一種新藥之研發過程是漫長的,且須投入大量資金,此外,專利藥之專利期間因上市許可而被縮短,反觀學名藥,無需支出龐大試驗費用,只需提出生體可用率/生物相等性(BA/BE)試驗即可獲得上市許可,一但學名藥上市,將會造成專利藥之藥價下跌,利潤驟減,市場瓜分,故專利藥廠莫不想盡辦法阻止學名藥上市。 我國製藥產業因為規模不及外國廠商,大部分製造之藥品均以學名藥為主,再加上全民健保以總額預算控制藥費支出趨勢下,學名藥漸漸成為我國醫藥品市場重心。 本論文依據Hatch-Waxman法中所涉及新藥研發之試驗免責例外、申請上市之資料專屬、上市審查之專利連結及上市核准所涉及仿單部分議題,進行探討,並就我國因上述各爭議所產生之實際例進行研究,並對我國專利法及藥事法等規範不足之處提出建議,有關引進美國專利連結制度,是否會對我國審查制度造成衝擊,進行通盤評估及討論。 最後,整理各章節所呈現之問題,說明醫藥與智慧財產權保護之衝突,並就我國目前醫藥市場與制度內容提出相關建議及結論。
The development process of a new drug is lengthy and involves a lot of capital. The patent term of patent drug is shortened due to the process of market approval application. In contrast, without spending significantly on drug testing, market approval will be granted for generic drug as long as tests of bioavailability and bioequivalence (BA/BE) are provided. Once generic drug is approved for sale in public market, it is expected to cause price collapse and profit plummeting of patent drug and the market will be carved up. Therefore pharmaceutical companies manufacturing patent drug are striving to prevent generic drugs from launching by all means. Due to the small-scaled size of pharmaceutical industries in Taiwan compared to those in foreign countries, coupled with the trend of setting total budget expenditure in order to control drug expenses under the current national health insurance system, generic drug has gradually become the main core of our pharmaceutical market. In this thesis, the author will focus on the issues under Hatch-Waxman Act, including experimental use exemption, data exclusivity, patent linkage system and copyrightable labeling. The author will also study actual cases arising from above-mentioned issues in Taiwan and provide advices regarding the Patent Act and the Pharmaceutical Affairs Act and relevant regulations. The author will also conduct a comprehensive evaluation and discusses the impact of our drug review system once USA patent linkage system is introduced into our country. Finally, this thesis will review all of the issues presented in every chapter, descript the conflict between medicine system and intellectual property right protection, and make recommendations and conclusions on our current pharmaceutical market and system.