Briefing note: Pharmaq v Intervet – E16/4. The EFTA Court rules on the application of Articles 2,3 & 4 SPC Regulation in the context of veterinary vaccines.

Powell Gilbert – Briefing note: Pharmaq v Intervet – E16/4. The EFTA Court rules on the application of Articles 2,3 &


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Briefing note: Pharmaq v Intervet – E16/4. The EFTA Court rules on the application of Articles 2,3 & 4 SPC Regulation in the context of veterinary vaccines.

Briefing note: Pharmaq v Intervet – E16/4. The EFTA Court rules on the application of Articles 2,3 & 4 SPC Regulation in the context of veterinary vaccines.

22/04/2015 12:06:10

Summary
In a referral of questions from the Oslo District Court relating to the grant of an SPC for a veterinary vaccine the EFTA court1 (“The Court”) has held that:
  • A provisional marketing authorisation properly granted under Art 26 (3) Directive 2001/82/EC relating to veterinary medicinal products (“Veterinary Medicines Directive”) may be the first authorisation to place the product on the market under Art 3(b) and (d) of Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary certificate for medicinal products (“SPC Regulation”), so can be the basis for an SPC application.
  • A provisional permission to place a product on the market under Art 8(1) Veterinary Medicines Directive will not amount to an authorisation for the purposes of Art 3(b) and (d) provided that it has been properly granted. Art 8(1) permissions being strictly limited to the use of immunological veterinary medicinal products , without a marketing authorisation, in the event of serious epizootic diseases where there is an absence of suitable medicinal products and after informing the Commission /EFTA surveillance authority of the detailed conditions of use.
  • An SPC is invalid as in breach of Art 4 SPC Regulation to the extent it has been granted with wider scope “than that set out in the relevant Marketing Authorisation (“MA”)”.
The case has been referred back to the Oslo District Court for interpretation of the EFTA Court’s judgment on the specific facts of the case.
Background
The case before the Oslo District Court concerns the validity and scope of an SPC granted to Intervet International BV (“Intervet”) on a Norwegian patent which broadly claims the F93-125 strain of Salmonid Pancreatic Disease