筆者將以三篇系列文章詳細介紹胃酸抑制藥物化學構造的顯而易見性,本文為第一篇:Yamanouchi Pharm. Co. v. Danbury Pharmacal,Inc. (Fed. Cir. 2000)[2]。
圖片來源 : shutterstock、達志影像
案件背景
本案被告Danbury學名藥廠因為向美國食品藥物管理局 (FDA) 提出了胃酸抑制藥物Pepcid® (成分為法莫替丁,famotidine) 的學名藥許可之簡易新藥上市程序 (ANDA) 。原告山之內製藥株式會社(Yamanouchi Pharm. Co.) 藥廠於是向美國紐約南區 (the Southern District of New York) 聯邦地方法院提出專利侵權訴訟,主張被告Danbury學名藥廠侵害了系爭專利的申請專利範圍第4項,Danbury學名藥廠則主張原告山之內製藥株式會社藥廠的系爭專利申請專利範圍因顯而易見性而無效,地方法院經過判決後認定系爭專利申請專利範圍有效,且被告Danbury學名藥廠侵權。被告Danbury學名藥廠不服地方法院的判決,所以提出上訴。
1. Guanidinothiazole compounds of the formula (圖1) wherein R represents a hydrogen atom or a lower alkyl group, R1 represents an amino group, a lower alkyl group, a halogeno lower alkyl group, a phenyl or naphthyl group which is unsubstituted or substituted by halogen, hydroxyl, amino, or alkoxy, a mono- or di-lower alkylamino group, an arylamino group or an aralkylamino group, R2 represents a hydrogen atom, a lower alkyl group, a lower alkenyl group or a lower alkynyl group, Y represents a sulfur atom or a methylene group, m and n, each represents an integer of 1-3, and the pharmacologically acceptable acid addition salts thereof.
4. The compound as claimed in claim 1 which is N - sulfamoyl – 3 - [ (2 – guanidinothiazol – 4 - yl) methylthio] propionamidine.