The history of the development of the concept of patent law confirms its European origins. The concept of patent law, as we understand it today, began in the early fifteenth century (i.e., 1421) when Filippo Brunelleschi invented the Badalone (a sea-vessel) in Florence, Italy for which no formal protection was available.⁴ As a consequence, Brunelleschi refused to disclose his invention unless the city of Florence granted him a limited right to exploit the sea-craft.⁵ Eventually, the city yielded to his demands on June 19 1421, thereby granting him a public letter to exploit his invention commercially.⁶ The city conferred an exclusive privilege on Brunelleschi for a method of loading and transporting heavy merchandise on the Badalone across the Arno River in Florence for a period of 3 years. This grant thus sowed the seed for a movement to secure the rights of inventors under some kind of formal or governmental arrangements. This formal arrangement crystallized in the form of patent law across Europe.

In 1474, the first substantive patent statute (Parte Veneziana) was passed in Venice, Italy. The preamble of the statute justified the grant of patents on grounds that it would induce people to invent devices for the common good of society.⁷ The original Venetian patent statute offered protection for a period of 10 years to all inventions that qualified for protection under the Act.⁸ Between 1475 and 1550, an estimated one hundred patent privileges were granted or applied for in respect of industrial inventions.⁹ In addition, this grant of a patent privilege was fortified with enforcement mechanisms to ward off potential infringers. This trend of granting patents for inventions diffused from the peripheries of Italy to Central and Western Europe, and subsequently to the rest of the world.¹⁰

Historically, patents began as monarchical ‘open letters’ to confer special titles, privileges, or status on people.¹¹ For example, German Prince August of Saxony granted privileges to inventors of novel and useful things, including methods of improving mine drainage in the sixteenth century.¹² Crown privileges were thus strategically employed to encourage the importation of foreign or new technology from abroad.¹³ Similarly, Britain employed patent privileges to further its domestic trade policy on grounds that if a person brings in a new invention or a new trade to the UK, then that person deserves a monopoly grant to use it for a specified period of time.¹⁴ This desire to encourage the introduction of new arts remained an important reason for the grant of monopoly by the Crown in the UK. For these reasons, Baxter has concluded that the early patent system was based largely on a regime of “invention by importation.”¹⁵

However, over the years, the patent system has changed in form and substance. Presently, the consent of the right holder is required to import/export the patented product or process, unless the right is exhausted. Patents also now cover a broad spectrum of subject matters, including pharmaceutical products and processes; and, the terms of patent protection have also increased. While a full survey of the history of patent law, which spans five centuries, is beyond the scope of this chapter, this brief historical narrative demonstrates that the character of patents has expanded with respect to objects of protection, scope/reach of protection, and period of protection.

Specifically to this text, the frontiers of patents in the pharmaceutical industry have expanded in recent years. Patentable inventions were traditionally limited to machines or processes involving new art, manufacture, compositions of matter, and design.¹⁶ Pharmaceutical products in particular and pharmaceutical processes in general were traditionally non-patentable subject matter. Today, the requirements of patentability have changed in tandem with the demands of the pharmaceutical and biotechnology industry, and the terms of patent protection have increased from 10 years or less to 20 years in most jurisdictions.¹⁷ This transformation has brought pharmaceutical products and processes into the ambit of patent law. At present, despite the controversies surrounding judicial decisions in the US, patent protection extends to cover business methods and financial service products,¹⁸ including a method of swinging from side to side (US patent no: 6368277), peanut butter and jelly sandwiches (US patent no: 6329919), and a method for drafting patent claims (US patent no: 6574645).¹⁹

Also, the privileged nature of patent grants has metamorphosed into near absolute rights,²⁰ such that the grant of property rights over patents now empowers persons to withhold (in near absolute terms) from others the exercise of the right to make, use, sell, and/or import the invention across jurisdictions.²¹ In addition, corporate entities, as non-natural persons, were traditionally not allowed to own patents.²² Presently, corporate entities (including many pharmaceutical corporations) have become the preeminent owners of patents, a remarkable shift from the situation that hitherto prevailed. It is estimated that 90 per cent of all patents are granted to businesses.²³ Governments have also come on board to confer on patentees the exclusive right to prevent others from using, making, selling, and/or importing the patented product or process for a set period of time within a jurisdiction. Today, patent concepts have been harmonized and mainstreamed as part of global trade governance.

According to Mgbeoji, this radical shift of patents from monarchical grants into governmental grants and subsequently into near global grants occurred as a result of four factors.²⁴ First, this transformation occurred as a result of migration. For example, the migration of British settlers to North America and Oceania contributed significantly to the dissemination of British technology into those parts of the world.²⁵ Accordingly, the British Statute of Monopolies, 1623²⁶ which introduced the idea of granting a patent to the first to invent including the first person to introduce a new art from abroad, became the direct ancestor of the US and Australian/New Zealand patent laws.²⁷ Under the Statute of Monopolies, 14 years protection was granted to the inventor.

Second, the change came about as a result of colonization. When a state is colonized, its laws and institutions are not left unscathed.²⁸ Most states in SSA were thrust into the Eurocentric patent system because at all material times they were subject to colonial control. Indeed, the first political independence in a black African country south of the Sahara occurred in Ghana in 1957. Third, the change in the character of patent law in most jurisdictions occurred through direct/volitional borrowing. Modeling laws in line with what has happened elsewhere has become a common phenomenon among policy-makers and legislators in the global economy. Indeed, apart from Japan which developed its own patent system with little regard to European patent tradition, all other states have followed the European approach to patent regulation.²⁹

The fourth transformative factor in the character of patents occurred as a result of external pressure to create and enforce patents within domestic jurisdictions. Economic and political pressures on less developed countries have established what can be termed ‘patent imperialism’—a phenomenon that imposes western systems of propertization of knowledge on poor countries and preys on the cultural and knowledge values of countries in the south. Patent imperialism also encapsulates the influence of big pharma in the design of the international regulatory framework for protecting pharmaceuticals in utter disregard for the social consequences in poor countries. For Rahmatian, patent imperialism contributes to maintaining trans-colonial empires for purposes of enforcing western interests in the legal and political systems of poor sovereign states.³⁰ The globalized patent regime has fulfilled this imperial role of securing and entrenching the interests of pharmaceutical patent holders in SSA with minimal checks-and-balances in force. This lack of effective counter-mechanisms to moderate relatively high patent protection standards has partly contributed to the anemic scope of access to medicines policies in SSA.

Meanwhile, the effects of the first two evolutionary factors (i.e., migration and colonization) have significantly diminished as compared to the last two factors (i.e., legal transplants and economic pressure). Hence, the issue of colonialism will not receive detailed attention here as other scholars have trodden that path already.³¹ Rather, I focus on the latter two factors (i.e., legal transplants and economic pressure) which predominate in modern international economic relations. In particular, the use of economic pressure in the name of economic globalization is emblematic of patent imperialism, of which TRIPS is the most potent multilateral expression. In this vein, IP-trade-related arrangements under TRIPS are fortified with dispute settlement mechanisms and trade sanctions to procure compliance. A state, therefore, cannot deviate from these established arrangements without the threat of trade sanctions from the dominant economic powers, such as the US and the EU. As discussed in chapter “Exploring the Conceptual Domains for Patent Discourse in Global Trade Relations,” the South African experience with its Medicines and Related Substances Control (Amendment) Act, 1997 is an apt illustration of this point. The effect is that poor countries show little resistance in complying with WTO patent rules.

Given that states are at different levels of development, rigid norms transplant and strict compliance with TRIPS would not do. Countries in SSA need to recalibrate WTO patent rules and fine-tune TRIPS implementation in domestic jurisdictions to facilitate access to medicines to treat epidemics that threaten human lives. Further, in exploring avenues to determine how patents can serve human development goals in SSA, it is imperative to appreciate some of the historical inequities and distortions in the evolution of the concept of patent law. Hence, this following section will bring to the fore some of these distortions and patent inequities that have historically militated against less developed countries and their knowledge control values.

The origin and development of the concept of patent law is not so much as to what patent law includes; but rather what it excludes. Most accounts omit, for example, that historical evidence of exclusion of slaves from owning patents allowed for black inventors to be exploited, mostly in the US and in parts of Europe.³² The slave trade and the resultant colonization of black people south of the Sahara also derailed many efforts to imitate, via reverse engineering, and, probably, develop the capacity to innovate in SSA.³³ Also, the fact that blacks in the early American patent system were denied patents on grounds that they lacked the requisite inventive agency to generate or possess patentable ideas created obstacles for black inventors to develop innovative ideas.³⁴ For instance, Aoki’s account on the invention of the cotton gin shows that Eli Whitney (a slave owner) was granted patents in the cotton gin even though a slave identified only by the name ‘Sam’ may have invented it.³⁵ This disdain for original black inventors disabled them from progressing into the patent aristocracy in the ‘primitive’ or antebellum era.

In essence, western cultures and knowledge systems have obfuscated the knowledge systems of African people. As Oguamanam observes, ‘cultural cosmopolitanism’ caused the colonial and post-colonial hierarchies of western power to view African knowledge systems and values with disdain and denigration.³⁶ Accordingly, the literature on the origin of patents traces the phenomenon to Europe, without mentioning the knowledge protection regimes in other civilizations which perhaps predate European economic systems.³⁷ This lacuna, probably, explains why folklore is a non-patentable subject matter.³⁸ Dutfield offers a different insight into the non-patentability of indigenous knowledge on grounds that the exclusion is “really a matter of social injustice rather than one of economic inefficiency.”³⁹

However, research has shown that prior to the introduction, if not imposition, of a western-conception of patent ownership on non-western societies, there were in existence sophisticated communal regimes of ownership and control of invention in the latter societies.⁴⁰ For example, Arab and Pharaonic civilizations recorded technological progress without the aid of the patent system.⁴¹ The existence of non-western knowledge systems, by logical implication, confirms the existence of inventive activities in pre-colonial times among the people of the global South. Indeed, what accounts for the deafening silence on the contributions of non-western states to the knowledge control systems is a site for debate. The convergence of asymmetrical power relations, cultural domination, colonization, and the pursuit of neoliberal politics has squelched the other side of the story.

As fallout from this exclusion, ancient civilizations/inventions of Egypt and other countries which predate the epoch of writing are left out of many accounts. Similarly, “the requirement of writing meant that indigenous peoples’ knowledge, often [un]recorded or transmitted orally, fell outside the ambit of protected information.”⁴² In other words, non-written means of transmitting information remain unaccounted for in modern patenting endeavours. However, it bears noting that non-recorded communal rights also exist in places such as SSA. The Eurocentric character of the development of patent concepts raises questions about efforts to promote the requirements of contemporary patent law as universal verities.⁴³

In addition, the western concept of ownership and the scientific notion of the inventive process, as the mantra for protecting knowledge forms, have been enacted as part of the international law on patents, beginning with the Paris Convention, to the present day. Contemporary patent law thus fails to accept the reality that the property right regimes in the south seem at odds with the individualistic conception of ownership and knowledge systems of the western worldview.⁴⁴ According to Mgbeoji, this failure of the concept of patent law to reflect the worldviews of indigenous people has provided the basis for the appropriation of traditional knowledge from the primitive era to the present.⁴⁵ This alleged appropriation of indigenous knowledge values was not salvaged by the first international legal instrument on industrial property—the Paris Convention, which I discuss below.

The Paris Convention was the first formal multilateral patent treaty to be adopted at the international level; it made the first international attempt to harmonize patent rules, among others. The primary aim of the Paris Convention is to secure the rights of industrial property holders. Such industrial property rights include patents, utility models, industrial designs, trademarks, service marks, trade names, indications of source or appellations of origin, and the repression of unfair competition.⁴⁶ Specifically to patents, the Paris Convention (Paris) rules now include various kinds of industrial patents such as patents of importation, patents of improvement, patents and certification of addition, among others.⁴⁷

The Paris Convention was drafted at a diplomatic conference in Paris in 1880 and was ratified by eleven states in 1884.⁴⁸ The original eleven member-states of the Paris Union comprised: Belgium, Brazil, France, Guatemala, Italy, the Netherlands, Portugal, Salvador, Serbia, Spain, and Switzerland. What is apparent from this Convention is not only who the founding nations were but the lack of participation by any African country in formulating the Paris rules. African interests were subsumed under western control. It also confirms the European dominance in the formal articulation of patent rules in an international treaty. In consequence, the Paris Convention laid the foundation for marginalizing African countries in international patent law making. Presently, the membership of the Paris Union includes SSA countries among the 171 member-state parties of the Convention.

The Paris Convention articulates four categories of rules.⁴⁹ The first category deals with rules of public international law that regulate the rights and obligations of member-states, organs of the organization, and the constitutional character of the organization.⁵⁰ Secondly, there are rules that require or permit member-states to legislate in the field of industrial property.⁵¹ As pointed out in chapter “Exploring the Conceptual Domains for Patent Discourse in Global Trade Relations,” this territorial regulatory discretion was removed by the norms of the TRIPS Agreement. Thirdly, there are substantive provisions in the field of industrial property regarding the rights and obligations of private parties.⁵² These provisions, which afford primacy to private property rights, have gained currency under the TRIPS Agreement up to now. The fourth and final category of rules under the Paris Convention deals with substantive law regarding the rights and obligations of states-parties.⁵³

Most importantly, the Paris Convention, in its quest to harmonize patent law, introduced the principles of ‘national treatment’ and ‘right of priority.’⁵⁴ By the national treatment principle, foreigners receive the same privileges under national patent laws as do nationals of the home country of a member state.⁵⁵ The right of priority rule also provides that if a patent application is filed in any Union state within 1 year of filing in a home country or other first Union filing, the subsequent application is effectively back-dated to the first filing date.⁵⁶ This priority rule makes it possible to designate countries where protection will be sought so that copies of the first filing are remitted for consideration in those countries. This rule has in turn mitigated the hardships that innovators had to endure to meet a 12-month deadline to file for patent protection throughout the world, failing which the invention receives no protection in a particular state. To a degree, the above principles standardized how patent rules worked or operated across jurisdictions.

The Paris rules have had substantively unequal effects even though they may on the surface act neutrally. According to Oddi, the low levels of inventiveness in developing countries mean that the Paris rules, including the national treatment principle and the right of priority rule, do not benefit these countries.⁵⁷ The rules thus fail to provide poor countries with assurances that the grant of patents predominantly to foreigners will lead to national development.⁵⁸ Mgbeoji on his part notes that the Paris rules are “akin to saying that an Olympian athlete and a cripple are all potential gold medalists in a compulsory 100-metre dash.”⁵⁹ This analogy fundamentally underscores the failure of the international standards to reflect domestic realities in places such as Africa where there are relatively low levels of inventiveness.

It is, however, significant to point out that, in spite of the Paris Convention’s pro-harmonization stance, it left issues of compulsory licensing to individual countries to legislate.⁶⁰ Also the Paris Convention did not obligate its members to provide patent protection to pharmaceutical products. As Oddi observes, the Convention allowed member states to: limit the classes of patentable subject matter, adopt high standards of patentability, limit the duration of patent grants, set the conditions for patent renewals, or impose high filing and maintenance fees.⁶¹ These domestic flexibilities allowed a number of Paris Union-members to exclude pharmaceutical products and processes from patent protection in accordance with their public policy objectives to promote innovation and development. Specifically, until the 1970s and 1980s, a number of western countries including Switzerland, Japan, Canada, Italy, Germany, and Sweden did not grant protection to pharmaceutical products, albeit some protected pharmaceutical processes.⁶² Spain and Portugal declined to grant patents to pharmaceutical products until 1992. A WIPO study in 1988 confirmed that out of the 98 Paris Union-members, 49 then excluded pharmaceutical products from patent protection.⁶³

In the context of SSA, the scenario is, however, different: patent laws were re-enacted in African countries without regard to local sensibilities and realities.⁶⁴ A number of SSA countries were ill-advised by ‘experts’ from the West to adopt patent protection mechanisms for pharmaceutical products.⁶⁵ Although this text does not assess the impacts of colonization on the legal systems of SSA countries, one thing is certain: since France and Britain colonized most countries in SSA and were among the early countries to adopt pharmaceutical product patents, SSA countries were socialized, if not forced, to follow suit. Accordingly, “OAPI members have provided for pharmaceutical product patents since the Bangui Agreement of 1977 and ARIPO members (except Ghana and Malawi) have done the same since 1984.”⁶⁶ Also, the instruments that establish OAPI and ARIPO vest both institutions with powers to grant regional patents. 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.

These European influences (i.e., legal transplants) partly laid the foundation for the present patent regulatory and institutional obstacles that impede access to medicines to treat epidemics in SSA. Also, this story of marginalization of SSA countries continued during the Rounds⁶⁷ of the GATT 1947 trade debate.

The Patent Cooperation Treaty (PCT) represents another major milestone towards a truly procedural harmonization of the concept of patent law after the Paris Convention.⁷⁵ The PCT was concluded in 1970 as an international instrument to streamline the administrative processes involved in filing a patent application in different jurisdictions. The PCT’s founding history shows the influence of Europe in its agenda-setting activities.⁷⁶ The primary purpose of this treaty is to lower the cost of securing international protection to patents by allowing innovators to acquire patent protection in all PCT signatory-countries on the basis of a single application and examination.⁷⁷ The PCT, therefore, introduced procedural mechanisms for making international patent application possible. In April 2011, WIPO confirmed that the two millionth international patent application under the PCT was filed by a US-based mobile technology company, Qualcomm.⁷⁸ Today, plans are underway to institutionalize electronic filing in order to further facilitate international patent applications.

Article 27(1) of the PCT prohibits member-states from invoking domestic law as requirements for non-compliance with the form and content of the international application system. To some extent, this obligation introduced certainty in the global patent application processes. It also limited the issue of exclusive territoriality of states over procedures for securing intangible property rights. In addition, the PCT establishes a Union to supplement the workings of the Paris Convention. Presently, the PCT has a total of 142 member-states. This increase in membership is remarkably different from the situation in the early 1970s when the treaty had 20-members with no African country as a member.

Like the Paris Convention, SSA countries did not participate in the design of the PCT. Yet, the PCT has become a blueprint for the design of the ARIPO and OAPI regional instruments in SSA. Both instruments seek to harmonize the filing of patent applications and to develop a common view on patent matters in SSA.⁷⁹ Given that the bulk of pharmaceutical patents in SSA are owned by non-Africans, regional harmonization of patents, via the ARIPO and OAPI instruments, raises legitimate questions for access to medicine issues in SSA.

Aside from the PCT (which was concluded outside the GATT system), patent matters did not receive particular attention in twentieth-century multilateral trade relations until 1979, when attempts were made to pass an international code against trading in counterfeit goods.⁸⁰ This attempt to adopt an anti-counterfeiting code failed to materialize, but it was resuscitated in the 1980s as part of the Uruguay Round of trade negotiations. The salient point to emphasize here is that under the GATT 1947 system countries still operated under a palimpsest of patent rules. As shown below, a new trend emerged in the 1980s when robust standards for IP protection were established in the developed world, especially in the US, and subsequently, those standards were globalized across the board through a multilateral treaty in the form of TRIPS.

The early 1980s witnessed major legal and political victories in relation to patent protection for the pharmaceutical, software and entertainment industries in the US and in other western economies. These industries made a case to the effect that globalizing US/western IP standards would fuel creativity and innovation, generate higher rents, attract foreign investment, and encourage a more rapid transfer of technology.⁸² Industry also portrayed less developed countries as ‘pirates’ and ‘thieves’ when it comes to the use of biotechnology protected materials.⁸³ The industries supplemented this anti-piracy stance by portraying themselves as embattled innovators who faced an uncertain future in a world where mercenary southerners were unwilling to engage in fair business practices.⁸⁴ In particular, the resurgence of China as a technologically proficient state involved in ‘piracy’ was considered as a threat to American innovators.⁸⁵ Also, the internet/information revolution was depicted as a potential threat to securing the traditional rights of innovators in the global economy.⁸⁶ The pharmaceutical, software and entertainment industries in the US, therefore, lobbied for the acceptance of an international regime that recognized the western standards of pharmaceutical patent protection, among others.

The arguments of Mossinghoff, the then President of Pharmaceutical Research and Manufacturers of America (PhRMA), vividly depict the rhetoric of the US industries.⁸⁷ First, he posits that effective patent protection in the US and abroad is vitally important to the pharmaceutical industry. Second, that America’s research-based pharmaceutical companies pour millions of dollars into the research and development of new technology every year.⁸⁸ In consequence, whether this commitment can continue depends greatly upon the extent to which foreign governments allow innovators to be rewarded for their inventiveness, monetary investment, and intellectual labour. Third, Mossinghoff argues that for the private sector pharmaceutical industry, which has been the primary source of new therapies for the past four decades, there is little incentive to provide an ever-increasing commitment to research unless there are reasonable expectations of financial return.⁸⁹ He consequently concludes that only effective patent protection provides the incentives necessary to enable pharmaceutical companies to commit the required resources for innovation.⁹⁰

Halle explains industry’s claim for increased global IP protection differently, however. He notes that for the trade world, IP rights are one of the pillars on which the entire trade edifice is built.⁹¹ As such, it would be difficult to muster the confidence necessary for international commerce without widespread recognition of property rights, without a considerable degree of harmony in how these rights are recognized, and without an assurance that these rights will be respected and—where necessary—enforced.⁹² Put another way, the growth and success of the US and other western companies would not be possible without the strong protection of IP materials around the world.

This pro-industry maximalist agenda for increased pharmaceutical protection standards convinced policy-makers in the US to begin a search for ‘effective’ and ‘adequate’ patent protection mechanisms across the globe in the early 1980s. Gervais refers to this early 1980-period as addition narratives era; it is an era in which a persuasive, if not coercive, case was made to the effect that if IP rights protection is good, then more protection for IP rights is better to jump-start economic growth in both rich and poor countries alike.⁹³ At the rent-seeking insistence of industry, policy-makers in the US and other western countries pushed for an upward expansion of the scope and levels of patent protection across the globe by bringing them to the levels in force in developed economies.

In this regard, the US courts, the US Congress, and the Executive branch of the US government joined industry’s anti-piracy/economic-dominance bandwagon for enhanced patent protection. For example, the US Supreme Court decided to extend patent protection to “anything under the sun that is made by man” including an oil-splitting bacterium.⁹⁴ This grant of patent to a genetically modified bacterium is said to have fueled a growing biotech industry in the US.⁹⁵ Further, in 1981 the US Supreme Court extended patent rights to software beyond the traditional focus on “physical elements or process steps.”⁹⁶ Also, in 1985 patent protection in the US was extended to higher life forms such as man-made sexually reproducing plants.⁹⁷ In tandem with the resurgence in patent rights in the 1980s was a relaxation of perceived stringent anti-trust policies by the Reagan Administration.⁹⁸

Another related event was the passage of the Bayh–Dole Act, 1980.⁹⁹ This Act encouraged universities and other federal-public funded institutions to patent discoveries arising from their research and to commercialize such technologies by transferring them to the private sector. The new Bayh–Dole Act property regime increased patent filings and private biotechnology investment.¹⁰⁰ Other scholars, however, discount the claim that the Bayh–Dole Act fuelled the rise of technology transfer in the biotechnology industry.¹⁰¹ Nonetheless, research has shown that between 1991 and 2004 patent applications by US universities rose from 1,584 to 10,517.¹⁰² This exponential rise in university patent applications also increased license income from $218 million to $1.4 billion, amounting to 6 per cent of federal research and development financing for universities.¹⁰³ The reason for the reported increases in university-licensing is that the Bayh–Dole Act encouraged universities to focus on areas where licensing is more effective.¹⁰⁴

The US also amended its section 301¹⁰⁵ of the Trade Act of 1974 to allow for the US Trade Representative to take action against nations which fail to protect IP.¹⁰⁶ The ‘Special 301’ regime empowered the US Trade Representative to review IP standards and practices in foreign countries in order to ascertain their levels of compliance with the US-standards of adequate and effective protection of IP rights. Through such ‘section 301’ annual reviews, immense pressure was brought to bear on less developed countries to enforce IP rights.¹⁰⁷ For example, the review caused Brazil, China, India, and Thailand to be named under the ‘Special 301’ regime in 1991.¹⁰⁸ Subsequently, threats to use this ‘Special 301’ retaliatory provision of the US Trade Act against countries that deny adequate and effective patent protection caused those countries to agree to the US demands during the Uruguay Round.¹⁰⁹ In short, this unilateral retaliation mechanism became a strong weapon in the hands of the US during TRIPS negotiations.¹¹⁰

Also, decisions of the US court system influenced the international patent agenda-setting activities of the 1980s. A special court—the Court of Appeals for the Federal Circuit (CAFC)—was set up to adjudicate over patent matters in the US.¹¹¹ The aim for establishing the CAFC was to make patent litigation more uniform.¹¹² This Court has, since its establishment, been liberal in its approach towards granting patents to products and processes in the US. According to Sell, the CAFC’s decisions have reflected a more pro-patent approach and have supported higher award of damages against patent infringers.¹¹³ On his part, Merges notes that CAFC has “increased the stability and predictability of patent doctrine, to the benefit of innovative private firms.”¹¹⁴ Studies confirm that the number of cases in which patents was found to be valid and infringed increased from 62 % in the early 1980s to 90 % in the early 1990s under the CAFC.¹¹⁵

The CAFC, for instance, ruled that it was an infringement where, before patents expire, the patented product was made and used in research to obtain data needed for receiving approval for generic medicines.¹¹⁶ Thus, the use of patented medicines for clinical tests conducted by generic manufacturers before patent expiration was held to be infringing even if the test was meant to fulfill the US Food and Drug Administration approval requirements. In Arrhythmia Research Tech., Inc. v Corazonix Corp., the CAFC followed the earlier noted Diehr decision, by holding that an invention is patentable if it involved a mathematical algorithm that was “applied to, or limited by, physical elements or process steps.”¹¹⁷ The CAFC’s pro-patent stance has triggered enthusiasm among patentees to seek judicial remedies for alleged patent infringements.¹¹⁸ This patent-friendly forum also makes it difficult to challenge patent grants, even if they ever get litigated.

The extraordinary influence of the US and its industry catapulted US patent standards to global benchmarks in international patent law making. Mgbeoji aptly sums up this point as follows:

Article 27 of…TRIPS, constituting the global minimum threshold of patentability, is an approximation of US jurisprudence and ideology…TRIPS is a product of the immense clout of the American pharmaceutical and biotechnology industries…the US patent system accounts for almost half of all patents issued in the world…the United States has the most appropriative regime on patents…the pronouncements and decisions of US courts on matters of patent law have immense international influence.¹¹⁹

Around the same time, other western countries, such as Japan, Canada and those in Europe felt the need to benefit from the biotechnology and information technology boom, and thus brought their IP laws into conformity with those of the US.¹²⁰ They thus joined the crusade to make all countries compete on the same patent regulatory terms and conditions as part of global trade governance. For instance, the European Community (EC)/EU, in line with the US approach, introduced its own proposal for negotiations on trade-related aspects of IP rights.¹²¹ The US also succeeded in enshrining IP rights protection in the North American Free Trade Agreement between itself, Canada and Mexico.¹²² By joining this crusade, the EU, Japan and Canada gave the US the needed impetus and imprimatur to push for the adoption of strong standards of patent protection in 1994. Today, the US administration has also linked counterfeiting and piracy of IP-protected materials with terrorism to serve its instrumentalist agenda.¹²³

History, however, tells us that today’s ardent defenders of western-style patent standards were yesterday’s ‘pirates’ of other people’s knowledge-based products and processes. The same developed states that today push for stronger IP protection did not observe strict IP standards until they had reached a high level of development and economic maturity facilitated by the exchange of ideas and transfer of technology.¹²⁴ For example, between 1790 and 1836 the US imported British technology by restricting the grant of domestic patents.¹²⁵ This fact is confirmed by a 1986 study for the US Congress, which indicates that “when the United States was a relatively young and developing country it refused to respect international intellectual property rights on the grounds that it was freely entitled to foreign works to further its social and economic development.”¹²⁶ The British Statute of Monopolies also excluded from patentability inventions that were mischievous to the state by raising prices of domestic commodities, or hurt trade, or were generally inconvenient.¹²⁷ In addition, China’s enhanced capacity to innovate is another example of what ‘piracy’ may offer in terms of industrial development.¹²⁸ Countries’ ability to imitate and import foreign technologies prior to the introduction of stringent global patent protection standards likely greatly benefited them and propelled their domestic technological capacities.

To conclude, three important events occurred that laid the foundation for patent-promotion efforts in the late 1980s. First, the pharmaceutical and software industries in the US succeeded in influencing government agencies and transforming domestic legislation in the US as part of a drive for a global IP renaissance. This influence of industry has further consolidated its control over pharmaceuticals, and provided avenues for rent-seeking activities in the global market-place. The influence of industry has established what Amani calls the ‘Corporate Republic’ in which public participation in important domestic policy decisions is diminished.¹²⁹

The second trigger for the 1980s maximalist patent agenda is based on a flawed ideology that the resurgence of China, as a technologically proficient state, if unchecked, could threaten the interests of American innovators. A case was, therefore, made for countries to model their IP rules in line with the US standards of IP rights protection to secure the interests of innovators. But, this much we also know: that, in an increasingly interdependent world, a state cannot sustain its growth and development if that state free-rides on the weakness of another. As Landes aptly puts it:

Failure to extend the benefits of technology and science to large parts of the world is not only morally wrong, but in the long run it denies to the total system its ultimate fulfillment. Prosperity like peace is indivisible. The accelerated pace of the West’s own economic progress could be nullified by the failure of the rise in the standard of living of the largest part of the world.¹³⁰

The third trigger relates to the computer-driven or information revolution of the late twentieth century. The internet/information revolution has facilitated the generation, processing, diffusion, manipulation and application of sensitive information across borders.¹³¹ This information volatility was depicted as a potential threat to securing the traditional rights of innovators in the global economy. As a result, frantic efforts were made to forestall this threat of possible global knowledge piracy. These triggers explain why US innovators framed the debate as a fight against piracy; the triggers also became a lightning rod to revamp the global knowledge control system by including IP matters in the Uruguay Round of multilateral trade negotiations, which began in 1986.

The Uruguay Round of multilateral trade negotiations ensued between 1986 and 1994. When the Round commenced in 1986, at the Uruguay resort city of Punta del Este, the aim was to clarify GATT provisions and elaborate upon new rules and subject-areas.¹³² At the inception of the Uruguay Round, these new rules and areas did not then include IP matters as part of the negotiations. IP matters would later become a necessary subject for the Uruguay Round, however.¹³³

IP matters were included in the Uruguay Round because the US government continued the crusade, began by the US pharmaceutical and biotechnology industries, for adequate and effective protection of the IP rights of innovators. As Sell explains,

[P]rivate actors pursued their interests through multiple channels and struck bargains with multiple actors: domestic interindustry counterparts, domestic governments, foreign governments, foreign private sector counterparts, domestic and foreign industry associations, and international organizations. They vigorously pursued their IP objectives at all possible levels and in multiple venues, successfully redefining intellectual property as a trade issue. However, it was not merely their relative economic power that led to their ultimate success, but their command of IP expertise, their ideas, their information, and their framing skills (translating complex issues into political discourse).¹³⁴

In other words, at the behest of industry, the US and other western governments moved to rectify flawed IP laws, via a multilateral treaty, in less developed countries so as to check piracy. Others contend that the US and EC/EU opened the TRIPS negotiations with a desire to limit compulsory licensing in domestic regimes.¹³⁵ Be that as it may, it is beyond doubt that the Uruguay Round altered the status quo by incorporating IP matters into multilateral trading system for the first time.¹³⁶ On his part, Ostergard notes that the Uruguay process elevated the IP rights issue from “an obscure, esoteric legal field to a critical economic and political issue that brought states to the brink of trade wars.”¹³⁷

Scholars also recount that the Uruguay Round of trade negotiations was dominated by the Quad: the US, EU, Japan and Canada.¹³⁸ The Quad states supported the US industry agenda. In addition, western negotiators adopted what is termed ‘green room’¹³⁹ consultations by reaching key decisions in informal settings and leaving out negotiators from the Third World.¹⁴⁰ During the Uruguay Round, the green room meetings became so intense that the delegates from less developed countries cynically referred to such meetings as ‘black room’ consultations.¹⁴¹ The point is that less developed countries, especially those in SSA, were largely absent from the negotiations and consensus-building activities in the green room meetings.

Also, western negotiators in conjunction with the pharmaceutical industry, among others, wanted to change the forum for trade-related IP law making. The position of Pfizer was that WIPO had failed to secure the higher patent standards that the large pharmaceuticals players wanted.¹⁴² The WTO was seen as better suited to implementing the TRIPS Agreement and to enforcing it through its dispute settlement mechanisms. This regime shift caused WIPO to lose its over-sight role as the UN Agency in charge of IP-related matters.

Meanwhile, less developed countries ‘opposed’ the West’s efforts to plug the gap in the regimes of knowledge protection via the GATT/WTO system. As Drahos and Braithwaite note, countries such as India and Brazil argued that WIPO was the appropriate forum for the development of IP standards and that the GATT/WTO’s involvement with IP issues was inappropriate.¹⁴³ Accordingly, a common ground had to be found to pave the way for the Uruguay Round to continue. Consequently, developed countries promised less developed counterparts relatively easy access to western markets for agricultural products and textiles as a quid pro quo for the latter to accept IP rights protection as part of global trade governance.¹⁴⁴ Developed countries also promised to refrain from using unilateral and bilateral trade pressures against less developed nations if the latter signed on to TRIPS.¹⁴⁵ Eventually, less developed countries agreed to the west’s demands for the negotiations to proceed with IP matters firmly on the agenda.

Conversely, the frontline of less developed countries was utterly divided. Like the Tower of Babel,¹⁴⁶ from which everyone speaks but with a different voice, less developed countries failed to pursue a common anti-liberalization agenda. According to Drahos and Braithwaite, as southern opposition began to solidify, western negotiators sowed a seed of confusion among the developing country group led by India and Brazil.¹⁴⁷ Shukla, then Indian Ambassador to the GATT, aptly notes that:

The impression went round that the show of firmness that the [southern] negotiators were making…was only a facade not backed by a firm political support at [country] capital. No negotiators can hope to muster support from other countries on difficult issues involving disagreement and even confrontation with major powers, if those [powerful] countries suspect the inherent strength of the stand or even the sincerity of its propounders.¹⁴⁸

More importantly, SSA countries became political inferiors who played no meaningful role in the Uruguay Round of negotiations that led to the passage of the TRIPS Agreement. The African Group, which consists mainly of SSA countries, was largely absent from the Uruguay Round of trade negotiations.¹⁴⁹ As some commentators have lamented, African countries had negligible or no input into the negotiations that resulted in the design of the WTO rules on patents.¹⁵⁰ Out of the 48 countries in SSA, it was not until 1989 that Nigeria and Tanzania joined the Group of ten Developing countries to object to the inclusion of IP protection as part of the WTO arrangements.¹⁵¹

On his part, Ogunkola observes that less than three per cent of the overall written proposals and comments circulated during the Uruguay Round were submitted by countries in SSA.¹⁵² By 1989, when Nigeria and Tanzania came on board, the ‘world’ had decided. It had become too late to save a sinking ship. Even a more skeptical view is that the Uruguay Round of trade negotiations had concluded by 1989.¹⁵³ The political superiors were the West (led by the US) and its multinational corporations who lobbied and pushed for the passage of TRIPS, a multinational treaty which sets western benchmarks for patent protection in SSA.

The reasons for the anemic participation of countries in SSA include, first, the failure of African countries to forge links with Geneva-based delegations (even where they existed), and secondly, the failure of policy makers to involve relevant domestic ministries and agencies with issues of international economic law making.¹⁵⁴ Negotiators from SSA did not also have significant expertise in international negotiations involving IP matters. Further, other scholars posit that the costs involved in maintaining any meaningful participation in the Uruguay Round, and the WTO processes had blocked SSA countries.¹⁵⁵ As Drahos and Braithwaite explain, “South African trade negotiators simply did not understand that they were signing an agreement that would contribute to a situation by 2001 where…a 15-year-old would have greater than a 50 per cent chance of dying of HIV-related causes.”¹⁵⁶ In essence, African states that signed on to TRIPS did not fully understand its impact on their citizens’ health.

In 1994, TRIPS was adopted as part of the establishment of the WTO to “reduce distortions and impediments to international trade…promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade.”¹⁵⁷ On January 1, 1995 the Agreement entered into force as a global benchmark for patent protection, among other IP rights. Industry was rewarded on grounds 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.”¹⁵⁸ The downside is that the grant of product patents gives the owner exclusive rights over the composition of the drug itself regardless of how it is produced, and the process patents give the owner exclusive rights over the scientific method of producing the drug.¹⁵⁹ Further, the enjoyment of patent rights is without discrimination as to whether the products are imported or manufactured locally.¹⁶⁰ Moreover, TRIPS requires each signatory country to provide an effective enforcement mechanism for patents.¹⁶¹ To cap it all, the grant of patents is backed by a dispute settlement mechanism that can hold states liable for any infringement.

Since the standards embodied in the TRIPS Agreement were high western standards, transition periods were offered to developing and LDCs to configure their legislation in order for them to become TRIPS-compliant. Developing countries had a deadline of January 1, 2005 to protect and enforce pharmaceutical patents; LDCs have until 2016 to protect and enforce pharmaceutical product patents.¹⁶² This extension of the transition period for LDCs is further evidence that the globalized patent regime is not serving the needs of such countries yet. According to Yu, “had the level of intellectual property protection been adjusted to reflect the countries’ needs, interests, and conditions, those transitional provisions in the TRIPS Agreement might not have been needed.”¹⁶³ On the other hand, developed countries such as the US and those in Europe, did not require any significant configuration of existing IP laws. After all, the TRIPS Agreement was modeled in line with their existing laws.

Aside from the above formal moratorium for poor countries, a new concept of ‘single undertaking’¹⁶⁴ was introduced to compel countries to accede to universal standards of patent protection, among others, irrespective of any diversity they may have. This single undertaking approach thus operated as a claw-back mechanism for the realization of any benefits under the transitional arrangements put in place. Countries that seek to use the transition period must institute mechanisms for granting exclusive marketing rights for pharmaceuticals during the transition period.¹⁶⁵ Also, TRIPS did not insulate less developed countries from adhering to substantive matters including compliance with the requirements of national treatment and most favoured nation treatment. As Harris explains, “TRIPS was presented to developing countries on a take-it-or-leave-it basis…developing countries had no meaningful choice but complete adherence to TRIPS.”¹⁶⁶ Since most SSA countries lack the capacity to manufacture drugs, coupled with the fact that there are strong patent systems in places where they may receive support, the formal transitional arrangements would not yield significant technology transfer to such places.

The reality is that the promise to accepting TRIPS conditionalities as a concession for access to subsidies from developed countries has not been fulfilled.¹⁶⁷ As Stiglitz crudely puts it: “as they signed, the trade ministers were so pleased that they had finally reached an agreement that they didn’t notice they were signing a death warrant for thousands of people in the poorest countries around the world.”¹⁶⁸ The prices of patented medicines are far beyond the means of the masses in SSA, and efforts to obtain generic substitutes are hampered by claimants of patent rights over pharmaceuticals. For critics, this skepticism towards pharmaceutical patents is a wake-up call for IP matters to be excised from the WTO due to their negative impacts on domestic social welfare policies in poor countries.¹⁶⁹

Not all scholars agree with these claims, however. Counter narratives have emerged that the protection of IP rights is an essential component of economic strategy regardless of whether the country is developed or developing.¹⁷⁰ Kitch explains the need for patent protection in less developed countries differently, however. According to Kitch, less developed countries signed on to TRIPS because it serves their interests to invent and commercialize technologies.¹⁷¹ It is, however, difficult to deny that SSA countries signed on to TRIPS because of assurances of technology transfer and export subsidies from the developed world. Those assurances were backed by threats of alienation from the community of trading nations if a country failed to comply with the multilateral framework.

In sum, for almost 10 years the developed world united to convince the less developed world to accept that IP issues are trade-related. The private sector was also instrumental in drafting most of the documents which became the broadly successful position advocated by the US and other developed countries.¹⁷² Throughout the negotiations, the interplay of power and politics subjugated the interests of developing countries to those of the West. Arewa posits that “hierarchies of power reinforced the exclusion of [less developed countries] from the global intellectual property framework, partly by replicating and continuing the exclusion of representatives of the vast majority of the world’s population from the negotiating table.”¹⁷³ This marginalization has led a scholar to conclude that TRIPS is a treaty of adhesion,¹⁷⁴ which undermines the legitimacy of global trade governance.¹⁷⁵ The implication is that TRIPS may not be efficient or command compliance at the domestic levels of states that were marginalized.¹⁷⁶ That said the question of TRIPS’ legitimacy deserves further theoretical probing, which I undertake below.

Stemming from the historical period until 1995 when TRIPS entered into force, the ‘participation’ of SSA countries in global trade relations has left a sour taste in the mouths of proponents of human development and public health policies in poor countries. Suppose SSA countries did not ‘participate’ in the Uruguay Round (as noted above), did the negotiations still meet the basic tenets of democratic bargaining? Do the undemocratic outcomes, if any, affect the implementation of TRIPS in SSA countries? The following discussion probes these questions.

To start with, the discourse on the political economy of IP rights is replete with intimations as to the existence of asymmetrical power relations between developed and less developed countries in the international economic law making arena.¹⁷⁷ Critics contend that the use of economic hegemony by developed countries in international economic law making has tilted the scale of globalization in favour of the North and its pharmaceutical industries, and this trend severely limits the powers of countries in SSA to effectively help their citizens.¹⁷⁸ For his part, Fuentes has used the term ‘democratic deficit’ to depict the lack of meaningful participation in international decision-making processes, which lead to the adoption of policies that affect a state and its citizenry.¹⁷⁹ Similarly, scholars in IP law have questioned the legitimacy of TRIPS on grounds that the Uruguay Round was undemocratic.¹⁸⁰ To respond to these concerns we need to test the ‘participation’ of SSA countries in TRIPS negotiations against the tenets of a theory of democratic bargaining.

The economic theory of democratic bargaining posits that an open discussion among self-interested and rational actors can produce efficient outcomes by allowing resources to go to those who value them the most.¹⁸¹ It surmises that deliberation and open discussion of ideas give the interlocutors a better chance of finding good solutions to societal problems. It follows that domination by one party over another in any negotiations is less likely to promote an efficient outcome. Based on this reasoning, Drahos and Braithwaite contend that we could develop an efficient set of IP rules if there is equal representation of producer and consumer interests in the production of information, and with both competing interests having roughly equal powers of influence.¹⁸² For them, this rationale of a theory of democratic bargaining applies to both domestic and international law making endeavours.

By application to the processes of international law making, Drahos and Braithwaite explain that in order for democratic bargaining to take place among sovereign states, at least three conditions must be met: first, all relevant interests have to be represented in the negotiation process (the condition of representation); second, all those involved in the negotiations must have full information about the consequences of the various possible outcomes (the condition of full information); and third, one party must not coerce the others (the condition of non-domination).¹⁸³ It follows that the absence of any of the basic conditions of a theory of democratic bargaining in TRIPS negotiations could affect the Agreement’s efficiency as well as legitimacy.

Putting theory into context, first, the conditions of representation and full information required SSA countries to take part in the TRIPS negotiations with full access to the Uruguay Round information. However, as the above narrative shows, the Uruguay Round of negotiations did not meaningfully involve countries in SSA. It was not until 1989 when negotiators from Nigeria and Tanzania joined the Uruguay Round of trade negotiations, by which time the negotiations had nearly concluded. Further, negotiators from SSA were constrained by insufficient access to proposals and comments circulated during the Uruguay Round of trade negotiations; they also lacked expertise in international IP norms.¹⁸⁴ Indeed, the use of green room meetings alienated many countries in SSA. Even negotiators from other developing countries such as Brazil and India, who ‘participated’ in the Uruguay Round, were constrained by insufficient access to Uruguay Round information that was at the disposal of western negotiators.¹⁸⁵ As Gervais points out, this resource asymmetry put developing countries’ experts at a disadvantage when discussing detailed and arcane drafting points that were linked to existing treaties such as the Berne and Paris Conventions.¹⁸⁶ The result is that SSA countries embraced high western standards of IP protection as part of their domestic laws without a strong appreciation of the ramifications.

Second, in regard to the condition of non-domination, the above narrative of TRIPS negotiations confirms that there were glimpses of coercion by the West to procure the consent of less developed countries to cede their autonomy on IP matters. This coercion is evidenced by threats of retaliatory sanctions under the US Trade Act and a possible forfeiture of GATT/WTO status. The coercion story portrays the United States as systematically threatening to close its borders to countries that would not agree to minimum IP standards.¹⁸⁷ Brazil and India came in for special trade pressure under the US’ Priority Watch List. In addition, developed countries used their superior bargaining power to ensure compliance by less developed countries. The point is that the trajectories of TRIPS negotiations failed to measure up to the benchmarks of a theory of democratic bargaining. Yet, less developed countries in SSA accepted TRIPS to ease trade pressures and avoid being left out of the then emerging WTO trading system.¹⁸⁸ As it turned out, the promise to avoid retaliatory sanctions against less developed states provided they signed on to TRIPS has not been met. Rather, the TRIPS-based patent regulatory framework is fortified with mechanisms to sanction a non-compliant WTO Member state.¹⁸⁹ The oft-cited South African experience that brought the country to the brink of trade wars with the US and 39 pharmaceutical corporations speaks volumes. Also, a recent upsurge in bilateral trade and investment agreements which impose higher TRIPS-plus obligations shows the troubling dimensions of the west’s broken promises.¹⁹⁰

By summary, the anemic participation of SSA countries in TRIPS negotiations shows all too well that that the three conditions of democratic bargaining were not met. The democratic deficits of the TRIPS negotiations cast doubt on the supposed beneficence of the globalized patent regulatory and institutional framework.¹⁹¹ Yet, TRIPS obligations and global institutional benchmarks have influenced the design of domestic patent regulatory frameworks in SSA. Thus, even though the question of legitimacy of TRIPS may be an issue for theoretical discourse, chapter “Patent Regulatory and Institutional Mechanisms in Sub-Saharan Africa” will show that SSA countries significantly comply with the formal requirements of the treaty in domestic IP laws. For fear of global alienation and threats of trade sanctions, SSA countries do not have the wherewithal to opt out of these established normative arrangements, even though TRIPS negotiations defied basic tenets of democratic bargaining.