DRUG NOLVADEX :

The Federal District Court in Boston has ruled that AstraZeneca's US patent covering its leading breast cancer drug Nolvadex® (tamoxifen) is valid and enforceable. In reaching this decision, District Judge Reginald Lindsay and a jury rejected the patent challenge asserted by the generic drug company, Pharmachemie B.V. As a result, the sale of tamoxifen citrate in the United States by Pharmachemie is prohibited until AstraZeneca's patent expires.

"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.