R (Napp Pharmaceuticals Ltd) v (1) Secretary of State for Health acting as The Licensing Authority (2) Sandoz Limited

The Claimant, Napp Pharmaceuticals Ltd, brought a claim for judicial review challenging the reliance by the Interested Party, Sandoz, upon data previously provided by Napp under the ‘hybrid abridged’ procedure in Article 10(3) of the Medicinal Code. Napp was first authorised to market a 7-day transdermal patch, called BuTrans®, in the United Kingdom in 2005. Sandoz later produced a new 7-day transdermal buprenorphine patch, Reletrans® – a pain killer used to relieve moderate to severe pain – and obtained marketing authorisations under Article 10(3) in a number of EU Member States in February 2016. It relied, in part, on data Napp had submitted over a decade earlier in support of its own application.

Napp claimed that Article 10(3) did not allow such reliance in circumstances where the first Article 10(3) applicant was not connected to the originator of the original medicinal product. The Defendant (the Medicines and Healthcare Regulatory Authority or ‘MHRA’) and Sandoz resisted the claim on the basis that it was contrary to the language of the Medicinal Code, EU and domestic case-law (in particular the CJEU’s Novartis judgment) and longstanding, consistent regulatory practice.

Mrs Justice Whipple concluded that the “[t]he case against Napp is overwhelming” (at [62]), with its construction of the Medicinal Code leading to “absurdity” (at [45]) facing the “insurmountable obstacle” of the case-law (at [48]), and finding no support either in the express language of the Medicinal Code (at [37]), advisory sources (at [49]) or any other material shown to the Court (at [50]). She emphasised that Article 10(3) conferred a “discretion on the competent authorities of the Member States to decide what data is “appropriate” to support an application” (at [53])

The judgment is a helpful clarification of the Article 10(3) procedure, and ensures that generic producers can rely upon so-called ‘bridging’ data from prior applications without having to conduct repetitive testing.

The full judgment can be read here.

Tom de la Mare QC and Ravi Mehta acted for Sandoz Limited, the Interested Party.