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題名:探討因應醫藥品專利之合理措施
書刊名:國立中正大學法學集刊
作者:陳文吟 引用關係
作者(外文):Chen, Wen-yin
出版日期:2002
卷期:8
頁次:頁67-112
主題關鍵詞:醫藥品專利強制授權特許實施真品平行輸入抑價措施價格區分制市場區隔專利權濫用耗盡原則Pharmaceutical patentsCompulsory licensingParallel importsPrice controlTiered pricingMarket segmentPatent misuseExhaustion doctrine
原始連結:連回原系統網址new window
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  • 被引用次數被引用次數:期刊(7) 博士論文(1) 專書(0) 專書論文(0)
  • 排除自我引用排除自我引用:6
  • 共同引用共同引用:53
  • 點閱點閱:21
基於鼓勵保護發明及國民健康福祉,賦予醫藥品專利不失為正確的政策,然而,在賦予專利的同時,應一併考量其負面影響,並宜審慎處理。 美國藥廠與南非的醫藥專利爭議,可顯高收入的已開發國家與低收入的開發中或低度開發國家間對醫藥品專利的對立立場。我國以已開發國家成為WTO的一員,已開發國家的立場固足供我國借鏡;然曲諸我國核准的醫藥品專利案件係以外國業者居多,開發中國家維護國民健康的經驗以及國際間對低度開發國家的建議,亦足以為我國面臨類似問題的參考。 真品平行輸入增加國內市場上的競爭,強制授權平緩供不應求的窘境,亦可增加市場上的競爭;二者均可達到平穩藥價的效果。惟,低收入開發中國家如何尋得低價來源俾進品藥品,恐為其能否順利採行真品平行輸入的首要關鍵。強制授權的先決條件為其本國業者有製藥能力,此為工業落後國家的另一難題。抑價措施雖為多國所採行,對低收入開發中國家(包括低度開發國)卻未必適宜,因其可能導致藥廠退出其市場;反之,價格區分制的合理優惠價格以及市場區隔,兼顧患者及藥廠權益。論者建議採行價格區分制輔以國際經濟授助,當可更有效地解決低收入開發中國家的醫藥問題。 以美國為首的已開發國家,亦有面臨藥價過高之虞。美國雖極力反對專利強制授權,惟,揆諸其立法暨司法實務,其廣泛運用強制授權俾達到公共利益的立場,可謂係主要工業國家之最,當則足以解決藥價過高及供應不足的問題。美國為確保專利權人之權益,禁止真品平行輸入,更為鼓勵藥廠的研發而未採行抑價措施。是以,美國僅得藉由強制授權暨市場的們自由競爭,達到平穩藥價的目的。 我國採行抑價措施,處方藥價較為合理;倘藥品供不應求、或藥價在抑價措施下,仍超乎大多數民眾之經濟能力者,強制授權(特許實施)及國際耗盡原則當足以發揮其足量供應及平抑價格的功能。 無論任一國家決定採行增進藥品供應及平穩藥價的措施時,宜權衡其國內容觀環境暨前揭各制度之利弊,採行最適度的措施。
It has been well established that to provide patent protection for pharmaceuticals is the best way to promote innovations and public health & welfare. However, for the past decades, AIDS disease brought us to reconsider the potential problem (or we should say real problem) arose from pharmaceutical patents, especially the dispute between South Africa and the U.S. pharmaceutical industry. It’s nor right to delete pharmaceuticals from the list of patentable subject matter, what we should do is to figure out the proper measures to solve the problems it brought (or will bring). Compulsory licensing and parallel imports, price control and tiered pricing are considered to be reasonable measures to prevent patent misuse, and, to protect public welfare as well. But, not all of them are good to each country of the world. For instance, to those less/least developed countries, compulsory licensing isn’t fit for them due t their lacing of manufacturing capacity; parallel imports is not a good measure to them either, because there is no place to find where the drug price is lower than that in their own countries. So do the price control raise some problem. Tiered pricing and international financial assistance shall be the only and proper measure for less/least developed countries to solve their pharmaceutical problem. To those developed countries and the top level of developing countries, including our own, the measures mentioned may be proper except tiered pricing which is deemed to be applied to the less/least developed countries. In sum, when a country decides to take some measure to protect public health, it shall consider the advantage as well as disadvantage or risk so as to make a right decision.
期刊論文
1.Bifani, Paolo(1989)。Intellectual Property Rights and International Trade Uruguay Round。PAPERS Selected Issues,129+174-176。  new window
2.陳文吟(19961000)。論專利法上醫藥品專利權期間之延長--以美國法為主。華岡法粹,24,171-218。new window  延伸查詢new window
3.Eisenberg, Rebecca S.(1989)。Patents and the Progress of Science: Exclusive Rights and Experimental Use。The University of Chicago Law Review,56(3),1017-1086。  new window
4.(2001)。New Bill Will Extend 100 Drug Patents, Consumer Group Says。Intell. Prop. Litig. Rep.,8,17。  new window
5.(2001)。south africa settles patent dispute with drug industry。AIDS Litig. Rep.,14,6。  new window
6.(2001)。South Africa's moral victory。The Lancet,357,1303。  new window
7.Adelman, Mirtin、Baldia, Sonia(1996)。Impact of the TRIPs Agreement on Specific Discipline Patentable Inventions: Prospects and Limits of the Patent Provision in the TRIPs Agreement: The Case of India。Vand. J, Transnat'l L.,29,507。  new window
8.Atkinson, Mary(2002)。Patent Protection for Pharmaceuticals: A Comparative Study of the Law in the United States and Canada。Pac. Rim L. & Pol'y,11,181。  new window
9.Barfield, Claude、Groombridge, Mark(1999)。Parallel Trade in the Pharmaceutical Industry : Implication for Innovation, Consumer Welfare and Health Policy。Fordham Intell. Prop. Media & Ent. L. J.,10,185。  new window
10.Griffin, Mary(1991)。AIDS drugs & the pharmaceutical industry: a need for reform。Am. J. L. & Med.,17,363。  new window
11.Harrelson, John(2001)。TRIPs, Pharmaceutical Patents, and HIV/AIDS Crisis: Finding The Proper Balance Between Intellectual Property Rights and Compassion。Wid. L. Symp. J.,7,175+195。  new window
12.Kolker, Carlyn(200202)。Doing the Doha Shuffle-At a WTO meeting, nations agreed。The American Lawyer。  new window
13.Miao, Emily(20000724)。TRIPs Agreement Impacts Pharmaceutical Sector: Not All Members, Especially Developing Nations Feel the Benefits of Increased Trade。Nat'l L. J.。  new window
14.Stanton, Jerry(2000)。Lesson for the united states from foreign price controls on pharmaceuticals。Conn. J. Int'l L.,16,149。  new window
15.Sherwood, Robert(1997)。The TRIPs agreement: implications for developing countries。IDEA,37,491。  new window
16.Slind-Flor, Victoria(20000110)。Doctor's Group Urges Ip Change: AIDS-Devastated Nations Deprived of Drugs by Patent Law。Nat'l L. J.,B7。  new window
17.Banta, David(20011205)。Public Health Triumphs at WTO Conference。JAMA,286(1)。  new window
研究報告
1.Barton, John(200107)。Differentiated Pricing of Patented Products。  new window
2.Correa, Carlos(1999)。Intellectual Property Rights and the Use of Compulsory Licenses: Options for Developing Countries。  new window
3.Correa, Carlos(200111)。Patent Law, TRIPs and R&D Incentives: A Southern Perspective。  new window
4.Danzon, Patricia(200112)。Differential pricing for pharmaceuticals: reconciling access, R&D and patents。  new window
5.Lanjouw, Jean(200105)。A Proposal to Use Patent Law to Lower Drug Prices in Developing Countries。  new window
6.Scherer, Mike、Watal, Jayashree(200106)。Post-Trips Options for Access to Patented Medicines in Developing Countries。  new window
7.WTO(20011120)。Ministerial Declaration。  new window
圖書
1.Adelman, Martin、Rader, Randall、Thomas, John、Wegner, Harold(1998)。Patent Law。  new window
2.Blakeney, M.(1996)。Trade Related Aspects of Intellectual Property Rights: A Concise Guide to the TRIPs Agreement。London:Sweet & Maxwell。  new window
3.陳文吟(200102)。我國專利制度之研究。new window  延伸查詢new window
4.Gadbaw, R. Michael、Richards, Timothy J.(1988)。Intellectual Property Rights: Global Consensus, Global Conflict?。Westview Press Inc。  new window
單篇論文
1.World Trade Organization(20011120)。Declaration on the TRIPS Agreement and Public Health,http://www.wto.org/English/thewto_e/minist_e/min01_e/mindecl_trips_e.htm,(WTO Doc. WT/MIN(01)/DEC/2)。  new window
其他
1.Int'l Intellectual Prop. Inst.。HIV/AIDS Pilot Project: To Deliver Patented Therapies & Other Treatments to Patients in Developing Countries,http://www.iipi.org/eng/projects/aids.asp, 2002/04/07。  new window
2.(19990810)。Prescription Drug Pricing in the 7th Congressional District of Maryland: An International Price Comparison,http://www.house.gov/cummings/pdf/intl.pdf, 2002/05/07。  new window
3.(19981101)。Prescription Drug Pricing in Vermont: An International Price Comparison,http://bemie.house.gov/presciiptions/intemational.asp, 2002/05/19。  new window
4.(20000613)。U.S. Chamber Letter to Senate Committee Warns Against Price Controls on Prescription Drugs,http://www.uschambercom/Press+Room/2000/00-086.htm, 2002/05/27。  new window
5.World Health Organization,World Trade Organization Secretariats(20010408)。Report of the Workshop on Differential Pricing and Financing of Essential Drugs,http://www.wto.org/english/tratopj2/txips_e/hosbjor_report_e.doc, 2002/05/14。  new window
6.Health Care in the Developing World,http://world.phama.org/faq.html, 2002/04/15。  new window
7.(20000426)。PhRMA Opposes Gorton Price Control Bill,http://www.phrnia.org/press/newsreleases/2000-4-26.17.phtml, 2002/05/27。  new window
8.Cohen, Mike(20011006)。Report Estimates AIDS Could Kill up to Million South Africans by 2010,http://www.aegis.org/news/ap/2001/ap011011.html, 2002/04/13。  new window
9.Correa, Carlos(2000)。Integrating Public Health Concerns into Patent Legislation in Developing Countries,http://www-southcentre.org./publications/publichealth/publichealth.pdf, 2002/04/15。  new window
10.Denny, Charlottee(20010419)。How patients come second to patents in the drug industry,http://www,theage_com,aü/news/2001/04/19/ FFXLH6UYNLC. html, 2002/05/07。  new window
11.Duckett, Margaret(199907)。Compulsory Licensing and Parallel Importing: What do they mean? Will they improve access to essential drugs for people living with HIV/AIDS?,http://www.icaso.org/docs/compulsoryenglish.htm, 2002/04/15。  new window
12.Vick, Karl(19991204)。African AIDS Victims Losers of Drug War: U.S. Policy Keeps Prices Prohibitive。  new window
13.Schoonveld, Ed。Market Segmentation and International Price Referencing,http://www.who.int/medicines/libraiy/cdm-general/who-wto-hosbjor/18Scho onveld.doc, 2002/05/07。  new window
14.Watal, Jayashree。Workshop on Differential Pricing and Financing of Essential Drugs16, Background Note,http://www.wto.org/ English/tratop_e/trips_e/wto_background_e.doc, 2002/05/19。  new window
 
 
 
 
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