Judicial review of marketing authorisation refused

April 2019

In R (Orion) v Secretary of State for Health and Social Care and another [2019] EWHC 689 (Admin), the UK's Administrative Court refused a claim for judicial review of a decision by the UK competent authority, the MHRA, to grant a marketing authorisation to a generic applicant.

In doing so, the Administrative Court followed the decision in Astellas Pharma GmbH1 in holding that the courts of one Member State – in this case, the UK – do not have jurisdiction to decide whether a marketing authorisation granted by the competent authority in another Member State is compatible with European Union (EU) law.

The background to the decision

On 19 October 2017, the MHRA granted a marketing authorisation (MA) to the interested party, EVER Neuro Pharma GmbH (EVER), for a generic medicinal product, DexEP, containing the active substance dexmedetomidine hydrochloride (DH).

The MHRA granted the DexEP MA having referred to pre-clinical tests and clinical trials submitted in relation to an existing medicinal product, Dexdor. The MHRA accepted that DexEP was the generic form of Dexdor and was therefore entitled to rely on Dexdor test results pursuant to Article 10(1) Directive 2001/83/EC (the Directive).

A further question related to whether the Dexdor test results were protected by data exclusivity. The Dexdor MA had only been granted in 2011. If data exclusivity applied, the MHRA would have acted unlawfully in referring to the Dexdor test results in granting the DexEP MA.

The MHRA concluded that Dexdor's data exclusivity had expired. An earlier DH product, Precedex, had been granted a MA in the Czech Republic in 2002. This Czech MA became an EU MA on 1 May 2004 (when the Czech Republic joined the EU).

The 1 May 2004 was therefore the date of the initial MA for the medicinal product DH within the EU. The Precedex MA formed a global marketing authorisation for DH with the later Dexdor MA pursuant to Article 6(1) Directive. Crucially, this meant the data exclusivity period, for both Precedex and Dexdor, had started on 1 May 2004 and had expired before the DexEP MA application.

The judicial review

The Claimant, Orion Corporation (Orion), sought judicial review of the MHRA's decision to grant the DexEP MA on the basis that the MHRA had not been entitled to refer to the Dexdor test data.

Orion argued that the Precedex MA had not complied with the requirements of EU law and could not form part of a global marketing authorisation with the Dexdor MA. As such, the data exclusivity period for the Dexdor test results should have commenced when the Dexdor MA was granted in 2011 and had not expired.

To support its position, Orion had to argue that the Administrative Court was entitled to determine whether the Czech Precedex MA had been compatible with EU law. This appeared inconsistent with the CJEU's prior ruling in Astellas that a domestic court was not entitled to determine whether a MA granted in another Member State was compatible with EU law. Orion sought to distinguish Astellas and invited the Administrative Court to refer questions to the CJEU to ascertain whether Astellas applied.

The MHRA and EVER contended that the Administrative Court was precluded by Astellas from reviewing the compatibility of the Czech Precedex MA with EU law and that no reference to the CJEU was required because the matter was clear.

What was decided?

The Administrative Court held that the Astellas judgment clearly precluded the holder of a MA from challenging in the courts of one Member State the compatibility with EU law of MAs granted by the competent authorities in another Member State. It was held that any such challenge must be made in the courts of that other Member State in accordance with relevant national procedure (including any applicable time limits).

Furthermore, the Administrative Court held that any issue as to the meaning and scope of the decision in Astellas could be resolved with complete confidence and no reference to the CJEU for a preliminary ruling was appropriate.

Finally, it was noted that the Administrative Court in Uppsala, Sweden, and the District Court of Central Netherlands had reached the same conclusions, for essentially the same reason, in equivalent proceedings in those two Member States.

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Angus Milne

Angus Milne

Angus is an associate in our London office, specialising in patents law.

"...the Astellas judgment clearly precluded the holder of a MA from challenging in the courts of one Member State the compatibility with EU law of MAs granted by the competent authorities in another Member State."