Source: https://www.hhrjournal.org/2013/12/incorporating-a-right-to-health-perspective-into-the-resolution-of-patent-law-disputes/
Timestamp: 2019-04-19 11:29:24+00:00

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This article adopts the view that the courts in developing countries can play an important role in improving access to medicines in their countries if they incorporate a right to health perspective when adjudicating patent cases involving pharmaceutical products. The article argues that, since patent rights are not human rights, they should not be allowed to trump the right to health. The paper examines two notable cases decided by the courts in Kenya that illustrate the crucial role that incorporating a right to health perspective can play in improving access to medicines. Finally, the paper provides five reasons why courts in developing countries cannot afford to ignore the right to health when adjudicating cases involving patent rights on pharmaceutical products.
This paper will examine two notable cases from Kenya where the courts had to adjudicate on disputes involving the impact of patent rights on access to medicines. Kenya was selected because it is a typical example of a developing country with significant public health challenges that also has obligations to protect patent rights. It has been estimated that about 1.6 million Kenyans are living with HIV/AIDS.17 There are also increasing concerns about non-communicable diseases such as cancer in the country. It has been estimated that cancer currently causes 7% of the total number of deaths in Kenya and cancer is ranked as the third highest cause of death in the country.18 These trends suggest that more Kenyans will need antiretroviral and cancer drugs: in the absence of cheaper generic versions of these drugs, many Kenyans may not be able to afford these essential drugs. Though the focus will be on Kenya, in the course of the analysis, references will be made to relevant cases from other developing countries facing similar public health challenges as Kenya.
The paper is structured into three main parts. The first part will critically examine the relationship between patent rights and the right to health. Specifically, an attempt will be made to determine the extent to which the TRIPS Agreement allows states to frame their patent laws in a manner that accords with their obligation to protect the right to health of their citizens. In addition, the question of the status of patent rights within the framework of international human rights law will be considered, that is, whether patent rights have the same status as other types of human rights and how the relationship between patent rights and human rights should be conceptualized. The second part of the paper will be devoted to a discussion of the two notable cases from Kenya where the courts had to adjudicate on issues pertaining to the impact of patent rights on the right to health and access to medicines. The third part offers five reasons why courts in developing countries should not ignore the right to health when deciding cases involving patents on pharmaceutical products.
It is, however, doubtful if a country can take the extreme measure of excluding pharmaceutical products from patent protection; this may be challenged by other countries as being contrary to the TRIPS Agreement and ultimately result in the imposition of trade sanctions on the country. At best, what can be done is to grant a compulsory license (i.e. a license issued by the government, or an administrative authority on behalf of the government, to a third party to exploit a patented invention without the consent of the patent owner) in accordance with the strict requirements of Article 31 of the TRIPS Agreement.
Apart from compulsory licenses, the TRIPS Agreement also offers certain flexibilities that countries can use to address public health challenges in their countries. Such flexibilities include the freedom to exclude new forms of known drugs from patent protection, freedom to adopt the principle of international exhaustion of patent rights to facilitate the parallel importation of drugs (Article 6), regulatory review exemption for producers of generic drugs, research exception, and delinking the grant of marketing approval for generic drugs from the patent status of branded drugs. The use of flexibilities was further reinforced and reaffirmed by the Doha Declaration on the TRIPS Agreement and Public Health of 2001.23 According to the Doha Declaration, the TRIPS agreement “does not and should not prevent members from taking measures to protect public health … in particular to promote access to medicines for all.”24 However, in practice, most developing countries are unable to make any beneficial use of these flexibilities (even when they are contained in their national patent laws) because of political pressure from industrialized countries.25 Thus, the current global patent law regime does not greatly assist developing countries in securing the right to health of their citizens.
Are patent rights human rights?
Thus, it is advisable for courts in developing countries—when adjudicating disputes involving patents on pharmaceutical products—to incorporate a right to health perspective that recognizes the essential distinction between the fundamental nature of human rights and the instrumental nature of patent rights. This does not necessarily mean that patent rights should no longer be protected, but it will ensure that patent rights are not exercised in ways that impede access to essential medicines.
In relation to the protection of patent rights, the 2001 Kenyan Industrial Property Act complies with the requirements of the TRIPS Agreement. It equally contains certain flexibilities such as provisions on compulsory licenses, research exception, and parallel importation.43 These flexibilities were incorporated into the patent law in order to protect the public health system in Kenya. For instance, during the Parliamentary debates on the 2001 act, it was stated that the provision on parallel importation was specifically introduced to permit the importation into Kenya of “medicines which are required for human life, especially [for the treatment of] HIV/AIDS and [other] opportunistic diseases, as well as malaria.”44 It should also be noted that the right to health is a justiciable right in Kenya pursuant to Article 43(1)(a) of the Kenyan Constitution, which provides that everyone has the right to “the highest attainable standard of health, which includes the right to health care services, including reproductive health care.” Thus, individuals can institute legal proceedings to challenge any governmental action (including legislative enactments on patent rights and other IPRs) that potentially or actually infringes on their right to health.
The tribunal thus failed to appreciate the essential distinction between the instrumental nature of patent rights and the fundamental nature of access to essential medicines. It can be argued that the tribunal failed to appreciate this essential distinction because Article 43(1)(a), which made the right to health justiciable in Kenya, was introduced into the Kenyan Constitution in 2010—two years after the tribunal’s judgment. However, even without invoking the constitutional right to health, a court that is mindful of the fundamental importance of securing access to medicines would have examined the rationale behind the inclusion of section 58(2) in the Kenyan patent law. As noted above, section 58(2) was introduced in order to facilitate the importation of medicines for the treatment of HIV/AIDS and opportunistic ailments. A court mindful of the fundamental importance of facilitating access to affordable medicines would have construed section 58(2) in accordance with the objective of ensuring that the enforcement of a patent right does not defeat the aims of the drafters of the patent law.
A classic example of a case where the court recognized this essential distinction, even in the absence of a constitutional right to health, is the English case of Roussel-Uclaf v. G. D. Searle & Co.55 In that case, the plaintiffs (who held a license under a patent to exclusively sell certain drugs) sought to restrain the defendants from selling one of those drugs in the UK. However, the court refused to grant an injunction restraining the defendants from selling the drug because it was a unique, life-saving drug with no precise equivalent in the market as the plaintiffs were not yet selling the drug in the UK. Thus, the English court was clearly concerned about preserving access to this life-saving drug for patients in the UK.
A court that is mindful of the fundamental importance of securing access to medicines will never permit the enforcement of patent rights in a manner that impedes access to medicines. In the Pfizer v. Cosmos case, the approach adopted by the Kenyan tribunal essentially elevated the rights of patentees above the right to health of patients in need of essential medicines. The tribunal lost sight of the fundamental importance of securing access to essential medicines while it was adjudicating the patent dispute between the parties.
Thus, unlike the approach adopted by the tribunal in the Pfizer v. Cosmos case, the decision of the Kenyan High Court in this case demonstrates the court’s recognition of the tension between the enforcement of intellectual property rights and the protection of the right to health. The court refused to be misguided into overlooking the fact that the Anti-Counterfeit Act was enacted to enhance the protection of intellectual property rights in Kenya. With the recognition that there was a tension to be resolved, the court equally demonstrated an implicit understanding of the essential distinction between the fundamental nature of the right to health and the instrumental nature of IPRs. This can be seen from the court’s statement that the danger posed by the Anti-Counterfeit Act to the petitioner’s right to access essential medicine was far greater and more critical than the protection of IPRs. It is therefore not surprising that the court, while not disparaging IPRs, held that the right to health must take priority over IPRs.
From the High Court’s decision, a two-stage process is discernible in the incorporation of a right to health perspective into the adjudication of patent law disputes. The first stage involves the recognition of the tension between patent rights and the right to health. The second stage involves the resolution of this tension by distinguishing between the fundamental nature of the right to health and the instrumental nature of patent rights.
These two cases from Kenya illustrate the important role that courts can play in enhancing access to medicines in developing countries. In a situation where most courts adopt the approach of the tribunal in the Pfizer case, there is no doubt that patent rights will almost always trump the right to health. However, if courts adopt the more robust approach that was applied by the High Court in the Ochieng case, it will lead to two things: one, states will be careful in implementing legislation (especially patent laws) that can significantly impede access to medicines; and, two, pharmaceutical companies that own patents on pharmaceutical products will ensure that they do not exercise their patent rights in ways that negatively affect the enjoyment of the right to health.
However, it should be noted that the ultimate resolution of the tension between patent rights and the right to health in each case may not always be the same. In some cases the enforcement of patent rights may not necessarily impede access to medicines, and in such cases, the rights of patentees need not be disregarded. For instance, in the South African case of Aventis v. Cipla, the South African Supreme Court of Appeal granted an injunction to restrain the infringement of the patent on a drug (Docetaxel) after having satisfied itself that the injunction would not necessarily impede access to the drug in question as the patentee (Aventis) was already supplying the patented drug to the South African government at a price cheaper than that of the defendant’s (Cipla) generic version.71 It was established before the court that Aventis was already selling the patented drug to the South African government at the rate of R680 for 20 mg and R2327 for 80 mg while Cipla’s generic version was being sold for R1000 and R3500 for 20 mg and 80 mg respectively.72 Thus, Aventis’ drug was more accessible to patients dependent on the public health care system.73 Therefore, it is not in every case that the tension will be resolved against the patentee: it all depends on the facts of each case.
There are five reasons why it is important for courts in developing countries not to ignore the right to health when adjudicating pharmaceutical patent cases.
One, the courts have to be more vigilant when scrutinizing legislation aimed at granting stronger protection to patents. Several bilateral and regional trade agreements currently pressure developing countries to adopt legislation providing stronger patent protection, but possibly significantly impeding access to medicines.74 Courts should be vigilant and careful when interpreting such laws to ensure that the right to health of poor patients is not trampled upon. The Kenyan Anti-Counterfeit Act is just one example of the current expansionist trends in international patent law which, among other methods, seeks to use border and customs control measures to prevent the movement of counterfeit goods across international borders.75 While such measures might actually be helpful in protecting people from harmful fake products, such measures can equally restrict access to low-cost generic medicines. The failure of the Kenyan Anti-Counterfeit Act to clearly distinguish between counterfeit drugs and generic drugs demonstrates this danger. Thus, where a country has been compelled to include a similar provision in its patent law by means of a trade agreement, the provision can be held to be unconstitutional on the basis that it can potentially impede the enjoyment of the right to health. Similar arguments can also be made with respect to any other provision incorporated into the domestic patent law framework that might impede the enjoyment of the right to health. For instance, where a trade agreement requires a country to provide patent protection for new forms (or new uses) of known drugs, a court could rule that such a provision in the patent law would impede the enjoyment of the right to health by permitting pharmaceutical companies to extend the length of their monopoly rights on essential medicines. In other words, the fundamental and critical need of providing access to essential medicines would not be served by extending the lifespan of the instrumental (monopoly) rights of pharmaceutical companies on essential drugs.
Three, courts in developing countries should equally be aware that courtrooms are now forums for shaping and reshaping global health diplomacy. While multinational pharmaceutical companies can successfully lobby for stronger patent protection in international trade forums, poor patients and civil society groups usually rely on domestic courts to ensure that their interests are protected at the local level. Consequently, in a situation where more courts in developing countries are adopting a right to health perspective in pharmaceutical patent cases, it will encourage litigants in other developing countries to seek the assistance of local courts to protect their right to health. These local courts may also decide to follow the example of other countries by incorporating a right to health perspective in pharmaceutical patent cases.
Four, as the impact of non-communicable diseases such as cancer continues to increase in developing countries, it is obvious that more patients will require access to expensive but essential drugs in order to sustain a healthy lifestyle. A right to health perspective will therefore ensure that courts are mindful of the importance of the availability of cheaper generic drugs in the market. The Kenyan High Court in the Ochieng case was mindful of the need to ensure that generic antiretroviral drugs remained affordable and accessible. The court noted that “[m]any of those who are infected with the virus are, like the petitioners, unemployed and therefore financially incapable of procuring for themselves the anti-retroviral branded medication that they need to remain healthy. They are therefore dependent on generic anti-retroviral medication which is much cheaper and therefore more accessible to them.”79 If the Kenyan Anti-Counterfeit Act had been implemented in the form in which it was enacted, it would have jeopardized the lives of the petitioners and other patients who rely on the availability of cheaper generic drugs.
Finally, it is important to note that, unlike the situation in industrialized countries where there are sophisticated mechanisms such as antitrust laws that can be used to curb the excesses of pharmaceutical companies, in several developing countries the legal framework to curb anti-competitive activities is either undeveloped, underutilized, or non-existent.80 In several developing countries, the right to health is the only potent weapon that can be effectively used to ensure that pharmaceutical companies do not abuse their patent rights.
It is essential for developing countries to devise strategies to curtail the current expansionist trends in international patent law. In the midst of growing demands for stronger patent laws, the right to health can be utilized to reclaim some policy space for developing countries to design their national patent laws in a manner that facilitates access to medicines. Domestic courts have a major role to play in this regard: when they are adjudicating disputes involving patents on pharmaceutical products, they can recognize the tension between patent rights and the right to health and resolve this tension by distinguishing between the instrumental nature of patent rights and the fundamental nature of the right to health.
The author is grateful to the Faculty of Law, University College Cork, for providing funding for his PhD studies.
Emmanuel Kolawole Oke, LLB, BL, LLM, is a PhD Candidate in the Faculty of Law, University College Cork, Cork, Ireland.
Please address correspondence to Emmanuel K. Oke, Faculty of Law, Áras na Laoi, University College Cork, Western Road, Cork, Ireland, email: e.oke@umail.ucc.ie.
1. Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization (WTO) (1994), 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994).
2. See G. Dutfield, Intellectual property rights and the life science industries: Past, present and future, 2nd ed. (Singapore: World Scientific Publishing, 2009), pp. 315–316; E. Schiff, Industrialization without national patents: The Netherlands, 1869–1912, Switzerland, 1850–1907 (Princeton, NJ: Princeton University Press, 1971).
3. See B. Lindstrom, “Scaling back TRIPS-plus: An analysis of intellectual property provisions in trade agreements and implications for Asia and the Pacific,” New York University Journal of International Law and Politics 42 (2010), p. 917.
4. See WTO General Council, “Amendment of the TRIPS Agreement,” Decision of 6 December 2005, WT/L/641.
5. See generally, E. M. Anderson, “Unnecessary deaths and unnecessary costs: Getting patented drugs to patients most in need,” Boston College Third World Law Journal 29/1 (2009), p. 85.
6. See also, H. Brennan, R. Distler, M. Hinman, and A. Rogers, “A human rights approach to intellectual property and access to medicines,” Global Health Justice Partnership Policy Paper 1, Yale Law School and Yale School of Public Health (September 2013), p. 1.
7. See the Constitution of the WHO, 1946; Universal Declaration of Human Rights, G.A. Res. 217A (III) (1948), Art. 25; International Covenant on Economic, Social and Cultural Rights, G.A. Res. 2200A (XXI), Art. 12 (1966); see also, Section 27 of the South African Constitution, 1996; Art. 43(1)(a) of the Kenyan Constitution, 2010; and Art. 196 of the Brazilian Constitution, 1988.
8. See State of Punjab v. Mohinder Singh Chawla (1997), 2 S.C.C. 83 (Judgment of the Indian Supreme Court).
9. S. Joseph, “Trade and the right to health,” in A. Clapham and M. Robinson (eds), Realizing the right to health, Swiss human rights book series, vol. 3 (Zurich, Switzerland: Ruffer & Rub, 2009), p. 360.
10. See Committee on Economic, Social and Cultural Rights (CESCR), General Comment No. 14, The Right to the Highest Attainable Standard of Health, UN Doc. E/C/12/2000/4 (2000). Available at http://www.unhchr.ch/tbs/doc.nsf/(symbol)/E.C.12.2000.4.En.
12. See World Health Organization, “Essential medicines.” Available at http://www.who.int/topics/essential_medicines/en/.
13. CESCR (see note 10), para. 12(b).
14. See M. V. Hristova, “Are intellectual property rights human rights? Patent protection and the right to health,” Journal of the Patent & Trademark Office Society 93/3 (2011), p. 356; see also, UN Human Rights Council, Access to Medicines in the Context of the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, A/HRC/RES/23/14 (2013). Available at http://www.refworld.org/docid/51cd52304.html.
15. CESCR (see note 10), para. 35.
16. S. P. Marks, “Access to essential medicines as a component of the right to health,” in Clapham and Robinson (see note 9), p. 90.
17. UNAIDS, “Kenya: HIV and AIDS estimates (2011).” Available at http://www.unaids.org/en/regionscountries/countries/kenya/.
18. See S. Mojtehedzadeh, “Killer cancer still neglected in Kenyan health care system,” Daily Nation (February 11, 2013). Available at http://www.nation.co.ke/Features/DN2/Cancer-The-elephant-in-the-room/-/957860/1689876/-/item/0/-/fcev4nz/-/index.html.
19. T. Bazzle, “Pharmacy of the developing world: Reconciling intellectual property rights in India with the right to health: TRIPS, India’s patent system and essential medicines,” Georgetown Journal of International Law 42 (2011), p. 795.
20. UNCTAD-ICTSD, Resource book on TRIPS and development (Cambridge: Cambridge University Press, 2005), p.126; see also, C. M. Correa, Trade related aspects of intellectual property rights: A commentary on the TRIPS Agreement (New York: Oxford University Press, 2007), p. 103.
21. UNCTAD-ICTSD (see note 20), p. 133.
22. Correa (see note 20), pp. 108–109; WTO, The Doha Declaration on the TRIPS Agreement and Public Health, WT/MIN(01)/DEC/2 (November 20, 2001).
25. R. M. Hermann, “Developing countries are not making the most of TRIPS flexibilities because of political pressure,” British Medical Journal 343 (2011), d7706 doi: 10.1136/bmj.d7706.
26. Marks (see note 16), p. 87; see also, J. Millum, “Are pharmaceutical patents protected by human rights?” Journal of Medical Ethics 34 (2008), p. e25.
27. See Committee on Economic, Social and Cultural Rights (CESCR), General Comment No. 17, The Right of Everyone to Benefit from the Protection of the Moral and Material Interests Resulting from any Scientific, Literary or Artistic Production of which He or She is the Author, UN Doc. E/C.12/GC/17 (2006), paras. 1, 3. Available at http://www.unhcr.org/refworld/docid/441543594.html.
29. See P. Yu, “Reconceptualizing intellectual property interests in a human rights framework,” UC Davis Law Review 40 (2007), p. 1073.
30. See A. Chapman, “Approaching intellectual property as a human right: Obligations related to Art. 15(1)(c),” Copyright Bulletin 35 (2001), pp. 10–11.
31. CESCR (see note 27), para. 2.
32. E. R. Gold, “Patents and human rights: A heterodox analysis,” Journal of Law, Medicine & Ethics 41/1 (2013), pp. 186–187.
33. Certification of the Constitution of the Republic of South Africa, 1996, Case CCT 23/96, September 6, 1996 (Judgment of the Constitutional Court of South Africa), para. 75.
34. Gold (see note 33), p. 189.
35. P. Drahos, “Intellectual property and human rights,” Intellectual Property Quarterly 3 (1999), p. 349.
36. CESCR (see note 27), paras. 2, 35.
37. P. Drahos and J. Braithwaite, Information feudalism: Who owns the knowledge economy? (London: Earthscan Publications Ltd., 2002), p. 200.
38. See P. Kameri-Mbote, “Intellectual property protection in Africa: An assessment of the status of laws, research and policy analysis on intellectual property rights in Kenya,” Working Paper 2005–2, International Environmental Law Research Centre, 2005, p. 6. Available online at http://www.ielrc.org/content/w0502.pdf.
40. See M. Wekesa, “An overview of the intellectual property rights (IPRS) regime in Kenya,” in M. Wekesa and B. Sihanya (eds), Intellectual property rights in Kenya (Nairobi: Konrad Adenauer Stiftung & SportsLink Limited, 2009), pp. 6–7.
43. See, respectively, Sections 72, 58(1) and 58(2) of the Kenyan Industrial Property Act of 2001.
44. Statement by the Kenyan Minister for Trade and Industry during the Parliamentary debates on the Act. See Kenyan National Assembly Official Record (Hansard), June 12, 2001, p. 1043.
45. See P.A. Ochieng, M. Atieno, and J. Munyo v. Attorney General (Petition No. 409 of 2009, Judgment of the Kenyan High Court, April 20, 2012).
46. See Pfizer Inc. v. Cosmos Limited (Case No. 49 of 2006, Judgment of the Industrial Property Tribunal at Nairobi, April 25, 2008).
49. Pfizer v. Cosmos (see note 46), pp. 3, 4.
50. See R. K. Rai and S. Jagannathan, “Parallel imports and unparallel laws: An examination of the exhaustion doctrine through the lens of pharmaceutical products,” Information & Communications Technology Law 21/1 (2012), p. 53.
51. Pfizer v. Cosmos (see note 46), p. 13.
52. See also, L. M. Opati, “Intellectual property rights in health—impact on access to drugs,” in Wekesa and Sihanya (see note 41), p. 27.
53. Pfizer v. Cosmos (see note 46), p. 16.
55. Roussel-Uclaf v. G. D. Searle & Co. Ltd & Another,  F.S.R. 125 (Judgment of the English High Court of Justice – Chancery Division).
56. Ochieng et al v. Attorney General (see note 45).
67. See A. G. Micara, “TRIPS-plus border measures and access to medicines,” The Journal of World Intellectual Property 15/1 (2012), p. 73; see also, B. K. Baker, “ACTA—risks of third party enforcement for access to medicines,” American University International Law Review 26 (2012), pp. 581–582.
68. Ochieng et al. v. Attorney General (see note 45), para. 78.
71. Aventis Pharma SA v.Cipla Life Sciences  ZASCA 108 (Judgment of the South African Supreme Court of Appeal).
74. See S. Sell, “TRIPs was never enough: Vertical forum shifting, FTAs, ACTA and TPP,” Journal of Intellectual Property Law 18/2 (2010), p. 447.
75. See F.M. Abbott, “Seizure of generic pharmaceuticals in transit based on allegations of patent infringement: A threat to international trade, development and public welfare,” World Intellectual Organization Journal 1 (2009), p. 43.
76. Ochieng et al. v. Attorney General (see note 45), para. 51.
77. Hoffmann-La Roche Ltd. v. Cipla Ltd., I.A. 642/2008 in CS(OS) 89/2008 (Delhi High Court March 19, 2008).
78. Ibid., para. 85. See also the Brazilian case of ANVISA v. Lundbeck Brazil Ltd., decided by the Brazilian Superior Court of Justice on August 17, 2011 (reported by F. Fischmann in International Review of Intellectual Property and Competition Law 43/2 (2012), pp. 217–221).
79. Ochieng et al. v. Attorney General (see note 45), para. 50.
80. A recent attempt to use competition law to facilitate access to medicines in India was unsuccessful. See Pardeshi v. Gilead Sciences Inc., USA (Case No. 41/2012, March 5, 2013, Competition Commission of India). The only developing country where competition law has been used to facilitate access to medicines with notable success is South Africa. See for instance, South African Competition Commission, “GSK and BI issue anti-retroviral licences,” Competition News (Edition 15, March 2004), pp. 1–2. Available at http://www.compcom.co.za/assets/Uploads/AttachedFiles/MyDocuments/March-04-Newsletter.pdf.

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