Napp Pharmaceuticals Ltd, R (On the Application Of) v Secretary of State for Health acting as The Licensing Authority

Article 10(3) of the Directive 2001/83/EC permits a later applicant for a hybrid-abridged marketing authorisation to rely on bridging data previously supplied for another product, provided the competent authority considers the evidence appropriate. The provision does not require the later applicant to have commissioned or produced the underlying clinical data. Bridging data supplied under Article 10(3) has no separate protection unless it falls within the limited protection in Article 10(5). The regulatory scheme is a deliberate balance between public health, generic competition, innovation and the avoidance of repetitive testing. Article 10(3) also permits a second-generation application based on data relating to the original and intermediate products, together with bioequivalence data. The authority retains discretion to determine what evidence is appropriate, subject to judicial oversight. There was no lacuna requiring a reference to the CJEU.

Napp challenged the MHRA’s decision to grant Sandoz marketing authorisations for Reletrans, a generic transdermal buprenorphine patch corresponding to Napp’s BuTrans. BuTrans had itself been authorised under Article 10(3), using bridging data relating to Temgesic. Sandoz relied on that bridging data and supplied bioequivalence data demonstrating equivalence between Reletrans and BuTrans.

Napp argued that Article 10(3) prohibited reliance on another applicant’s bridging data, that the Medicinal Code contained a regulatory lacuna, and that a reference under Article 267 TFEU was required. It also raised EU-law and property-rights arguments. The central issue was whether the MHRA lawfully accepted the combination of existing bridging data and new bioequivalence data.

1. The claim was dismissed. Sandoz was entitled to rely on Napp’s bridging data in support of its Article 10(3) application, and no reference to the CJEU was required.
2. Article 10(3) requires appropriate pre-clinical tests or clinical trials but does not specify who must have commissioned or produced them. Where a later product is the same as, or materially identical to, the intermediate product, appropriate evidence may include existing bridging data together with new bioequivalence data.
3. The conclusion was consistent with the scheme and purpose of the Medicinal Code. It avoided repetitive testing, facilitated generic competition and did not undermine the express periods of innovator protection in Article 10(1).
4. Bridging data supplied under Article 10(3) receives no separate protection under the Code unless the limited conditions in Article 10(5) are satisfied. BuTrans did not qualify because it was not a new indication. The absence of further protection was a deliberate policy choice, not a lacuna.
5. The prohibition on a generic of a generic under Article 10(1) and Article 10(2) did not determine the Article 10(3) question. Article 10(3) uses different language and gives the competent authority scope to decide what evidence is appropriate. A second-generation application may therefore rely on data relating to Products A and B, together with bioequivalence data relating Product C to Product B.
6. The principles identified in R (Merck Sharp and Dohme Ltd) v The Licensing Authority were accepted. The identity of the applicant was irrelevant, and the European authorities provided an insurmountable obstacle to Napp’s argument.
7. The separate argument based on R (on the application of Synthon BV) v Licensing Authority of the Department of Health was not decided. The MHRA had recognised the German assessment, and it was unnecessary to determine whether recognition was obligatory or discretionary in circumstances where no public-health risk had been identified.

The remaining grounds were moribund once the Article 10(3) ground failed. The application for judicial review was dismissed.