Delhi Patent Office Turn Down Gefitinib Patent Application

Following pre-grant opposition hearing by Indian drug companies Natco Pharma Ltd. and JM Pharmaceuticals Ltd. made last year, the Delhi Patent Office lately rejected AstraZeneca’s Patent Application No. 841/DEL/1996 for its anticancer drug Gefitinib on the ground of “known prior use.” Both Natco and JM opposed the patent application citing that the drug has been in the public domain before the patent application filed in India. Natco spokesperson and company secretary Adi Narayana said his company filed a pre-grant opposition since the drug was not a new drug under the Patents Act, 1970 and lack inventive step. Gefitinib, worldwide marketed as Iressa, is oral tablet medication approved by the US Food and Drug Administration having three Orange Book listed US Patent Nos. 5,457,105 (genus); 5,616,582 (indication) and 5,770,599 (species). The ‘841 patent is Indian equivalent of the species patent.