General Court annuls additional year of marketing protection for Biogen’s Tecfidera

The General Court concluded that the correct interpretation of Article 14 (11) of Regulation 726/2004 is that:

“only the grant of an authorisation for one or more new therapeutic indications during the first 8 years of the 10 years of combined regulatory data protection and marketing protection for a medicinal product for human use is capable of allowing that period to be extended from 10 to 11 years.”

On the facts of the tortuous regulatory history of Tecfidera, Biogen was notified of the grant of a marketing authorisation for Tecfidera on 3 February 2014, yet the Commission granted an additional one year of marketing protection on 13 May 2022, over three months after the expiry of the first eight years of the marketing authorisation for Tecfidera. The basis of that grant was the Commission’s approval of a new indication for the use of Tecfidera in relapsing remitting multiple sclerosis in patients 10 years and older. The Commission judged this new indication fulfilled the requirement that it brought a significant clinical benefit in addition to existing therapies, leading to the grant of an additional year of market protection pursuant to Article 14 (11).

But Biogen had actually first applied for the additional year extension of marketing protection on 2 June 2021. This Committee for Human Medicinal Products of the European Medicines Agency, which advises the Commission, had adopted an initial opinion on 27 January 2022, recommending that the grant of the additional one year be refused. This followed a judgment of the General Court on an application by a generic company that Tecfidera was not a new active substance and did not benefit from any marketing protection. This judgment was subsequently set aside, however, by the Court of Justice in March 2023.

The General Court has now ruled that the 8 year time limit in Article 14 (11) is strict and that the Commission has no discretion to disapply it. The Court dismissed the Commission’s argument that the appeal procedure, slowly progressing between May 2021 and March 2023, coupled with “the factual complexity” of the case, had some sort of suspensory effect such that the time limit should have been paused during that time.

The General Court has now effectively erased Biogen’s extra year of market protection although the extra year had already expired back in February 2025 and so there have been no regulatory exclusivity hurdles to launch of generic dimethyl fumarate in the EU since then.

The Commission was ordered to pay the costs of the generic companies, including those relating to interim proceedings. It is possible, however, that the Commission and Biogen may appeal before the Court of Justice of the EU. The question of whether the generic companies should be entitled to any damages in respect of their inability to market their products competing with Tecfidera for a year may also generate yet further litigation in this mammoth legal saga.

Footnotes

1. T-256/23 Mylan Ireland v Commission; T-257/23 Neuraxpharm Pharmaceuticals v Commission; T-258/23 Zaklady Farmaceutyczne Polpharma v Commission; T-278/23 Zentiva and Zentiva Pharma v Commission; T-299/23 Hexal v Commission; T-309/23 Aliud Pharma v Commission; T-351/23 Kern Pharma v Commission and T-393/23 Teva v Commission. Full judgment available here: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:62023TJ0393.