袪痰藥物之均等侵權:Adams Respiratory Therapeutics, Inc. v. Perrigo Co.(Fed. Cir. 2010)
郭廷濠╱專利師
當我們由外界吸入空氣之後,呼吸道中的黏液會將一些外來異物包覆,形成痰液。健康的個體,不會產生太多的痰液,因此,多半無須借助外力,即可自行將痰液咳出。然而,嚴重感染症或長期發炎的患者,痰液的量會變多且濃稠,較不易自行將痰液咳出體外,因此,亟需借助袪痰藥物的使用,輔助患者順利將痰液排出體外,以保持呼吸道暢通。Adams藥廠為袪痰藥物Mucinex®之專利權人,其認為培瑞克學名藥廠申請該袪痰藥物之學名藥簡易新藥上市程序,侵害其專利權。因此,Adams藥廠以原告身分向聯邦地方法院提起了該袪痰藥物之侵權訴訟,於本件訴訟中,究竟是被告培瑞克學名藥廠侵害該袪痰藥物之專利權,還是能成功抗辯而被法院認定未侵權?結果如何,讓本文藉由Adams Respiratory Therapeutics, Inc. v. Perrigo Co.(Fed. Cir. 2010)[1]案件,來研究袪痰藥物的均等侵權問題。
圖片來源 : shutterstock、達志影像
案件背景
本案被告培瑞克學名藥廠 (Perrigo Co.) 因為向美國食品藥物管理局 (FDA) 提出了袪痰藥物Mucinex® (成分為癒瘡甘油醚,guaifenesin) 的學名藥許可之簡易新藥上市程序 (ANDA) 。原告Adams藥廠(Adams Respiratory Therapeutics, Inc.) 於是向美國密西根州西區 (the Western District of Michigan) 的聯邦地方法院提出專利侵權訴訟,主張被告培瑞克學名藥廠侵害系爭專利,然而,地方法院經過判決後認定被告培瑞克學名藥廠未侵害系爭專利。原告Adams藥廠不服地方法院的判決,所以提出上訴。
24. A modified release product having two portions, wherein a first portion comprises a first quantity of guaifenesin in an immediate release form which becomes fully bioavailable in the subject's stomach and a second portion comprises a second quantity of guaifenesin in a sustained release form wherein the ratio of said first quantity to said second quantity provides a C.sub.max in a human subject equivalent to the C.sub.max obtained when the first of three doses of a standard immediate release formulation having one third the amount of guaifenesin is dosed every four hours over a 12 hour period and wherein said product also provides therapeutically effective bioavailability for at least twelve hours after a single dose in a human subject according to serum analysis.