Astra maintains that Azupharma's action infringes Astra's formulation patent, which expires in 2007. In addition, Azupharma's action infringes Astra's Supplementary Protection Certificate (SPC)  [1] for the substance patent.

'We will strongly assert our patent rights pertaining to omeprazole. The research and development work behind the product is very extensive and concerns - in addition to the substance - formulations, manufacturing methods and intermediates. As a result of this advanced work, Losec today is protected by a number of different patents,' says Martin Nicklasson, head of AstraZeneca's Gastrointestinal Franchise.

Sales of Losec in Germany amounted to approximately USD 185 M. in 1998, corresponding to approximately 4 per cent of total sales of the product. In Germany, omeprazole is marketed under the brand name Antra MUPS® (MUPS - Multiple Unit Pellet System). Antra MUPS was launched during the fourth quarter of 1998 and has successfully replaced the old capsule formulation. MUPS is a new tablet formulation that offers additional patient benefits.

The substance patent for omeprazole begins expiring in the first countries in 1999. In most countries, Astra has been granted Patent Term Extensions or SPCs. This extended coverage for the substance expires in the USA in 2001, in most European countries in 2002-2004, and in Japan in 2004. The product is also protected by patents directed to formulation, uses, inter-mediates and processes, which expire in most markets between 2005 and 2016.