結果如何,讓本文藉由Smithkline Beecham Corp. v. Excel Pharmaceuticals, Inc.(Fed. Cir. 2004)[1]案,來研究憂鬱症治療藥物的均等侵權議題。
圖片來源 : shutterstock、達志影像
案件背景
本案被告Excel學名藥廠因向美國食品藥物管理局 (FDA) 提出了憂鬱症治療藥物Wellbutrin®及Zyban® (成分為安非他酮鹽酸鹽,bupropion hydrochloride) 的學名藥許可之簡易新藥上市程序 (ANDA) ,原告史克貝克曼藥廠於是向美國維吉尼亞州東區 (the Eastern District of Virginia) 聯邦地方法院提出專利侵權訴訟,主張被告Excel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Excel學名藥廠未侵害系爭專利。原告史克貝克曼藥廠不服地方法院的判決,因此提出上訴。
1. A controlled sustained release tablet comprising 25 to 500 mg of bupropion hydrochloride and hydroxypropyl methylcellulose, the amount of hydroxypropyl methylcellulose to one part of bupropion hydrochloride being 0.19 to 1.1 and said tablet having a surface to volume ratio of 3:1 to 25:1 cm.sup.-1 and said tablet having a shelf life of at least one year at 59.degree. to 77.degree. F. and 35 to 60% relative humidity, said tablet releasing between about 20 and 60 percent of bupropion hydrochloride in water in 1 hour, between about 50 and 90 percent in 4 hours and not less than about 75 percent in 8 hours.
14. A controlled sustained release tablet comprising an admixture of 100 mg of bupropion hydrochloride and hydroxypropyl methylcellulose which after oral administration of a single one of said tablets in adult men produces plasma levels of bupropion as free base ranging between the minimum and maximum levels as shown in FIG. 5 over twenty four hours.
18. A sustained release tablet containing a mixture of (a) 100 mg of bupropion hydrochloride and (b) means for releasing between about 25 and 45% of bupropion hydrochloride in one hour, between 60 and 85% in 4 hours and not less then 80% in eight hours in distilled water said means comprising hydroxypropyl methylcellulose.