藥品創新與專利保護關聯之探討

Abstract

一般公認依賴專利保護生存程度最甚的產業,非製藥產業與化學產業莫屬,製藥產業的競爭優勢來自創新成果所取得的專利,但從事以研發為主要基礎的製藥產業風險相當大,研發一種新藥大約需要十至十五年,一個化學成分只有四千到萬分之一的機率能夠上市,新藥能夠上市一般的成本是八億美元。所以製藥產業一貫主張,沒有專利保護,根本無法提供研發的原動力,專利保護期對製藥產業而言是絕對必要的獲利回收期。本文先就智財權保護制度加以探討,瞭解專利保護制度存在的意義,接下來將就製藥產業何以倚賴專利保護甚密加以剖析,從新藥研發的成本、上市的困難到競爭的激烈,說明製藥產業極力主張專利保護才有新藥的原因。但專利保護是否導致藥品價格居高不下,一直為各界所關注,本文透過文獻的收集和整理,針對專利保護對藥價的影響以及專利保護對於藥品研發重要性探討,雖然未能得出一明確的結論,但仍對欲瞭解此一議題之讀者提供一清晰的視野。

It is generally agreed that pharmaceutical and chemical industries rely substantially in the provision of patent protection. The pharmaceutical industry achieves its competition advantages by the patenting of innovations. However, there are tremendous risks in the research based pharmaceutical industry. It generally takes ten to fifteen years to successfully develop and launch a new drug, a chemical only has an odd of one in four thousands to ten thousands of being approved and marketed to the market with an average cost of US