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Court of Justice finally settles Tecfidera regulatory data exclusivity dispute

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A medicinal product containing only one of two active substances contained in an earlier product is not part of the global marketing authorisation and is, therefore, entitled to its own data protection period.

The Court of Justice has finally settled a long running dispute concerning regulatory data protection periods between Biogen, and Polpharma, a Polish generic company, in Biogen’s favour.

The Court decided that Biogen’s treatment for multiple sclerosis, Tecfidera, is not part of the global marketing authorisation for Fumaderm, a treatment for psoriasis that had been approved by BfArM in 1994. Polpharma was, therefore, not entitled to use Tecfidera as a reference medicinal product for its generic version of diethyl fumarate (DMF), even though any regulatory data protection for Fumaderm which contains both DMF and monoethyl fumarate (MEF) salts had long ago expired.

The European Commission and the European Medicines Agency supported Biogen in this appeal from a judgment of the General Court which had overturned the original decision of the EMA that Polpharma’s application was invalid as the regulatory data protection period for Tecfidera had not expired. The EMA’s original decision not to validate the Polpharma marketing authorisation application and their reasoning is now restored.

The Court of Justice examined the concept of global marketing authorisation as it is defined in Article 6(1) of Directive 2001/83.  They concluded that Article 6(1) defines exhaustively the subsequent developments of a product –any additional strengths, pharmaceutical forms, administration routes, presentations, variations and extensions- that will belong to the same global marketing authorisation and will, therefore, share the same regulatory data protection period. Substances containing different therapeutic moieties or active substances, such as Tecifidera and Fumaderm do not fall within the definition in Article 6 (1). The Court of Justice found that the General Court had erred in law in asking the EMA to undertake an examination of whether MEF in Fumaderm has any contribution to its therapeutic effects.  The simple fact that Fumaderm and Tecfidera differed in their qualitative compositions was sufficient to conclude that they did not belong to the same global marketing authorisation.

Tecfidera is now confirmed to be protected from generic copying in the EU until at least 2024 (this may be extended to 2025 in light of Biogen’s attempt to seek +1 year exclusivity for a new indication bringing significant clinical benefit in comparison with existing therapies which had been rejected on the basis that Tecfidera was not entitled to an independent period of regulatory exclusivity in light of the  General Court’s decision). 

Following the General Court’s decision, Polpharma’s generic product as well as generics of Tecfidera developed by other generics had been authorised by the EU on the basis of a fresh scientific assessment by the EMA which concluded that DMF was the only active substance exerting a therapeutic effect in Fumaderm. That scientific assessment was stated to be without prejudice to the then pending appeals of the General Court’s decision. Polpharma’s marketing authorisation is still presently listed as being authorised on the EMA website and the EU’s Community Register of Medicinal Products. However in light of the CJEU’s decision it would seem that the decision to authorise Polpharma’s product and that of other generics cannot stand and should be revoked. A separate, interesting issue which would be a first as far as we are aware is whether Biogen will seek damages from Polpharma and other generics and/or EU institutions in respect of sales of the generics that may have taken place during Tecfidera’s regulatory.