ASTRAZENECA RETAINS US PATENT RIGHTS TO WORLD'S LEADING BREAST CANCER DRUG--NOLVADEX®

"AstraZeneca is pleased that its patent rights have been supported by the Judge and a jury of American citizens and Pharmachemie's baseless allegations rejected at the end of this long proceeding," stated C G Johansson, Chief Executive Officer, AstraZeneca US and Executive Vice President, AstraZeneca PLC.

AstraZeneca subsidiary Zeneca Limited ("Zeneca") began patent infringement proceedings against Pharmachemie following Pharmachemie's filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration to seek to allow it to commercialise a generic version of the life-saving drug, Nolvadex, prior to its patent expiration in August 2002. After several weeks of trial in Boston, the Judge rejected Pharmachemie's claims of inequitable conduct and the jury rejected its claims of alleged technical violations of the patent law. In earlier decisions in this case, the Court similarly rejected as without merit other defenses raised by Pharmachemie in response to Zeneca's claims of infringement.

Although this Decision is subject to any appeal by Pharmachemie, AstraZeneca would vigorously resist any such appeal, not least in view of the exhaustive and thorough review of the issues undertaken by the Court and AstraZeneca would be confident that any Pharmachemie appeal should be unsuccessful.

A similar proceeding against Mylan Laboratories was pending in the Federal District Court in Pittsburgh, but was suspended pending the resolution of the Pharmachemie case. AstraZeneca believes that it should be successful in the Mylan case (if Mylan chooses to re-open that case) on the same grounds upon which it has prevailed in the Pharmachemie case.

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