AstraZeneca accused of patent abuse
EC says AstraZeneca got patent extensions on false pretences |
AstraZeneca has been accused by the European Commission of misusing European government procedures to delay the introduction of generic competition to Losec (omeprazole).
The commission says that AstraZeneca sought extensions to its patents
for Losec that it was not entitled to. Supplementary protection certificates
(SPCs) can be granted by patent offices to extend patent lives by up
to five years to take into account the prolonged development time for
pharmaceuticals between filing a patent and gaining marketing authorisation.
Such SPCs are only available for products marketed in Europe after certain
cut-off dates. The EC says that AstraZeneca deliberately misrepresented
the first date of authorisation for Losec to gain extra protection.
Additionally, the EC says that requests to deregister marketing authorisations
for the original capsule form of Losec when a tablet formulation was
launched were intended to stop generic manufacturers and parallel importers
obtaining licences since, in principle, these are only granted in relation
to an existing authorisations.
The EC’s statement of objections marks the opening of a formal
investigation. The company will be able to make its defence in writing
or at oral hearings.
In a statement issued on 31 July, AstraZeneca said it would vigorously
refute any alleged wrongdoing. |
