專利藥立體商標之保護要件

Abstract

我國商標法第一條規定：「為保障商標權及消費者利益，維護市場公平競爭，促進工商企業正常發展，特制定本法。」，保護商標權係為使消費者能識別商品來源，商標權具有無限期保護的特性。在製藥產業，除了藥廠名稱的商標權，另就藥品的外盒包裝，以及藥品本身的大小、顏色及形狀，在滿足具有「識別性」且「不具功能性」的要件下，可獲得立體商標權的保護。依美國法院實務見解，藥品本身的設計不具先天識別性，藥廠須支出更多的廣告費用，使消費者在看見該藥品外觀時，能聯想到是來自某家藥廠，如此，才能取得後天識別性。此外，用藥者遵醫囑服藥的特性，使得藥品有別於一般消費性商品，法院就功能性的涵攝範圍及舉證責任分配的實務見解，影響藥品外觀設計是否受商標權保護甚巨。 醫藥產業中，新藥的研發期間長及研發費用龐大，促使專利藥廠從新藥研發到藥品上市的過程中，無所不用其極的藉由專利權、著作權、營業密秘及商標權，對原廠藥進行層層的保護，獲取其最大利益。專利藥及學名藥間價差極大，專利藥廠在專利20年的專屬排他期間過後，得以立體商標創造藥品無限期的市場生命。美國是新藥研發的主要市場，本文擬就美國專利藥立體商標保護的理論及實務見解進行評析，以利我國以學名藥為主的製藥產業，就藥品立體商標之法律攻防有所借鏡與參考。

The purpose of trademark protection is to enable consumers to identify the source of goods, trademarks have indefinite protection duration. In the pharmaceutical industry, in addition to the trademark of company name, drug packaging, as well as the size, color and shape of the drug acquire the trade dress protection while meeting with the requirements of distinctiveness and non-functionality. According to US court practice, drug design itself does not have inherent distinctiveness, pharmaceutical companies have to spend more on advertising to gain the secondary meaning. Moreover, the characteristics of medication adherence makes drugs different from general consumer goods, courts’ practical insights about the range of functionality and the allocation of burden of proof impact hugely on whether the drug design achieves trade dress protection. The U.S. is the main market of new drug development, this paper intends to analyze and make comments on the US theoretical and practical insights of trade dress protection to facilitate our generics-based pharmaceutical industry to refer to as a legal strategy.