1 A Kapczynski, BN Sampat and KC Shadlen “Trade agreements, patents, and drug prices: Continuing the debate” (2017, Yale Law & Economics research paper no 572) at 1, available at: <https://ssrn.com/abstract=2933574> (last accessed 6 January 2020); LO Gostin et al “Advancing the right to health: The vital role of law” (2017) 107/11 American Journal of Public Health 1755, available at: <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5637685/> (last accessed 6 January 2020).

2 Diependaele, L, Cockbain, J and Sterckx, S “Raising the barriers to access to medicines in the developing world: The relentless push for data exclusivity” (2017) 17/1Developing World Bioethics 11CrossRefGoogle ScholarPubMed; R Artecona and RM Plank-Brumback “Access to medicines and incentives for innovation: The balance struck in the Trans-Pacific Partnership (TPP) on intellectual property (patent and data exclusivity) protection for pharmaceutical products” (2016) at 21–29, available at: <http://repositorio.cepal.org/handle/11362/40729> (last accessed 6 January 2020).

3 Office of the US Trade Representative “Trade agreements”, available at: <https://ustr.gov/trade-agreements> (last accessed 6 January 2020); Vadi, V “Towards a new dialectics: Pharmaceutical patents, public health and foreign direct investments” (2015) 5/1New York University Journal of Intellectual Property and Entertainment Law 113Google Scholar.

4 TRIPS provides important flexibilities for accessing more affordable medicines. See Marrakesh Agreement Establishing the WTO 33 International Legal Materials 81 (1994), annex 1C, art 8(1). The TRIPS provisions on health flexibilities include: art 6, which provides for the exhaustion of IP rights (otherwise referred to as parallel importation); arts 7 and 8 relating to objectives and principles respectively; art 27 relating to exemptions from patentability and stringent patentability requirements; art 30 relating to limited exceptions to patent rights; and art 31 allowing for involuntary licences. Other flexibilities include art 40 pertaining to the control of anti-competitive practices in contractual licences and part VI concerning transitional arrangements. See also “Declaration on the TRIPS Agreement and public health” (November 2001, WTO), doc WT/MIN(01)/DEC/W/2, available at: <http://www.who.int/medicines/areas/policy/tripshealth.pdf?ua=1> (last accessed 6 January 2020).

5 Ruse-Khan, H Grosse “The international law relation between TRIPS and subsequent TRIPS-plus free trade agreements: Towards safeguarding TRIPS flexibilities?” (2011) 18/2Journal of Intellectual Property Law 327Google Scholar.

6 TRIPS, arts 7 and 8 generally encourage technology transfer. Arguably, these provisions could be relied upon for the transfer of health technology, but this could be undermined by the emerging regimes of restrictive trade agreements.

7 “Undermining access to medicines: Comparison of five US FTAs” (June 2004, Oxfam briefing note), available at: <http://www.twn.my/title2/FTAs/Intellectual_Property/IP_and_Access_to_Medicines/UnderminingAccessToMedicines.pdf> (last accessed 6 January 2020).

8 See D Matthews “Exclusivity for biologics” (2016, Queen Mary School of Law legal studies research paper no 240/2016) at 15, available at: <http://ssrn.com/abstract=2840393> (last accessed 6 January 2020).

9 “Global intellectual property rights” (October 2015, Pfizer), available at: <https://www.pfizer.com/files/about/Position-Global-Intellectual-Property-Rights.pdf> (last accessed 6 January 2020).

10 Global Innovation Policy Center “Transatlantic trade and investment partnership”, available at: <http://www.theglobalipcenter.com/ttip/> (last accessed 6 January 2020).

11 Dutfield, GM “Healthcare innovation and patent law's ‘pharmaceutical privilege’: Is there a pharmaceutical privilege? And if so, should we remove it?” (2017) 12/4Health Economics, Policy and Law 453CrossRefGoogle Scholar.

12 L Forman, I Abdillahi and J Samuel “Assessing the UN High-Level Panel on Access to Medicines report in light of the right to health” (2016), available at: <http://www.mdpi.com/2075-471X/5/4/43> (last accessed 6 January 2020).

13 Huddart, S et al. “The Doha Declaration in action: An examination of patent law flexibilities in the South African acquired immunodeficiency syndrome epidemic” (2017) 5/1Journal Health Specialties 30CrossRefGoogle Scholar.

14 X Seuba “Trade, public health, and the 2030 agenda for sustainable development” (2017, International Centre for Trade and Sustainable Development), available at: <http://frederickabbott.com/sites/default/files/Seuba%20%282017%29%20Trade%20Public%20Health%20and%20the%202030%20Agenda_0.pdf> (last accessed 6 January 2020).

15 Global Innovation Policy Center “Transatlantic trade”, above at note 10.

16 Modisenyane, SM, Hendricks, SJH and Fineberg, H “Understanding how domestic health policy is integrated into foreign policy in South Africa: A case for accelerating access to antiretroviral medicines” Global Health Action (2017) 10/1 at 1–2CrossRefGoogle ScholarPubMed, available at: <http://dx.doi.org/10.1080/16549716.2017.1339533> (last accessed 6 January 2020); “Patent barriers to medicine access in South Africa: A case for patent law reform” (2016, Fix the Patent Laws), available at: <http://www.fixthepatentlaws.org/wp-content/uploads/2016/09/MSF-FTPL-report-FINAL-VERSION.pdf> (last accessed 6 January 2020).

17 See “Intellectual property policy of the Republic of South Africa phase I” (2018, Department of Trade and Industry), available at: <https://www.thedti.gov.za/news2018/IP_Policy2018-Phase_I.pdf > (last accessed 6 January 2020).

18 Id at 4.

19 See the Constitution, secs 27(2) and 28.

20 See “Intellectual property policy”, above at note 17 at 13.

21 “Why we need to fix the patent laws in South Africa” (2015, Cancer Alliance) 1, available at: <https://www.cansa.org.za/files/2015/06/Fix-Patent-Laws-Briefer.pdf> (last accessed 16 January 2020).

22 “Patents and exclusivity” (May 2015) FDA / CDER SBIA Chronicles 1, available at: <https://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm447307.pdf> (last accessed 6 January 2020).

23 Matthews “Exclusivity for biologics”, above at note 8 at 15.

24 “Data exclusivity is not the same as market exclusivity” (2010, Generics and Biosimilars Initiative), available at: <http://www.gabionline.net/Policies-Legislation/Data-exclusivity-is-not-the-same-as-market-exclusivity> (last accessed 6 January 2020).

25 R Mayne “Regionalism, bilateralism, and ‘TRIP plus’ agreements: The threat to developing countries” (UN Human Development Report occasional papers 2005–18) at 16–17, available at: <https://ideas.repec.org/p/hdr/hdocpa/hdocpa-2005-18.html> (last accessed 6 January 2020).

26 Global Innovation Policy Center “Transatlantic trade”, above at note 10.

27 Ajibo, CC and Nwafor, NA “TPP, TTIP and the shifting dynamics of threat to public health: Options for sub-Saharan Africa” (2018) 8/2Queen Mary Journal of Intellectual Property 89 at 89–91CrossRefGoogle Scholar.

28 For US patent extension treaty practice, see Office of the US Trade Representative “Free trade agreements”, available at: <https://ustr.gov/trade-agreements/free-trade-agreements> (last accessed 6 January 2020).

29 See US-Jordan FTA (2010), art 4(23); and Trans-Pacific Partnership Agreement (TPPA), arts 18.46 and 18.48.

30 See US-Oman FTA (2009), art 15.8(6)(a)–(b); US-Panama Trade Promotion Agreement (2012), art 15.9(6)(b); US-Morocco FTA (2004), art 15.9(7).

31 “Why we need to fix”, above at note 21 at 2.

32 “Intellectual property policy”, above at note 17 at 18–19.

33 See “The potential impact of free trade agreements on public health” (2012, UNDP, UNAIDS issue brief) at 2, available at: <http://www.unaids.org/sites/default/files/media_asset/JC2349_Issue_Brief_Free-Trade-Agreements_en_0.pdf> (last accessed 6 January 2020).

34 For regulation of the evergreening of patents, see Kumar, A and Nanda, A “Ever-greening in Pharmaceuticals: Strategies, consequences and provisions for prevention in USA, EU, India and other countries” (2017) 6/1Pharmaceutical Regulatory Affairs 1 at 1–2Google Scholar.

35 In the case of KSR International Co v Teleflex Inc 550 US 398 (2007), the US Supreme Court noted (at 398) that: “Granting patent protection to advances that would occur in the ordinary course without real innovation retards progress and may, in the case of patents combining previously known elements, deprive prior inventions of their value or utility.”

36 Civil appeals nos 2706–2716, 2728 and 2717–2727 of Supreme Court of India (1 April 2013).

37 YA Vawda “After the Novartis judgment: ‘Evergreening’ will never be the same again!”(2014) Law, Democracy and Development 305 at 305–06.

38 E Sagonowsky “Johnson & Johnson falls short in a Remicade patent case as star drug slips in Q4” (2018), available at: <https://www.fiercepharma.com/legal/j-j-falls-short-a-remicade-patent-case-as-it-works-to-hold-off-biosim-entrants> (last accessed 6 January 2020).

39 “Why we need to fix”, above at note 21 at 2.

40 “Intellectual property policy”, above at note 17 at 14–16.

41 B Baker and Y Vawda “Why is it so difficult to understand whether medicines are under patent and when patent monopolies actually expire?” in “Patent barriers to medicine”, above at note 16, 14.

42 “Intellectual property policy”, above at note 17 at 14–16.

43 Id at 19–20.

44 Id at 14–16.

45 “Patient groups welcome release of draft intellectual property policy” (2017, Fix the Patent Laws), available at: <https://www.fixthepatentlaws.org/patient-groups-welcome-release-of-draft-intellectual-property-policy/> (last accessed 6 January 2020).

46 “Intellectual property policy”, above at note 17 at 16–17.

47 Ibid.

48 Markush claims constitute broad patent claims that only “disclose a general chemical structure” potentially covering millions of compounds on the basis of multiple functionally equivalent chemical entities. Markush claims need not “specify the actual lead compound with therapeutic functions”, which makes it almost impossible to determine whether a particular chemical compound, which may be used as a medicine, is covered or not. See Baker and Vawda “Why is it so difficult”, above at note 41 at 15.

49 Id at 14.

50 CM Correa “Pharmaceutical innovation, incremental patenting and compulsory licensing” (2011, South Centre research paper 41), available at: <http://apps.who.int/medicinedocs/documents/s21395en/s21395en.pdf> (last accessed 6 January 2020).

51 C Correa “Guidelines for the examination of pharmaceutical patents: Developing a public health perspective” (2007), available at: <https://www.researchgate.net/publication/23777563_Guidelines_for_the_Examination_of_Pharmaceutical_Patents_Developing_a_Public_Health_Perspective> (last accessed 6 January 2020).

52 Baker and Vawda “Why is it so difficult”, above at note 41 at 16.

53 TPPA, art 18.53. However, TRIPS, art 29(2) requires information on foreign patent applications.

54 See US-Singapore FTA (2003), art 16.8(4)(c); US-Bahrain FTA (2006), art 14.9(1)–(2); and US-Peru FTA (2009), art 16.10(4).

55 Artecona and Plank-Brumback “Access to medicines”, above at note 2 at 22.

56 Diependaele, Cockbain and Sterckx “Raising the barriers”, above at note 2 at 13.

57 Ibid.

58 D Dohmen et al “Pharmaceutical IP and competition law in South Africa: Overview” (2017), available at: <https://uk.practicallaw.thomsonreuters.com/9-564-9225?transitionType=Default&contextData=(sc.Default)&firstPage=true&bhcp=1> (last accessed 6 January 2020).

59 See TRIPS, art 6.

60 “Guideline for parallel importation of medicines in South Africa” (2003, Medicines Control Council), available at: <http://www.mccza.com/documents/077af4945.02ParallelimportationJun03v11.pdf> (last accessed 6 January 2020).

61 See “Comment by the NAPM on the draft IP policy issued by the Department of Trade and Industry” (2013, National Association of Pharmaceutical Manufacturers) at 12, available at: <http://napm.org.za/legislative-submissions/> (last accessed 6 January 2020).

62 See TRIPS, art 31.

63 CM Ho “Compulsory licenses under TRIPS: An introduction” (2011, Loyola University Chicago School of Law research paper no 2011–030), available at: < http://ssrn.com/abstract=1922803> (last accessed 6 January 2020).

64 See TPPA, art 18.6 and US-Singapore FTA, art 16.7(6)(a)–(b).

65 See US-Singapore FTA, art 16.7(6)(a)–(b)(i)–(iii).

66 TRIPS, art 31(h).

67 Mayne “Regionalism, bilateralism”, above at note 25 at 16.

68 “Intellectual property policy”, above at note 17 at 22–23.

69 Ibid.

70 Médecins Sans Frontières “South Africa: Patient groups welcome release of draft intellectual property policy” (press release, 13 August 2017), available at: <https://www.msfaccess.org/south-africa-patient-groups-welcome-release-draft-intellectual-property-policy> (last accessed 16 January 2020).

71 C Park, A Prabhala and J Berger “Using law to accelerate treatment access in South Africa: An analysis of patent, competition and medicines law” (2013, UNDP), available at: <http://www.undp.org/content/dam/undp/library/hivaids/English/using_law_to_accelerate_treatment_access_in_south_africa_undp_2013.pdf> (last accessed 6 January 2020).

72 “Patient groups welcome”, above at note 45.

73 Artecona and Plank-Brumback “Access to medicines”, above at note 2 at 23.

74 “Intellectual property policy”, above at note 17 at 23.

75 E Misati and K Adachi “The research and experimentation exceptions in patent law: Jurisdictional variations and the WIPO development agenda” (2010, UNCTAD-ICTSD Project on IPRs and Sustainable Development policy brief no 7) at 2–3, available at: <http://unctad.org/en/Docs/iprs_in20102_en.pdf> (last accessed 6 January 2020).

76 “Intellectual property policy”, above at note 17 at 21.

77 “Access to healthcare” (2016, AstraZeneca sustainability update) at 10, available at: <https://www.astrazeneca.com/content/dam/az/PDF/Sustainability/Access%20to%20healthcare.pdf> (last accessed 6 January 2020).

78 Ibid.

79 European Medicines Agency “Generic and hybrid medicines”, available at: <http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000335.jsp&mid=WC0b01ac0580514d5c> (last accessed 6 January 2020).

80 Misati and Adachi “The research”, above at note 75 at 2–3.

81 Agreement Revising the Bangui Agreement of 2 March 1977 on the Creation of an African IP Organization (1999), annex I, art 8(1)(c).

82 Canada-Patent Protection of Pharmaceutical Products, WT/DS114/R, 17 March 2000, para 7.69.

83 Ibid.

84 “Exceptions and limitations to patent rights: Experimental use and / or scientific research” (WIPO Standing Committee on the Law of Patents, 20th session, Geneva, 27–31 January 2014) at 4, available at: <http://www.wipo.int/edocs/mdocs/patent_policy/en/scp_20/scp_20_4.pdf> (last accessed 6 January 2020).

85 “Intellectual property policy”, above at note 17 at 22.

86 T Farer “The hierarchy of human rights” (1992) 8/1 American University International Law Review 115.

87 UDHR, art 25.

88 Office of the High Commissioner for Human Rights “CESCR general comment no 14: The right to the highest attainable standard of health”, adopted at the 22nd session of the Committee on Economic Social and Cultural Rights, 11 August 2000, doc E/C.12/2000/4 at 16, available at: <http://www.refworld.org/pdfid/4538838d0.pdf> (last accessed 6 January 2020).

89 Id at 4, para 12(b).

90 AR Chapman “Approaching intellectual property as a human right: Obligations related to article 15(1)(c)” (2001) 35/3 Copyright Bulletin (UNESCO) 4, available at: <http://unesdoc.unesco.org/images/0012/001255/125505e.pdf> (last accessed 6 January 2020).

91 Report of Special Rapporteur in the Field of Cultural Rights, Farida Shaheed (2013, UN) Human Rights Council, 23rd session, agenda item 3 at 17, available at: <https://digitallibrary.un.org/record/755488/files/A_HRC_23_34-EN.pdf> (last accessed 6 January 2020).

92 Fragmentation of International Law: Difficulties Arising from the Diversification and Expansion of International Law (report of the Study Group of the ILC), ILC 58th session, doc A/CN.4/L.702, 18 July 2006, available at: <http://legal.un.org/ilc/documentation/english/a_cn4_l702.pdf> (last accessed 6 January 2020).

93 Id at 4.

94 Id at 6.

95 Ibid.

96 Id at 8–13.

97 Id at 20.

98 Vienna Convention on the Law of Treaties, art 53.

99 Erga omnes obligations enjoy a special status due to their universal applicability, but jus cogens is superior to rights erga omnes.

100 By virtue of art 103 of the UN Charter, UN norms such as the right to health should ordinarily be superior to international trade norms such as the right to IP. Moreover, international trade norms such as the right to IP merely affect individuals or participants in international trade, while the UN norms, such as the right to health, affect everyone. See S Joseph Blame it on the WTO? A Human Rights Critique (2011, Oxford University Press), chaps 1 and 6, available at: <http://www.oxfordscholarship.com/view/10.1093/acprof:oso/9780199565894.001.0001/acprof-9780199565894-chapter-8> (last accessed 6 January 2020).

101 N Boschiero “Intellectual property rights and public health: An impediment to access to medicines and health technology innovation?” (2017) at 20, available at: <http://www.statoechiese.it/images/uploads/articoli_pdf/Boschiero.2_Intellectual.pdf> (last accessed 6 January 2020).

102 Id at 27.

103 Ibid.

104 “Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health”, HRC res 32/15 (1 July 2016), doc A/HRC/RES/32/15, available at: <https://documents-dds-ny.un.org/doc/UNDOC/GEN/G16/156/12/PDF/G1615612.pdf?OpenElement> (last accessed 6 January 2020).

105 “Promoting the right of everyone to the enjoyment of the highest attainable standard of physical and mental health through enhancing capacity-building in public health” HRC 32nd session, agenda item 3 (2016), UN doc A/HRC/32/L.24/Rev.1, available at: <https://documents-dds-ny.un.org/doc/UNDOC/LTD/G16/140/43/PDF/G1614043.pdf?OpenElement> (last accessed 6 January 2020).

106 “Access to medicines”, above at note 104 at 3.

107 Id at 2–4.

108 Ibid.

109 Office of the High Commissioner for Human Rights “Intellectual property rights and human rights” (2000) Sub-Commission on Human Rights res 2000/7, adopted 17 August 2000, available at: <https://www.aaas.org/sites/default/files/SRHRL/PDF/IHRDArticle15/E-CN_4-SUB_2-RES-2000-7_Eng.pdf> (last accessed 6 January 2020).

110 Boschiero “Intellectual property rights”, above at note 101 at 13.

111 Ibid.

112 Report of the United Nations Secretary-General's High-Level Panel on Access to Medicines: Promoting Innovation and Access to Health Technologies (2016) at 20, available at: <https://static1.squarespace.com/static/562094dee4b0d00c1a3ef761/t/57d9c6ebf5e231b2f02cd3d4/1473890031320/UNSG+HLP+Report+FINAL+12+Sept+2016.pdf> (last accessed 6 January 2020).

113 Ibid.

114 In the case of Barcelona Traction Case, Light and Power Co Ltd (New Application) (Belgium v Spain) 1970 ICJ rep 4 (judgment of February 5), the International Court of Justice observed (at 3) that the basic right of the human person creates obligations erga omnes. This has been interpreted to mean that some rights are obligatory to all states.

115 Promoting Access to Medical Technologies and Innovation: Intersections Between Public Health, Intellectual Property and Trade (2013, WTO-WIPO-WHO) at 42, available at: <http://www.wipo.int/edocs/pubdocs/en/global_challenges/628/wipo_pub_628.pdf> (last accessed 6 January 2020).

116 Boschiero “Intellectual property rights”, above at note 101 at 19.

117 Report of the UN Secretary-General's, above at note 112 at 56.

118 Ibid.

119 The Constitution, secs 27(2) and 28.

120 Baker, BK “International collaboration on IP / access to medicines: Birth of South Africa's Fix the Patent Laws campaign” (2016) 60 New York Law School Review 297Google Scholar.

121 “Intellectual property policy”, above at note 17 at 33–36.

122 Ibid.

123 UN Conference on Trade and Development “International investment agreements navigator: IIAs by economy: South Africa bilateral investment treaties”, available at: <https://investmentpolicy.unctad.org/international-investment-agreements/countries/195/south-africa> (last accessed 16 January 2010).

124 “Undermining access”, above at note 7 at 3.

125 Id at 2.

126 Ibid.

127 Report of the UN Secretary-General's, above at note 112 at 19.

128 Ibid.

129 Id at 19–20.

130 Id at 13–37.

131 “Patient groups march for access to medicines in South Africa” (October 2017, Fix the Patent Laws), available at: <http://www.fixthepatentlaws.org/?p=1179> (last accessed 6 January 2020).

132 Ibid.

133 “US civil society sends letter to US government in support of patent law reform in South Africa” (November 2017, Fix the Patent Laws), available at: <http://www.fixthepatentlaws.org/?p=1182> (last accessed 6 January 2020).

134 “Stop investor-state dispute settlement” (2017, ISDS Platform), available at: <http://isds.bilaterals.org/?-africa-263-> (last accessed 6 January 2020).

135 Access to Medicine Index 2016 (2016, Access to Medicines Foundation), available at: <https://accesstomedicineindex.org/media/atmi/Access-to-Medicine-Index-2016.pdf> (last accessed 6 January 2020).

136 Ibid.

137 Access To Vaccines Index 2017: How Vaccines Companies Are Responding To Calls For Greater Immunisation Coverage (2017, Access to Medicines Foundation), available at: <https://accesstovaccinesindex.org/media/atvi/2017-Access-to-Vaccines-Index.pdf> (last accessed 6 January 2020).

138 Promoting Access, above at note 115 at 42.

139 S Ranchod et al “South Africa's hospital sector: Old divisions and new developments” (2017) South African Health Review 2017 (2017, Health Systems Trust) 101, available at: <http://www.hst.org.za/publications/south-african-health-review-2017> (last accessed 6 January 2020).

140 JR Hunter et al “The ideal clinic in South Africa: Progress and challenges in implementation” South African Health Review, id, 111 at 114–22; A Jenner, N Bhagwandin and S Kowalski “Antimicrobial resistance (AMR) and multidrug resistance (MDR): Overview of current approaches, consortia and intellectual property issues” (2017, WIPO Global Challenges Report) at 117–18, available at: <http://www.wipo.int/export/sites/www/policy/en/global_health/pdf/gc_amr_report_2017.pdf> (last accessed 6 January 2020).

141 R Bonorchis and J Kew “How South Africa stumbles on health care for all” (2017), available at: <https://www.bloomberg.com/news/articles/2017-07-27/how-south-africa-stumbles-on-health-care-for-all-quicktake-q-a> (last accessed 6 January 2020).

142 Ibid.

143 Ibid.

144 Id at 117–18.

145 Hunter et al “The ideal clinic”, above at note 140 at 119–22.

146 L Rispel “Analysing the progress and fault lines of health sector transformation in South Africa” in South African Health Review 2016 (2016, Health Systems Trust) 18, available at: <https://www.hst.org.za/publications/Pages/South-African-Health-Review-2016.aspx> (last accessed 6 January 2020).

147 Id at 19.

148 P Williams “Saving SARS: Why SARS is failing and what can be done to get it back on track” (2018) <https://www.bowmanslaw.com/insights/tax/saving-sars-sars-failing-can-done-get-back-track/> (last accessed 6 January 2020).

149 Rispel “Analysing the progress”, above at note 146 at 19.

150 Ibid.

151 “Global health: South Africa” (USAID), available at: <https://www.usaid.gov/south-africa/global-health> (last accessed 6 January 2020).