Paroxetine investigation: anti-competitive agreements and conduct
| Decision Date | 12 February 2016 |
| Date | 12 February 2016 |
| Subject Matter | CA98 and civil cartels |
| Court | Competition and Markets Authority (EW) |
Case CE-9531/11
Decision of the Competition and
Markets Authority
Paroxetine – Case CE-9531/11
12 February 2016
Case CE-9531/11
© Crown copyright 2016
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Case CE-9531/11
3
Contents
Page
1. INTRODUCTION .................................................................................................. 8
A. The purpose of this document ........................................................................ 8
B. Summary of the Infringing Agreements .......................................................... 9
C. Summary of GSK’s Infringing Conduct ......................................................... 13
D. Summary of the action being taken .............................................................. 14
E. The Annexes to the Decision ........................................................................ 15
2. THE CMA’S INVESTIGATION ........................................................................... 16
A. The origins and scope of the Investigation ................................................... 16
B. Information gathering by the OFT prior to the issue of the SO ..................... 17
C. Issue of the SO and the appointment of a Case Decision Group ................. 18
D. Further information gathering by the OFT and CMA following the
representations on the SO ................................................................................. 20
E. Issue of the First Letter of Facts ................................................................... 20
F. Issue of the SSO .......................................................................................... 21
G. Further information gathering by the CMA following the representations on
the SSO ............................................................................................................. 21
H. Issue of the NGFA Decision ......................................................................... 21
I. Issue of the Draft Penalty Statements .......................................................... 22
J. Further information gathering by the CMA following the representations on
the Draft Penalty Statements ............................................................................. 22
K. Issue of the Second Letter of Facts .............................................................. 22
L. Issue of the Third Letter of Facts .................................................................. 23
3. BACKGROUND INFORMATION AND THE FACTS .......................................... 24
A. The Parties ................................................................................................... 24
B. The product – paroxetine .............................................................................. 29
C. The process and benefits of generic competition ......................................... 37
D. Regulatory framework .................................................................................. 42
E. Background to the Patent Disputes .............................................................. 61
F. Outline of the Agreements between GSK and the Generic Companies ....... 67
G. Developments in the UK supply of paroxetine ............................................ 167
4. MARKET DEFINITION AND DOMINANCE ..................................................... 185
A. Introduction ................................................................................................. 185
B. Legal framework ......................................................................................... 186
C. Overview, approach and key findings ......................................................... 189
D. Market Definition......................................................................................... 194
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