2006/857/EC: Commission Decision of 15 June 2005 relating to a proceeding under Article 82 of the EC Treaty and Article 54 of the EEA Agreement (Case COMP/A.37.507/F3 — AstraZeneca) (notified under document number C(2005) 1757)   (Text with EEA relevance)
Date: 2006-11-30
Institutions: European Commission
Subjects: Sweden, United Kingdom, fine, infringement of EU law, intellectual property, pharmaceutical industry, sanction (EU)

L 332/24

EN

Official Journal of the European Union

30.11.2006

COMMISSION

COMMISSION DECISION

of 15 June 2005

relating to a proceeding under Article 82 of the EC Treaty and Article 54 of the EEA Agreement
(Case COMP/A.37.507/F3 — AstraZeneca) (1)

(notified under document number C(2005) 1757)

(Only the English and Swedish texts are authentic)

(Text with EEA relevance)

(2006/857/EC)

On 15 June 2005, the Commission adopted a decision relating to a proceeding under Article 82 of the
EC Treaty and Article 54 of the EEA Agreement. In accordance with the provisions of Article 30 of
Regulation (EC) No 1/2003 (2), the Commission herewith publishes the names of the parties and the
main content of the decision, including any penalties imposed, having regard to the legitimate interest of
undertakings in the protection of their business secrets. A non-confidential version of the full text of the
decision in the authentic languages of the case (English and Swedish) can be found at DG COMP’s
website at http://europa.eu.int/comm/competition/index_en.html

1. SUMMARY OF THE INFRINGEMENTS

Addresses and the nature of the infringements

The decision is addressed to the Swedish company AstraZeneca
AB and the UK company AstraZeneca Plc (hereinafter ‘AZ’) due
to their infringements of Article 82 of the EC Treaty and Article
54 of the EEA Agreement.

which are used for gastro-intestinal acid related diseases (such as
ulcers). AZ’s Losec was the first PPI. More specifically,
the
decision finds that a PPI market can be established at least
from 1993 in Belgium, Denmark, Germany, the Netherlands,
Sweden and the UK and from 1992 in Norway.

States

in seven EEA Contracting

The infringements concern abuses by AZ of government
procedures
aimed at
excluding generic firms and — in the context of the second
infringement — parallel traders from competing against AZ’s
pharmaceutical product Losec. The first abuse involved misuses
of a Council Regulation (3) (hereinafter ‘SPC Regulation’) under
which the basic patent protection for pharmaceutical products
can be extended. The second abuse concerned misuses of
procedures relating to the authorisation of marketing of phar-
maceutical products.

Relevant market and dominance

The relevant market comprises national markets for so-called
proton pump inhibitors (hereinafter ‘PPIs’) sold on prescription

(1) Opinion of the Advisory Committee (OJ C 291, 30.11.2006).
(2) OJ L 1, 4.1.2003, p. 1. Regulation as amended by Regulation (EC)

No 411/2004 (OJ L 68, 6.3.2004, p. 1).

(3) SPCs are granted pursuant to Council Regulation (EEC) No 1768/92
of 18 June 1992 concerning the creation of a supplementary
protection certificate for medicinal products (OJ L 182, 2.7.1992,
p. 1).

The decision finds that AZ held a dominant position on the PPI
market in Belgium, the Netherlands, Sweden (from 1993 until
the end of 2000), Norway (from 1994 until the end of 2000),
Denmark and the UK (from 1993 until the end of 1999) and
Germany (from 1993 until the end of 1997).

The first infringement

The first infringement of Article 82 of the EC Treaty and Article
54 of the EEA Agreement constitutes a single and continuous
abuse and consists of a pattern of misleading representations
made by AZ before patent offices
in Belgium, Denmark,
the Netherlands, Norway and the UK and before
Germany,
national courts in Germany and Norway.

The misleading information was initially provided by AZ in the
context of its applications to several patent offices in June 1993
and December 1994 within the EEA for extra protection for
omeprazole (the active substance in AZ’s product Losec) in the
form of so-called supplementary protection certificates.

30.11.2006

EN

Official Journal of the European Union

L 332/25

The second infringement

The second infringement of Article 82 of the EC Treaty and
the EEA Agreement constitutes a single and
Article 54 of
continuous abuse and consists of AZ’s
the
its market authorisations for Losec capsules in
surrender of
Denmark, Norway and Sweden combined with its withdrawal
from the market of Losec capsules and launch of Losec MUPS
tablets in those three countries.

requests

for

the infringements as serious takes into
The qualification of
account that the abuses in this case present some specific and
novel features regarding the means used and cannot be said to
have been clear-cut ones.

The decision also takes account of the fact that AstraZeneca Plc
is only jointly and severally liable for the infringements with
effect from the merger between Astra AB (currently AstraZeneca
AB) and Zeneca Plc on 6 April 1999.

2. FINES

The decision finds that the nature of the infringements and their
geographic scope are such that
the infringements must be
qualified as serious.

The fine of EUR 60 000 000 is divided as follows. AstraZeneca
AB and AstraZeneca are jointly and severally liable for
EUR 46 000 000 whereas AstraZeneca AB is solely liable for
EUR 14 000 000.