生物科技的發展，使得一向為科學家們所忽視、甚至鄙視的傳統知識，逐漸受到青睞。研究人員發現利用遺傳資源研發遠較化學物質為經濟，亦不致如化學作用般產生環境污染的問題。是以，研究人員暨相關業者著手探索傳統知識與遺傳資源。研究人員暨相關業者主要來自於已開發國家，而傳統知識則多為開發中或落後國家居民的知識與技術，遺傳資源亦多為生長繁殖於後者所在區域。傳統知識除關乎當地居民 (尤以原住民居多)的權益，遺傳資源更因業者進入大肆採伐而影響環境生態，破壞生物的多樣性。 傳統知識係指特定地區的居民，因著地域、生態環境等客觀因素所衍生的知識，藉由世代傳承而得以延續；並隨著客觀環境的改變而異動。它，不等同於古老、落後或一成不變的知識。傳統知識涵蓋科學技術、人文、藝術等方面，其中，以科學與遺傳資源的利用關係最為密切，其利用結果又以取得專利權益之保護為首要考量。由此可窺知傳統知識與專利制度之關聯。然而，傳統知識必竟不同於西方科學，致使因應西方科學所制定的專利制度未能全然保護傳統知識。 開發中國家試圖就CBD、WTO的TRIPs協定及WIPO等國際性公約 (包括專利制度)，達到保護傳統知識的目的，然而，充其量只得禁止他人申請專利，無從積極行使其權利。一向主張強化智慧財產權保護的己開發國家，如，美國等，卻未曾於前揭公約中支持傳統知識的保護，概因該等國家正係剽竊他國傳統知識的主要國家。 傳統知識並不宜列為專利保護客體，亦難以符合專利要件；況且，縱令賦予其專利權，亦有損於傳統知識的保存。傳統民族仍得藉由專利制度排除他人 (傳統民族以外主人) 利用傳統知識取得專利權；其方法有二：(一)將傳統知識列為不予專利保護之客體；(二)將傳統知識列為先前技術。令審查人員審查專利申請案時，得一併檢索審查其專利要件。此舉亦符合CBD、WTO的TRIPs協定 及WIPO之相關規定暨委員會建議。 單獨立法之必要性由此可見，以單獨立法保護傳統知識，應兼顧下列原則：避免法規的衝突，與專利法的協調，以及與國際公約的協調暨合作。立法內容應確保傳統知識持有者得據其權利禁止他人未經其同意的使用，就他人之侵害行為要求損害賠償；並要求合法之利用者，須將利用傳統知識所衍生之利益與傳統民族分享。進而藉由國際性公約及互惠協定，使各國間相互承認對方的傳統知識。 凡此，在兼採專利制度、國際公約及各國單獨立法規範的情況下，當可予傳統知識週延的保護。

　　　　　Traditional knowledge means knowledge possessed by people within a specific community. Though it is passed down from generation to generation, it does not become antiquated. It may be altered due for masons related to locality as well as the ecological. environment. It may be of a scientific technological or artistic nature, among others. This article concerns itself with scientific technology and the patent system. For decades, traditional knowledge has become increasingly important due to its being free from environmental pollution and its economic value. People who own traditional knowledge are from developing or least developed countries, while those who use traditional knowledge are from developed countries. Scientists from developed countries developed inventions by utilizing traditional knowledge and genetic resources; though they reaped profits from those invention patents, traditional people got none. Moreover, the ecological environment was destroyed, depriving traditional people lost of their genetic resources. Ironically, they might be forced to pay royalties to patentees from developed countries by using the latter's inventions, which were created from their traditional knowledge. Neem tree and turmeric are just two cases among many others. It is time for traditional people to defend their own traditional knowledge. Since 1980, developing as well as least developed countries have been seeking help from international organizations; none of them, however, including CBD, WTO's TRIPs Agreement and WIPO, is willing able to solve the problem independently. But, they may work together to prevent bio-piracy. The prerequisite is that each country, whether developed or developing, shall is to revise its patent system to exclude traditional knowledge from patentable subject matter and adopt traditional knowledge as a prior art. Though the patent system may be an ideal measure to protect innovations, it is a system designed for western science, which may not be appropriate for traditional knowledge. As mentioned, traditional knowledge may be listed as unpatentable subject matter, and as prior art, so that, the authorities may prevent others from obtaining patents by using traditional knowledge without prior informed consent. This would be the only function the patent system may provide for traditional knowledge, so, sui generis, it is necessary for the protection of traditional knowledge. It shall establish affirmative rights for the holder of traditional knowledge: holders may exclude others from using their traditional knowledge and genetic resources without prior informed consent; they may also require the equal sharing of interests, all those consenting and sharing shall be entered into a written contract. The establishment of a new law shall take into account the following considerations: to avoid any conflict with existing laws and coordinate it with the patent system and international conventions.