AstraZeneca begins patent rights lawsuit

AstraZeneca, the Anglo-Swedish pharmaceuticals giant, yesterday began its long-awaited lawsuit against rivals who want to produce cheap copies of its multi-billion pound leading drug.

Losec, a treatment for stomach acid-related disorders such as ulcers, is the world's biggest selling drug, with more than £10m-worth sold every day. It accounts for 40 per cent of AstraZeneca's turnover and analysts predict sales will slide dramatically after the arrival of competition, which is likely to spark a price war.

The patent on its main ingredient, omeprazole, expired in October and AstraZeneca has been accused by rivals of stalling and using bogus patent filings to delay the onset of competition.

The case has been brought by AstraZeneca against four companies, two of which – Andrx and Dr Reddy's – already have regulatory approval to start marketing their versions of omeprazole.

AstraZeneca is arguing their copycat products infringe additional patents on the way it formulates the drug.

Omeprazole is an unstable ingredient and it took AstraZeneca's scientists several years to develop a formulation that is not destroyed inside the body, according to Tom McKillop, the chief executive.

Mr McKillop argued on BBC Radio's Today programme that research and development on new drugs could be harmed if AstraZeneca lost the case. It takes $800m (£563m) to develop a new product, he said, and only one in 10 makes it on to the market.

"These are enormous risks that pharmaceutical manufacturers run. If they don't have a period of exclusivity governed by patents then there will be absolutely no incentive to invest and that will be very bad for the health of people in the years to come."

The hearing, in a New York district court, is expected to run until the end of January, with its outcome set to go to appeal.

Meanwhile, AstraZeneca is attempting to switch users of Losec on to Nexium, a newer version of the drug that remains patent-protected.