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  • 學位論文

論藥品及植物品種專利於雙邊投資協定的保護

A Discussion of Patent Protection of Pharmaceutical Drugs and Plant Varieties under a Bilateral Investment Treaty

指導教授 : 羅昌發

摘要


『大部分的「雙邊投資協定」是由已發展國家與發展中國家簽訂的,歐洲國家及亞洲國家簽訂的這類協定最多。然而有四分之一的雙邊投資協定現在是由發展中國家它們之間所簽訂的。 實質上,這些協議對兩國間之投資的進入(entry)、保護及退場(exit)建立了規則 ─ 而且在這些協定理所定義的「投資」特定包含了智慧財產。協定當事國是被期待於將他們的邊界對外人投資(foreign investments)開放,並且在「國民待遇」及「最惠國」原則的頌詞之下,於他們內國領土裡提供給對方「最高國際標準」的智慧財產權保護 …. 這看起來令人驚恐因為協定裡的條款是不緊密且沒有止盡(open-ended)。 誰的法律或標準是被拿來引用或是被指定來應用是不明確的。連這些雙邊投資協定是包含已設立的投資(established investments)還是可能的投資(potential investments)也不明確。至於智慧財產方面,天空似乎是保護智慧財產的標準限定。』 GRAIN非政府組織 所指出的智慧財產權保護之標準不僅是一個令人關切的論點,而且已發展國家要求開發中地主國於數個雙邊投資協定(之後稱為「BITs」)裡間接地加速後者對於與貿易有關的智慧財產保護協定(之後稱為「TRIPS 協定」)裡所定之標準的遵守也值得注意。這些主題強調了一些問題:因為BIT談判的步態以及張力(tension)則由具有強大的協定交涉權力之國家 來控制的,而且每一位協定當事國於談判過程中各自主張鞏固內國國家發展以及促進經濟進步,所以一些問題不僅在雙邊投資協定談判中顯現出來,並且也在談判過程的真正結果中顯露出來。況且,根據雙邊投資協定之當事國的極不平衡的協定交涉權力,給予內國市場的智慧財產權保護之標準的選擇,在某個程度上,則受到影響。 雖然雙邊投資協定的性質是屬於雙邊的,而且可以確定的是給予智慧財產權保護之「最高國際標準」措辭是根據協定當事國的意向而容納的,然而這措辭的適用卻可被視為含糊的。它是因為這措辭可能是指TRIPS 協定或是已開發中國家所期待的智慧財產權保護的標準。其次,這措辭也指出一些暗示;這些暗示中的其中之一表示,於最惠國待遇原則之下,開發中國家(地主國)通常要提供給外國投資人與其母國(home country) 所保護的智慧財產權制度一樣的保護程度。雖然這雙邊投資協定是根據雙方當事國的意願而制訂的,但是這雙邊投資協定之形成所要給予他人何種意味是令人質疑的。 除了雙邊投資協定所提及的「最高國際標準」 之外,發展中國家與已開發中國家所簽訂的其他雙邊投資協定中也考量到植物培育家權利為開發中國家之新進投資 、加入植物新品種保護國際公約 、可專利的發明物(還沒在其他地方有正式法定保護的產品或方法) 、以及在過渡性期間完畢之前過早地且完全地實施TRIPS 協定 。 這些條款本身對發展中國家的國民健康以及幫助供給生命的農夫,可會造成傷害。換句話說,雖然實施其他與智慧財產有關之權利的高標準保護也雪|產生不好的結果,但是人類性命之保存是依賴著必要的藥品以及植物 - 所以實施藥品與植物之專利的策略則需要小心地策劃,特別是針對窮困的開發中國家與未開發國家。然而,在對外國投資人的智慧財產型投資的加強保護時,如何讓每個不同經濟程度之國家的國民都能夠從中獲益,更是非常複雜。 除了那些方面之外,在雙邊投資協定裡提及的最惠國待遇以及國民待遇原則,意味著每個玩家(雙邊投資協定之協定當事國以及非協定當事國)需要針對與藥品與植物專利有關的爭點,進而在損失代價與利益津貼(costs and benefits)尋求平衡。 現在世界國貿易組織裡已有一百四十七個會員 。因為他們是WTO的會員,他們則必須遵守TRIPS 協定裡所提供的最低標準要求的規定。實際上,TRIPS 協定要求那些會員國實施不能低於TRIPS標準的智慧財產權保護措施。如果雙邊投資協定之協定當事國也是WTO會員,把雙邊投資協定裡的智慧財產權保護標準提到比TRIPS 協定還高的話,可能會產生是要遵守TRIPS協定還是遵守雙邊投資協定之規定的一個必要性問題。因此,這論文試著回答前幾段所提及的,或雙邊投資協定之協定當事國可能會面臨的爭點。探究下面幾個問題應該能回答這些論點: 1. 特別地在雙邊投資協定裡保護智慧財產的何種理由? 2. 簽訂雙邊投資協定可否解決智慧財產型投資所產生的問題(特別是在專利上)? 有智慧財產權條款的雙邊協定是否能幫忙解決例如健康保護與農夫全力之保護的問題? 3. 雙邊投資協定裡是否應該有智慧財產權保護的條款? 這類條款是否應該被分的更細,例如:對藥品及植物品種專利保護而加入的排除措辭(exclusion phrase)? 4. TRIPS 協定是否可以解決運用智慧財產型投資所產生的問題? 5. TRIPS 協定是否能對專利之保護達到平衡? 6. 最後,是否可能在TRIPS 協定裡容納一些與投資有關的專利爭點的條款?

並列摘要


“Most [bilateral investment treaties] are between developed and developing countries, with Europe and Asia having signed the largest share. But a full quarter are now brokered between developing countries themselves. In essence, these deals set up rules for the entry, protection and exit of investments between two countries – and ‘investment’ in these treaties specifically includes intellectual property. Parties are expected to open their borders to foreign investments, provide the ‘highest international standards’ of [IPRs] protection for them in their domestic territories under the mantra of ‘national treatment’ and ‘Most Favoured Nation’(MFN) principles …. This is frightening in and of itself because the terms of the treaties are imprecise and open-ended. It’s not clear whose law or whose standards are being referred to or are meant to apply. It’s not even clear whether these BITs cover established investments or potential investments. With respect to intellectual property, the sky seems to be the limit.” Not only the standard of IPRs protection as pinpointed by the GRAIN in cooperation with the South Asia Network for Food, Ecology and Culture (SANFEC) is a concerned issue, but also the fact that the developed country required the host developing countries to indirectly accelerate their compliance with the standard provided by the Agreement on Trade-Related Aspects of Intellectual Property Rights (thereafter is called, “the TRIPS Agreement “) in a number of bilateral investment treaties (thereafter is called “BITs”) deserves attention. These subjects highlight the problems that are not only revealed in the negotiation of a BIT during which a country of the strong bargaining power controls the pace and tension, but they are also shown in the very results of the negotiation process in which each contracting party persists to consolidate their national developments and promote economic progression. Based on the very imbalanced bargaining powers of both contracting parties to a BIT, the power to choose the standard of IPRs protection for its domestic markets, to a certain extent, is influenced. Although the nature of a BIT is bilateral and it is certain that the inclusion of the phrase “highest international standards” of the IPRs protection is subject to the intention of the contracting parties, the application of the phrase may be vague. It is because the phrase may refer the TRIPS Agreement or the standard as expected by the developed countries. In addition, there are some implications underlied by such a phrase, and one of the implications indicates that under the most-favoured nation treatment clause, the host developing country is usually supposed to provide the same level of protection for the investor’s IPRs as the investor would enjoy in his home country. Although that implication indicates certain expectation of a technologically-advanced and wealthy home country and the conclusion of a BIT is subject to the intentions of both parties there are doubts on what the phenomena of this type of BIT (a number of them are patterned on a similar model text) tends to imply. In spite of the reference to the “highest international standards” in the BIT, the references specifically to plant breeders’ rights as incoming investments to a developing country, accession to the International Convention for the Protection of New Varieties of Plants (thereafter is called “the UPOV”), patentable inventions (products or processes that are not under formal legal protection anywhere yet) and implement the TRIPS Agreement in full far earlier then the end of the transition period have also been considered under the BITs concluded by the developing and developed countries. On the face of the BITs, it seems that there is nothing wrong with the incorporation of those provisions, taking into consideration the need to stimulate creative process for future technological and innovative developments. Nevertheless, after one perceives deeply the potential harms that may cause to the nationals of the developing countries with respect to their wellbeing in health and to farmers who assist in giving life, then the aforesaid references become problematic. In other words, although the extent of application of these references is not limited to patent protection and there may be the generation of adverse consequences from implementing the higher standard of protection of other IP-related rights, human life relies mostly on two main ingredients, essential medicines and plants - and therefore the strategies in patenting drugs and plants are in need of thorough planned, especially in poor developing countries and least-developed countries. However, with the increasing protection on the foreign investors for their IP model of investments, the situations on how the nationals of developed countries, developing countries and least-developed countries can respectively benefit from such ways of incorporation of the IPRs provisions in the BITs and respectively benefit from the BITs as a whole, become even more complicated. In addition to those aspects, the references to the MFN treatment and the national treatment, as mentioned in BITs, imply a need to look for a balance of benefits and costs with respect to the related issues on patenting drugs and plants by each player (contracting parties to a BIT and a third party who is not party to the bilateral treaty). It is noted that there are 147 Members of the World Trade Organization. By being the Members of the WTO, they have to comply with the provisions of the TRIPS Agreement. In effect, the TRIPS Agreement requires those Members to implement IPRs measures not lower than its standard. They have to comply with the provisions of the TRIPS Agreement that provides the minimum requirements. Upon keeping the core issues as pinpointed in the previous paragraphs in mind, if the contracting parties to a BIT are the Members of the WTO, then the inclusion of the IPRs provision in the standard higher than that of the TRIPS Agreement in the BITs may pose an essential question in relation to the reference of the authorities. For example, should the provisions of the TRIPS Agreement be considered as an authority to govern the practices of the IPRs provisions as incorporated under the BITs by the contracting parties, or should those IPRs provisions under the BITs be binding the contracting parties over the provisions provided by the TRIPS Agreement? This paper is, therefore, designed to answer the concerned issues that were stated in the previous paragraphs and that may be encountered by the contracting parties to those specific types of BITs. Exploring the following questions listed as follows should be able to answer these issues: 1. What are the reasons for IP to be protected specifically under a bilateral investment agreement? 2. Can BITs solve the problems of the IP model of investment (patent in particular)? Are the multilateral agreements on IPRs helpful to solve the problems, such as the health protection and the protection of the farmers’ rights? 3. Should there be IPR provisions in a BIT? Should there be a division of IPR provision to be incorporated in a BIT, i.e. the incorporation of a separate exclusion phrase with respect to patent protection on drugs and plant varieties? 4. Can the TRIPS Agreement solve the problems effected by applying the IP model of investment? 5. Can the TRIPS Agreement strike a balance on patent protection? 6. Finally, will it be possible to incorporate some provisions with respect to investment-related patent issues in the TRIPS Agreement?

參考文獻


42. Raghavan, C. “Patents vs Public Health issue won’t go away”. Third World Network. Available from: http://www.twnside.org.sg/title.away.htm
1. Agreement between the United Nations and the World Intellectual Property Organization
2. Agreement between the World Intellectual Property Organization and the World Trade Organization (of December 22, 1995)
3. Agreement on Trade-Related Aspects of Intellectual Property Rights
4. Agreement on Trade-Related Investment Measures

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