Prilosec Patents Ruling

AstraZeneca PLC 14 October 2002 PRILOSEC PATENTS RULED VALID IN US TRIAL AstraZeneca announced today that following a trial in the Southern District Court of New York, Judge Barbara Jones ruled that two patents ('230 and '505) relating to the formulation of omeprazole, the active ingredient in Prilosec, are valid until 2007. On the matter of infringement in the consolidated proceedings, the judge made the following ruling: Company Patent '230 Patent '505 Andrx infringed infringed Genpharm infringed infringed Cheminor infringed infringed Kudco Not infringed Not infringed The Judge did not render a decision on the '281 patent relating to a process involved in the manufacture of omeprazole. AstraZeneca brought suit under this patent against Andrx only. The trial, which started on December 6, 2001, concluded in June of this year. Sir Tom McKillop, Chief Executive Officer of AstraZeneca, said: 'We are pleased by today's judgment upholding the validity of our formulation patents and the decision that Andrx, Genpharm and Cheminor have infringed the patents. We are reviewing the Judge's ruling with respect to Kudco and are considering the appropriate course of action.' Prilosec, a treatment for acid-related stomach disorders, is AstraZeneca's US brand name for omeprazole. In 2001, Prilosec had sales of $3.7bn in the US. - Ends - Date: 14 October 2002 Media Enquiries: Investor Relations: Rachel Bloom, Tel: + 1 302 886 7858 Jonathan Hunt, Tel: +44 (0) 207 304 5087 Steve Brown, Tel: +44 (0) 207 304 5033 Mina Blair-Robinson, Tel: +44 (0) 207 304 5084 Emily Denney, Tel: +44 (0) 207 304 5034 Ed Seage, Tel: +1 302 886 4065 Chris Major, Tel: +44 (0) 207 304 5028 Jorgen Winroth, Tel: +1 212 581 8720 Staffan Ternby, Tel: +46 (0) 70 557 4300 NOTE TO NEWS EDITORS: The consolidated case in the South District Court of New York involving the four generic manufacturers involved several patents, including those ('505 and' '230) which were the subject of Judge Jones' decision today. Patent '281 involved Andrx alone. The proceedings also involved these further patents: Patent '499 (sulphenamide salt of omeprazole) was declared not infringed in summary dismissal and may be appealed by AstraZeneca. Patents '794 (omeprazole in combination with clarithromycin in the treatment of H.pylori); '305 (combination therapy for H.pylori related disease); and '342 (H.pylori treatment) have all previously been declared invalid in summary proceedings. AstraZeneca may also appeal these decisions as part of the overall appeal process in the case. Patent '431 relates to the substance of omeprazole, which expired in October, 2001, following six months' additional market exclusivity after AstraZeneca complied with the FDA's formal request for information on the use of prescription Prilosec in children. This was originally part of the case but, as the patent has already expired, was not part of the judgment. In 2001, the worldwide sales of AstraZeneca omeprazole brands totalled $5.7bn. In a separate case, it was announced on June 25, that United States District Court Judge Jed Rakoff, of the Southern District of New York, had dismissed with prejudice two federal class action antitrust lawsuits brought by consumers and third-party payors against AstraZeneca. In dismissing the cases, Judge Rakoff concluded that the plaintiffs failed to demonstrate that the Prilosec patent infringement litigation brought by AstraZeneca against 10 generic manufacturers was a 'sham' or an unlawful attempt to prevent generic competitors from entering the market. The manufacturers included the four companies involved in the consolidated trial relating to the infringement of the patents. The third and only other consumer anti-trust case was voluntarily dismissed by plaintiffs following Judge Rakoff's decision. This information is provided by RNS The company news service from the London Stock Exchange

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