# C_2023321EN.01005501.xml

| 11.9.2023 | EN | Official Journal of the European Union | C 321/55 |
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11.9.2023

EN

Official Journal of the European Union

C 321/55

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Action brought on 13 July 2023 — Teva v Commission

(Case T-393/23)

(2023/C 321/61)

Language of the case: English

Parties

Applicant: Teva GmbH (Ulm, Germany) (represented by: Z. West, S. Love and G. Morgan, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

| — | declare the applicant’s request for annulment admissible and well- founded; |
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declare the applicant’s request for annulment admissible and well- founded;

| — | annul the Contested Decision of 2 May 2023 (published on May 2023) amending the marketing authorisation granted by Decision C(2014)601(final) for ‘Tecfidera — Dimethyl fumarate’, a medicinal product for human use, as well as any later decision, to the extent that they perpetuate and/or replace that decision including any follow-up regulatory actions, in so far as they relate to the applicant; |
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annul the Contested Decision of 2 May 2023 (published on May 2023) amending the marketing authorisation granted by Decision C(2014)601(final) for ‘Tecfidera — Dimethyl fumarate’, a medicinal product for human use, as well as any later decision, to the extent that they perpetuate and/or replace that decision including any follow-up regulatory actions, in so far as they relate to the applicant;

| — | order the Commission to pay the costs of the proceedings. |
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order the Commission to pay the costs of the proceedings.

Pleas in law and main arguments

In support of the action, the applicant relies on one plea in law alleging that the European Commission failed to observe the simple time limit for meeting the substantive requirement that is necessary to obtain an extension of market protection as required by Article 14(11) of Regulation (EC) No 726/2004 of the European Parliament and of the Council: (1)

| — | An extension of the marketing protection to eleven years may only be granted if an authorisation for a new therapeutic indication is obtained within the first eight years of the marketing authorisation being granted; |
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An extension of the marketing protection to eleven years may only be granted if an authorisation for a new therapeutic indication is obtained within the first eight years of the marketing authorisation being granted;

| — | Biogen was required to obtain an authorisation for the new indication during the first eight years following the grant of Tecfidera’s marketing authorisation; |
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Biogen was required to obtain an authorisation for the new indication during the first eight years following the grant of Tecfidera’s marketing authorisation;

| — | The marketing authorisation for Tecfidera was granted on 30 January 2014 and took effect on 3 February 2014. However, the Commission decision to grant an authorisation for the new therapeutic indication was not issued until 13 May 2022 (over three months after the end of the initial eight year period); |
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The marketing authorisation for Tecfidera was granted on 30 January 2014 and took effect on 3 February 2014. However, the Commission decision to grant an authorisation for the new therapeutic indication was not issued until 13 May 2022 (over three months after the end of the initial eight year period);

| — | Tecfidera therefore should not be granted an additional year of market exclusivity since Biogen failed to meet the statutory requirements of Article 14(11). |
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Tecfidera therefore should not be granted an additional year of market exclusivity since Biogen failed to meet the statutory requirements of Article 14(11).

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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 (OJ 2004 L 136, p. 1).

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