Official Journal of the European Union

C 190/3

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Appeal brought on 23 March 2015 by Teva Pharma BV and Teva Pharmaceuticals Europe BV against the judgment of the General Court (Sixth Chamber) delivered on 22 January 2015 in Case T-140/12: Teva Pharma BV and Teva Pharmaceuticals Europe BV v European Medicines Agency (EMA)

(Case C-138/15 P)

(2015/C 190/03)

Language of the case: English

Parties

Appellants: Teva Pharma BV and Teva Pharmaceuticals Europe BV (represented by: G. Morgan, Solicitor, K. Bacon, Barrister and E.S. Mackenzie, Solicitor)

Other parties to the proceedings: European Medicines Agency, European Commission

Form of order sought

The appellants claim that the Court should:

—Set aside the judgment of the General Court;

—Annul the decision of the EMA, contained in its letter of 24 January 2012, refusing to validate the appellant’s application for a marketing authorization;

—Order the EMA to pay the costs of the Appellants.

Pleas in law and main arguments

In support of the appeal, the appellants advance one ground of appeal, which is that the General Court erred in law in its interpretation of Article 8 of Regulation (EC) No 141/2000 (1). Three distinct errors of law are alleged. First, it is alleged that the General Court misinterpreted Article 8(3) read together with Article 8(1), in that it failed to appreciate that a second similar orphan product authorised under an Article 8(3) derogation cannot attract the reward of market exclusivity that is provided for the first orphan product under Article 8(1).

Second, it erred in concluding that its interpretation of Article 8 does not have the effect of extending the market exclusively attaching to the first product.

Third, the General Court incorrectly described and thus failed properly to address the appellant’s alternative case in respect of the original ground for annulment, which was that even if the second product did in principle benefit from its own period of market exclusivity, that exclusivity should not operate to exclude from the market a generic version of the first product.

The appellant requests that the Court of Justice give final judgment annulling the contested decision.

(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.

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