# C_2016136EN.01003701.xml

| 18.4.2016 | EN | Official Journal of the European Union | C 136/37 |
| --- | --- | --- | --- |

18.4.2016

EN

Official Journal of the European Union

C 136/37

---

Action brought on 23 February 2016 — Shire Pharmaceuticals Ireland v EMA

(Case T-80/16)

(2016/C 136/52)

Language of the case: English

Parties

Parties

Applicant: Shire Pharmaceuticals Ireland Ltd (Dublin, Ireland) (represented by: D. Anderson, QC, M. Birdling, Barrister, G. Castle and S. Cowlishaw, Solicitors)

Applicant:

Defendant: European Medicines Agency

Defendant:

Form of order sought

Form of order sought

The applicant claims that the Court should:

| — | annul the decision of the European Medicines Agency dated 15 December 2015 and communicated to the applicant on 18 December 2015 refusing to validate an application pursuant to Regulation (EC) No 141/2000 (1) for designation as an orphan medicinal product; and |
| --- | --- |

—

annul the decision of the European Medicines Agency dated 15 December 2015 and communicated to the applicant on 18 December 2015 refusing to validate an application pursuant to Regulation (EC) No 141/2000 (1) for designation as an orphan medicinal product; and

1

| — | order the defendant to pay the applicant’s costs. |
| --- | --- |

—

order the defendant to pay the applicant’s costs.

Pleas in law and main arguments

Pleas in law and main arguments

In support of the action, the applicant relies on one plea in law, alleging that the contested decision erred in its interpretation and application of Regulation (EC) No 141/2000. The applicant contends that the defendant:

| — | misapplied Article 5 of Regulation (EC) No 141/2000 by failing to appreciate the procedural nature of the validation process; |
| --- | --- |

—

misapplied Article 5 of Regulation (EC) No 141/2000 by failing to appreciate the procedural nature of the validation process;

| — | should not have concluded that the conditions for designation were not (or could not be) established; |
| --- | --- |

—

should not have concluded that the conditions for designation were not (or could not be) established;

| — | erroneously elided the concepts of ‘medicinal product’ and ‘active substance’ contrary to Articles 3 and 5 of Regulation (EC) No 141/2000; |
| --- | --- |

—

erroneously elided the concepts of ‘medicinal product’ and ‘active substance’ contrary to Articles 3 and 5 of Regulation (EC) No 141/2000;

| — | misapplied and erroneously relied upon the communication from the European Commission on Regulation (EC) No 141/2000 (2); |
| --- | --- |

—

misapplied and erroneously relied upon the communication from the European Commission on Regulation (EC) No 141/2000 (2);

2

| — | erroneously placed reliance on the fact that the applicant had previously received protocol assistance pursuant to Article 6 of Regulation (EC) No 141/2000; and |
| --- | --- |

—

erroneously placed reliance on the fact that the applicant had previously received protocol assistance pursuant to Article 6 of Regulation (EC) No 141/2000; and

| — | frustrated the objective of Regulation (EC) No 141/2000 as identified by Article 1 of Regulation (EC) No 141/2000 and its recitals. |
| --- | --- |

—

frustrated the objective of Regulation (EC) No 141/2000 as identified by Article 1 of Regulation (EC) No 141/2000 and its recitals.

---

(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).

1

(2)  Communication (2003/C 178/02) from the Commission on Regulation (EC) No 141/2000 of the European Parliament and of the Council on orphan medicinal products (OJ 2003 C 178, p. 2).

2

---