Skip to main content
SpringerLink
Log in

Patent Regulatory and Institutional Mechanisms in Sub-Saharan Africa

  • Chapter
  • First Online:
Patenting of Pharmaceuticals and Development in Sub-Saharan Africa

  • 656 Accesses

Abstract

The preceding chapters have informed us about the historical processes (and its inherent inequities) that led to the prevailing international patent system. The historically rooted marginalization of SSA countries and their citizens in the adoption and implementation of TRIPS pose a significant challenge to the functioning of the globalized patent regime and its domestic variations in SSA. In addition, the dominant economic rationale undergirding the globalized patent system promotes a one-size-fits-all system, which is a poor fit for the social conditions in SSA, and eventually contributes to impoverishing countries in SSA. These conclusions have been arrived at both by critiquing developments that led to TRIPS and by examining the theoretical justifications for patents. Today, those same power politics and the messianic assumptions that have served the economic interests of big pharma continue to shape the international patent system and its reflections in SSA.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Notes

  1. 1.

    Paris Convention for the Protection of Industrial Property, 1883, 21 UST 1538, 828 UNTS 305 (last revision: 14 July 1967).

  2. 2.

    Concluded at Washington on 19 June 1970, amended on 28 September 1979, modified on 3 February 1984, and on 3 October 2001.

  3. 3.

    Mgbeoji (2006) at 45.

  4. 4.

    1976 YBUN 1052. This Statute was concluded in San Francisco on 26 June 1945, and entered into force on 24 October 1945.

  5. 5.

    See Harris (2006) at 694.

  6. 6.

    See de Carvalho (2006) at 100.

  7. 7.

    See Dreyfuss et al. (2004) at xi.

  8. 8.

    This instrument was adopted on 9 December 1976, and amended by the Administrative Council of ARIPO on 10 December 1982, 12 December 1986 and 27 November 1996, and was further amended by the Council of Ministers on 13 August 2004. Presently, there are 18 ARIPO member states.

  9. 9.

    OAPI was established in 1962 at Libreville. Presently, it has 16 member-states, which consist of Benin, Burkina Faso, Cameroon, Central Africa, Congo, Cote d'Ivoire, Equatorial Guinea, Gabon, Guinea, Guinea Bissau, Mali, Mauritania, Niger, Senegal, Chad, and Togo.

  10. 10.

    Tabaro (2009) at 579 [Tabaro, “Patent Law Reform in Uganda”].

  11. 11.

    See the Harare Protocol on Patents and Industrial Designs, 1982. This Protocol amended the ARIPO instrument to accord the organization more powers.

  12. 12.

    See Mey (2010).

  13. 13.

    This amendment by the Administrative Council of ARIPO took effect from 1 July 1994.

  14. 14.

    See Mey (2010), supra note 12 at 408.

  15. 15.

    See Mgbeoji (2007) 259 at 224.

  16. 16.

    See Mgbeoji (2007), ibid at 290-291; La Croix and Liu (2008) at 439.

  17. 17.

    El-Said (2005) at 55.

  18. 18.

    See Morin (2006).

  19. 19.

    Tabaro (2009) supra note 10 at 589. The reality is that LDCs such as Benin, Burkina Faso, Burundi, Chad, Central African Republic, Democratic Republic of Congo, Gambia, Guinea, Guinea-Bissau, Lesotho, Madagascar, Malawi, Mali, Mauritania, Mozambique, Niger, Rwanda, Senegal, Sierra Leone, Swaziland, Tanzania, Togo, Uganda, and Zambia all provide protection for pharmaceutical patents.

  20. 20.

    Oguamanam (2010) at 558.

  21. 21.

    Bhagwati (2004) at 182–183.

  22. 22.

    See Part II of TRIPS—Standards Concerning the Availability, Scope and Use of Intellectual Property Rights.

  23. 23.

    Article 8 of the TRIPS Agreement (emphasis added).

  24. 24.

    See paragraph 5(a) of the Doha Declaration; paragraph 19 of the Doha Ministerial Declaration.

  25. 25.

    Kihwelo (2006).

  26. 26.

    Article 27.1 of the TRIPS Agreement.

  27. 27.

    Endeshaw (2002) at 61 [Endeshaw, “The Paradox of IP Law-Making”].

  28. 28.

    See Article 27.1 of the TRIPS Agreement.

  29. 29.

    Article 3.1 of the TRIPS Agreement.

  30. 30.

    Article 4 of the TRIPS Agreement.

  31. 31.

    See Article 1 of the TRIPS Agreement.

  32. 32.

    See Sections 34-38 of Botswana’s Industrial Property Act No. 14 of 1996.

  33. 33.

    See Sections 16-18 of Ghana’s Patents Act, 2003.

  34. 34.

    Sections 41-44 of Uganda’s Patent Act, 1993.

  35. 35.

    Utility patents are lower forms of inventions that are new and industrially applicable but do not involve an inventive step.

  36. 36.

    World Bank, World Development Indicators, 2000.

  37. 37.

    See Swakopmund Protocol on the Protection of Traditional Knowledge and Expressions of Folklore, 2010.

  38. 38.

    See Article 33 of the TRIPS Agreement.

  39. 39.

    See Article 39.3 of TRIPS.

  40. 40.

    See US Drug Price Competition and Patent Term Restoration Act of 1984, Pub L No. 98-417, 98 Stat. 1585 [granting protection to marketing exclusivity for 5 years extends from the approval of the original drug to the approval of a generic version based on bioequivalence]; Canada Food and Drug Regulations (as amended) 2006 [granting clinical test data protection for 8 years. However, the generic companies are able to submit application for approval drug using such data after 6 years of protection]; Directive 2004/27/EC [granting protection to clinical data exclusivity for 11 years].

  41. 41.

    ’t Hoen (2009) at 2.

  42. 42.

    See Article 28.1 of TRIPS.

  43. 43.

    See Article 28.2 of TRIPS.

  44. 44.

    See Article 41 of TRIPS.

  45. 45.

    See Llewelyn (2005) at 20 [Llewelyn, “Schrodinger’s Cat”].

  46. 46.

    See Article 27.3 of the TRIPS Agreement.

  47. 47.

    See Article 31(f) of the TRIPS Agreement. As I explain below, the amendment of Article 31 (which becomes Article 31bis) of TRIPS comes into force when two-thirds of WTO members ratify the amendment.

  48. 48.

    Article 29.1 of the TRIPS Agreement.

  49. 49.

    Free World Trust v Electro Santé Inc, [2002] 2 SCR 1024, 2000 SCC 66 at para 44.

  50. 50.

    Piper (2008) at 21.

  51. 51.

    Vaver (1997) at 139.

  52. 52.

    Hestermeyer (2007) at 67.

  53. 53.

    An example of such a threat was issued in 1997 against Mandela’s government by the US for permitting the manufacture of generic versions of HIV/AIDS medicines.

  54. 54.

    See Decision of the Council for TRIPS, Extension of the Transition Period under Article 66.1 for Least-Developed Country Members (29 November 2005); Paragraph 7 of the Doha Declaration. See also “The Doha Declaration Explained – TRIPS”, online: http://www.wto.org/english/tratop_e/dda_e/dohaexplained_e.htm.

  55. 55.

    On the national treatment principle, Article 3 of the TRIPS Agreement (Part I) provides that each WTO member shall accord to nationals of other member states treatment no less favourable than it accords to its own nationals with regard to protection.

  56. 56.

    On the most favoured nation principle, Article 4 of the TRIPS Agreement (Part I) stipulates that any advantage, favour, privilege or immunity granted by a WTO member to the nationals of any other country shall be accorded immediately and unconditionally to the nationals of all other member states.

  57. 57.

    Hestermeyer (2007), supra note 52 at 74 [mandating members to provide what is called a ‘mailbox’ system for exclusive marketing of pharmaceuticals for 5 years in consonance with Article 70.8 & 70.9 of TRIPS].

  58. 58.

    See Article 65.5 of the TRIPS Agreement.

  59. 59.

    See Hill and Johnson (2004) at 7.

  60. 60.

    See Smith et al. (2009) at 688.

  61. 61.

    See e.g. Stiglitz (2008) at 1701.

  62. 62.

    Stiglitz (2008), supra note 61 at 1701.

  63. 63.

    Endeshaw (2002), supra note 27 at 50.

  64. 64.

    Sell (2003) at 160.

  65. 65.

    Paragraph 4 of the Doha Declaration.

  66. 66.

    Paragraph 4 of the Doha Declaration.

  67. 67.

    See Paragraphs 1 and 5 of the Doha Declaration; Outterson (2008) at 281.

  68. 68.

    Article 31(b) of the TRIPS Agreement.

  69. 69.

    Paragraph 5(d) of the Doha Declaration.

  70. 70.

    Paragraph 6 of the Doha Declaration.

  71. 71.

    See Article 31(f) of TRIPS.

  72. 72.

    Mgbeoji (2007), supra note 15 at 274–275.

  73. 73.

    Goodwin (2008) at 580.

  74. 74.

    See Ghana’s High Court (Civil Procedure) Rules, 2004 (CI. 47); Tanzania’s High Court Registries (Amendment) Rules 1999 [all establishing Commercial High Courts to enforce IP rights].

  75. 75.

    Section 3(1) of Ghana’s Patents Act, 2003 (Act 657).

  76. 76.

    Section 8 of Uganda’s Patents Act, 1993.

  77. 77.

    Section 8 of Botswana’s Industrial Property Act No. 14 of 1996.

  78. 78.

    Section 25(1) of South Africa’s Patent Act No. 57 of 1978 (as amended).

  79. 79.

    Amani (2009) at 50.

  80. 80.

    Llewelyn (2005), supra note 45 at 28.

  81. 81.

    Ho (2011) at 18 [Ho, Access to Medicine].

  82. 82.

    Llewelyn (2005), supra note 45 at 23.

  83. 83.

    Prior art consists of any oral or written disclosure, in connection with the invention, made anywhere to the public prior to the filing of the patent application.

  84. 84.

    Amani (2009), supra note 79 at 50.

  85. 85.

    Hestermeyer (2007), supra note 52 at 66.

  86. 86.

    See Boldrin and Levine (2008) at 7.

  87. 87.

    I rely on a research proposal submitted by Professor Ikechi Mgbeoji, Osgoode Hall Law School, York University, for an Open A.I.R. study in writing this section. I am also indebted to a number of patent examiners/administrators and practitioners in Ghana, ARIPO, Uganda, and South Africa for sharing pieces of information that helped in validating claims in the literature about patent administration in SSA countries.

  88. 88.

    UNCTAD-ICTSD (2005) at 19.

  89. 89.

    See Okediji (2004) at 250 [Okediji, “Africa and the Global IP System”].

  90. 90.

    Ho (2011), supra note 81 at 19.

  91. 91.

    Mgbeoji (2011).

  92. 92.

    Mgbeoji (2011), ibid.

  93. 93.

    See World Bank, World Development Indicators (2000).

  94. 94.

    Ikechi Mgbeoji, “Rethinking the Failure of African States to Examine and Collate Patent Applications” (2011) [unpublished, on file with the author].

  95. 95.

    See Okediji (2004), supra note 89 at 249.

  96. 96.

    These public interest considerations of patent protection were taken from Mgbeoji’s ongoing research proposal on “Rethinking the Failure of African States to Examine and Collate Patent Applications” (Open AIR Project proposal, unpublished, 2011).

  97. 97.

    Correa (2007).

  98. 98.

    This refers to importing certain elements of different legal systems, selected for their suitability. On this point see Bedner (2008) 171.

  99. 99.

    See Novartis AG & Another v Union of India & Others (2007) 4 MLJ 1153, online: http://www.gnaipr.com/GNACaseLaws/Judgement_GliveCpdf; Chennai Patent Office order in the application for patent no. 1602/MAS/98 filed on 17 July 1998, online: http://www.gnaipr.com/Articles/Glivec%20Order.pdf.

  100. 100.

    See section 25(1) of South Africa’s Patent Act No. 57 of 1978 (as amended). Other countries’ formulation is a verbatim reproduction of the patentability requirements contained in the TRIPS Agreement: see section 3(1) of Ghana’s Patents Act, 2003 (Act 657); section 8 of Uganda’s Patent Act, 1993; Botswana’s Industrial Property Act No. 14 of 1996.

  101. 101.

    See Oddi (1987) at 843, 853; Mgbeoji (2007), supra note 15 at 292. The reality is that only 0.01 % of patent applications filed in 1997 were by residents in SSA. This reality calls into question whether these countries have derived any benefits from changing their IP laws and creating the institutions for the enforcement of patent rights.

  102. 102.

    See section 45(1) of South Africa’s Patent Act No. 57 of 1978 (as amended); section 11 of Ghana’s Patents Act, 2003 ( Act 657).

  103. 103.

    See section 11(2) of Ghana’s Patents Act, 2003 (Act 657); section 25 of Uganda’s Patent Act, 1993.

  104. 104.

    See Section 46(1) of South Africa’s Patent Act No. 57 of 1978 (as amended); section 12(1) of Ghana’s Patents Act, 2003 (Act 657).

  105. 105.

    See Section 4 of South Africa’s Patent Act No. 57 of 1978 (as amended).

  106. 106.

    Section 56(2) of South Africa’s Patent Act No. 57 of 1978 (as amended).

  107. 107.

    Section 56(2) of South Africa’s Patent Act No. 57 of 1978 (as amended).

  108. 108.

    See TAC Electronic Newsletter: “Generic Antiretroviral Procurement Project (GARPP) and TAC Treatment Project Request Permission to Import Generic Nevirapine”, online: http://www.taCorg.za/newsletter/2003/ns28_09_2003.htm.

  109. 109.

    National Drug Policy for South Africa (1996) at 3.

  110. 110.

    Section 30(2) of Botswana’s Industrial Property Act No. 14 of 1996.

  111. 111.

    See Sections 13(3) of the Ghana’s Patents Act, 2003.

  112. 112.

    See Sections 13(9)(10) of the Ghana’s Patents Act, 2003.

  113. 113.

    Sections 13(11) of the Ghana’s Patents Act, 2003.

  114. 114.

    Section 30 of Uganda’s Patent Act, 1993.

  115. 115.

    See UNAIDS (2011) at 3.

  116. 116.

    Ho (2011), supra note 81 at 40.

  117. 117.

    Outterson (2005) at 209–210.

  118. 118.

    See section 45 of South Africa’s Patent Act No. 57 of 1978 (as amended).

  119. 119.

    No. 90 of 1997.

  120. 120.

    I discuss below how to use problem-solving or evidence-based methodology to improve patent lawmaking in SSA.

  121. 121.

    Section 11(4)(a) of Ghana’s Patents Act, 2003 (Act 657).

  122. 122.

    Section 24(3) of Botswana’s Industrial Property Act No. 14 of 1996.

  123. 123.

    See section 28(b) of Uganda’s Patents Act, 1993.

  124. 124.

    See Correa (2010) at 15.

  125. 125.

    Avafia et al. (2010) at 192 [Avafia, et al., “Using Competition Law and Policy”].

  126. 126.

    See the Preamble to the Competition Act No. 89 of 1998 (assented to on 20 October 1998) online: http://www.saflii.org/za/legis/num_act/ca1998149.pdf.

  127. 127.

    See Hazel Tau and Others v GlaxoSmithKline and Boehringer Ingelheim, online: http://www.section27.org.za/wp-content/uploads/2010/10/TauvGSKevidenceAndLegalSubmissions.pdf.

  128. 128.

    Avafia et al. (2010), supra note 125 at 199.

  129. 129.

    Medicross Healthcare Group (Pty) Ltd and Prime Cure Holdings (Pty) Ltd (Competition Tribunal, case no: 11/LM/Mar05, 13 October 2005).

  130. 130.

    Medicross Healthcare Group (Pty) Ltd and Prime Cure Holdings (Pty) Ltd v The Competition Commission, 55/CAC/Sep05, online: http://www.comptriBco.za/assets/Uploads/Case-Documents/Medicross%2055CACSep05.pdf.

  131. 131.

    This suggestion is taken from: Schovsbo (2011) at 352.

  132. 132.

    Avafia et al. (2010), supra note 125 at 200.

  133. 133.

    31 ILM 818 (1992).

  134. 134.

    Oguamanam (2006) at 4.

  135. 135.

    See the Swakopmund Protocol on the Protection of Traditional Knowledge and Expressions of Folklore, 2010. This Protocol was adopted by the Diplomatic Conference of ARIPO at Swakopmund (Namibia) on 9 August 2010. This Protocol was adopted by the ARIPO member states and signed by nine States comprising: Botswana, Ghana, Kenya, Lesotho, Liberia, Mozambique, Namibia, Zambia, and Zimbabwe.

  136. 136.

    See ARIPO website http://www.aripo.org/.

  137. 137.

    See South Africa’s Patents Amendment Act No. 20 of 2005.

  138. 138.

    See de Werra (2009).

  139. 139.

    See Carrier (2004) at 110.

  140. 140.

    See Park (2010) at 108, citing MacDonald Netshitenze, South Africa Department of Trade and Industry, online: http://203.90.70.117/PDS_DOCS/B4552.pdf.

  141. 141.

    Section 43(1) of South Africa’s Patent Act No. 57 of 1978 (as amended).

  142. 142.

    See Hoen (2009), supra note 41 at 78; MANU/TN/1217/2008.

  143. 143.

    Ho (2011), supra note 81 at 225.

  144. 144.

    For a comprehensive study on how to undertake such south-south cooperation see Musungu et al. (2004).

  145. 145.

    See Pound (1960) at 107. Pound criticizes the blind application of law without regard to the consequences; according to him, law is bound to fail if it does not respond accurately to social needs or standards.

  146. 146.

    See Seidman and Seidman (2006, 2008).

  147. 147.

    See Seidman and Seidman (2008), ibid; Seidman and Seidman (2006), ibid; Seidman and Seidman (1994). Other theories of lawmaking discussed by the Seidmans include: the ends-means methodology that defines an end and looks for the most efficient means to achieve such end, and incrementalism, which suggests gradual but minimal changes in lawmaking.

  148. 148.

    See Seidman et al. (2001).

  149. 149.

    Seidman and Seidman (2008), supra note 146 at 105–116.

  150. 150.

    Abbott (2005) at 77–78.

  151. 151.

    See Okediji (2004), supra note 89 at 236.

  152. 152.

    See Doctors for Life International v The Speaker of the National Assembly & Others 2006 (12) BCLR 1399 (CC) (SA).

  153. 153.

    See International Covenant on Civil and Political Rights, 16 December 1966, 999 UNTS 171 (entered into force on 23 March 1976), Article 25(a).

Bibliography

Literature

  • ’t Hoen EFM (2009) The global politics of pharmaceutical monopoly power: drug patents, access, innovation and the application of WTO declaration on TRIPS and public health. AMB, Amsterdam

    Google Scholar 

  • Abbott FM (2005) Toward a new era of objective assessment in the field of TRIPS and variable geometry for the preservation of multilateralism. J Int Econ Law 8:77

    Article  Google Scholar 

  • Amani B (2009) State agency and the patenting of life in international law: merchants and missionaries in a global society. Ashgate, Surrey

    Google Scholar 

  • Avafia T et al (2010) Using competition law and policy to increase access to a sustainable supply of affordable medicines. In: Intellectual property and access to medicines: papers and perspectives. Geneva: WHO, pp 191. Online: http://203.90.70.117/PDS_DOCS/B4552.pdf

  • Bedner AW (2008) Amalgamating environmental law in Indonesia. In: Arnscheidt J et al (eds) Lawmaking for development: explorations into the theory and practice of international legislative projects. Leiden University Press, Leiden

    Google Scholar 

  • Bhagwati J (2004) In defense of globalization. Oxford University Press, New York

    Google Scholar 

  • Boldrin M, Levine D (2008) Against intellectual monopoly. Cambridge University Press, New York

    Google Scholar 

  • Carrier MA (2004) Cabining intellectual property through a property paradigm. Duke Law J 54:1

    Google Scholar 

  • Correa C (2007) Guidelines for the examination of pharmaceutical patents: developing a public health perspective (Geneva, ICTSD, UNCTAD, WHO, UNDP, 2007). Online: http://www.emro.who.int/emp/media/pdf/patentability_guidelines.pdf

  • Correa CM (2010) Intellectual property rights and public health: the general context and main trips compliant flexibilities. In: Intellectual property and access to medicines: papers and perspectives. Geneva: WHO, pp 11. Online: http://203.90.70.117/PDS_DOCS/B4552.pdf

  • de Carvalho NP (2006) The TRIPS regime of trademarks and designs. Kluwer Law International, The Hague

    Google Scholar 

  • de Werra J (2009) Fighting against biopiracy: does the obligation to disclose in patent applications truly help? Vanderbilt J Transnatl Law 42:143

    Google Scholar 

  • Dreyfuss R et al (eds) (2004) Expanding the boundaries of intellectual property: innovation policy for the knowledge society. Oxford University Press, Oxford

    Google Scholar 

  • El-Said M (2005) The road from TRIPS-minus, to TRIPS, to TRIPS-plus: implications of IPRS for the Arab World. J World Intellect Prop 8:53

    Article  Google Scholar 

  • Endeshaw A (2002) The paradox of intellectual property law-making in the new millennium: universal templates as terms of surrender for non-industrial nations; piracy as an offshoot. Cardozo J Int Comp Law 10:47

    Google Scholar 

  • Goodwin PE (2008) Right idea, wrong result – Canada’s access to medicines regime. Am J Law Med 34:567

    Google Scholar 

  • Harris DP (2006) Carrying a joke too far: TRIPS and treaties of adhesion. Univ Pa J Int Econ Law 27:681

    Google Scholar 

  • Hestermeyer H (2007) Human rights and the WTO: the case of patents and access to medicines. Oxford University Press, Oxford

    Google Scholar 

  • Hill S, Johnson K (2004) Emerging challenges and opportunities in drug registration and regulation in developing countries. DFID Health System Resource Centre, London

    Google Scholar 

  • Ho CM (2011) Access to medicine in the global economy: international agreements on patents and related rights. Oxford University Press, New York

    Google Scholar 

  • Kihwelo PF (2006) Intellectual property rights jurisprudence in Tanzania: turning an eye to the commercial division of the High Court. J World Intellect Prop 9:673

    Article  Google Scholar 

  • La Croix S, Liu M (2008) Patents and access to essential medicines. In: Maskus KE (ed) Intellectual property, growth and trade. Elsevier, Amsterdam, p 423

    Chapter  Google Scholar 

  • Llewelyn M (2005) Schrodinger’s Cat: an observation on modern patent law. In: Drahos P (ed) Death of patents. Lawtext, London, p 11

    Google Scholar 

  • Mey BP (2010) Unfettered consumer access to affordable therapies in the post-TRIPS era: a dead-end journey for patients? Kenya and India case studies. J World Intellect Prop 13:403

    Article  Google Scholar 

  • Mgbeoji I (2006) Global biopiracy: patents, plants, and indigenous knowledge. UBC Press, Vancouver

    Google Scholar 

  • Mgbeoji I (2007) TRIPS and TRIPS-plus impacts in Africa. In: Gervais DJ (ed) Intellectual property, trade and development: strategies to optimize economic development in a TRIPS-Plus era. Oxford University Press, Oxford

    Google Scholar 

  • Mgbeoji I (2011) A promise betrayed? Rethinking the clerical natures of IPRs practice in the Third World. Online: http://www.iposgoode.ca/2011/06/a-promise-betrayed-rethinking-the-clerical-natures-of-iprs-practice-in-the-third-world/

  • Morin J-F (2006) Tripping up TRIPS debates: IP and health in bilateral agreements. Int J Intellect Prop Manag 1:37

    Article  Google Scholar 

  • Musungu SF et al (2004) Utilizing TRIPS flexibilities for public health protection through south-south regional frameworks. South Perspectives Report. Geneva, South Center

    Google Scholar 

  • Oddi AS (1987) The International Patent System and Third World Development: Reality or Myth? Duke Law J 63:831

    Article  Google Scholar 

  • Oguamanam C (2006) International law and indigenous knowledge: intellectual property, plant biodiversity, and traditional medicine. University of Toronto Press, Toronto

    Google Scholar 

  • Oguamanam C (2010) Patents and pharmaceutical R&D: consolidating private–public partnership approach to global public health crises. J World Intellect Prop 13:556

    Google Scholar 

  • Okediji RL (2004) Africa and the global intellectual property system: beyond the agency model. Afr YB Int Law 12:207

    Google Scholar 

  • Outterson K (2005) Pharmaceutical arbitrage: balancing access and innovation in international prescription drug markets. Yale J Health Policy Law Ethics 5:193

    Google Scholar 

  • Outterson K (2008) Should access to medicines and TRIPS flexibilities be limited to specific diseases? Am J Law Med 34:279

    Google Scholar 

  • Park C (2010) Challenging pharmaceutical patents: the case of India. In: Intellectual property and access to medicines: papers and perspectives. Geneva: WHO, pp 107

    Google Scholar 

  • Piper ST (2008) The Emergence of a Medical Exception from Patentability in the 20th Century. D. Phil Thesis, University of Oxford

    Google Scholar 

  • Pound R (1960) Mechanical jurisprudence. In: Henson RD (ed) Landmarks of law. Beacon, Boston, p 101

    Google Scholar 

  • Schovsbo J (2011) Fire and water make steam – redefining the role of competition law in TRIPS. In: Kur A, Levin M (eds) Intellectual property rights in a fair world trade system: proposals for reform of TRIPS. Edward Elgar, Cheltenham, p 308

    Google Scholar 

  • Seidman A, Seidman RB (1994) State and law in the development process: problem-solving and institutional change in the Third World. Macmillan, Basingstoke

    Google Scholar 

  • Seidman A, Seidman RB (2006) Law in aid of development: ‘Hasty Legal Transplants’ and the fatal race. J Comp Law 1(2):282

    Google Scholar 

  • Seidman AW, Seidman RB (2008) Lawmaking, development and rule of law. In: Arnscheidt J et al (eds) Lawmaking for development: explorations into the theory and practice of international legislative projects. Leiden University Press, Leiden, p 91

    Google Scholar 

  • Seidman A et al (2001) Legislative drafting for democratic social change: a manual for drafters. Kluwer Law International, The Hague

    Google Scholar 

  • Sell SK (2003) Private power, public law: the globalization of intellectual property rights. Cambridge University Press, Cambridge

    Book  Google Scholar 

  • Smith RD et al (2009) Trade, TRIPS, and pharmaceuticals. Lancet 373:684

    Article  Google Scholar 

  • Stiglitz JE (2008) Economic foundations of intellectual property rights. Duke Law J 57:1693

    Google Scholar 

  • Tabaro E (2009) Patent law reform in Uganda: addressing priorities and strategies. J World Intellect Prop 12:571

    Article  Google Scholar 

  • UNAIDS (2011) Using TRIPS flexibilities to improve access to HIV treatment. In: AIDS at 30: nations at the crossroads. Online: http://www.unaids.org/en/resources/unaidspublications/2011/

  • UNCTAD-ICTSD (2005) Resource book on TRIPS and development. Cambridge University Press, Cambridge

    Book  Google Scholar 

  • Vaver D (1997) Intellectual property law copyright, patents, trademarks. Irwin Law, Concord

    Google Scholar 

Treaties and Legislation

  • Paris Convention for the Protection of Industrial Property, 1883, 21 UST 1538, 828 UNTS 305.

    Google Scholar 

  • Patent Cooperation Treaty, concluded at Washington on 19 June 1970, amended on 28 September 1979, modified on 3 February 1984, and on 3 October 2001.

    Google Scholar 

  • Statute of the International Court of Justice, 1976 YBUN 1052.

    Google Scholar 

  • Harare Protocol on Patents and Industrial Designs, 1982.

    Google Scholar 

  • Industrial Property Act No. 14 of 1996 (Botswana).

    Google Scholar 

  • Patents Act, 2003 (Act 657) (Ghana).

    Google Scholar 

  • Swakopmund Protocol on the Protection of Traditional Knowledge and Expressions of Folklore, 2010(ARIPO).

    Google Scholar 

  • Drug Price Competition and Patent Term Restoration Act, 1984, Pub L No. 98-417, 98 Stat. 1585 (1984).

    Google Scholar 

  • High Court (Civil Procedure) Rules, 2004 (CI. 47) (Ghana).

    Google Scholar 

  • High Court Registries (Amendment) Rules 1999 (Tanzania).

    Google Scholar 

  • Patent Act No. 57 of 1978 (South Africa).

    Google Scholar 

  • Patents Act, 2003 (Act 657) (Ghana).

    Google Scholar 

  • Competition Act No. 89 of 1998 (South Africa).

    Google Scholar 

  • United Nations Convention on Biological Diversity, 31 ILM 818 (1992).

    Google Scholar 

  • Swakopmund Protocol on the Protection of Traditional Knowledge and Expressions of Folklore, 2010(ARIPO).

    Google Scholar 

  • International Covenant on Civil and Political Rights, 16 December 1966, 999 UNTS 171.

    Google Scholar 

  • Evidence Act, 1975 (NRCD 323) (Ghana).

    Google Scholar 

  • Limitations Act, 1972 (NRCD 54) (Ghana).

    Google Scholar 

  • Medicines and Related Substances Control (Amendment) Act No.90 of 1997 (South Africa).

    Google Scholar 

Jurisprudence

  • Free World Trust v Electro Santé Inc, [2002] 2 SCR 1024, 2000 SCC 66

    Google Scholar 

  • Novartis AG & Another v Union of India & Others (2007) 4 MLJ 1153.

    Google Scholar 

  • Hazel Tau and Others v GlaxoSmithKline and Boehringer Ingelheim (South Africa)

    Google Scholar 

  • Medicross Healthcare Group (Pty) Ltd and Prime Cure Holdings (Pty) Ltd (Competition Tribunal, case no: 11/LM/Mar05, 13 October 2005.

    Google Scholar 

  • Medicross Healthcare Group (Pty) Ltd and Prime Cure Holdings (Pty) Ltd v The Competition Commission, 55/CAC/Sep05.

    Google Scholar 

  • Doctors for Life International v The Speaker of the National Assembly & Others, 2006 (12) BCLR 1399 (CC) (SA).

    Google Scholar 

Documents

Download references

Author information

Authors and Affiliations

  1. Faculty of Law, University of Ghana, Accra, Ghana

    Poku Adusei

Authors
  1. Poku Adusei
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Poku Adusei .

Rights and permissions

Reprints and permissions

Copyright information

© 2013 Springer-Verlag Berlin Heidelberg

About this chapter

Cite this chapter

Adusei, P. (2013). Patent Regulatory and Institutional Mechanisms in Sub-Saharan Africa. In: Patenting of Pharmaceuticals and Development in Sub-Saharan Africa. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32515-1_5

Download citation

Publish with us

Policies and ethics

Search

Navigation