發(fā)布時間：2018-05-09 14:51

  本文選題：孤兒藥 + 市場獨占銷售權(quán)��； 參考：《華東政法大學》2015年碩士論文

【摘要】：對于許多研習知識產(chǎn)權(quán)法的人而言,“孤兒藥”可能屬于一個極其陌生的概念。隨著人類醫(yī)療衛(wèi)生水平提升、社會倫理道德進步以及知識產(chǎn)權(quán)法、競爭法、藥事法等相關(guān)法律的演進,對于創(chuàng)設(shè)“孤兒藥”特殊激勵、保護、規(guī)制機制的研究,理應(yīng)得到更多法律人的關(guān)切。“孤兒藥”,亦稱罕見病專用藥,專門指稱用于預防、診斷、治療或者控制罕見疾病或者罕見狀態(tài)的藥物,廣義的孤兒藥還包括疫苗、診斷試劑、醫(yī)用器械等。較之普通藥物,“孤兒藥”針對的目標市場狹窄、研發(fā)難度極大、研發(fā)投入驚人,同時還面臨藥物專利審查期間冗長、專利有效保護期間被占用、臨床實驗樣本有限無法滿足行政審批要求、相關(guān)專門性立法空白等法律困境。故,極易成為被藥企“遺棄的孤兒”。但是,罕見病患者對于“孤兒藥”的依賴卻往往是攸關(guān)性命且終其一生的,這一對困擾法律、醫(yī)學乃至社會的矛盾亟待解決,且應(yīng)當尋求妥善之策。“孤兒藥”,亦稱罕見病專用藥,專門指稱用于預防、診斷、治療或者控制罕見疾病或者罕見狀態(tài)的藥物,廣義的孤兒藥還包括疫苗、診斷試劑、醫(yī)用器械等。較之普通藥物,“孤兒藥”針對的目標市場狹窄、研發(fā)難度極大、研發(fā)投入驚人,同時還面臨藥物專利審查期間冗長、專利有效保護期間被占用、臨床實驗樣本有限無法滿足行政審批要求、相關(guān)專門性立法空白等法律困境。故,極易成為被藥企“遺棄的孤兒”。但是,罕見病患者對于“孤兒藥”的依賴卻往往是攸關(guān)性命且終其一生的,這一對困擾法律、醫(yī)學乃至社會的矛盾亟待解決,且應(yīng)當尋求妥善之策。本文以“孤兒藥”之中可專利化、不適宜專利化的智力成果為焦點,集中考查美、歐、日、韓等發(fā)達國家在孤兒藥立法、司法方面的先行經(jīng)驗,嘗試探索解決我國“孤兒藥”困局的法律出路。從宏觀法律體系層面來看,筆者認為解決孤兒藥專利特殊保護機制的路徑大致存在兩種模式:第一,在現(xiàn)有專利制度框架內(nèi),創(chuàng)設(shè)針對孤兒藥的例外規(guī)則;第二,借鑒發(fā)達國家廣泛采用的模式,在廣義的知識產(chǎn)權(quán)法框架內(nèi)創(chuàng)設(shè)孤兒藥法案——形成一套與專利制度并行不悖的特殊保護機制,并允許和鼓勵藥企根據(jù)研發(fā)潛在藥物的不同屬性選擇合適的保護路徑。同時,本文充分結(jié)合我國特殊國情和相關(guān)立法傾向性,總結(jié)和歸納一些有益的啟示和經(jīng)驗,撰此拙文,權(quán)作拋磚引玉之用。本文共分五個章節(jié)。第一章對“孤兒藥”及罕見病的相關(guān)背景知識進行概述,厘清本文將會涉及的醫(yī)藥概念,為后文展開論述做必要鋪墊。同時,在此基礎(chǔ)上對世界范圍內(nèi)主要國家、尤其是發(fā)達國家關(guān)于“孤兒藥”立法情況進行了整理和匯編,大致闡明了“孤兒藥”立法的總體發(fā)展脈絡(luò)。第二章將視角返回中國,本人通過大數(shù)據(jù)整理、法律法規(guī)梳理、文獻比較研究等方式,深入剖析了中國“孤兒藥”的發(fā)展現(xiàn)狀,揭示了中國“孤兒藥”研發(fā)遲滯、求藥無門、藥價畸高的尷尬。另外,針對上述“孤兒藥”的現(xiàn)實窘境,本人從專利法、不正當競爭法等相關(guān)領(lǐng)域的既定規(guī)則出發(fā),分析了現(xiàn)行規(guī)則對于此類特殊客體激勵和保護機制失靈的法律根源,以及“孤兒藥”尋求現(xiàn)行法律保護掣肘的其他深層根源。第三種重在闡述和分析以美國孤兒藥法案(Orphan Drugs Act)、孤兒藥實施條例(Orphan Drugs Regulations)、《藥價競爭和專利期限補償法》(“哈奇·維克斯曼修正案”,Hatch-Waxman Amendments)為代表的各國立法經(jīng)驗,總結(jié)和梳理了一些列值得借鑒的規(guī)則,既包括激勵機制,也包括對不正當競爭的規(guī)制機制。同時,本人收集、考查、分析、比較了豐富詳實的案例資料,如Baker Norton Pharmaceuticals,Inc.v.United States Food and Drug Administration,Genentech,Inc.v.Bowen,Sigma-Tau Pharmaceuticals,Incorporated,v.Bernard A.Schwetz,Intermedics.Inc.v.Ventritex.Inc.,Amgen.Inc.v.International Trade Commission等。通過上述經(jīng)典判例,動態(tài)闡述了司法判例推動立法日臻完善的進程,探討和反思各國“孤兒藥”法案創(chuàng)設(shè)的激勵和規(guī)制機制的成效和缺陷。第四章嘗試探討我國“孤兒藥”智力成果特殊保護機制的解決之道。在前文的基礎(chǔ)上,本人提出了兩種宏觀的構(gòu)想:(一)在現(xiàn)行廣義的知識產(chǎn)權(quán)法、藥事法框架內(nèi)創(chuàng)設(shè)針對性的“孤兒藥”的例外規(guī)則;(二)仿效發(fā)達國家經(jīng)驗,創(chuàng)設(shè)專門的孤兒藥法案。本文進一步考慮到我國尚處于發(fā)展中國家的特殊國情,不適合仿效傾向經(jīng)濟利益的美國規(guī)則,也不適合復制歐盟、日本等尋求平衡的立法初衷,應(yīng)當以適當照顧公共健康為創(chuàng)設(shè)規(guī)則的根本要義和精神。故,本文在提出一些激勵機制構(gòu)想的同時,側(cè)重于對相關(guān)限制和規(guī)制不正當競爭的研究,主要指:(一)在現(xiàn)行廣義的知識產(chǎn)權(quán)法、藥事法框架內(nèi)創(chuàng)設(shè)針對性的“孤兒藥”的例外規(guī)則,同時相應(yīng)地完善和細化Bolar例外(Bolar Exemption)規(guī)則,包括桔皮書制度(Orange Book)、專利鏈接(Patent Linkage)制度,涉訴中止審查制度、仿制藥市場獨占銷售期制度等,鼓勵仿制藥企積極挑戰(zhàn)現(xiàn)有醫(yī)藥專利;(二)如果通過創(chuàng)設(shè)孤兒藥法案的途徑,那么同時應(yīng)當考慮孤兒藥上市后限制藥價畸高、消除市場壟斷、撤銷市場獨占銷售權(quán)、控制藥物倫理風險等問題,注重兼顧病患福祉、社會公共利益與制藥行業(yè)經(jīng)濟利益之間利益平衡。第五章總結(jié)全文核心觀點,闡述對我國改革和探索“孤兒藥”特殊保護機制的啟示,重申對“孤兒藥”特殊激勵和規(guī)制機制的研究正是“為天才之火澆上利益之油”的延伸。無論今后的立法實踐會選擇何種方式,在平衡患者福祉和藥企利益的過程中,知識產(chǎn)權(quán)法律都應(yīng)該發(fā)揮它應(yīng)有的積極作用。
[Abstract]:For many people studying intellectual property law, "orphan medicine" may belong to an extremely strange concept. With the improvement of the level of human health and health, the progress of social ethics and morality, the law of intellectual property, the law of competition and the law of medicine, the study of the special incentive, protection and regulation mechanism for the creation of "orphan drugs", "Orphan drugs", also known as special drugs for rare diseases, specifically refer to drugs used in the prevention, diagnosis, treatment or control of rare diseases or rare states. The generalized orphan drugs include vaccines, diagnostic reagents, medical instruments, and so on. It is narrower than the target market for universal drugs and orphan drugs. It is very difficult, the R & D investment is amazing, and it also faces the lengthy period of drug patent examination, the occupation of the patent effective protection, the limited clinical experimental samples can not meet the administrative examination and approval requirements, the relevant special legislative blanks and other legal difficulties. Therefore, it is very easy to be abandoned by the pharmaceutical enterprises. "The dependence of" is often a life and a lifetime. This is an urgent solution to the contradictions of law, medicine and society. "Orphan medicine", also known as a special medicine for rare diseases, specifically refers to drugs used in the prevention, diagnosis, treatment or control of rare diseases or rare States, and a broad sense of orphan drugs. It includes vaccines, diagnostic reagents, medical instruments and so on. The target market is narrower than the common drug, "orphan medicine", the research and development is very difficult, the R & D investment is astonishing, the period of drug patent examination is long, the patent effective protection is occupied, the clinical laboratory sample is limited to meet the requirements of administrative examination and approval, related special legislation. Therefore, it is very easy to be abandoned by the pharmaceutical enterprises. However, the dependence of the rare patients on the "orphan medicine" is often a vital and final life. This is an urgent solution to the contradictions of law, medicine and even the society, and should be sought. This article is patented in the "orphan medicine". It is not suitable for the intellectual achievements of patentability to focus on examining the legislative and judicial experience of orphan drugs in the developed countries of the United States, Europe, Japan, Korea and other developed countries, trying to explore the legal way out to solve the dilemma of "orphan medicine" in our country. From the macro legal system level, the author thinks that the path to solve the special protection mechanism of orphan drug patent exists roughly. Two models: first, in the framework of the existing patent system, create exceptional rules for orphan drugs; second, draw on the widely adopted model in the developed countries, create an orphan drug bill within the framework of the broad sense of intellectual property law - to form a set of special protection mechanisms that do not run counter to the patent system, and to allow and encourage pharmaceutical enterprises to submerse according to research and development. At the same time, this article fully combines our country's special national conditions and the relative legislative tendency to sum up and sum up some useful revelations and experiences in this article. This article is divided into five chapters. The first chapter is about the related background knowledge of "orphan medicine" and rare diseases. The article clarifies the concept of medicine that will be involved in this article, and makes the necessary paving for the later article. At the same time, on this basis, the main countries in the world, especially the developed countries, have been collated and compiled about the legislation of "orphan medicine", and the general development of the "orphan medicine" legislation is roughly clarified. The second chapter returns the angle of view. In my country, I have thoroughly analyzed the development status of "orphan medicine" in China through large data sorting, law and regulation, literature comparison and so on. It reveals the awkward situation of Chinese "orphan medicine" research and development, no door and high price. In addition, in view of the realistic predicament of the "orphan medicine", I from the patent law, the unfair competition law and so on. According to the established rules of the related fields, the legal origin of the failure of the incentive and protection mechanism of such special objects, and the other deep roots of the "orphan medicine" for the protection of the existing legal protection are analyzed. The third emphasis is on the American Orphan Drug Act (Orphan Drugs Act), the orphan drug implementation Ordinance (Orphan Dr) UGS Regulations), < price competition and patent term compensation law > ("Hacci Waxman amendment", Hatch-Waxman Amendments) as the representative of the legislative experience of various countries, summed up and combed some of the rules worthy of reference, including the incentive mechanism, including the regulation mechanism of unfair competition. At the same time, I collect, examine, analyze, and compare More detailed and detailed case data, such as Baker Norton Pharmaceuticals, Inc.v.United States Food and Drug Administration, Genentech, Inc.v.Bowen, Sigma-Tau, etc. In the fourth chapter, we try to explore the solution to the special protection mechanism of the intellectual achievement of "orphan medicine" in our country. On the basis of the previous article, I put forward two kinds of macro ideas. (1) to create an exceptional rule of "orphan medicine" in the framework of the current broad sense of intellectual property law and medicine law; (two) to create a special orphan drug bill in the imitation of the experience of the developed countries. This article further considers that the special national conditions of China are still in the developing countries and are not suitable for the imitation of the American rules of economic interest. To copy the European Union, Japan and so on to seek the balance of legislation, we should take proper care of public health as the fundamental meaning and spirit for the creation of rules. Therefore, this article puts forward some ideas of incentive mechanism and focuses on the study of the related restrictions and regulation of unfair competition, mainly: (1) in the current broad sense of intellectual property law and the framework of the pharmaceutical law To create an exceptional rule of "orphan medicine", and to improve and refine the Bolar exception (Bolar Exemption) rules, including the orange book system (Orange Book), the patent link (Patent Linkage) system, the prosecution suspension review system, the pharmaceutical market monopolizing the sale period system and so on, encourage the generic pharmaceutical enterprises to challenge the existing medical specialty. (two) if the orphan drug bill is created, it should be considered at the same time to consider the limit of the drug price after the orphan drug listing, eliminate the market monopoly, revoke the market monopoly and control the risk of drug ethics, pay attention to the welfare of the patients and balance the interests of the social public interests and the economic interests of the pharmaceutical industry. The full text points out the inspiration of the special protection mechanism for the reform and exploration of "orphan medicine" in our country, reaffirms the extension of the study on the special incentive and regulation mechanism of "orphan medicine", which is the extension of "the oil of interest for the fire of genius". In the process, intellectual property law should give full play to its positive role.

【學位授予單位】：華東政法大學
【學位級別】：碩士
【學位授予年份】：2015
【分類號】：R95;D923.42

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