Jurisdiction(s):
United Kingdom

Related legal acts

Key definition

Generic definition

What does Generic mean? In medicines regulation, a generic is a medicinal product that contains the same active substances and has the same pharmaceutical form as an earlier authorised branded reference medicinal product, and whose bioequivalence to that reference has been shown by appropriate bioavailability studies. The term is defined in EU law (Directive 2001/83/EC, Article 10(2)(b)); Great Britain adopts a materially identical definition in the Human Medicines Regulations 2012, while Northern Ireland and Ireland apply the EU definition. Key legal features include: - The same qualitative and quantitative composition in active substances. - The same pharmaceutical form (immediate‑release oral forms are treated as...

Paroxetine pay‑for‑delay: UK CAT upholds CMA’s findings on object/effect and abuse of dominance; overall penalties reduced after CJEU ruling

Published by a LexisNexis Competition expert

Practice notes

ARCHIVED —this archived case hub sets out the position as at the judgment dated 7 May 2021; it is no longer updated or maintained. See the timeline and related cases for detail and context.

Case facts Outline

Generics UK Limited v CMA (1251/1/12/16), GlaxoSmithKline PLC v CMA (1252/1/12/16), Xellia Pharmaceuticals APS and Alpharma LLC v CMA (1253/1/12/16), Actavis UK Limited v CMA (1254/1/12/16) and Merck KGaA v CMA (1255/1/12/16) – all appeals before the CAT arising from the CMA’s decision of 12 February 2016 in GlaxoSmithKline and others (paroxetine) (CE/9531-11).

Latest development

On 10 May 2021, the CAT handed down a supplementary judgment which affirmed the CMA’s infringement finding, namely that:

Generics (UK) Limited and Alpharma were potential rivals of GlaxoSmithKline PLC at the point they entered the settlement agreements;
the settlement agreements were restrictive of competition by object as well as by effect; and
GlaxoSmithKline PLC had abused its dominant position in relation to the supply of paroxetine.

However, the CAT held that the 10% reduction applied at Step 4 of the calculation of the fine, to reflect proportionality, was insufficient given, in particular, the Novelty of the case and the duration of the investigation. The CAT concluded that...

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Web page updated on 21/05/2026

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