ECJ Decides on Protection for Drug Dose and Formulation Types

The European Court of Justice ("ECJ") ruled on 29 April 2004 that, among other things, innovator pharmaceutical companies will not have the benefit of data exclusivity for new formulations or doses of existing drugs. The decision means that generic drug companies will be able to rely upon the clinical and other data generated by innovator pharmaceutical companies to support authorisation of new formulation types and doses without waiting for the data-exclusivity period (up to 10 years) to expire.

The case involved Novartis' immunosuppressant drug containing the active ingredient cyclosporin.¹ Sandoz Pharmaceuticals (UK) Ltd (now Novartis) had originally formulated the product in a macroemulsion form sold under the name Sandimmun. The product in this macroemulsion formulation type was the first cyclosporin product to receive authorisation in the European Union when it was approved in 1983.