# C_2011347EN.01001302.xml

| 26.11.2011 | EN | Official Journal of the European Union | C 347/13 |
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26.11.2011

EN

Official Journal of the European Union

C 347/13

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Appeal brought on 19 September 2011 by Sepracor Pharmaceuticals (Ireland) Ltd against the order of the General Court (Fourth Chamber) delivered on 4 July 2011 in Case T-275/09: Sepracor Pharmaceuticals (Ireland) Ltd v European Commission

(Case C-477/11 P)

2011/C 347/20

Language of the case: English

Parties

Parties

Appellant: Sepracor Pharmaceuticals (Ireland) Ltd (represented by: I. Dodds-Smith, Solicitor, D. Anderson QC, J. Stratford, Barrister)

Appellant:

Other party to the proceedings: European Commission

Other party to the proceedings:

Form of order sought

Form of order sought

The applicant asks that:

| — | The order of the General Court be set aside; |
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The order of the General Court be set aside;

| — | Sepracor's action for annulment be declared admissible and the case be determined in Sepracor's favour (on the essential procedural requirement point) and/or referred back to the GC so that it may examine the substance of the action for annulment; |
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Sepracor's action for annulment be declared admissible and the case be determined in Sepracor's favour (on the essential procedural requirement point) and/or referred back to the GC so that it may examine the substance of the action for annulment;

| — | The Commission be ordered to pay Sepracor's costs of the present proceedings and those arising at the first instance relating to the plea of inadmissibility; and |
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The Commission be ordered to pay Sepracor's costs of the present proceedings and those arising at the first instance relating to the plea of inadmissibility; and

| — | The costs be reserved as to the remainder. |
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The costs be reserved as to the remainder.

Pleas in law and main arguments

Pleas in law and main arguments

The Appellant claims that the contested order dismissing the Appellant' action as inadmissible should be set aside on the following two grounds:

| (a) | Contravention of the Appellant's rights to access to justice and an effective remedy |
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(a)

Contravention of the Appellant's rights to access to justice and an effective remedy

| (b) | Infringement of an essential procedural requirement arising out of reliance on third party representations, a plea raised before the General Court but not considered by it. |
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(b)

Infringement of an essential procedural requirement arising out of reliance on third party representations, a plea raised before the General Court but not considered by it.

Infringement of essential procedural requirement

Infringement of essential procedural requirement

The General Court failed even to address Sepracor's submission as to infringement of an essential procedural requirement arising out of the reliance on third party representations. The failure to inform Sepracor of representations which had been received and taken into account until after a decision had been issued resulted in a breach of the right to be heard, which is a fundamental principle of EU law.

Contravention of rights to access to justice and an effective remedy

Contravention of rights to access to justice and an effective remedy

The Appellant submitted in July 2007 an application for a centralised marketing authorisation for its product Lunivia, backed by extensive and expensive research, on the basis that Lunivia was eligible for centralised assessment as a new active substance (‘NAS’) in accordance with Article 3(2)(a) of Regulation (EC) 726/2004 (1). There were at least substantial reasons for contending that the Appellant's product Lunivia was a new active substance (‘NAS’) and it was accepted for assessment centrally on that basis by EMA.

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The contested decision amounted to a final determination by the Commission that Lunivia would not be treated as a NAS (and was thus the functional equivalent of a negative decision on eligibility). That decision had legal consequences, notably the removal of the protection from cross-reference by generic second applicants and from the exploitation of copy authorisations for a total period of 10 years.

In the circumstances, the Appellant had no choice but to withdraw its application. To allow a centralised marketing authorisation to be granted without the protection for its dossier of research that follows from the grant of NAS status would have enabled immediate reliance by generic applicants across the EU on all the valuable pre-clinical and clinical data on the Appellant's dossier. No innovative pharmaceutical company could have contemplated allowing this to happen. The ‘remedies’ of an application for annulment and interim relief would have been ineffective, since they could not have reversed these irrevocable consequences.

The only prospect for a practical and effective remedy (as opposed to a theoretical and illusory one) therefore lies in permitting a challenge to be brought to the contested decision.

In that respect, the Appellant relies, inter alia, upon:

inter alia

| (a) | The right to access to justice and to an effective remedy, protected by the European Convention on Human Rights, Articles 6 and 13 and by Article 47 of the EU Charter of Fundamental Rights |
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(a)

The right to access to justice and to an effective remedy, protected by the European Convention on Human Rights, Articles 6 and 13 and by Article 47 of the EU Charter of Fundamental Rights

| (b) | The requirement that procedural rules governing actions brought before the courts of the Union be interpreted consistently with those principles |
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(b)

The requirement that procedural rules governing actions brought before the courts of the Union be interpreted consistently with those principles

| (c) | The case law of the European Court of Human Rights and of national courts |
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(c)

The case law of the European Court of Human Rights and of national courts

| (d) | Policy considerations relating to the interrelationship of the centralised procedure and national procedures |
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(d)

Policy considerations relating to the interrelationship of the centralised procedure and national procedures

| (e) | The case law of the Court of Justice concerning:






  1. | the separation of powers |
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(e)

The case law of the Court of Justice concerning:

1.

the separation of powers

| 2. | the admissibility of challenges to acts forming the culmination of a special and distinct procedure |
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2.

the admissibility of challenges to acts forming the culmination of a special and distinct procedure

| 3. | the existence of adequate legal protection |
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3.

the existence of adequate legal protection

| 4. | the disclosure of confidential information. |
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4.

the disclosure of confidential information.

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(1)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

1

OJ L 136, p. 1

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