It is the first time that the Commission has used competition
laws to combat patent abuse, according to reports.
The Commission began an investigation into the Anglo-Swedish
pharmaceutical giant in 1999 after a generic competitor complained
that the firm had breached European competition rules by blocking
or delaying market access for generic versions of Losec, and by
preventing parallel imports of the drug.
Last week the Commission found that AstraZeneca’s actions
constituted serious abuses of its dominant market position, in
breach of European competition rules, and fined the company €60
million (£40 million).
Losec, the pioneer of a new generation of medicines to treat
stomach ulcers and other acid-related diseases, was initially
patented in Europe in 1979, and was at one time the world’s
best-selling prescription medicine.
However, between 1993 and 2000, according to the Commission,
AstraZeneca gave misleading information to several national patent
offices, resulting in the company gaining extended patent
protection for Losec through what are known as supplementary
protection certificates (SPCs).
SPCs are rights relating to medicinal products, and are designed
to last for a maximum of five years. They have to be applied for
separately in each state, and do not come into force until the
patent in a particular product has expired.
The date on which the first EU state granted marketing approval
to the patent is important in calculating the length of time
permitted under any particular SPC and, according to the
Commission, AstraZeneca is guilty of misleading patent offices in
Belgium, Denmark, Germany, the Netherlands, Norway and the UK as to
the date of first approval of the drug.
The Commission also considered allegations that AstraZeneca had
misused rules and procedures applied by national medicines agencies
when issuing market authorisations for medicines.
At the time, generic products could only be marketed, and
parallel importers only obtain import licenses, in national markets
if there was an existing reference market authorisation for the
original corresponding product.
Last week the Commission found that AstraZeneca had selectively
deregistered market authorisations for Losec capsules in Denmark,
Norway and Sweden with the intent of blocking or delaying entry by
generic firms and parallel traders.
“I fully support the need for innovative products to enjoy
strong intellectual property protection so that companies can
recoup their R & D expenditure and be rewarded for their
innovative efforts,” said Competition Commissioner Neelie Kroes.
“However, it is not for a dominant company but for the legislator
to decide which period of protection is adequate.”
“Misleading regulators to gain longer protection acts as a
disincentive to innovate and is a serious infringement of EU
competition rules,” she added.
AstraZeneca is to appeal. According to Sir Tom McKillop, chief
executive of AstraZeneca:
"AstraZeneca has not made misrepresentations
or behaved inappropriately. We believe that a proper evaluation on
appeal of all the facts and legal position will confirm that the
Commission's analysis is fundamentally flawed."
