Zeneca's US patent for Nolvadex (tamoxifen citrate), the most-commonly prescribed drug for the treatment of breast cancer, is valid and enforceable, the US Maryland District Court has ruled. As a result, sale of tamoxifen by Canadian generics firm Novopharm would be prohibited because this would be infringement of the patent. Patent proceedings against Novopharm were started by Zeneca in January 1995, after the Canadian firm filed for US approval of its generic product.
Novopharm will have the opportunity to go to the Court of Appeals for the Federal Circuit, but Zeneca Pharmaceutical president Robert Black contends: "we remain confident that Zeneca's patent.....will continue to be upheld until it expires in August 2002." Zeneca has also received separate patent challenges from Mylan, Pharmachemie BV and Lemmon Ltd.
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