Orion Corporation v The Secretary of State for Health and Social Care & Anor

A court in one Member State may review the calculation of the data-exclusivity period for a reference medicinal product, but may not review whether the initial marketing authorisation granted by another Member State complied with EU law. Any challenge to that initial authorisation must be brought in the courts of the granting Member State, subject to its procedural rules and time limits.

Pre-accession marketing authorisations granted by the Czech authorities were treated on accession as compliant with EU law because the Act of Accession contained no derogation affecting them. The court therefore could not investigate the alleged defects in the Czech authorisation and dismissed the judicial review claim.

Orion held the marketing authorisation for Dexdor, a medicinal product containing dexmedetomidine hydrochloride. Ever applied for a UK marketing authorisation for a generic product, relying on Dexdor and on an earlier Czech marketing authorisation for Precedex as part of a single global marketing authorisation.

The defendant accepted that the relevant data-exclusivity period began when the Czech Republic acceded to the European Union. Orion challenged the UK authorisation, arguing that the Czech authorisation had not complied with EU law and could not lawfully be used as the initial authorisation. The central questions were whether this court could review that foreign authorisation and whether a reference to the Court of Justice under Article 267 TFEU was required.

1. Claim dismissed. The court had no jurisdiction to review whether the Czech marketing authorisation for Precedex had been granted in accordance with Directive 2001/83/EC.
2. The ruling in Astellas Pharma v Helm AG EU:C:2018:181 permitted the holder of a reference-product authorisation to challenge the calculation of the data-exclusivity period. It did not permit that holder to challenge, in another Member State, the compatibility with EU law of the initial authorisation granted by the competent authorities of the first Member State. Such a challenge had to be brought in the courts of that Member State, under its national procedural rules and any applicable time limits.
3. The restriction applied despite the fact that the Czech authorisation had been granted before accession. Under the Treaty and Act of Accession, EU law became binding on the Czech Republic on accession. Unlike the provisions concerning certain Polish and Lithuanian authorisations, there was no derogation restricting the validity or use of Czech authorisations granted before accession. Those authorisations were therefore to be treated from accession as authorisations for the purposes of Article 6 of the Directive.
4. Generics (UK) Ltd v Licensing Authority EU:C:2009:379 concerned a materially different situation. There, the reference product had never been authorised in accordance with EU law or equivalent Community legislation. It did not justify reopening the Czech authorisation in the present case. Commission v Lithuania EU:C:2010:642 was also distinguishable because Lithuania was subject to specific transitional provisions.
5. The court could resolve the meaning and scope of Astellas Pharma v Helm AG with complete confidence. No reference to the Court of Justice was therefore appropriate. The court did not need to determine the factual allegations concerning the Czech application or authorisation.

First-instance judicial review proceedings. The judgment itself does not state any prior appellate decision in this litigation.