在醫藥專利侵權訴訟中,當被告的被控侵權物落入文義範圍中則有「文義侵權」,若被控侵權物未落入文義範圍中,但落入均等範圍,此時就會被認定有「均等侵權」。因此,文義範圍及均等範圍的認定與文義侵權及均等侵權息息相關,就讓我們藉著Cadence Pharmaceuticals Inc. v. Exela Pharm Sci Inc.(Fed. Cir. 2015)案件[1]來了解關於止痛退燒藥物的文義侵權及均等侵權。
案件背景
本案被告Exela學名藥廠因為向食品藥物管理局 (FDA) 提出了Ofirmev ® (成分為乙醯胺酚acetaminophen,或有稱為paracetamol) 的學名藥許可之簡易新藥上市程序 (ANDA) ,原告Cadence藥廠於是向美國德拉瓦州(the District of Delaware)的地方法院提出專利侵權訴訟,主張被告Exela學名藥廠侵害了系爭專利的申請專利範圍,地方法院經過判決後作出被告有均等侵權之判決,被告不服地方法院的判決結果,所以提出上訴。
● '222專利
1. A stable, liquid formulation consisting essentially of acetaminophen dispersed in an aqueous medium containing a buffering agent and at least one member of the group consisting of a free radical scavenger and a radical antagonist.
● '218專利 1. A method for preparing an aqueous solution with an active nature susceptible to oxidation, which is paracetamol, while preserving for a prolonged period, comprising deoxygenation of the solution by bubbling with at least one inert gas and/or placing under vacuum, until the oxygen content is below 2 ppm, and optionally the aforementioned aqueous solution with an active principle is topped with an inert gas atmosphere heavier than air and placed in a closed container in which the prevailing pressure is 65,000 Pa maximum, and the oxygen content of the aqueous solution is below 2 ppm, and optionally the deoxygenation of the solution is completed by addition of an antioxidant.