Poku AduseiPatenting of Pharmaceuticals and Development in Sub-Saharan Africa2013Laws, Institutions, Practices, and Politics10.1007/978-3-642-32515-1_5© Springer-Verlag Berlin Heidelberg 2013
Patent Regulatory and Institutional Mechanisms in Sub-Saharan Africa
(1)
Faculty of Law, University of Ghana, Accra, Ghana
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.
I. Introduction
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.
Building on the political processes and the theoretical assumptions detailed in the preceding chapters of this book, this chapter provides an analytical description of the patent regulatory and institutional frameworks in SSA countries and assesses the implications of these frameworks in Africa. This discussion seeks to achieve three objectives: first, to show that the concept of patent law has become part and parcel of the legal systems and institutional frameworks of SSA countries; second, to suggest patent regulatory and institutional changes that take into account the impact-in-fact of patent rules on societies in SSA; third, to provide a contextual background for understanding the discussions in the other chapters of this book. The discussion in this chapter will, however, be limited to the salient patent law provisions that affect public health and human development issues in SSA, with particular regard being paid to the patent legislation of the four countries that are the primary focus of this book: Ghana, Uganda, Botswana, and South Africa. The South African patent regulatory and institutional framework will lead this comparative analysis as a case study.
Following this introduction, Part II examines the sources of patent laws in domestic jurisdictions in SSA. It articulates the point that international IP instruments such as the Paris Convention,1 the Patent Cooperation Treaty (PCT),2 and the TRIPS Agreement have served as the sources of patent laws in SSA countries. These international instruments coupled with other African regional instruments have induced SSA countries to cede their autonomy in matters of domestic patent law and policy making to the World Trade Organization (WTO), the African Regional Intellectual Property Organization (ARIPO) and/or Organisation Africaine de la Propriété Intellectuelle (OAPI).
Part III then discusses the key international instrument (i.e., the TRIPS Agreement) that sets global minimum standards of protection for patents. It highlights some salient patent law provisions under TRIPS that affect public health and human development issues in SSA. Here, I also discuss post-TRIPS ‘humanitarian’ measures under the Doha Declaration and its subsequent WTO ‘August 30’ Decision. A major caveat, however, is that although the rules that will be discussed in this part reflect general norms on patents, the principles underlying the discussion apply equally to pharmaceuticals.
Part IV then undertakes a comparative analysis of some national patent law provisions and institutional mechanisms as they relate to access to medicine issues in SSA. This comparative analysis draws on the patent regulatory and institutional experiences of South Africa in making a case for pharmaceutical patent reforms across SSA. In so doing, it investigates whether pharmaceutical patent applications are evaluated by the national patent offices to ensure compliance with the requirements of patentability under the patent laws of SSA countries. I conclude that SSA countries (save South Africa) lack the institutional capacity/competence to evaluate the merits of supposed pharmaceutical inventions as mandated by law. Instead, SSA countries accept the ‘examination-verdicts’ of foreign patent offices and/or institutions via the PCT/ARIPO/OAPI systems. Further, a number of statutory provisions in SSA countries impede efforts to invoke the flexibilities under the international patent system to supply medicines at affordable prices. I urge SSA countries to adopt evidenced-based approaches to implementing international patent norms in order to make patent rules relevant to their citizens. Part V concludes this chapter’s discussion.
II. Sources of Patent Laws and Their Effects in SSA
The juridical sources of patent laws in SSA do not differ from the traditional articulation of the sources of general international law.3 Article 38 of the Statute of the International Court of Justice (ICJ Statute)4 authoritatively provides the sources of general international law as:
(a)
International conventions, whether general or particular, establishing rules expressly recognized by the contesting states;
(b)
International custom, as evidence of a general practice accepted as law;
(c)
The general principles of law recognized by civilized nations;
(d)
Judicial decisions and the teachings of the most highly qualified publicists of the various nations.
Despite controversies as to the extent of application of these primary and secondary sources of law, courts have accepted them as authoritative and apply these sources in resolving disputes.5
In regard to this text, the TRIPS Agreement serves as the key international instrument for the globalization of patent norms in both developed and developing countries alike. TRIPS has also become the main normative instrument in setting IP law and policy in SSA. TRIPS itself incorporates earlier pro-harmonization treaties such as the Paris Convention, which made the first international attempt at ‘harmonization’ of patent rules, among others. As discussed in chapter “Evolutionary Trajectories of Patents and the Politics of Exclusion in Sub-Saharan Africa,” the Paris Convention introduced the national treatment and right of priority rules to facilitate the cross-border patenting of inventions. Yet, ‘harmonization’ under the Paris Convention still permitted “the existence of asymmetries in the national systems of industrial property, particularly in the field of patents.”6 Today, the existence of any regulatory diversity in the terms and scope of patents under the Paris Convention has abated with the coming into force of TRIPS.
The TRIPS Agreement operates alongside the PCT. The PCT has streamlined the administrative processes involved in filing a patent application in SSA countries. By the operations of the PCT, the cost of securing international protection for patents is lowered by allowing innovators to acquire patent protection in all PCT signatory-countries on the basis of a single application and examination.7 Presently, more than two million patent applications have been filed under the PCT.
There are also other regional instruments reflecting the globalization of patent standards in Africa. These African regional instruments include the agreements for the creation of ARIPO8 and OAPI.9 The ARIPO and OAPI instruments are modelled along the same assumptions as the international patent regime; they are based on the presupposition that effective protection and administration of patents is what is needed for countries to attract technology transfer.10 The two regional instruments vest the ARIPO and OAPI with powers to grant regional patents. Such regional patent grants are enforceable across all member states irrespective of any domestic regulatory and institutional lapses. Moreover, many SSA countries use the examination processes established by both ARIPO and OAPI in granting domestic patents.11 Further, there is a system in place for domestic patent applicants to designate other ARIPO/OAPI contracting states as places where they want their inventions to be accorded automatic protection once the requirements of patentability are met.12
More fundamentally, ARIPO members have adopted an amendment to the Harare Protocol to facilitate the creation of a link between the ARIPO and the PCT.13 This link allows for PCT applicants to designate any of the ARIPO member states in their patent applications. That way, the applicant would be deemed to have automatically designated all contracting states that are parties to the Harare Protocol and the PCT. Likewise, the ARIPO office would, as stipulated under the PCT, forthwith serve as a receiving office for all PCT contracting states.14 Presently, it is possible for PCT applicants to designate for ARIPO patent applications in states such as Botswana, Ghana, Lesotho, Sierra Leone, Swaziland, Uganda, Zimbabwe, Malawi, and Sudan. According to Mgbeoji, this alliance between the ARIPO and PCT systems amounts to an automatic extraterritorial application of patent law.15
In sum, patent laws and institutional frameworks have become established in SSA countries. This is backed by studies which confirm that over 90 % of the patent laws of SSA countries are TRIPS-compliant.16 The linkage of IP rights issues to global trade governance has driven SSA to adopt an ‘effective’ and ‘adequate’ patent protection of pharmaceuticals in domestic jurisdictions. Economic globalization has thus induced SSA countries to cede their autonomy, and consequently embrace the dictates of the international patent regime as provided by TRIPS. This economic globalization became successful because developing countries were promised that they would receive agricultural and textile subsidies from the developed world. Another assurance was that developed countries would refrain from resorting to unilateral and bilateral pressures against developing countries if the latter signed up to TRIPS.17 In essence, the absence of democratic bargaining in TRIPS negotiations has not discouraged policy makers from implementing TRIPS obligations in SSA countries.
However, as shown in chapter “Evolutionary Trajectories of Patents and the Politics of Exclusion in Sub-Saharan Africa,” the key proponents of TRIPS have failed to live up to their promises in various ways. A recent increase in bilateral trade and investment agreements which impose higher levels of IP protection (commonly known as TRIPS-plus obligations) shows the troubling dimensions of the west’s broken promises. The introduction of TRIPS-plus obligations via bilateral free trade agreements represents the frontline of impeding access to affordable medicines in developing countries.18 Worse still, the promises that induced the less developed world to sign up to TRIPS were backed by threats of alienation from the community of trading nations if a country failed to comply with the multilateral framework. Certainly, many SSA countries lack the economic wherewithal to resist such threats of alienation from global trade relations, hence their decision to subscribe to relatively strong patent standards under TRIPS.
Further, through technical assistance initiatives, many LDCs in SSA have suffered the unfortunate fate of enacting TRIPS-compliant and TRIPS-plus laws in spite of the moratorium under the WTO system for them not to do so. Bilateral assistance programs have steered LDCs in SSA to strengthen their patent laws in blatant disregard for TRIPS’ transition rules.19 Indeed, the TRIPS-based framework and its underlying theories have effectively secured standards of patents in SSA countries similar to those adopted in industrialized countries. Meanwhile, big pharma continues to push for longer patent terms to leverage market competition in the industry and to delay the entrance of generic drug makers to the market.20 The consequence is that the prevailing international patent system has turned SSA countries into toll collectors for big pharma while their citizens remain impoverished and die from diseases such as HIV/AIDS, malaria, and TB.21 The next part briefly analyzes some specific patent-related provisions under TRIPS that implicate public health and human development issues in SSA.
III. The TRIPS Agreement Patent Standards
TRIPS emerged as part of the Uruguay Round of multilateral trade negotiations that ushered into force the liberalized trade policies of the WTO in 1995. This Agreement sets the minimum threshold for IP rights protection and enforcement for all member states of the WTO. It declares that IP rights are private rights, which must be accorded an ‘effective and adequate protection’ in all WTO member states. Consequently, the TRIPS’ rules have, since their entry into force, become the foundation of legitimacy for patent systems across the globe. Needless to add that TRIPS’ rules also serve as the juridical foundations for the protection of other fields of IP rights such as copyright, trademarks, geographical indications, industrial designs, layout-designs of integrated circuits, and undisclosed information.22
Article 7 of TRIPS sets out the objectives of the Agreement as follows:
The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.
The governing principles of TRIPS provide that:
1.
Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technical development, provided that such measures are consistent with the provisions of this Agreement.
2.
Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.23
The above objectives and principles serve as the guiding imperative for reading and implementing the provisions of TRIPS in domestic jurisdictions.24 Indeed, paragraph 19 of the Doha Ministerial Declaration singles out Articles 7 and 8 of TRIPS as having a special significance in matters of interpretation within the WTO system. These objectives and principles of TRIPS demonstrate that the issue of accessibility to medicine is significant to the international patent law balance. As argued further in chapter “Pharmaceutical Patents and Human Development in Sub-Saharan Africa,” these objectives and principles of TRIPS should guide the TRIPS Council and policy-makers in SSA in incorporating human development and social justice-oriented principles into the design and interpretation of WTO patent rules.
Another key feature of TRIPS is that its rules confirm the commitment of the international community to “achieve uniformity as to the nature of the [IP] rights, combined enforceability and sanctions for breaches thereof.”25 As a consequence, TRIPS rules do not differentiate between essential life-saving medicines and non-essential commodities in the area of patents, among others. TRIPS provides that “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.”26 To this end, all nations subscribe to universal patent standards irrespective of any diversity in innovation cultures they may have.27
Additionally, under the TRIPS regime, patent rights are enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.28 The TRIPS regime obligates all WTO member states to comply with the principles of national treatment and Most Favoured Nation (MFN) treatment. By the national treatment principle, “each Member shall accord to the nationals of other Members treatment no less favourable than that it accords to its own nationals with regard to the protection of intellectual property.”29 The MFN principle provides that “any advantage, favour, privilege or immunity granted by a Member to the nationals of any other country shall be accorded immediately and unconditionally to the nationals of all other Members.”30 These non-discriminatory rules serve as the bedrock of the globalized patent regime and its reflection in domestic jurisdictions.
Notwithstanding the above, the obligations under TRIPS are said to be ‘minimum standards of IPR protection’, and thus leave WTO Members with discretion to adopt higher standards. Thus, WTO members may implement in their laws “more extensive protection than is required” by TRIPS.31 The fact that TRIPS sets minimum regulatory standards has emboldened developed countries to push for enhanced protection for patents, among others, across nations. For example, many SSA countries including Botswana,32 Ghana,33 and Uganda34 grant protection to ‘inventions’ which do not meet the threshold for patent protection, otherwise known as ‘utility models’,35 even though the need to protect such lower forms of invention is not explicitly mandated by TRIPS. The protection of utility models is provided for under the Paris Convention, which has been incorporated into the TRIPS Agreement. The rationale for protecting utility models is that such protection will secure local incremental innovations (i.e., petty inventions) that may not meet the relatively high threshold of patentability as mandated by law. The converse is that protecting petty inventions may constrain the public domain. Also given that only 0.01 % of patent applications filed in 1997 in SSA belonged to local residents,36 there is no guarantee that local innovators in SSA will benefit from the protection of utility models.
Further, the absence of ‘maximum standards’ under TRIPS has caused many SSA countries to institutionalize regional mechanisms for protecting traditional knowledge.37 These domestic and regional arrangements are, therefore, examples of what are known as TRIPS-plus arrangements. TRIPS-plus arrangements may also involve compelling LDCs to implement and enforce patent standards under TRIPS before the end of its specified transition period. Currently, 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. Nevertheless, the question as to whether the concept of patent law is relevant to these technologically deficient states remains a site for debate among scholars and commentators. The general lack of adequate indigenous capability to maximize the benefits of global patent rules in SSA should raise legitimate concerns for policy-makers in the African region.
In short, but of particular relevance to this text, TRIPS makes it obligatory for all members of the WTO to grant 20-years of patent protection to pharmaceutical products and processes, among others.38 It also allows states to grant protection for medicinal test data, thereby creating an additional form of monopoly for data needed to obtain marketing approval for medicines.39 Presently, the protection of clinical test data in places such as the US, Canada, and the EU lasts between 5 years and 11 years, thereby preventing technologically proficient countries, such as South Africa, from taking advantage of such data for the production of generics.40 To this end, all new health-related products and processes, such as medicines, vaccines and diagnostics, are enclosed in the ‘fence’ of protection by the TRIPS-based patent framework.41 The grant of such pharmaceutical patents confers exclusive rights on the owner to make, use, sell and/or import protected medicines.42 The owner shall also have the right to assign, or transfer by succession, the rights over patents to a third party and to conclude licensing contracts thereto.43
There are also extensive provisions under TRIPS that oblige states to provide effective and adequate enforcement procedures against the infringement of IP rights.44 The TRIPS Agreement also crucially insists on states’ compliance with standardized administrative rules and procedures. The protection of patents under TRIPS is fortified with dispute settlement mechanisms and trade sanctions to procure compliance. Prima facie, the exercise of these exclusive rights conferred by patents could serve as a barrier to access to medicines for the citizens of SSA who are the neediest consumers of pharmaceuticals. Given the spectre of epidemics in SSA, the grant of pharmaceutical patent rights can only be justified if the threshold of protection is commensurate with the deprivation.45
A. TRIPS-Based Patenting: Exclusions, Moratoriums and Exceptions
Besides TRIPS’ requirements for a country to grant or enforce pharmaceutical patents, proponents of the globalized patent regime allude to the built-in flexibilities under TRIPS. In this regard, Article 27.2 of TRIPS allows states to exclude inventions from patentability on the basis of ordre public or morality, including protecting human life or health. Additionally, TRIPS allows states to exclude diagnostic, therapeutic and surgical methods for the treatment of humans from patentability.46 It is however debatable whether a state can invoke the ordre public or the public interest exception to deny patent rights that interfere with the public right to have access to essential medicines. The answer to this debate is provided in chapters “The ‘Myth’ of Patent Justifications: Triumph and Failure Dichotomy in the North and South” and “Pharmaceutical Patents, the Right to Health, and Constitutional Supremacy in Sub-Saharan Africa” of this book.
In particular regard to this text, Article 31 of TRIPS allows states to make provisions for pharmaceutical patent exceptions in cases of emergency and extreme urgency, public non-commercial use, and anti-competitive use. However, before Article 31 of TRIPS was amended, any such authorization without the consent of the right holder could only be used predominantly for the supply of medicines to the domestic market.47 This meant that countries which lacked manufacturing capacities could not benefit from the use of compulsory licensing mechanisms under TRIPS to procure medicines for their citizens from abroad.
Importantly, the TRIPS Agreement also obliges patent applicants to disclose sufficient and clear information for the invention to be carried out by a person “skilled in the art.”48 That person ordinarily skilled in the art is
a hypothetical person possessing the ordinary skill and knowledge of the particular art to which the invention relates, and a mind willing to understand a specification that is addressed to him. This hypothetical person has sometimes been equated with the ‘reasonable man’ standard in negligence law. He is assumed to be a man who is not going to try to achieve success and not one who is looking for difficulties or seeking failure.49
Admittedly, the requirement of disclosure functions as an essential quid pro quo in the granting of patents. However, this requirement of disclosure which may inure to the benefit of a person skilled in the relevant art is a far cry from offering accessibility to the general public (particularly where one of the problems in SSA is a lack of capacity or training).50 Further, this requirement of disclosure is often subverted by the arcane language in which patent claims are couched. Also the modus operandi of patentees, especially in highly competitive industries, is to reveal as little and to claim as much protection as possible in order to maintain their competitive edge.51 Suffice it to say that patents can fulfill the goal of providing social benefit only if the disclosure is enabling.52
On the whole, when TRIPS came into force developing countries were given an extra five years to bring their laws into conformity with international law or, in default, face trade sanctions.53 By this initial deadline, developing countries had up to January 1, 2000 to comply with TRIPS. This grace period was extended to the end of 2004, however. For LDCs (the majority of which are in SSA), the grace period from granting or enforcing pharmaceutical patents will last until 2016.54 Besides pharmaceuticals, the protection for other forms of IP rights in LDCs was deferred until July 1, 2013. These grace periods, however, did not make an exception for the immediate application of the national treatment principle55 and the MFN principle56 in both developing and LDCs alike. Also, in seeking to utilize the transition periods, countries must accept the filing of pharmaceutical patent applications as well as create mechanisms for granting exclusive marketing rights for pharmaceuticals.57
To conclude, although LDCs have the option of not complying with TRIPS in its entirety until 2013 (and 2016 in the case of pharmaceutical patents), if a state commits to grant full patent protection, that protection must be TRIPS-compliant. This is intended to ensure that any patent laws, regulations, and practices during the transition period remain consistent with the provisions of TRIPS.58 As I discuss further below, the reality is that a number of LDCs in SSA comply with the treaty, to the extent that some have been compelled to assume more obligations than the minimum standards required by TRIPS.59 These countries have accepted that higher protection will better serve their interests in receiving increased investments and other support from developed countries.60 Whatever the truth of this tale, complying with the strong patent standards under TRIPS may undermine the post-TRIPS mitigation measures under the Doha Declaration and the WTO ‘August 30’ Decision.
B. Post-TRIPS Mitigation Measures
Over the years, concern and outrage have been expressed about the rigidities associated with TRIPS. Critics contend that TRIPS makes it difficult for the less developed world to use automatic compulsory licenses that would allow easy access to life-saving medicines.61 For Stiglitz, signing the TRIPS Agreement amounts to “signing the death warrants of thousands of people in sub-Saharan Africa and elsewhere in the developing countries.”62 The general impression has been that pandemics in Africa have “reached such levels that entire nations may perish while the treatment, though available, is locked away through systematic patenting or becomes unaffordable as a result of the pricing strategies of the major pharmaceutical companies.”63 These concerns, among others, attracted international attention, and efforts were made in the post-TRIPS negotiations at Doha, Cancún, and Hong Kong to address some of the inflexibilities associated with the global legal order.
In November 2001, efforts were made at the fourth WTO ministerial conference in Doha, Qatar to address the apparent rigidity in the global patent system. The Doha Round of negotiations sought to redesign and re-position the globalized patent regime to meet the health care needs of individuals in poor countries and thus promote development. At Doha, a group of developing countries “sought a legally binding declaration that would affirm an interpretation of TRIPS that would permit them to pursue policies affording access to essential medicines without fear of retribution from other WTO members.”64 Eventually, Doha concluded that “the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health.”65 And that the TRIPS Agreement should be “interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.”66 Arguably, Doha introduced the most significant ‘humanitarian’ measure regarding public health and human development in poor countries.
The Doha Declaration also clarified the issue as to whether the TRIPS Agreement limits the use of the built-in flexibilities to particular diseases, such as HIV/AIDS, malaria, and TB. It noted that nothing in the TRIPS Agreement limits the use of compulsory licences or other ‘flexibilities’ to a narrow category of diseases.67 Thus, in addition to HIV/AIDS, malaria, and TB, ‘other epidemics’ can form part of national emergency or other circumstances of extreme urgency in domestic jurisdictions, thereby necessitating the use of compulsory licensing mechanisms to tackle such epidemics.
Further, paragraph 5(c) of the Doha Declaration explained that domestic governments should determine the grounds upon which compulsory licences are granted to tackle health-related emergencies. States are also not required to consult patent right holders before issuing compulsory licences to address public health concerns.68 Notice must be given of the use as soon as reasonably practicable, however. This waiver of prior consultation is aimed at avoiding inordinate delays in the issuance of compulsory licences in cases of national emergency, or in cases of public non-commercial use, or to remedy anti-competitive practice.
In addition, Doha explained that WTO members have the latitude to determine their own policies and rules on the subject of exhaustion of rights.69 This doctrine of exhaustion is captured under Article 6 of TRIPS to the effect that nothing under the Agreement shall be used to address the issue of the exhaustion of IP rights. The doctrine of exhaustion provides that the first sale of a patented drug exhausts the public law rights of the patent holder for that item. The exhaustion rule thus operates to remove patent law barriers to cross-border trade in patented and generic medicines.
Doha also recognized that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under TRIPS.70 The reason was that the production of medicines to alleviate human suffering was to “be authorized predominantly for the supply of the domestic market” of the country so licensed.71 This meant that compulsory licences could not be granted to produce generic medicines for export. Having recognized this inequity, the Council for TRIPS was instructed to find an expeditious solution to such restrictions on access to medicines in places such as SSA, where there is a general lack of production capacity, and to report same to the General Council.
Subsequently, the WTO Council decided on August 30, 2003 to allow for the export of medicines manufactured under compulsory licences into countries that lack domestic production capacity. This ‘August 30’ Decision gives a temporary waiver to Article 31(f) of TRIPS, by allowing compulsory licenses to be used in producing generic medicines for export, provided approval is sought from the General Council. The ‘August 30’ Decision has culminated in the permanent amendment to Article 31 of TRIPS. This new amendment (i.e., Article 31bis of TRIPS) comes into force when two-thirds of all WTO members ratify the change. However, doubts still remain whether the implementation of the ‘August 30’ Decision or the permanent amendment will remove significant obstacles to access to medicines in places such as SSA. So far, “it is doubtful whether African countries have fared much better in terms of developing local industrial manufacturing capacity and thus significantly addressing the dire health challenges in Africa that compelled the amendment of Article 31 of the TRIPS Agreement.”72 As of 2011, only Rwanda has notified the TRIPS Council and in fact utilized the ‘August 30’ mechanism to import generic medicines, ApoTriAvir, from Canada. Even with this Rwandan experience, the rigid nature of the application procedures under Canada’s Access to Medicines Regime and the high cost of Canadian generics as compared with that of India made the entire deal unattractive.73
In conclusion, the WTO’s TRIPS provisions have laid the foundation for uniform patent rules across nations. As a consequence, SSA countries have adopted patent systems that are consistent with international standards, as stated and defined under the WTO system. Countries in SSA have also created domestic institutions, including specialized courts to enforce patent rights, among others.74 Suffice it to say that the implementation of these WTO patent rules has far reaching consequences for access to medicine issues in SSA. Next I will analyze the implementation of these WTO-patent standards in domestic jurisdictions in SSA countries as well as point out any pitfalls and suggest ways to overcome these obstacles.
IV. A Primer on the Patent Regimes in SSA and the Need for Patent Reforms
Generally speaking, a patent is a right granted to an inventor by the state, or by regional office(s) acting for several states, to exploit an invention for commercial purposes. This protection is based on the assumption that patents facilitate pharmaceutical research and development (R&D) for the benefit of the public. The public benefit is supposed to be realized when the patent holder exploits the invention commercially. However, this commercial exploitation of patents allows the inventor to prevent the public from using, making, selling or importing the patented product or process (or their hybrid) for a set period of time within a jurisdiction. Normally, this exploitation of patent rights subsists for a period of 20 years if the criteria for patentability are met in a particular jurisdiction.
The next task, therefore, is to describe the general patentability requirements for pharmaceutical protection in SSA countries. This discussion is linked with the practice(s) and/or administration(s) of patents in SSA countries in order to ascertain whether pharmaceutical patent applications are examined to ensure compliance with statutory provisions on patentability.
A. Patentability Criteria in SSA Countries
This section does not intend to look at each of the patent-granting criteria in SSA countries. Rather, it stresses the commonalities among the patentability criteria in SSA countries. These commonalities have come about as a result of the fact that patent laws in SSA are modelled on the basis of TRIPS. Therefore, Article 27 of TRIPS should provide a starting point for this discussion. It requires that in order for an invention to be patentable, it must meet the granting criteria of ‘newness’, ‘inventive step’, and ‘industrial application’. Countries in SSA have included these patentability requirements in their patent legislation with somewhat insignificant variations.
For example, the patent legislation of Ghana employs the terms: ‘new’, ‘inventive step’, and ‘industrial applicability’.75 Likewise, Uganda’s patent law uses the terms: ‘new’, ‘inventive step’, and ‘industrial applicability’.76 That of Botswana provides that “an invention shall be patentable if it is new, involves an inventive step, and is industrially applicable.”77 Equally, the patent law of South Africa provides that a patent may be granted for “any new invention which involves an inventive step and which is capable of being used or applied in trade or industry or agriculture.”78 Perhaps, South Africa’s somewhat different formulation of the requirement of industrial application nuances the country’s focus on inventions that can spur its economic growth and development. The patent law of South Africa limits protectable inventions to those that provide solutions to a specific problem in the field of trade, industry and/or agriculture. The salient point here is that the applications of these patentability standards (discussed in greater depth below) determine whether or not an invention is eligible for patent protection in a particular jurisdiction.
To be patentable, an invention must be industrially applicable. Thus, the invention must have a known and described utility.79 This requirement of industrial application mandates the applicant to show that the invention is complete, that it does not require any further R&D, and that it is capable of being industrially used.80 It follows that a patent will not be granted if the invention cannot perform its designated function. It should be an invention that works, or an invention capable of being reduced to practice, by providing a solution to a specific problem in the field of technology. It is for this reason that structured observations of natural phenomena (i.e., discoveries) are not protected by patents. This is not to say that an invention needs to demonstrate superiority to existing products or processes. Also, the invention does not necessarily need to demonstrate strict commercial viability in order to satisfy the utility or industrial applicability requirement. Utility only requires that an invention performs the functions specified in the patent-claim and that it achieves some beneficial results to society. In this regard, society will be assured of some positive benefits before granting an exclusive right to an applicant/inventor over a pharmaceutical product or process. It is, however, worth stressing that the requirement of usefulness is a much lower threshold than the regulatory requirement that a drug be safe and effective.81
The second requirement of patentability is that an invention should be new or novel at the time of the application for patents. Generally, this novelty requirement is intended to ensure that the material being claimed as an invention has not been available to the public prior to making the patent application.82 In other words, novelty in patent law requires that the subject matter of the invention has not previously been disclosed to the public anywhere in the world. In this vein, a publication of the inventor’s research work before the filing of a patent application may destroy novelty. Therefore, in any patent application, a search of the prior art83 is conducted to ensure that the application is in fact for a new invention and, that it does not infringe any other patented invention.84 To mitigate the hardships of this patentability criterion, most patent systems in SSA countries assure patent applicants a one year grace period within which any disclosure made during the patent application process by the applicant will not cause the invention to lose its novel character. This one year moratorium (also known as the ‘right of priority’ rule) allows the applicant to designate other countries where they want to seek protection for the said invention. This exception relates to applications made in countries that are parties to the Paris Convention, however.
Finally, for an invention to be patentable, it must meet the requirement of inventive step. This requirement is also referred to as the requirement of non-obviousness. It requires that the invention must represent an improvement over the prior art before it can receive patent protection. This prior art may include any scientific and technical information that exist before the effective date of a particular patent application. Equally, the invention must not have been obvious to a person who is ordinarily skilled in the art. In effect, a product or process cannot be patented if a person of average skill in the relevant scientific/technical field can put together different pieces of known information and arrive at the same result. The invention must either involve a technical advance compared to the existing knowledge or should have an economic significance or both. States have the liberty to insist on meeting higher standards for the inventive step requirement, however.85 The inventive step requirement is at the heart of the patent system, as it measures an invention’s contribution to the technological progress. Preferably, SSA countries should grant patents to inventions that depart significantly from the prior art (rather than incremental development or minor improvements to prior art) in order to avoid the ‘evergreening’ of pharmaceutical patents.
On the whole, the above patentability requirements have been enacted as part of the patent legislation of many SSA countries. Once the patentability requirements are met, patent protection is granted to the claimed invention to commence from the date the application was filed. In many SSA countries, this protection is granted to the first person to file and not the first person to invent. In consequence, there is pressure to apply for patent protection as soon as possible in many SSA countries. Equally, the protection offered by patents in SSA countries is relatively broad: a person cannot legally use the same idea, even if he or she independently rediscovers it without permission from the patent holder.86 Simply put, patents have become a state sanctioned anti-competition device in the hands of private companies, and their impact on access to medicine in parts of Africa is being felt across the board. Strict enforcement of the requirements of patentability by national patent institutions can prevent minor pharmaceutical inventions (i.e., inventions that do not show significantly improved efficacy) from being patented in SSA.
It is however doubtful whether local patent offices in SSA countries scrutinize patent applications in order to ensure compliance with the above requirements of patentability before granting such monopolies. In order to ensure that patent rules serve the interests of SSA countries, the above patentability safeguards must be reflected in the patent administration(s) and practice(s) in SSA countries.
Tests of Patentability in SSA87
As noted in chapter “Exploring the Conceptual Domains for Patent Discourse in Global Trade Relations” (i.e., under the analysis of patent practices), the behaviour of patent administrators and examiners can be a more reliable indicator for measuring the extent of compliance with the formal requirements of patentability in SSA countries. Also, the efficient use of patent administration could help tailor pharmaceutical patent rules to redress some of the access to medicine challenges in SSA countries. The reason is that the grant of pharmaceutical patents is considered as a matter for domestic law. Equally, the definition of the regulatory scope and contents of the requirements of patentability is left to national patent granting institutions for determination and application. Countries have the freedom to examine whether the requirements for patentability under their national laws are fulfilled before granting the patent. It follows that a strict application of patentability standards may be employed to check patent quality and thus facilitate access to medicine.
More significantly, the threat posed by weak patents to access to medicine issues has not been lost on a number of intergovernmental organizations; UNCTAD has observed that “if a government grants patents without adequate attention to whether true novelty and inventive step are involved, it may create unjustified impediments to market entry for products both of local and foreign origin.” 88 The reality is that many SSA countries lack the institutional competence to scrutinize patent applications in order to ensure compliance with the above requirements of patentability before granting pharmaceutical patent monopolies. As stated earlier in this chapter, interpretations of patentability criteria by state agencies in SSA have followed approaches under international (i.e., the PCT) and regional (i.e., ARIPO/OAPI) arrangements such that the potency of any sovereign discretion is compromised. In particular, the instruments that establish OAPI and ARIPO vest both institutions with powers to grant regional patents in SSA. Such regional grants are enforceable across all member states irrespective of domestic regulatory and institutional lapses. In addition, SSA countries use the examination processes established by both ARIPO and OAPI in granting domestic patents. Thus, save South Africa, the patent offices in SSA countries lack the institutional competence to thoroughly examine pharmaceutical patent applications to ensure compliance with statutory provisions on patentability. Instead, countries have outsourced these key obligations of vetting patent applications to foreign institutions via the PCT/ARIPO/OAPI systems. Local patent offices are simply agents of an international system that is at best indifferent to the particular needs of the citizens of SSA countries.89 The issue here is not that international or regional harmonization of the regime of patents is a bad idea. The point is that patent offices in SSA should develop institutional competencies to evaluate the merits of pharmaceutical patent applications as mandated by national laws.
Related to the above institutional quandary is the lack of qualified examiners in many SSA countries to scrutinize pharmaceutical patent applications in order to ensure strict compliance with the requirements of patentability. The practice of patent examination requires the examiner to first determine whether the product/process is a patentable subject matter. The second phase of the examination process is to determine whether the product/process meets the requirement of industrial application or usefulness. Once that hurdle is cleared, the examiner is required to ensure that the product/process is new and also that it meets the final test of inventive step: that someone with similar skill to the inventor would not have easily created the invention.
Perhaps, there is no task more difficult than that of examining and applying these patentability requirements in practice. To understand and apply these patentability requirements in the field of pharmaceuticals, the patent examiner requires an in-depth understanding of chemistry.90 The examiner must also have background training in drug discovery; this training will enable the examiner to use the clinical data to identify slight variations on a microscopic level. However, such local expertise required to understand the intricacies of pharmaceutical patent claims as well as check for quality is generally not available in the patent offices in many SSA countries. The reality, as Mgbeoji points out, is that most patents filed in SSA are drafted by foreign patent lawyers, examined in foreign patent offices and mailed to patent offices in the capital cities for filing.91 There is zero input from patent offices in SSA countries, except the collection of filing fees. In essence, the capacity of most SSA countries (save South Africa) to vet/check pharmaceutical patent quality remains largely utopian.
The above problems associated with patents administration in SSA is further exacerbated by the absence of a system in place to collate and make the technical and scientific information contained in patent applications accessible to local researchers. Also local innovators do not feel motivated to file for patent applications partly because many lawyers in SSA lack the skill in drafting the requisite applications, without even considering prosecuting such applications in the patent offices in developed countries. Perhaps mirroring the general problems with patent law practice in SSA, many patent law practitioners in SSA serve as agents of foreign law firms by submitting ready-made patent applications to the domestic/regional patent offices with little or no local input, except the collection of professional fees.92 Unsurprisingly, a World Bank report in 2000 confirmed that only 0.01 % of patent applications filed in 1997 in SSA belonged to local residents.93 This disconsolate situation has not changed for the better in many SSA countries. The perverse result is that market monopolies are granted mostly to foreign pharmaceutical patent holders without a corresponding transfer or dissemination of scientific data to local innovators.94 Presumably, the absence of local input in checking the merits of pharmaceutical patents hardly helps in ensuring that the social benefits of patents in promoting access to life-saving medicines for the citizens of poor countries is served.
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