Extending the Limits of Protection of Pharmaceutical Patents and Data Outside the EU – Is There a Need to Rebalance?

IIC - International Review of Intellectual Property and Competition Law - Tập 45 - Trang 256-286 - 2014
Daniel Acquah1
1Turun Yliopisto, Turku, Finland

Tóm tắt

The European Union (EU) has instituted internal and external measures aimed at protecting and enforcing intellectual property rights. In the area of pharmaceutical patents, the Union has also sought to protect its industries through patent term extension and data exclusivity. Recent EU Free Trade Agreements (FTAs) with developing countries contain chapters on intellectual property that extend patent terms and data exclusivity for pharmaceutical products. Such acts further prolong the lifespan of protection given to existing products and limit generic market entry. This article identifies the issue as one of “cross-pollination” of laws and argues that since similar laws exist in the internal regime of the EU, incorporating them into the EU would not be technically too difficult. However, to an extent this regime is simulated in developing countries, implementation will bring major difficulties to the health sector and economies of these countries. The article thus proposes that developing countries should not be forced to adopt such laws through FTAs, and if they are, there should be the compulsory inclusion of both (1) a clause on transitional arrangements for developing countries specific to intellectual property; and (2) a clause that clearly links the objectives for intellectual property protection and enforcement (in this context, patent term extension and data exclusivity) to balancing between the promotion of technological innovation and access to medicines.

Tài liệu tham khảo

Atkinson M (2002) Patent protection for pharmaceuticals: a comparative study of the law in the United States and Canada. Pac Rim L Policy 11:184

Abbott FM (2002) The Doha Declaration on TRIPS agreement and public health: lighting a dark corner at the WTO. J Int Econ L 469–505

Abbott F (2004) The Doha Declaration on the TRIPS agreement and public health and the contradictory trend in bilateral and regional free trade agreements. Quaker United Nations Office Occasional Papers, vol 14, p 8. Available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1977300

Adamini S, Maarse H, Versluis E, Light DW (2009) Policy making on data exclusivity in the European Union: from industrial interests to legal realities. J Health Polit Policy L 34(6):989–992

Adamski J, Godman B, Ofierska-Sujkowska G, Osińska B, Herholz H, Wendykowska K, Laius O, Jan S, Sermet C, Zara C, Kalaba M, Garuolienè K, Haycox A, Garattini S, Gustafsson LL (2010) Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European Payers. BMC Health Serv Res 10(153):1. Available at http://www.biomedcentral.com/1472-6963/10/153

Baker BK (2008) Ending drug registration apartheid: taming data exclusivity and patent/registration linkage. Am J L Med 34:305

Cameron A, Ewen M, Ross-Degnan D, Ball D, Laing R (2009) Medicine prices, availability and affordability in 36 developing and middle-income countries: a secondary analysis. Lancet, p 1. Available at http://www.thelancet.com/journals/lancet/issue/current?tab=past

Clarke DC (2003) China’s legal system and the WTO: prospects for compliance. Wash Univ Glob Stud L Rev 97:97–118

Correa CM (2001) Review of the TRIPS agreement: fostering the transfer of technology to developing countries, 13. Third World Network Trade & Development Series

Correa CM (2006) Implications of bilateral free trade agreements on access to medicines. Bull World Health Organ 84(5):401

Dahrendorf A (2009) Global proliferation of bilateral and regional trade agreements: a threat for the World Trade Organization and/or for developing countries. Maastricht Faculty of Law Working Paper, vol 6, p 18

David M (2010) Providing access to medical products at prices patients can afford is a priority for the European Parliament. J Generic Med 7(4):304

Di Masi JA, Grabowski HG, (2007) The cost of biopharmaceuticals R&D: is biotech different? Manag Decis Econ 28:469, 473

Di Masi JA, Seibring MA, Lasagna L (1994) New drug development in the United States from 1963 to 1992. Clin Pharmacol Ther 55:609–622

Di Masi JA, Hansen RW, Grabowski HG (2003) The price of innovation: new estimates of drug development costs. J Health Econ 22(3):141–185

Dommen C (2005) Trade and human rights: towards coherence. SUR Int J Hum Rights 3:7–23. Available at http://www.surjournal.org

Drahos P (2001) BITS and BIPS: Bilateralism in intellectual property. J World Intellect Prop 4:791

Drahos P (2007) Trust me: patent offices in developing countries. Centre for Governance of Knowledge and Development Working Paper, Australian National University (2007), pp 1–34. Unavailable at http://www.cgkd.anu.edu.au

Drexl J (2012) Intellectual property and implementation of recent bilateral trade agreements in the EU. Max Planck Institute for Intellectual Property and Competition Law Research Paper No. 12-09, pp 7–8

El Said MK (2010) Public health Related TRIPS-plus provisions in bilateral trade agreements: a policy guide for negotiators and implementers in the Eastern Mediterranean Region. World Health Organization and International Centre for Trade and Sustainable Development publication, p 17

Fisher JA (1986) Disclosure of safety and effectiveness under the drug price competition and Patent Term Restoration Act. Food Cosmet L J 41:269

Flynn SM, Baker B, Kaminski M, Koo J (2012) The U.S proposal for an intellectual property chapter in the Trans-Pacific Partnership Agreement. Am Univ Int L Rev 28(105):107

Gitter DM (2008) Innovators and imitators: an analysis of proposed legislation implementing an abbreviated approval pathway for follow-on biologics in the United States. Fla State Univ L Rev, pp 555, 590–609

Godman B, Haycox A, Schwabe U, Joppi R, Garattini S (2008) Having your cake and eating it: office of fair trading proposal for funding new drugs to benefit patients and innovative companies. PharmacoEconomics 26(2):91–98

Godman B, Shrank W, Wettermark B, Andersen M, Bishop I, Burkhardt T, Garuolienè K, Kalaba M, Laius O, Joppi R, Sermet C, Schwabe U, Teixeira I, Tulunay FC, Wendykowska K, Zara C, Gustafsson LL (2010) Use of generics: a critical cost containment measure for all healthcare professionals in Europe? Pharmaceuticals 3:2470–2494

Govaere I (2008) With eyes wide shut: the EC strategy to enforce intellectual property rights abroad. In: Dashwood A, Maresceau M (eds) Law and practice of EU external relations. Salient features of a changing landscape. Cambridge University Press, New York, pp 406–421

Grabowski HG (2007) Data exclusivity for new biological entities. Duke University Department of Economics Working Paper, pp 2–38

Grabowski HG (2008) Follow-on-biologic: data exclusivity and the balance between innovation and competition. Nat Rev Drug Discov AOP, pp 1–9

Grosse Ruse-Khan H (2009) Time for a paradigm shift? exploring maximum standards in international IP protection. Trade L Dev 1(56):57–102

Grosse Ruse-Khan H (2011a) The International law relation between TRIPS and subsequent TRIPS-plus free trade agreement: towards safeguarding TRIPS flexibilities? J Intell Prop L 18(2):327

Grosse Ruse-Khan H (2011b) Protecting intellectual property under BITs, FTAs, and TRIPS: conflicting regimes or mutual coherence? Max Planck Institute for Intellectual Property, Competition & Tax Law Research Paper Series No. 11-02, p 11. Available: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1757724

Helfer LR (2004) Regime shifting: the TRIPs agreement and new dynamics of international intellectual property lawmaking. Yale J Int L 29(1):6–9

Higgins MJ, Graham SJH (2009) Balancing innovation and access: patent challenges tip the scales. Science 326:370

Ho CM (2011a) Beyond Patents: protecting drugs through regulatory laws. Loyola University Chicago School of Law Public Law and Legal Theory Research Paper No. 34

Ho CM (2011b) An OVERVIEW of ‘TRIPS-plus’ Standards. Loyola University Chicago School of Law Public Law & Legal Theory Research Paper No. 33, pp 224–251

Ho CM (2011c) Access to medicine in the global economy: international agreements on patents and related rights. Oxford University Press, Oxford, pp 89–124

Kur A, Grosse Ruse-Khan H (2008) Enough is enough—the notion of binding ceilings in international intellectual property protection. Max Planck Institute for intellectual property, competition & tax law research paper series No. 09-01

Lourie AD (1985) Patent term restoration: history, summary and appraisal. Food Drug Cosmet L J 40:351

Love JP (1997) Health registration data exclusivity, biomedical research, and restrictions on the introduction of generic drugs. Statement before U.S. Senate, Subcommittee on Labor, Health, and Human Services and Education and Related Agencies Committee on Appropriations. 105th Cong., 1st Sess. Available: http://www.cptech.org/pharm/senhregd.html

Maxwell MR (2010) Regulation of innovation under follow-on biologics legislation: FDA exclusivity as an efficient incentive mechanism. Columbia Sci Technol L Rev XI:95

Mazer EH (1993) Supplementary protection certificate in the European Economic Community. Food Drug L J 48:572

Moore JW (1998) Patent term restoration for pharmaceutical products in Europe: the supplementary protection certificate. Can Intell Prop Rev 14:137

Mulaje SS, Birajdar SM, Patil BR, Bhusnure OG (2013) Procedure for drug approval in different countries: a review. J Drug Deliv Ther 3:233

Mylly T (2014) Constitutional functions of the EU’s intellectual property treaties. In: Drexl J et al. (eds) EU bilateral trade agreements and intellectual property: For better or worse? MPI studies on intellectual property and competition law, vol 20. Springer, Berlin/Heidelberg, pp 241–262

Okediji RL (2003–2004) Back to bilateralism? Pendulum swings in international intellectual property protection. Univ Ottawa L Technol J 127–147

Pugatch MP (2005) Data exclusivity: implications for developing countries. Comment – Nos. 6–7. Bridges, p 21

Reichman JH (2009) The international legal status of undisclosed clinical trials data: from private to public goods? Marquette Intellect Prop L Rev 13(1):17

Roffe P, Vea G (2008) The WIPO development agenda in an historical and political context. In: Netanel NW (ed) The development agenda: global intellectual property and developing countries. Oxford University Press, Oxford, pp 79–111

Sanjuan JR (2006) US and EU protection of pharmaceutical test data. Consumer Project on Technology Discussion Paper No. 1, p 4. Available at: http://www.keionline.org/miscdocs/

Seeley E, Kanavos P (2008) Generic medicines from a societal perspective: savings for healthcare systems. Eurohealth 14(2):18–22

Sell SK (2007) TRIPS-plus free trade agreements and access to medicines. Liverp L Rev 28

Sell S (2010) The global IP upward ratchet, anti-counterfeiting and piracy enforcement efforts: the state of play. Program on Information Justice and Intellectual Property Research Paper No. 15, American University Washington College of Law, pp 1–22

Sell SK (2011) TRIPS was never enough: vertical forum shifting, FTAs, ACTA and TPP. J Intellect Prop L 18:448–478

Shaffer ER, Brenner JE (2009) A trade agreement’s impact on access to generic drugs. Health Aff 28:957, 961, 964–965

Simeons S (2008) Generic medicine pricing in Europe: current issues and future perspective. J Med Econ 11(1):171–175

Simoens S, De Coster S (2006) Sustaining generic medicines markets in Europe, Report. Katholieke Universiteit Leuven, Leuven

Simoens S, Verbeken G, Huys I (2011) Market access of biologics: not only a cost issue. Oncologie 13:218–221

Soehnge H (2003) The drug price competition and patent term restoration act of 1984: fine-tuning the balance between the interest of pioneer and generic drug manufacturers. Food Drug L J 58(51):51–80

Storz U (2012) Patent lifecycle management, supplementary protection certificates and data exclusivity in biopharmaceutics. In: Hubel A et al (eds) Biopatent law: patent strategies and patent management, p 32 (SpringerBriefs in Biotech Patents)

Tandon Y (2008) Editorial: WIPO, WCO, Intellectual property and border guards. South Bull (South Centre, Geneva, Switzerland). Available at http://vi.unctad.org/uwist08/sessions/tue0513/southcentrebull.pdf

Vernon JA, Bennett A, Golec JH (2010) Exploration of potential economics of follow-on biologics and implications for data exclusivity periods for biologics. BU J Sci Technol 16(55):55–74

Vogler S, Zimmermann N, Leopold C, de Joncheere K (2011) Pharmaceutical policies in European countries in response to the global financial crisis. South Med Rev 4(2):22–30

Walker S (2001) The TRIPS agreement, sustainable development and the public interest, vol 23. IUCN Environmental Policy and Law Paper No. 41. Available at http://data.iucn.org/dbtw-wpd/edocs/EPLP-041.pdf

WHO (2004) Equitable access to essential medicines: a framework for collective action. World Health Organisation, Geneva

Yu PK (2012) Intellectual property and human rights in the nonmultilateral era. Fla L Rev 64(4):1046

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IIC - International Review of Intellectual Property and Competition Law

Tập 45

256-286

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