Language of document :

Appeal brought on 1 June 2018 by European Medicines Agency against the judgment of the General Court (Seventh Chamber) delivered on 22 March 2018 in Case T-80/16: Shire Pharmaceuticals Ireland v EMA

(Case C-359/18 P)

Language of the case: English

Parties

Appellant: European Medicines Agency (represented by: S. Marino, A. Spina, S. Drosos, T. Jabłoński, Agents)

Other part to the proceedings: Shire Pharmaceuticals Ireland Ltd,

European Commission

Form of order sought

The appellant claims that the Court should:

grant EMA’s appeal and set aside the judgment of the General Court in Case T-80/16;

reject the application of annulment as unfounded; and

order the applicant at first instance to pay all the costs of these proceedings (including the costs before the General Court).

Pleas in law and main arguments

EMA submits two grounds of appeal.

The first ground of appeal comprises two limbs. Under the first limb of this first ground of appeal, EMA submits that the General Court erred in law when holding, at paragraph 50 of the judgment under appeal, that Article 5(1) of the Orphan Regulation1 should be read separately from Article 5(2). Such interpretation stands in violation of Article 5(1), as it undermines the effectiveness of the provision.

Under the second limb of the first ground of appeal, EMA submits that the General Court erred in law when holding, at paragraph 64 of the judgment under appeal, that the notion of medicinal product should be relied upon by the EMA when it establishes for the purpose of Article 5(1) whether an application for orphan designation and a previously submitted application for marketing authorisation overlap.

Under the second ground of appeal, EMA submits that the General Court relied on an incorrect reading of the notion of medicinal products as set out in Article 1(2) of Directive2 2001/83/EC, insofar as it held that a difference in excipients and routes of administration between two products would render them different for the purpose of Article 5(1) of the Orphan Regulation.

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1 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000, L 18, p. 1)

2 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001, L 311, p. 67)