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  • 學位論文

探討醫藥品之改良發明專利與長青專利

Incremental Innovation and Evergreening Patent of pharmaceuticals

指導教授 : 陳文吟
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摘要


醫藥品專利,關乎專利權人、學名藥廠與消費者之權益至深。專利權人憑藉專利制度所賦予之排他性權利,得以獨占技術與市場,以豐富的獲利填補龐大的研發成本;學名藥廠於專利屆期、落入公共領域後,得以製造與銷售與原專利藥同成分、同劑型、同劑量與同療效之學名藥,大幅降低研發成本,而能提供低價醫藥品並使其普及於有需求之大眾;消費者,即病患,同時因專利權人研發新藥之動能,與學名藥廠促使藥品之低價普及,而得著益處。理想狀況下,專利權人、學名藥廠與消費者,三方之權益應取得平衡並相輔相成,惟所謂平衡,實係由其間各方權益之相互消長而形成,故如有任一方過於強勢,將形成矛盾與失衡,而「長青專利」即屬權益失衡的肇因之一。 「長青專利」係以對於原醫藥品發明作細瑣、微小與無價值之修改,雖不符合專利要件,卻仍不當取得專利者;與之相反者係「改良發明專利」,雖同為就原醫藥品發明之修正,卻更新穎、更進步而有價值,符合專利要件而取得專利者。「長青專利」既然無存在之正當性,其專利自當被撤銷,故認定某醫藥品發明專利究屬「長青專利」或「改良發明專利」,關乎專利權人、學名藥廠與消費者間之權益消長與平衡。本文藉由探討「長青專利」與「改良發明專利」之區別與分際,一窺在外國立法例與我國法制下,前揭三方權益之消長與平衡,並試對我國醫藥品專利制度與實務提出建議,盼望能供給眾位先進與同道作為參考。

並列摘要


The protection of pharmaceutical patent is deeply related to the rights and interests of patentees, generic manufacturers, and consumers. The patentees can exclusively occupy, possess, or control the manufacturing technology and pharmaceutical market with the power of patent. Generous profits therefore generated may also surpass the research and development costs. The generic manufacturers can make and sell generic drugs after the original patent comes to expiration. Research and development costs are greatly reduced, so is the market price for the drugs. The customers, in other words, the patients, will benefit both from the new drugs developed by patentees and the generic drugs made by generic manufacturers. Ideally, there will be a balance between patentees, generic manufacturers, and consumers. However, the foresaid balance can be broken by “evergreening patent”.“Evergreening patent” means modifying the original pharmaceutical invention with changes of no significance, and is not qualified for patent protection even though such protection is provided. In contrast, “incremental innovation” means the reinvention of the original one, which is entitled for patent protection. The identification of one patent as evergreening patent or incremental innovation can be a matter of significance to patentees, generic manufacturers, and consumers because it changes the pattern of rights and interests among the three parties. This thesis aims that, by discovering the differences between evergreening patent and incremental innovation and introducing foreign and domestic cases, we may figure out how things have changed and reached their balances between the aforementioned three parties. In the end of this thesis, suggestions on domestic pharmaceutical patent system will be given with the intention to enhance the due protection of pharmaceutical patent.

參考文獻


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1、Apotex, Inc. v. Thompson, 347 F.3d 1335 (Fed. Cir. 2003).

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