This paper looks at the history, consequences and current situation with respect to marketing a generic omeprazole product in the EU. In 1997, Astra (now AstraZeneca) took the disruptive strategy of limiting or avoiding generics competition, by withdrawing their capsule reference product and replacing it with a tablet product prior to generics registration being approved.
(1997) ‘News about Astra's strategy in the gastrointestinal area’, press release, 29th September, Södertälje, Sweden.
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RansonP. (2003) ‘Data protection in the pharmaceutical industry’Journal of Generic MedicinesVol. 1, No. 1, pp. 48–56.
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Point 8 (a)(iii) of the third paragraph of Art. 4 of Directive 65/65 (the provision at issue) lays down the conditions which must be met by the applicant for marketing authorisation in order that they be exempted from having to provide the results of pharmacological and toxicological tests or of clinical trials — in other words, in order for the abridged procedure to apply. To that end, the applicant must show that:. •The medicinal product for which the marketing authorisation is sought is essentially similar to another medicinal product, namely the reference medicinal product;. •The reference medicinal product has been authorised within the European Community, in accordance with the European Community provisions in force, for at least six or ten years;. •The reference medicinal product is marketed in the member state for which the application is made.
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The full text of the result can be found at http://europa.eu.int/cj/en/content/juris/index.htm. (Click on recent case-law of the Court of Justice and the Court of First Instance, cases after 06/1997, and insert the case number.).
