醫藥發明之專利個案探討：以我國長青樹藥品專利為例

A Study on Pharmaceutical Patents: Some Observations from Evergreening Patent of Pharmaceutical Sector in Taiwan

李素華(Su-Hua Lee)

《臺大法學論叢》 41卷2期 (2012/06) Pp. 647-723

https://doi.org/10.6199/NTULJ.2012.41.02.04

摘要

專利法賦予發明人於一定期間享有排他性權利，其乃鼓勵醫藥研發之重要制度。相較於其他產業，醫藥領域之研發成本高及風險大，法律制度上應使醫藥業者之研究成果獲得足夠保護及享有研發誘因。相對的，醫藥發明若受到過廣的智慧財產保護，不僅不利於學名藥廠參與競爭，亦對公共衛生政策之落實有不利影響。近年來，醫藥專利權行使而阻礙學名藥上市及醫藥領域之「長青樹專利」問題，在國際間引起關注與討論，醫藥業者不當利用專利策略之現象，亦已在我國浮現。本文以我國准予之活性代謝物、組合藥品及藥品併用醫藥組成物等專利個案為例，探討醫藥發明之可專利性標準及其權利行使問題。

關鍵字

醫藥發明 ； 醫藥專利 ； 代謝物 ； 組合藥品 ； 藥品併用 ； 學名藥 ； 專利權 ； 公共衛生 ； 可專利性

並列摘要

Patent law plays a decisive role in stimulating the development of new medical products by offering an exclusive right as incentive for investing in expensive and long-term research. Without patents, existing medical products would not have been invented, and innovative and better medical products needed to overcome the diseases would not be developed. However, the tendency of patent protection expansion and the inadequate enforcement of patent rights in the pharmaceutical fields seem to impede the access of medicine and adversely affect the implementation of public health. Also the issues over patent-related barriers to market entry for generic medicines and ”evergreening patents” in pharmaceutical industry have aroused strong opinions from the public in recent years. It is noteworthy that the inappropriate development and implementation of pharmaceutical patent strategy occur in Taiwan too. This article reviews the patentability of pharmaceutical inventions and enforcement of patent rights from Taiwan Jurisprudence, using the active metabolite, combination preparation and compositions of combination therapies as examples.

並列關鍵字

pharmaceutical invention ； pharmaceutical patent ； metabolite ； combination preparation ； combination therapy ； generic medicine ； patent right ； public health ； patentability

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