Declaratory relief in bendamustine marketing authorisation case

Accord Healthcare & Anor v Astellas Pharma GmbH & Anor [2015] EWHC 3676 (Ch) is an unusual decision in that it concerns only declaratory relief rather than any claim to damages. Accord sought a declaration that it could rely on an earlier marketing authorisation granted to Astellas in Germany in 2005, in accordance with provisions of the European Medicines Directive, for the purpose of launching its generic bendamustine product. Mr Justice Morgan found in favour of Accord on all of the issues and granted the declaratory relief sought.

We will provide a more detailed review of this interesting case in the February edition of Synapse.

The decision

Progress on the proposed Trade Secrets Directive

The European Council has reached 'provisional' agreement with the European Union Parliament on the proposed trade secrets Directive, which is intended to provide common measures against the unlawful acquisition, use and disclosure of trade secrets in Europe. A European Council press release states that after a 'legal-linguistic' review of the text, the directive will be submitted for confirmation through a vote in the European Parliament next year. After publication of the directive in the Official Journal of the EU and its entry into force, member states will then have a maximum of two years to incorporate the new provisions into domestic law.

Council note and text of the proposed Directive

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