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Case T-303/16: Action brought on 14 June 2016 — Novartis Europharm v Commission
ECLI:EU:UNKNOWN:62016TN0303
62016TN0303
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Official Journal of the European Union
C 296/24
(Case T-303/16)
(2016/C 296/33)
Language of the case: English
Parties
Applicant: Novartis Europharm Ltd (Camberley, United Kingdom) (represented by: C. Schoonderbeek, lawyer)
Defendant: European Commission
Form of order sought
The applicant claims that the Court should:
—annul the Decision by the European Commission of 4 April 2016 (C(2016) 2083(final)); and
—order the European Commission to pay its own costs and those of Novartis.
Pleas in law and main arguments
In support of the action, the applicant relies on two pleas in law.
1.First plea in law, alleging that the Commission’s Decision of 4 April 2016 is unlawful in that it constitutes an infringement of the orphan market exclusivity rights of Novartis for its product TOBI Podhaler pursuant to Article 8(1) of Regulation (EC) No 141/2000 (1) on orphan medicinal products and because the conditions in Article 8(3) of that regulation for granting a derogation from these orphan market exclusivity rights have not been fulfilled.
2.Second plea in law, alleging that the Commission’s Decision of 4 April 2016 has been prepared and adopted in violation of the ‘Duty of Care’ also known as the ‘Principle of Diligence’, specifically because of a failure to take into account all relevant scientific data about the medicinal products concerned, and because of a failure to consult Novartis as an interested party in the scientific assessment.
(1) Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1)