Generics (UK) limited, The Wellcome Foundation Limited and Glaxo Operations UK limited and Others, 3 December 1998 (Court of Justice of the European Union Case C-368/96)

Case Description

This case concerned the protection of pharmaceutical test data under European Union (EU) legislation. The Court of Justice of the European Union (CJEU) interpreted EU law as authorizing generic producers to rely on the test data submitted by an originator firm once the original product has been in the market for at least six or ten years (depending on national law), as long as the generic product is essentially similar to the original product. Such abridged approvals may even include generic versions of indications or dosages of the original products that have been in the market for less than six or ten years.

Decision Year
Case Summary