Accord Healthcare Ltd v Astellas Pharma GmbH [2015] EWHC 3676 (Ch)
This case concerned the correct interpretation of Articles 6, 8 and 10 of Directive 2001/83/EC on medicinal products for human use (the “Directive”).
Accord applied for marketing authorisations in a number of Member States for a generic version of bendamustine, an anti-tumour drug. It sought to take advantage of the Article 10 exemption from the requirement to file results of pre-clinical tests and clinical trials by relying upon an earlier marketing authorisation for bendamustine, the “Ribomustin MA”. Astellas was the holder of the Ribomustin MA, which had been granted in 2005. Astellas challenged Accord’s marketing authorisations on the basis that the Ribomustin MA was not an MA within the meaning of the Directive because it had been granted subject to post-authorisation conditions and pursuant to a German transitional procedure, designed to speed up the process with which East German products were granted marketing authorisations upon reunification.
To avoid any challenge to its application for a UK marketing authorisation, Accord applied for a declaration from the Court that the Ribomustin MA had been granted in accordance with the Directive and that Ribmoustin could be relied upon as a reference product under Article 10.
Morgan J granted the declaratory relief sought by Accord. He found that the competent authorities were able to grant marketing authorisations subject to post-authorisation conditions and that the Ribomustin MA had been granted in accordance with Article 8 Directive. He further held that, under German law, the effect of a settlement agreement reached between Astellas and the competent authority in 2011, was not such as to render the Ribomustin MA void ab initio.
Iain Purvis QC and Kathryn Pickard appeared for Accord.