# C_2016038EN.01004001.xml

| 1.2.2016 | EN | Official Journal of the European Union | C 38/40 |
| --- | --- | --- | --- |

1.2.2016

EN

Official Journal of the European Union

C 38/40

---

Appeal brought on 24 November 2015 by Novartis Europharm Ltd against the judgment of the General Court (Second Chamber) delivered on 15 September 2015 in Case T-67/13: Novartis Europharm Ltd v European Commission

(Case C-630/15 P)

(2016/C 038/54)

Language of the case: English

Parties

Parties

Appellant: Novartis Europharm Ltd (represented by: C. Schoonderbeek, avocate)

Appellant:

Other parties to the proceedings: European Commission, Hospira UK Ltd

Other parties to the proceedings:

Form of order sought

Form of order sought

The appellant claims that the Court should:

| — | Set aside the Judgment under appeal in that, by that judgment, the General Court dismissed the action of annulment in case T-67/13, |
| --- | --- |

—

Set aside the Judgment under appeal in that, by that judgment, the General Court dismissed the action of annulment in case T-67/13,

| — | Remit the case back to the General Court, if necessary, and |
| --- | --- |

—

Remit the case back to the General Court, if necessary, and

| — | Order the Commission to pay the costs. |
| --- | --- |

—

Order the Commission to pay the costs.

Pleas in law and main arguments

Pleas in law and main arguments

By its application for annulment in Case T-67/13 Novartis requested the General Court to annul the Commission Implementing Decision C(2012) 8605 final of 19 November 2012 granting a marketing authorisation in accordance with Regulation (EC) No. 726/2004 (1) for the medicinal product for human use ‘Zoledronic acid Hospira — zoledronic acid’ because this decision constitutes a violation of Novartis’ data exclusivity rights for its medicinal product Aclasta pursuant to Article 13(4) of Regulation (EC) No. 2309/93 (2) read in conjunction with Article 14(11) and 89 of Regulation (EC) No. 726/2004 and Article 6(1) of Directive 2001/83/EC (3). By the judgment under appeal the application of annulment was dismissed.

1

2

3

In support of this appeal, the appellant claims that the General Court made an error in law in that it incorrectly interpreted Article 6(1) of Directive 2001/83/EC, which lays down the concept of the global marketing authorisation, and because the General Court failed to provide an adequate statement of reasons in the judgment under appeal.

In this respect the appellant claims first that the judgment under appeal is based on a misunderstanding of the wording and purpose of Article 6(1) of Directive 2001/83/EC and of the legal framework for the authorisation of new therapeutic indications and on the incorrect assumption that the appellant’s interpretation of the Article 6(1) of Directive 2001/83/EC would facilitate manipulation and circumvention of data protection and indefinite extension of data protection for reference medicinal products.

Second, the appellant claims that the General Court’s conclusion that Article 6(1) of Directive 2001/83/EC applies to Aclasta because this medicinal product could have been authorised as variation or extension of the medicinal product Zometa runs counter to the principle of legal certainty and would take away the incentive for pharmaceutical companies to invest in research and development of new treatments and is therefore not in the interest of public health.

It is on the basis of this incorrect interpretation of Article 6(1) of Directive 2001/83 that the General Court failed to recognize that the Commission Implementing Decision constitutes an infringement of Novartis data protection rights for Aclasta under Article 13(4) of Regulation 2309/93, read in conjunction with Article 14(11) and Article 89 of Regulation 726/2004, and that, for this reason, the Commission Implementing Decision had to be annulled.

---

(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

(2)  Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products

2

OJ L 214, p. 1

(3)  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

3

OJ L 311, p. 67

---