NO EXCLUSIVITY FOR BRIDGING DATA UNDER ARTICLE 10(3) OF THE MEDICINES DIRECTIVE: R (Napp Pharmaceuticals v The Secretary of State for Health acting as The Licensing Authority) [2016] EWHC 1982

02 Aug 2016 | by Ronit Kreisberger

Ronit Kreisberger is a leading senior junior who has acted for a number of leading pharmaceutical companies including: Merck, Teva, Roche and Pfizer and is currently acting in the Lundbeck and paroxetine “pay for delay” cases in the UK and Luxembourg.

The Administrative Court has rejected Napp’s claim that bridging data submitted to the MHRA for its analgesic skin patch benefits from a period of data exclusivity under the Article 10(3) hybrid-abridged procedure.

Facts

This is a case about the interpretation of Article 10(3) of the Medicines Directive 2001/83/EC which provides that:

In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided.

George Peretz QC acted for the MHRA.

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