Generics UK Ltd v Synaptech Inc

Generics UK Ltd v Synaptech Inc

The Court of Appeal referred questions to the Court of Justice of the European Communities regarding whether the first authorisation under Article 13(1) must comply with Directive 65/65/EEC and whether the 1963 Austrian authorisation can be deemed compliant, as the resolution of these points is determinative of the correct expiry date for the galantamine SPC.

Parties
Appellant: Generics UK Limited; Respondent: Synaptech Inc
Jurisdiction
England and Wales
Judgment Date
16 October 2009
Procedural Posture
Civil Appeal / Reference for Preliminary Ruling to the Court of Justice of the European Communities
Outcome
reference for preliminary ruling granted; proceedings stayed
Legal Topics
Supplementary Protection Certificates, Expiry Date Calculation, Interpretation of Regulation (eec) 1768/92, Marketing Authorisations
Intellectual Property Patents EU Law Supplementary Protection Certificates Expiry Date Calculation Interpretation of Regulation (eec) 1768/92 Marketing Authorisations

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Parties

Generics UK Limited

Appellant

Synaptech Inc

Respondent

Procedural Posture

Civil Appeal / Reference for Preliminary Ruling to the Court of Justice of the European Communities

Legal Issues

  1. 1 Whether the 'first authorisation to place the product on the market in the Community' under Article 13(1) of Regulation 1768/92 must comply with Directive 65/65/EEC or if any authorisation suffices
  2. 2 Whether an Austrian authorisation from 1963, not compliant with Directive 65/65/EEC, can be deemed compliant for the purposes of Article 13(1)

Ratio Decidendi

The Court of Appeal referred questions to the Court of Justice of the European Communities regarding whether the first authorisation under Article 13(1) must comply with Directive 65/65/EEC and whether the 1963 Austrian authorisation can be deemed compliant, as the resolution of these points is determinative of the correct expiry date for the galantamine SPC.

Court Disposition

reference for preliminary ruling granted; proceedings stayed

Orders

  • Questions concerning interpretation of Regulation (EEC) 1768/92 referred to the Court of Justice of the European Communities under Article 234 EC.
  • Request for joinder with Case C-195/09 Synthon v Merz.