Accord Healthcare Ltd & Anor v Astellas Pharma GmbH & Anor

Accord Healthcare Ltd & Anor v Astellas Pharma GmbH & Anor

The July 2005 BfArM authorisation for Ribomustin was a valid marketing authorisation under Directive 2001/83/EC, granted in accordance with Article 8, and the imposition of post-authorisation conditions was permissible. The subsequent appeal and settlement did not retrospectively invalidate the authorisation for NHL and MM indications. BfArM did not delegate its decision-making power to an expert. Accordingly, Ribomustin is a reference medicinal product for purposes of Article 10 data exclusivity.

Parties
Claimant: Accord Healthcare Limited; Claimant: Intas Pharmaceuticals Limited; Defendant: Astellas Pharma GmbH; Defendant: Napp Pharmaceuticals Limited
Jurisdiction
England and Wales
Judgment Date
16 December 2015
Procedural Posture
Commercial/administrative / Final Judgment After Expedited Trial
Outcome
Declarations granted in favour of Accord; Astellas' counterclaim dismissed.
Legal Topics
Marketing Authorisation, Data Exclusivity, Directive 2001/83/ec, Conditional Authorisation, German Medicines Act, Mutual Recognition Procedure, Judicial Review
Pharmaceutical Law European Union Law Administrative Law Marketing Authorisation Data Exclusivity Directive 2001/83/ec Conditional Authorisation German Medicines Act +2 more

Case Brief

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Parties

Accord Healthcare Limited

Claimant

Intas Pharmaceuticals Limited

Claimant

Astellas Pharma GmbH

Defendant

Napp Pharmaceuticals Limited

Defendant

Procedural Posture

Commercial/administrative / Final Judgment After Expedited Trial

Legal Issues

  1. 1 Whether the July 2005 BfArM authorisation for Ribomustin was a marketing authorisation in accordance with Directive 2001/83/EC
  2. 2 Whether conditions imposed by BfArM were permissible under the Directive
  3. 3 Whether the appeal and subsequent settlement affected the status of the authorisation

Ratio Decidendi

The July 2005 BfArM authorisation for Ribomustin was a valid marketing authorisation under Directive 2001/83/EC, granted in accordance with Article 8, and the imposition of post-authorisation conditions was permissible. The subsequent appeal and settlement did not retrospectively invalidate the authorisation for NHL and MM indications. BfArM did not delegate its decision-making power to an expert. Accordingly, Ribomustin is a reference medicinal product for purposes of Article 10 data exclusivity.

Court Disposition

Declarations granted in favour of Accord; Astellas' counterclaim dismissed.

Orders

  • Declarations that the July 2005 BfArM authorisation was a valid marketing authorisation under Directive 2001/83/EC for NHL and MM indications.
  • Dismissal of Astellas' counterclaim for declarations in the opposite sense.