Marketing authorisation - no data exclusivity period for third party bridging data

In a decision that will be good news for producers of generic products in particular, the High Court has confirmed that NAPP Pharmaceuticals’ test data in relation to its authorised analgesic skin patch BuTrans could be used by Sandoz to support its own application for marketing authorisation (MA) for Reletrans, its generic version of BuTrans.

The Medicinal Code (Directive 2001/83), which governs the question of marketing authorisation for medicines, grants innovators a 10-year period of protection for clinical and pre-clinical test data submitted to support their application for authorisation; after this the data can be relied on by others to obtain authorisation for generic products.  The ten-year period may be extended to 11 years in some cases if new therapeutic indications are introduced. However, case law has established that innovators cannot obtain extra periods of data exclusivity for “line extensions” to their original product consisting of variations such as, for example, new dosages, pharmaceutical forms or administration routes.

This recent case raised the question whether test data submitted in support of a variation developed by a third party (in this case NAPP), rather than by the producer of the original product could attract protection. NAPP argued that if it could not then its considerable investment in developing its BuTrans patch would have no protection.

BuTrans and Reletrans are variations on Schering Plough’s original product Temgesic, an opioid analgesic (Buprenorphine), which was first registered by Schering Plough as a tablet that is put under the tongue.  NAPP developed the BuTrans trans-dermic patch and obtained an MA for it under the ‘hybrid-abridged’ procedure, relying on Temgesic as the reference product and submitting ‘bridging data’ in relation to the patch as a new route of administration. This bridging data consisted of 26 clinical trials performed over nine years. Sandoz’s application for an MA for its own product referred to bridging data provided by NAPP for BuTrans and its own bioequivalence studies.

In a strong judgment Mrs Justice Whipple in the High Court firmly rejected NAPP’s argument that it should have protection for its bridging data, commenting that the case against NAPP was ‘overwhelming’. She also refused to refer the point to the Court of Justice of the European Union (CJEU) emphasising that the point was one of policy.  The issue of paramount importance under the Code was to show that a product is safe and effective.  Where bridging data had already been submitted (as here by NAPP) there was no reason to repeat the clinical trials; this would lead to unnecessary repeat testing which would act as a disincentive to the development of generic alternatives.

It is interesting to note that in this particular case NAPP has a patent on its BuTrans patch and is currently engaged in patent infringement proceedings against Sandoz. At the time of writing the patent has been held not infringed in the High Court and a decision from the Court of Appeal is awaited.

Case: R (on the application of NAPP Pharmaceuticals Ltd) v Secretary of State for Health (acting as licensing authority) and Sandoz Ltd [2016] EWHC 1982 (Admin)

If you would like more information or would like to discuss the case, do please contact Charlotte Tillett, Intellectual Property Partner and Head of Life Sciences or Michael Frisby, Dispute Resolution Partner or your usual contact at Stevens & Bolton.

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Charlotte Tillett, Michael Frisby

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