Synthon BV v Merz Pharma GmbH & Co KGaA (Rev 2)

Synthon BV v Merz Pharma GmbH & Co KGaA (Rev 2)

The court provisionally finds that if a national authorisation is granted under a law implementing Directive 65/65/EEC, it should be treated as a qualifying authorisation for SPC purposes, regardless of whether the national authority actually conducted a full safety and efficacy assessment. If so, the Luxembourg...

Source-derived case information.

Parties
Claimant: SYNTHON B. V.; Defendant: MERZ PHARMA GmbH & Co. KGaA
Jurisdiction
England and Wales
Judgment Date
02 April 2009
Procedural Posture
Patent Revocation Action / Judgment on Reference to Ecj; Pre Final Determination
Outcome
Reference to the European Court of Justice (ECJ) for preliminary ruling; no final determination on validity of SPC pending ECJ decision.
Legal Topics
Supplementary Protection Certificate (spc), Patent Term Extension, Marketing Authorisation, Interpretation of EU Regulation 1768/92, Validity of Spcs
Intellectual Property Law Pharmaceutical Law European Union Law Supplementary Protection Certificate (spc) Patent Term Extension Marketing Authorisation Interpretation of EU Regulation 1768/92 Validity of Spcs

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Parties

SYNTHON B. V.

Claimant

MERZ PHARMA GmbH & Co. KGaA

Defendant

Procedural Posture

Patent Revocation Action / Judgment on Reference to Ecj; Pre Final Determination

Legal Issues

  1. 1 Whether a marketing authorisation granted under national law but without safety and efficacy testing as per Directive 65/65/EEC qualifies as a 'first authorisation' under Articles 13 and 19 of Regulation 1768/92
  2. 2 Whether non-65/65 compliant authorisations can be considered for SPC term calculation
  3. 3 Whether products placed on the market without 65/65 authorisation are within the scope of the Regulation

Ratio Decidendi

The court provisionally finds that if a national authorisation is granted under a law implementing Directive 65/65/EEC, it should be treated as a qualifying authorisation for SPC purposes, regardless of whether the national authority actually conducted a full safety and efficacy assessment. If so, the Luxembourg authorisation was the first in the Community, rendering the SPC invalid or of zero term. However, the court refers the questions to the ECJ for authoritative interpretation due to conflicting national decisions and lack of clear guidance.

Court Disposition

Reference to the European Court of Justice (ECJ) for preliminary ruling; no final determination on validity of SPC pending ECJ decision.

Orders

  • Parties to make submissions on the wording of the reference to the ECJ.
  • Order to be made directing reference to the ECJ.