Pharmaceutical data exclusivity

Bayer Inc. v. The Attorney General of Canada and the Minister of Health (1998), Federal Court of Canada, 84 C.P.R. (3d) 129

This case dealt with the interpretation of the Canadian Food and Drug Regulations, subsection C.08.004.1(1) concerning data exclusivity protection. The Federal Court of Canada ruled that the five-year data protection to originator manufacturers is not triggered if the subsequent manufacturer, generally a generic manufacturer, can establish the safety and effectiveness of its product on the basis of bioequivalence or bioavailability studies without the Minister having to consult the confidential data filed by the innovator.

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)

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.

Case Summary