The Court of General Instance (formerly (?) the EU’s CFI) has upheld the European Commission’s ruling that AstraZeneca abused its dominant position in the market by practices designed to block or delay generic drugs competing with Losec from entering the market.
The abusive practices were:
- submitting deliberately misleading statements to patent agents, national patent offices and national courts in order to acquire or preserve supplementary protections certificates for omeprazole to which AstraZeneca was not entitled or to which it was entitled for a shorter duration; and
- requesting (and obtaining) the withdrawal of regulatory marketing authorisations for Losec capsules and replacing those marketing authorisations with marketing authorisations for Losec MUPS tablets.
The result of the second practice was to delay entry on to the market of competing generic products as they could not use the abridged marketing approval process.
The Court did reduce, however, the fine from Euros 60 million to Euros 52.5 million.
The case concerned patents for omeprazole, the patent protection for which has generated some controversy in Australia.
Like the EU, Australian law does provide for supplementary protection certificates and there is the potential for abridged marketing approval processes for generics (pdf – e.g). Art. 82 of the Treaty also has some resemblance to s 46 of the TPA and, while we might think that the EU has a fairly idiosyncratic approach to determining market power, the Hoffman-La Roche ruling relied on by the Court of General Instance has been referred to with approval by the High Court in Australia.
Case T?321/05 AstraZeneca AB v Commission
which has been conveniently summarised by Linklaters and Gibson Dunn.
Now, we might think this is an application of the peculiar EU approach to