药品专利常青化策略及应对之探讨
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摘要
药品专利常青化指的是品牌药制药商为了延长其核心药物的专利期或者市场独占期而采取的法律和商业措施,这些措施会阻碍相关仿制药进入市场,使得药品价格居高不下,进而对公共健康产生负面影响。本文采用了比较法研究、案例研究等方法,介绍了国外实践中制药企业常采取的专利常青化策略,以诺华案为例评述了印度法院对次级专利是否具有创新性的判断过程;分析了专利常青化的影响,并对各国对于常青专利的应对措施做了梳理;最后结合我国医药产业的发展现状,从事前和事后两方面,探讨了我国应对常青化专利的态度以及可采取的措施。
Evergreening of drug patent is any of legal and commercial measures by which branded drug producers extend patent period or market exclusivity of core drugs. These measures could have a negative impact on public health by preventing generic drugs from entering the market and keeping drug prices high. Using the methods of comparative legal research and case study, this paper introduces strategies of patent evergreening which are often adopted by pharmaceutical companies in foreign practice, and takes the case of Novartis AG v. Union of India as an example to review the judgment process of Indian court on whether the secondary patent is innovative or not. This paper analyzes the influences of patent evergreening and sorts out the countermeasures to evergreen patent in various countries. Finally, based on the development status of Chinese pharmaceutical industry, this paper discusses China′s attitude and measures to be taken to evergreen patent from pre-and post-event aspects.
Evergreening of drug patent is any of legal and commercial measures by which branded drug producers extend patent period or market exclusivity of core drugs. These measures could have a negative impact on public health by preventing generic drugs from entering the market and keeping drug prices high. Using the methods of comparative legal research and case study, this paper introduces strategies of patent evergreening which are often adopted by pharmaceutical companies in foreign practice, and takes the case of Novartis AG v. Union of India as an example to review the judgment process of Indian court on whether the secondary patent is innovative or not. This paper analyzes the influences of patent evergreening and sorts out the countermeasures to evergreen patent in various countries. Finally, based on the development status of Chinese pharmaceutical industry, this paper discusses China′s attitude and measures to be taken to evergreen patent from pre-and post-event aspects.
引文
[1] Inderjit Singh Bansal, Deeptymaya Sahu, Gautam Bakshi,Sukhjeet Singh. Evergreening A Controversial Issue inPharma Milieu[J]. Journal of Intellectual Property Rights,2009, 14(4).
[2] GauravDwivedi, SharanabasavaHallihosur, LathaRangan.Evergreening:A deceptive device in patent rights[J].Technology in Society, 2010, 22(4):324-330.
[3] Richard A. Castellano. Patent Law for New Medical Usesof Known Compounds and Pfizer's Viagra Patent[J].IDEA-The Intellectual Property Law Review, 2005, 46(2):283-315.
[4] Saby Ghosray. 3(d)View of India's Patent Law:Social Jus-tice Aspiration Meets Property Rights in Novartis v. Unionof India&Others[J]. The John Marshall Review of Intel-lectual Property Law, 2014(13):721-759.
[5] Shamnad Basheer. First Mailbox Opposition(Gleevec)De-cided in India. From SpicyIP, 11 March, 2006 http://spicyip.com/2006/03/first-mailbox-opposition-gleevec.html.
[6] Thamaray Govender, Danie Dohmen. Novartis A.G. V U-nion of India-The Gleevec Case and Evergreening, 10November, 2013, https://www.lexology.com/library/detail.aspxg=97441a81-b27b-43aa-a8ee-bf2522339cf0.
[7] Novartis AG v. Union of India, 2007 A.I.R. 24759(2013)(Madras H.C.).
[8] Novartis AG vs Union of India&Ors on 1 April, 2013.
[9] William J. Bennett. Indian Pharmaceutical Patent Law andthe Effects of Novartis AG v. Union of India[J]. Washing-ton University Global Studies Law Review, 2014(13):535-557.
[10] Michael Enzo Furrow. Pharmaceutical Patent Life-CycleManagement after KSR v. Teleflex[J]. Food and Drug LawJournal, 2008(63):275-320.
[11] Kerstin R觟hss, G觟ran Hasselgren, Hans Hedenstr觟m. Ef-fect of Esomeprazole 40 mg vs Omeprazole 40 mg on 24-Hour Intragastric pH in Patients with Symptoms of Gas-troesophageal Reflux Disease[J].Digestive Diseases andSciences, 2002, 47(5):954-958.
[12] Shuchi Midha. Strategies for drug patent ever-greening inthe pharmaceutical industry[J].International Journal ofPharmaceutical Sciences and Business Management,2015,3(3).
[13] Lawsuit filed over tamoxifen, Deseret News Business, May10, 2001, https://www.deseretnews.com/article/841973/Law-suit-filed-over-tamoxifen.html.
[14] Joblove v. Barr Labs., Inc.(In re Tamoxifen Citrate An-titrust Litig.), Docket No. 03-7641.
[15] European Commission DG Competition Staff Working Pa-per, Pharmaceutical Sector Inquiry Preliminary Report, 28November 2008, Retrieved from http://ec.europa.eu/com-petition/sectors/pharmaceuticals/inquiry/preliminary_re-port.
[16] Dennis Z. Kvesic. Marketing Strategy Product lifecyclemanagement:marketing strategies for the pharmaceuticalindustry[J].Journal of Medical Marketing:Device, Diagnostic and Phar-maceutical Marketing, 2008, 8(4):293-301.
[17] Kupecz A, Simmons&Simmons, E. SPCs covering com-bination products current validity issues across Europe?Retrieved from http://www.eplawpatentblog.com/2010/April/spc%20article%20eplaw%20blog%20final%20with%20refs.
[18] Sigma Pharmaceuticals(Australia)Pty Ltd v Wyeth[2011]FCAFC 132(28 October 2011).
[19]崔国斌.专利法:原理与案例[M].北京:北京大学出版社,2016.
[20] V. Sasirekha. Ethically Practiced Unethical Strategies InPharma Industry Whom to be blamed[J]. InternationalJournal of Research Granthaalayah, 2018, 6(2):32-45.
[21]Drug Price Competition and Patent Term Restoration Actof 1984, Sec.101 vii.
[22] Thomas A Faunce, Joel Lexchin.'Linkage'pharmaceuti-cal evergreening in Canada and Australia[J]. Australia andNew Zealand Health Policy, 2007, 4(8).
[23] Suzanne Marie Porter, Canadian Generic PharmaceuticalAssociation:The patented medicines(notice of compli-ance)regulations,多伦多大学法学院硕士学位论文.
[24] National Institute for Health Care Management:ChangingPatterns of Pharmaceutical Innovation. Research Report.2002, For a good discussion on evergreening techniquesand the Hatch-Waxman law.
[25] Office of the US Trade Representative:Proposed text:US-Korea Free Trade Agreement, http://www.ustr.gov/Trade_Agreements/Bilateral/Republic_of_Korea_FTA/Draft_Text/Section_Index.html.
[26] Bhaven N.Sampat, Kenneth C, Shadlen. TRIPS imple-mentation and secondary pharmaceutical patenting inbrazil and india[J]. Studies in Comparative InternationalDevelopment, 2015, 50(2):228-257.
[27] Jodie Liu. Compulsory Licensing and Anti-Evergreening:Interpreting the TRIPS Flexibilities in Sections 84 and 3(d)of the Indian Patents Act[J]. Harvard International LawJourna, 2015, 56(1).
[28] CompareAlbertI.Wertheimer&ThomasM.Santella, Pharma-coevolution:TheBenefitsofIncremental Innovation, 8(IPNWorking Paper on Intellectual Property, Innovation andHealth, 2005)with Kapczyn-ski, supra note 7, at 1577.转引自Jodie Liu. Compulsory Licensing and Anti-Ever-greening:Interpreting the TRIPS Flexibilities in Sections84 and 3(d)of the Indian Patents Act[J]. Harvard Interna-tional Law Journa,2015, 56(1):.
[29] Kenneth C. Shadlen. The Political Contradictions of Incre-mental Innovation:Lessons from Pharmaceutical PatentExamination in Brazil[J]. Politics&Society, 2011, 39(2).
[30] 42家典型的创新型医药企,https://xueqiu.com/1762274635/57461222.
[31] WHO. Protection of data submitted for the registration ofpharma-ceuticals:implementing the standards of the tripsagreement[EB/OL][2010-10-20]. http://www. who.int/medicines/areas/policy/protection of data.pdf.转引自刘金洁.完善中国药品数据保护的研究[J].中国新药杂志,2012,21(1):6-9.
[32]李晓秋.常青药品专利的司法控制加拿大礼来案评析及其镜鉴[J].知识产权, 2015(10):130-135.
(1)药物的固体形式是指”当药物本身被制造时,各个分子一起被包装成固体的方式”。诺华公司1993年的专利申请仅涉及游离碱伊马替尼,并未指明尚未配制的格列卫的特定属性。
(2)在此期间,药品注册审批部门不受理其他相同药物成分的新药申请,以及依赖新药的试验数据并且未得到数据持有人授权而提出的仿制药申请。
(3)对于符合条件的药品专利,延长其专利保护期间。
[2] GauravDwivedi, SharanabasavaHallihosur, LathaRangan.Evergreening:A deceptive device in patent rights[J].Technology in Society, 2010, 22(4):324-330.
[3] Richard A. Castellano. Patent Law for New Medical Usesof Known Compounds and Pfizer's Viagra Patent[J].IDEA-The Intellectual Property Law Review, 2005, 46(2):283-315.
[4] Saby Ghosray. 3(d)View of India's Patent Law:Social Jus-tice Aspiration Meets Property Rights in Novartis v. Unionof India&Others[J]. The John Marshall Review of Intel-lectual Property Law, 2014(13):721-759.
[5] Shamnad Basheer. First Mailbox Opposition(Gleevec)De-cided in India. From SpicyIP, 11 March, 2006 http://spicyip.com/2006/03/first-mailbox-opposition-gleevec.html.
[6] Thamaray Govender, Danie Dohmen. Novartis A.G. V U-nion of India-The Gleevec Case and Evergreening, 10November, 2013, https://www.lexology.com/library/detail.aspxg=97441a81-b27b-43aa-a8ee-bf2522339cf0.
[7] Novartis AG v. Union of India, 2007 A.I.R. 24759(2013)(Madras H.C.).
[8] Novartis AG vs Union of India&Ors on 1 April, 2013.
[9] William J. Bennett. Indian Pharmaceutical Patent Law andthe Effects of Novartis AG v. Union of India[J]. Washing-ton University Global Studies Law Review, 2014(13):535-557.
[10] Michael Enzo Furrow. Pharmaceutical Patent Life-CycleManagement after KSR v. Teleflex[J]. Food and Drug LawJournal, 2008(63):275-320.
[11] Kerstin R觟hss, G觟ran Hasselgren, Hans Hedenstr觟m. Ef-fect of Esomeprazole 40 mg vs Omeprazole 40 mg on 24-Hour Intragastric pH in Patients with Symptoms of Gas-troesophageal Reflux Disease[J].Digestive Diseases andSciences, 2002, 47(5):954-958.
[12] Shuchi Midha. Strategies for drug patent ever-greening inthe pharmaceutical industry[J].International Journal ofPharmaceutical Sciences and Business Management,2015,3(3).
[13] Lawsuit filed over tamoxifen, Deseret News Business, May10, 2001, https://www.deseretnews.com/article/841973/Law-suit-filed-over-tamoxifen.html.
[14] Joblove v. Barr Labs., Inc.(In re Tamoxifen Citrate An-titrust Litig.), Docket No. 03-7641.
[15] European Commission DG Competition Staff Working Pa-per, Pharmaceutical Sector Inquiry Preliminary Report, 28November 2008, Retrieved from http://ec.europa.eu/com-petition/sectors/pharmaceuticals/inquiry/preliminary_re-port.
[16] Dennis Z. Kvesic. Marketing Strategy Product lifecyclemanagement:marketing strategies for the pharmaceuticalindustry[J].Journal of Medical Marketing:Device, Diagnostic and Phar-maceutical Marketing, 2008, 8(4):293-301.
[17] Kupecz A, Simmons&Simmons, E. SPCs covering com-bination products current validity issues across Europe?Retrieved from http://www.eplawpatentblog.com/2010/April/spc%20article%20eplaw%20blog%20final%20with%20refs.
[18] Sigma Pharmaceuticals(Australia)Pty Ltd v Wyeth[2011]FCAFC 132(28 October 2011).
[19]崔国斌.专利法:原理与案例[M].北京:北京大学出版社,2016.
[20] V. Sasirekha. Ethically Practiced Unethical Strategies InPharma Industry Whom to be blamed[J]. InternationalJournal of Research Granthaalayah, 2018, 6(2):32-45.
[21]Drug Price Competition and Patent Term Restoration Actof 1984, Sec.101 vii.
[22] Thomas A Faunce, Joel Lexchin.'Linkage'pharmaceuti-cal evergreening in Canada and Australia[J]. Australia andNew Zealand Health Policy, 2007, 4(8).
[23] Suzanne Marie Porter, Canadian Generic PharmaceuticalAssociation:The patented medicines(notice of compli-ance)regulations,多伦多大学法学院硕士学位论文.
[24] National Institute for Health Care Management:ChangingPatterns of Pharmaceutical Innovation. Research Report.2002, For a good discussion on evergreening techniquesand the Hatch-Waxman law.
[25] Office of the US Trade Representative:Proposed text:US-Korea Free Trade Agreement, http://www.ustr.gov/Trade_Agreements/Bilateral/Republic_of_Korea_FTA/Draft_Text/Section_Index.html.
[26] Bhaven N.Sampat, Kenneth C, Shadlen. TRIPS imple-mentation and secondary pharmaceutical patenting inbrazil and india[J]. Studies in Comparative InternationalDevelopment, 2015, 50(2):228-257.
[27] Jodie Liu. Compulsory Licensing and Anti-Evergreening:Interpreting the TRIPS Flexibilities in Sections 84 and 3(d)of the Indian Patents Act[J]. Harvard International LawJourna, 2015, 56(1).
[28] CompareAlbertI.Wertheimer&ThomasM.Santella, Pharma-coevolution:TheBenefitsofIncremental Innovation, 8(IPNWorking Paper on Intellectual Property, Innovation andHealth, 2005)with Kapczyn-ski, supra note 7, at 1577.转引自Jodie Liu. Compulsory Licensing and Anti-Ever-greening:Interpreting the TRIPS Flexibilities in Sections84 and 3(d)of the Indian Patents Act[J]. Harvard Interna-tional Law Journa,2015, 56(1):.
[29] Kenneth C. Shadlen. The Political Contradictions of Incre-mental Innovation:Lessons from Pharmaceutical PatentExamination in Brazil[J]. Politics&Society, 2011, 39(2).
[30] 42家典型的创新型医药企,https://xueqiu.com/1762274635/57461222.
[31] WHO. Protection of data submitted for the registration ofpharma-ceuticals:implementing the standards of the tripsagreement[EB/OL][2010-10-20]. http://www. who.int/medicines/areas/policy/protection of data.pdf.转引自刘金洁.完善中国药品数据保护的研究[J].中国新药杂志,2012,21(1):6-9.
[32]李晓秋.常青药品专利的司法控制加拿大礼来案评析及其镜鉴[J].知识产权, 2015(10):130-135.
(1)药物的固体形式是指”当药物本身被制造时,各个分子一起被包装成固体的方式”。诺华公司1993年的专利申请仅涉及游离碱伊马替尼,并未指明尚未配制的格列卫的特定属性。
(2)在此期间,药品注册审批部门不受理其他相同药物成分的新药申请,以及依赖新药的试验数据并且未得到数据持有人授权而提出的仿制药申请。
(3)对于符合条件的药品专利,延长其专利保护期间。