstances pursuant to Article 26(3) of the Veterinary Medicinal Code; and/or (ii) the grant of permission to use unauthorised immunological products in the event of serious epizootic diseases under Article 8 of the Veterinary Medicinal Code, could be considered a valid MA for the purposes of the SPC Regulation.
Additionally the EFTA Court considered: (iii) the scope of an SPC for a vaccine in the situation where the SPC and basic patent extended to several strains of a viral vaccine, but where not all strains were referred to in the MA; and (iv) the validity of an SPC granted with a product definition that is wider than its associated MA.
The EFTA Court’s findings
- The EFTA Court noted that the marketing authorisation procedure in the Veterinary Medicinal Code includes authorisations granted in exceptional circumstances pursuant to Article 26(3). The Court therefore held that such an authorisation would constitute a valid MA and may also constitute the first authorisation to place the veterinary medicinal product on the market for the purposes of the SPC Regulation.
- In contrast, the EFTA Court noted that the strictly limited, provisional permission to supply vaccines in the event of serious epizootic disease under Article 8 of the Veterinary Medicinal Code does not require the same safety and efficacy testing. This permission also does not entitle the producer to market the product, but only to supply it to the extent necessary to combat the disease in question. The Court therefore held that such permission does not constitute an MA and will generally not constitute placing the product on the market for the purposes of the SPC Regulation.
According to this opinion, the provisional use of an unauthorised vaccine in the face of an outbreak of disease would not usually disqualify the product from subsequently obtaining an SPC, thus alleviating some concerns that patent holders might lose the entitlement to a SPC if they were to make their unauthorised product available in response to an epizootic crisis.
- The EFTA Court held that the scope of an SPC will only extend to a specific strain of virus that is covered by the basic patent, but which is not referred to in the relevant MA, if (a) the strain constitutes the same active ingredient as the authorised medicinal product, and (b) it has therapeutic effects falling within the therapeutic indications for which the MA was granted.
It therefore remains for the national court to determine, on the basis of the specific facts of the case, whether two different strains of a virus used in vaccines – hence biological products – can be considered to be the same active ingredient. The national court must then assess whether the therapeutic effects of the potentially infringing vaccine fall within the therapeutic indication of the relevant MA. The debate over what constitutes an ‘active ingredient’ in biological products therefore looks set to continue.
- Finally, the Court held that if an SPC is granted a wider scope than is set out in the relevant MA, this will be a breach of Article 4 of the SPC Regulation. Whilst this is not a ground for invalidity listed in Article 15(1) of the SPC Regulation, the SPC will nevertheless be invalid to the extent that it is wider in scope than the relevant MA.