AstraZeneca Loses Appeal At ECJ

On 6 December 2012, the Court of Justice of the European Union (CJEU) dismissed AstraZeneca ("AZ")'s appeal against the EU General Court's ruling in Case AstraZeneca v Commission, in which it was fined AZ €52.5 million for breaching competition laws.

The case deals with two forms of abusive conduct on the part of AZ. First, AZ made "misleading representations" to - and withheld regulatory information from - the patent offices of certain Member States in order to obtain or maintain supplementary protection certificates (SPCs) for its ulcer treatment drug, Losec, for the purpose of improperly extending patent protection in order to block generic competition. And second, AZ selectively delisted its marketing authorisations of Losec capsules in certain EU countries to replace them with Losec tablets and thus prevent the introduction of generic products via parallel imports.

The CJEU dismissed AZ's arguments and upheld the General Court's ruling that AZ's regulatory strategies in respect of Losec constituted an abuse of dominant position in violation of EU laws.

In essence, the CJEU has confirmed that dominant companies have a "special responsibility" and a duty to behave in a "transparent" way when dealing with regulatory authorities.

Misleading patent authorities

The General Court's 2010 ruling (which largely dismissed AZ's action for annulment of Commission Decision C(2005) 1757) found that AZ had submitted "misleading information" to patent-granting authorities in various EU Member States during the 1990s. AZ had submitted applications to acquire supplementary protection certificates (SPCs) which would increase the life of its patent protection of Losec, the world's best selling ulcer drug at the time.

Each application included the date on which the supplementary patent protection should begin. This date was calculated by AZ according to its interpretation of the applicable EU law which provides that the date should begin on the date of "the first authorisation to place the product on the market". AZ's interpretation of this provision meant that the SPC would begin on a later date, when the market authorisation became effective, rather than when it was granted, thereby giving a longer period of patent exclusivity.

The General Court held that since AZ had not explained this interpretation, it had retained critical information and misled the national patent offices who were likely to assume that the date referred to by AZ was the date when...