“An ingenious attempt to exploit a loophole”: High Court rejects generic manufacturer’s JR of marketing authorisation refusal

26 Feb 2018

R (Teva B.V.) v Secretary of State for Health [2018] EWHC 228 (Admin)

Biogen Idec Ltd was an interested party


On 13 February 2018, the High Court (Jay J) dismissed the application of Teva BV (“Teva”) for judicial review of the decision of the UK’s Medicines and Healthcare Products Regulatory Agency (“MHRA”) not to grant Teva a marketing authorisation (“MA”) for its generic version of Tecfidera, a drug used to treat multiple sclerosis.

Teva’s argument that the MHRA was not bound by a conclusion, appearing in a recital to the Commission Decision granting an MA to the reference product, as to the applicable period of data exclusivity for that reference product was found to be “ingenious” ([152]) but ultimately unsuccessful.

The judgment has important implications for pharmaceutical regulation, both now and post-Brexit. The High Court made key rulings about the role of national licensing authorities, including the requirement that they give effect to the package of rights emanating from the grant of a marketing authorisation by the Commission.

Please click here to read the full case note.

Anneli Howard and Anneliese Blackwood were instructed by the Government Legal Department for the Defendant.

The comments made in this case note are wholly personal and do not reflect the views of any other members of Monckton Chambers, its tenants or clients.