Judge Rules Three Generic Drug Makers Violated AstraZeneca’s Patent for Prilosec

A federal judge on Friday ruled that three generic drug makers have infringed on AstraZeneca's patent for its ulcer treatment Prilosec and cannot market their own versions of the medication, Dow Jones/Wall Street Journal reports (DeBaise, Dow Jones/Wall Street Journal, 10/14). In a 277-page opinion, Manhattan-based District Judge Barbara Jones ruled that drug makers Andrx, Cheminor and Genpharm violated two of AstraZeneca's Prilosec patents, which AstraZeneca claims are valid until 2007. However, Jones also found that Kudco, an American unit of German drug maker Schwarz Pharma, had not violated AstraZeneca's patents, "[leaving] the door wide open" for that company to produce generic Prilosec, which could be worth $50 million in sales in 2003 (Freudenheim, New York Times, 10/14). Kudco argued in court that it plans to sell omeprazole, the generic version of Prilosec, by coating it with a nonalkaline substance that differs from the coating AstraZeneca uses. But the Dow Jones/Journal reports that it is "far from clear" how soon Kudco might be able to market omeprazole (Dow Jones/Wall Street Journal, 10/14). The Times notes that the FDA has granted Andrx and Genpharm 180-day exclusivity rights to sell generic Prilosec because the two companies were the first to file for permission, which could delay Kudco's rollout of its generic version. A Kudco spokesperson said the drug maker plans to "talk to Andrx, talk to the FDA and talk to Genpharm" in order to "get around" the exclusivity problem (New York Times, 10/14). Andrx officials have announced they plan to appeal the ruling (Hovey, Wall Street Journal, 10/15).