本文選題：傳統(tǒng)中醫(yī)藥 + 專(zhuān)利權(quán)保護(hù)��； 參考：《吉林大學(xué)》2017年碩士論文

【摘要】：中藥是中華民族為世界人類(lèi)健康作出的偉大貢獻(xiàn),凝聚著我國(guó)古人幾千年來(lái)的智慧結(jié)晶與心血,其擁有悠久的歷史和深厚自成體系的理論基礎(chǔ)。我國(guó)是中藥資源大國(guó)和中醫(yī)藥發(fā)源國(guó),有著豐富的中藥品種、廣袤的中藥材種植基地、浩如煙海的中藥經(jīng)典單方古籍以及獨(dú)特的診療理念。然而,囿于技術(shù)條件所限,我國(guó)中藥專(zhuān)利權(quán)難以受到高質(zhì)量的保護(hù),大量中藥資源被發(fā)達(dá)國(guó)家搶注專(zhuān)利變?yōu)椤把笾兴帯敝蠓赐兜街袊?guó)市場(chǎng)上高價(jià)銷(xiāo)售,攫取巨額專(zhuān)利利潤(rùn)。我國(guó)中藥專(zhuān)利權(quán)保護(hù)面臨一種尷尬的境地,通過(guò)設(shè)計(jì)構(gòu)建適應(yīng)我國(guó)國(guó)情、契合中藥自身特點(diǎn)的立法制度來(lái)有效地保護(hù)中藥專(zhuān)利刻不容緩。本文分為引言、正文以及結(jié)論三大部分,其中正文又由三部分組成。正文第一部分首先分別從中藥學(xué)的狹義角度和知識(shí)產(chǎn)權(quán)法學(xué)的廣義角度對(duì)我國(guó)傳統(tǒng)中藥的內(nèi)涵定義進(jìn)行了界定,介紹了中藥相對(duì)于西藥化學(xué)物質(zhì)所獨(dú)具的本質(zhì)區(qū)別特性;接著通過(guò)目前我國(guó)對(duì)中藥各種保護(hù)模式的比較得出了對(duì)我國(guó)中藥進(jìn)行專(zhuān)利權(quán)保護(hù)是目前公認(rèn)的保護(hù)力度最強(qiáng)、排他性最強(qiáng)的保護(hù)模式的結(jié)論,闡述了在我國(guó)實(shí)施中藥專(zhuān)利權(quán)保護(hù)的正當(dāng)性;之后本文梳理了我國(guó)中藥專(zhuān)利權(quán)保護(hù)立法制度的歷史沿革,并對(duì)專(zhuān)利申請(qǐng)的現(xiàn)狀進(jìn)行介紹,探討了我國(guó)中藥專(zhuān)利權(quán)保護(hù)的立法缺陷和障礙,集中論述了我國(guó)中藥專(zhuān)利權(quán)保護(hù)存在的立法缺陷及成因分析。指出了現(xiàn)行專(zhuān)利法規(guī)定的充分公開(kāi)原則及關(guān)于專(zhuān)利權(quán)審查中新穎性、創(chuàng)造性和實(shí)用性的定義標(biāo)準(zhǔn)對(duì)我國(guó)中藥專(zhuān)利權(quán)保護(hù)的障礙,現(xiàn)有中藥行政保護(hù)模式與專(zhuān)利保護(hù)模式立法上的沖突矛盾對(duì)我國(guó)中藥專(zhuān)利權(quán)保護(hù)的障礙,并以我國(guó)專(zhuān)利權(quán)保護(hù)法規(guī)與中藥特質(zhì)之間存在著的沖突為視角,深入分析了專(zhuān)利侵權(quán)判定邊界模糊導(dǎo)致認(rèn)定維權(quán)困難的保護(hù)障礙。第二部分是對(duì)美國(guó)、德國(guó)、泰國(guó)、日本的中藥、植物藥或漢方藥專(zhuān)利權(quán)保護(hù)制度及專(zhuān)利保護(hù)情況進(jìn)行比對(duì)研究,借鑒評(píng)析了這幾個(gè)國(guó)家在傳統(tǒng)醫(yī)藥專(zhuān)利權(quán)保護(hù)領(lǐng)域的制度與實(shí)踐經(jīng)驗(yàn)。第三部分在前兩部分的基礎(chǔ)上,通過(guò)對(duì)我國(guó)現(xiàn)有中醫(yī)藥專(zhuān)利權(quán)保護(hù)制度體系立法上的保護(hù)障礙的分析,和對(duì)先進(jìn)國(guó)家傳統(tǒng)醫(yī)藥專(zhuān)利權(quán)保護(hù)立法經(jīng)驗(yàn)的總結(jié)借鑒,我對(duì)完善我國(guó)中藥專(zhuān)利權(quán)保護(hù)的立法制度提出了一些完善建議,筆者提出了以下解決對(duì)策:理順我國(guó)中藥專(zhuān)利權(quán)保護(hù)立法體系,解決中藥行政保護(hù)和專(zhuān)利權(quán)保護(hù)二者法律法規(guī)沖突的問(wèn)題;引入傳統(tǒng)知識(shí)來(lái)源披露制度和事先知情同意制度,以期發(fā)揚(yáng)我國(guó)中藥資源的優(yōu)勢(shì),彌補(bǔ)技術(shù)申請(qǐng)上的劣勢(shì),從而遏制發(fā)達(dá)國(guó)家無(wú)償利用我國(guó)中藥資源、搶注中藥專(zhuān)利的“生物海盜”現(xiàn)狀;根據(jù)中藥自身的特點(diǎn)有針對(duì)性地細(xì)化完善中藥發(fā)明專(zhuān)利對(duì)“三性”的審查標(biāo)準(zhǔn),即調(diào)整放寬中藥專(zhuān)利權(quán)新穎性、創(chuàng)造性和實(shí)用性標(biāo)準(zhǔn);規(guī)定秘密審查制度防止中藥專(zhuān)利申請(qǐng)信息泄露導(dǎo)致被侵權(quán)仿制;延長(zhǎng)中藥專(zhuān)利保護(hù)期限以提高企業(yè)及個(gè)人的專(zhuān)利申請(qǐng)積極性,利于中藥專(zhuān)利權(quán)保護(hù)的良性發(fā)展;進(jìn)一步具體細(xì)化中藥的專(zhuān)利侵權(quán)判定界限,完善中藥侵權(quán)認(rèn)定立法制度;建立中藥專(zhuān)利保護(hù)的鏈接機(jī)制,將我國(guó)食品藥品監(jiān)督管理局(簡(jiǎn)稱(chēng)SFDA)與國(guó)家專(zhuān)利局(簡(jiǎn)稱(chēng)SIPO)這兩個(gè)行政部門(mén)的職能無(wú)縫銜接,更有助于中藥的專(zhuān)利權(quán)查詢(xún)與保護(hù)。本文對(duì)我國(guó)中藥專(zhuān)利權(quán)保護(hù)的立法障礙與完善建議的探討涉及到法學(xué)與藥學(xué)兩個(gè)學(xué)科體系的復(fù)合型研究。文章的總體遵照:梳理歷史沿革——介紹現(xiàn)狀——發(fā)現(xiàn)問(wèn)題——分析成因——總結(jié)借鑒先進(jìn)經(jīng)驗(yàn)——給出完善建議對(duì)策的行文脈絡(luò)進(jìn)行論述。本文采用立法理論結(jié)合實(shí)踐的方式,為了保證全文的邏輯嚴(yán)密性和規(guī)范性,作者主要運(yùn)用了以下幾種研究方法進(jìn)行論文的撰寫(xiě):(一)跨學(xué)科領(lǐng)域復(fù)合研究法:本文涉及到藥學(xué)、中藥學(xué)、知識(shí)產(chǎn)權(quán)法、民法等多個(gè)學(xué)科體系的知識(shí),作者采用了以知識(shí)產(chǎn)權(quán)法學(xué)研究為主,中藥學(xué)知識(shí)為輔的交叉研究方法。(二)文獻(xiàn)分析法:作者閱讀參考了大量著作圖書(shū)、法律法規(guī)、網(wǎng)絡(luò)資料、權(quán)威核心期刊文獻(xiàn)以及優(yōu)秀碩博士學(xué)位論文等翔實(shí)的資料,在前人已有的研究成果基礎(chǔ)上加以拓展細(xì)化,探尋完善我國(guó)中藥專(zhuān)利權(quán)保護(hù)的立法制度完善對(duì)策。(三)比較研究法:本文通過(guò)對(duì)美國(guó)、泰國(guó)、日本、德國(guó)等世界上代表性國(guó)家的傳統(tǒng)醫(yī)藥專(zhuān)利權(quán)保護(hù)法律制度進(jìn)行歸納、評(píng)析,再與我國(guó)相關(guān)對(duì)應(yīng)的法律制度進(jìn)行比較研究,總結(jié)出了各國(guó)在傳統(tǒng)醫(yī)藥(或植物藥)專(zhuān)利權(quán)保護(hù)立法方面的優(yōu)劣之處,并選取其中符合我國(guó)國(guó)情特色的先進(jìn)經(jīng)驗(yàn)作為我國(guó)立法完善的借鑒。(四)歷史研究法:本文開(kāi)篇對(duì)我國(guó)中藥專(zhuān)利權(quán)保護(hù)的立法沿革進(jìn)行了梳理與歸納,追溯了我國(guó)各階段法律規(guī)定的立法背景與當(dāng)時(shí)的設(shè)計(jì)考量,對(duì)整個(gè)中藥專(zhuān)利權(quán)保護(hù)的立法進(jìn)程演變進(jìn)行了總結(jié),為后文的立法缺陷成因分析與完善建議做好鋪墊。
[Abstract]:Chinese medicine is the great contribution made by the Chinese nation to the human health of the world. It has condensed the wisdom and blood of the ancient people of our country for thousands of years. It has a long history and a profound theoretical basis. China is a great country of Chinese medicine resources and the origin of traditional Chinese medicine. There are rich varieties of traditional Chinese medicine and a vast planting base of Chinese medicinal materials. However, limited by the technical conditions, the patent rights of Chinese traditional medicine are difficult to be protected by high quality. A large number of Chinese medicine resources have been converted into "foreign medicine" by developed countries and turned into high prices in the Chinese market, and a huge amount of patent profits are grabbed. The right protection is faced with an awkward situation. Through the design and construction of the legislative system adapting to the national conditions of China to fit the characteristics of Chinese medicine, it is divided into three parts: introduction, text and conclusion. The text is composed of three parts. The first part of the text begins with the narrow sense of Chinese materia medica. The definition of the connotation of traditional Chinese medicine is defined in the broad sense of intellectual property law, and the essential distinguishing feature of traditional Chinese medicine relative to western medicine chemicals is introduced. Then, through the comparison of various protection modes of Chinese medicine, the protection of patent rights of Chinese traditional medicine is the most widely recognized protection force at present. The conclusion of the strong and exclusive protection model expounds the legitimacy of the implementation of the patent protection of Chinese medicine in China. After that, this article combs the historical evolution of the legislative system of the patent protection of Chinese medicine, introduces the status of patent application, probes into the legislative defects and obstacles of the protection of Chinese traditional Chinese medicine patent right, and concentrates on me. The legislative defects and causes of the protection of patent rights in Chinese medicine are analyzed. The full public principle of the current patent law and the obstacles to the protection of patent rights of Chinese traditional medicine are discussed, and the conflict spear of the existing traditional Chinese medicine administrative protection mode and the patent protection mode is also discussed. The second part is the patent protection of Chinese medicine, plant medicine or Chinese medicine in the United States, Germany, Thailand, Japan and the patent rights of the United States, Germany, Thailand and Japan. The protection system and patent protection are compared and analyzed, and the system and practice experience of these countries in the field of traditional medicine patent protection are analyzed and analyzed. The third part, based on the first two parts, analyzes the legislative protection barriers of the existing Chinese traditional Chinese medicine patent protection system and the traditional medicine in the advanced countries. As a summary of the legislative experience of patent patent protection, I put forward some suggestions for improving the legislative system of patent protection of Chinese medicine. The author puts forward the following solutions: to straighten out the legislative system of patent protection of Chinese medicine and to solve the conflicts between the two laws and regulations of the administrative protection of Chinese medicine and the patent protection; and the introduction of traditional knowledge. In order to make up the advantages of Chinese traditional Chinese medicine resources and make up for the disadvantages of the technology application, the system of knowledge source disclosure and prior informed consent can be made up to contain the resources of Chinese traditional medicine and the "biological piracy" status of Chinese traditional medicine patents, and to refine the patent of Chinese medicine according to its own special point. " The standard for the review of the "three sex" is to adjust and relax the novelty of patent rights of traditional Chinese medicine, creative and practical standards; to stipulate that the secret censorship system prevents the disclosure of information from patent application of traditional Chinese medicine to be imitated by infringement; to extend the duration of patent protection of traditional Chinese medicine to improve the patent application of enterprises and individuals and to the benign development of patent protection of traditional Chinese medicine; Further refining the limit of patent infringement judgment of Chinese medicine, perfecting the legislative system of Chinese medicine tort identification, establishing the link mechanism of patent protection of Chinese medicine, and connecting the functions of the two administrative departments of the food and Drug Administration of China (SFDA) and the State Patent Office (SIPO), which is more helpful to the inquiry and protection of patent rights of Chinese medicine. The discussion of the legislative obstacles and suggestions for the protection of patent rights of Chinese traditional medicine involves a complex study of the two disciplinary systems of law and pharmacy. The overall compliance of the article is: combing the historical evolution - the introduction of the present situation - the discovery of the problems - the analysis of the causes - the summary of the experience of the first and the suggestions for the improvement of the suggestions In order to ensure the logical and normative of the full text, the author uses the following methods to write the paper: (1) the interdisciplinary research method: This article involves the knowledge of many disciplines, such as pharmacy, Chinese pharmacy, intellectual property law, civil law and so on. The author adopted the cross research method based on intellectual property law research and traditional Chinese medicine knowledge. (two) literature analysis: the author read a lot of books, laws and regulations, network data, authoritative core periodicals and excellent doctorate theory and so on, based on previous research results. To expand and refine the legislative system to perfect the protection of patent rights of Chinese medicine. (three) comparative study method: This article through the United States, Thailand, Japan, Germany and other representative countries of the world's traditional medical patent protection legal system to sum up, evaluation, and the corresponding legal system in China to compare the general research, The advantages and disadvantages of various countries in the patent protection legislation of traditional medicine (or plant medicine) are put forward, and the advanced experience which conforms to the national characteristics of our country is selected as a reference for the perfection of our country's legislation. (four) the historical research law: This article has combed and summed up the legislative evolution of the patent protection of Chinese traditional medicine, and traces back to every order of our country. The legislative background of the paragraph and the design consideration at that time, summarize the evolution of the legislative process of the protection of the patent right for the whole Chinese medicine, and pave the way for the analysis of the causes of the later legislative defects and the suggestions for perfection.

【學(xué)位授予單位】：吉林大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類(lèi)號(hào)】：D923.42

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6 趙瑩;失效專(zhuān)利淘金[N];經(jīng)理日?qǐng)?bào);2003年

7 胥曉琦;專(zhuān)利保護(hù)規(guī)則及相關(guān)問(wèn)題解決[N];中國(guó)中醫(yī)藥報(bào);2005年

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