Generics (UK) Ltd v Synaptech Inc [2009] EWHC 659 (Ch) (20 May 2009)

Generics (UK) Ltd v Synaptech Inc [2009] EWHC 659 (Ch) (20 May 2009)

The ECJ's judgment in Hässle AB v Ratiopharm GmbH is binding and establishes that only Directive 65/65 compliant marketing authorisations are relevant for calculating the term of an SPC under Article 13(1) of Regulation 1768/92. Earlier authorisations not compliant with Directive 65/65 cannot be used for this purpose.

Citation
[2009] EWHC 659 (Ch)
Parties
Claimant: Generics (UK) Limited; Defendant: Synaptech Inc
Jurisdiction
England and Wales
Judgment Date
20 May 2009
Procedural Posture
Patent Rectification Action / Judgment After Streamlined Procedure, No Disclosure or Cross Examination
Outcome
Claim dismissed
Legal Topics
Supplementary Protection Certificates, Patent Term Extension, Marketing Authorisation, Directive 65/65/eec Compliance
Intellectual Property Pharmaceutical Law European Union Law Supplementary Protection Certificates Patent Term Extension Marketing Authorisation Directive 65/65/eec Compliance

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Parties

Generics (UK) Limited

Claimant

Synaptech Inc

Defendant

Procedural Posture

Patent Rectification Action / Judgment After Streamlined Procedure, No Disclosure or Cross Examination

Legal Issues

  1. 1 Whether the first marketing authorisation under Article 13(1) of the SPC Regulation must be Directive 65/65 compliant or whether any prior authorisation suffices for SPC term calculation

Ratio Decidendi

The ECJ's judgment in Hässle AB v Ratiopharm GmbH is binding and establishes that only Directive 65/65 compliant marketing authorisations are relevant for calculating the term of an SPC under Article 13(1) of Regulation 1768/92. Earlier authorisations not compliant with Directive 65/65 cannot be used for this purpose.

Court Disposition

Claim dismissed

Orders

  • Claimant's action for rectification of the patent register is dismissed
  • No rectification of SPC term; SPC expiry remains 15 January 2012