ABSTRACT Traditional Chinese Medicines (TCM) are great treasures of china. TCM industry is also one of the competitive and preponderant industries of china in the world. Nowadays, pharmacy industry, all over the world, depends on intellectual property (IP) greatly. So how to strengthen the IP protection of TCM is the safeguard to the internationalization of TCM in legal. It is also one of the core missions of the modernization of TCM and the key measure in prompting the development of TCM as well. Now in china, though the IP protection of medicine is normative. But refer to TCM, no matter in aspect of technology or its character, there are always some things incompatible with the modern IP rules. In general, neglecting the importance of IP protection, lacking of official and high-tech inventions, weak protection power to the right, unsuitable rules and regulations, etc., are the main problems in the IP protection of TCM. So it is necessary to do some researches on this topic, especially after china entering the WTO and facing so many rivals. In this paper, there are 5 chapters as follows: Chapter 1: Overall summary chapter. Briefly introduce the topic and paper, such as research background and meanings, paper structure, methodologies and objectives. Chapter 2: Explain some related definitions. Chapter 3: Secondly important chapter of this paper. From the aspects of laws and regulations, the situation of china, influence after entering the WTO and the status of domestic TCM industry, this chapter gives a through and detailed analysis of the status of IP protection on TCM. Chapter 4: The most important chapter in this paper. On the basis of last chapter's analysis, face up to the difficulties and problems in the IP protection of TCM, some strategies are advised. In this chapter, it is suggested that we should fully use all legal means of IP protection on TCM firstly. And then integrate the standardization with the IP protection of TCM together to make some strategies. These strategies involve many contents. They are mainly about the TCM patent examining standards, the data or information which needed in TCM patent examine and prove, how to strengthen the IP protection power, some problems related in applying for overseas patent and so on. Chapter 5: Conclusion and expectation chapter. In this paper, not only quantitative analysis method is applied, for example, the comparison of the status of IP protection on TCM between US and China, bus also qualitative analysis method is applied, for example, SWOT analysis of domestic TCM industry. Furthermore, methods such as case study and key information interview are used as well, for example, the analysis of the successful internationalized path of Guangzhou BaiYunShan pharmaceutical factory. Surely, legal protection is the safeguard in course of internationalization of TCM. But how the law is will greatly influence the course. Only suitable, reasonable and special IP protection law can do good to TCM. So we should fully take our advantages as the original country of TCM, not only enact our own IP laws, but also influence overseas legislating. Try our best to provide a good legal surrounding to TCM. In a word, finding good IP protection methods of TCM is the main aim of this paper. Basing on the principle that "Inherit and carry forward the theoretic of TCM, respect and protect the IP of TCM reasonably", this paper gives more attention to the technology and law about TCM. According to the requirements of WTO and modernization of TCM, some strategies on the TCM IP protection are advised, both internationalized and characteristic. Expect that they can be helpful to the modernization and internationalization of TCM. Keywords: Tradition Chinese Medicine; Intellectual Property Protection; Modernization; Standardization

摘要 中藥是我國的國粹,是目前我國在國際上佔有優勢的少數學科之一。作為我國醫藥產業中的重要支柱,中藥產業又是蘊涵著巨大前景、具國際競爭力的民族產業之一。隨著全球崇尚綠色、回歸自然的風氣及天然藥物的興起,我國中藥產業正面對著巨大的機遇與挑戰。當今世界,醫藥工業最大的特點是產業的高度知識產權依賴性和專利藥品發達國家的高度壟斷性。因此,如何加強中藥的知識產權保護,這是中藥國際化的法律保護基礎,是中藥現代化的核心內容,是中藥產業發展的重要戰略。 目前我國有關藥品的知識產權保護工作,雖然已經進入了規範化、法制化的軌道,但在中藥知識產權保護方面還是剛剛起步。而且由於中藥的特殊性,有許多具體法律、技術方面的問題還有待進一步地研究、探討。這對於加入WTO後,我國中藥產業要面對世界強手如林的競爭局面顯得尤其重要。總體而言,目前我國中藥知識產權保護的大體情況是,相關從業人員的知識產權保護意識淡薄,職務發明比例較低,申請的科技含量偏低,保護力度不夠,審批標準模糊及關鍵技術不過關,獲批數量和效率不高,大量自主知識產權還正在流失等。 本論文共分為五個章節進行了討論: 第一章,闡述了課題研究的背景和意義,並簡單介紹了本文的基本內容、架構、研究方法及目的。 第二章,主要為概念、定義性的介紹,為下文做鋪墊。 第三章,為本文的次重點章節。本章從法律法規、國情政策、入世衝擊、產業狀況等幾方面,對中藥知識產權保護的現狀及問題做了全面細緻地分析探討。 第四章,為本文的核心篇章。在前一章分析的基礎上,面對我國中藥知識產權保護中存在的一些難點及問題,依據當前的競爭形勢,本章先是提出了使用傳統方式綜合保護中藥知識產權的策略。其中,筆者選擇了中藥專利作為重點內容加以討論,並從六個方面給出了一些具體對策,這六個方面分別是中藥專利的審查標準、需要提交的審查資料、關鍵保密步驟、保護力度、國外專利申請和防止權利流失。 接著,在綜合保護的基礎上,本章又提出要充分結合法律與技術,即將中藥知識產權保護與中藥標準化聯繫起來,相輔相成,共同探索中藥知識產權保護之路。 第五章,結語,並對我國中藥知識產權保護的發展方向和趨勢做了展望。 在文章中,即有資料比較型的定量分析,如中美中醫藥專利申請、授權情況的比較分析:也運用了態勢分析等定性分析方法,如中國中藥產業 SWOT分析及戰略矩陣。此外,還有關鍵人物訪談和案例,如與國家知識產權局專利局醫藥生物發明審查部藥物製劑處某審查員的談話,及廣州白雲山板藍根的國際化成功之路。 誠然,立法保護是中藥產業在海內外發展的保障,是中藥國際化的必經之路, 但如何立法又會影響中藥海外存亡的命運,對中藥海外發展來說,只有適當、合理、有爭對性的立法保護,才可能為中藥的海外發展創造良性空間。因此,我們不但要立法,更要影響立法,以期能實現對中藥知識產權進行合理、適當、有爭對性地保護,盡力為中藥進入國際市場奠定良好的法律保護基礎。尋求好的保護方法,這也正是此課題研究的最終目的。 本文特色為注重法律與技術相結合,兼顧國際化和本土化,並依據中藥現代化的要求和我國入世後的適應性需要,將“繼承和發揚中醫藥理論傳統,尊重並合理保護中藥知識產權”作為基本原則,提出了一些即能與國際要求銜接又能體現中藥本身特色的知識產權保護策略,期望能以此來配合、促進我國中藥產業現代化、國際化的進程。 關鍵字:中藥; 知識產權; 现代化; 标准化