AstraZeneca, the pharmaceuticals company, faces the eventual loss of more than £500m of sales after the decision yesterday by the European Patent Office to revoke its patent on the blockbuster drug Symbicort.
The EPO issued a final judgment on the dispute, upholding an appeal against the patent by a group of generic drug manufacturers that are keen to launch their own versions of Symbicort.
AstraZeneca said it was disappointed to lose the case, which means it will no longer be able to claim patent protection for Symbicort in any of the European Union's 32 member states. The drug, a powder-based combination therapy used to combat asthma, is one of its best sellers, accounting for 6 per cent of the company's profits, according to analysts at Citibank.
AstraZeneca itself said sales of Symbicort were $1.18bn (£590m) last year, with the EU accounting for $1.02bn of that total. The drug was only launched in the US last year and has yet to take off.
However, while those revenues are now potentially at risk, the generic industry does not have the option of launching cheaper rival products straight away. Symbicort will retain its data exclusivity, which means rivals would have to conduct their own safety trials before launching a product. In practice, this makes it unlikely that any competitor will emerge before 2010.
AstraZeneca also retains the advantage of its patent on the Turbuhaler delivery device used to administer Symbicort, which is valid in the EU until 2019. Rival companies may be able to develop alternatives to this device, but doing so will take time and money.
"Although we are clearly disappointed with today's EPO decision, Symbicort will remain an important part of our growth potential over the next few years in Europe and over the longer term in other major markets," said David Brennan, AstraZeneca's chief executive. "We do not believe the EPO decision will have an immediate impact in the EU or any impact on the US or Japanese patents."
Even so, yesterday's ruling represents a major victory for the generic drugs sector. The ruling is also another blow to Astra-Zeneca, which has endured a difficult a year.Reuse content