8.2 Orthodoxy and Heterodoxy in Intellectual Property Rights, the Right to Health and Constitutional Law

Before analyzing the decision by the Brazilian Supreme Court on the unconstitutionality of the patent extension regime, it is important to define the concepts of legal orthodoxy and heterodoxy in the fields of intellectual property law, the right to health, and constitutional law. Based on those definitions, I will propose the concept of ultra-orthodoxy.

In the areas of intellectual property, the right to health, and constitutional law, I consider legal orthodoxy to be the legal institutions that Duncan Kennedy regarded as characteristic of the “third globalization of law” initiated in the 1980s. Those would be legal institutions resulting from a combination of (i) liberal constitutionalism regarding human rights and public law in general and (ii) the doctrine of law and economics regarding private law and regulation of private economic agents, and exported to developing countries as a supportive legal discourse for neo-liberal economic reforms.Footnote ⁵

In previous work I have argued that the hallmarks of orthodoxy are disregarded for the distributive effects of legal reforms and celebration of legal transplants, departing from the premise that legal institutions adopted by developed countries are inherently efficient.Footnote ⁶ My argument is that, when legal institutions from the Global North are segregated for export, the rest of the legal infrastructure that provides economic equality is usually forgotten. As an example, neo-liberal reforms were implemented in the United States and the United Kingdom, on top of institutions of the welfare state. In many countries of the Global South such institutions still do not exist. The result is that neoliberal legal reforms in countries of the Global South tend to have negative distributive effects, because only the legal institutions that increase inequality were exported and not those that compensate for such effects. That is the core of my critique of neo-liberal reforms in developing countries in general and Brazil in particular.

Regarding intellectual property law, the orthodox approach is the intellectual movement that supported the adoption of the framework of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), without questioning its distributive consequences and, in particular, failing to consider the implications for inequality. Conversely, a heterodox approach in this field recognizes certain problematic aspects of the TRIPS agreement and the World Trade Organization (WTO) structure, particularly in countries marked by social and economic inequality.

As Yugank Goyal noted, the traditional “legal architecture” of intellectual property rights established by the legal framework of the TRIPS agreement tried to “synonymize trade with development.”Footnote ⁷ This agreement originated from the bargaining power of the United States and pressure from the pharmaceutical industry, which developing countries could not resist due to their lack of economic power and sufficient knowledge regarding the use and effects of such standardized intellectual property regimes.Footnote ⁸ Countries that wanted to be members of the WTO had to adhere to the TRIPS and thereby grant broad intellectual property protection for a general period of twenty years, without any detailed analysis of which local industries would be affected and which parts of the population would pay the cost of such legal protection.Footnote ⁹

By contrast, a heterodox approach to intellectual property law questions the consequences of the protection of certain intellectual property rights in countries marked by social and economic inequality, recognizing, for example, that when governments fail to regulate the pricing of medicinal drugs by pharmaceutical companies this interferes directly in individuals’ health.Footnote ¹⁰ As noted by Sandra Fredman, the international protection of intellectual property rights under the TRIPS has been particularly problematic in this sense. The concern is that the TRIPS allows pharmaceutical companies to patent drugs and therefore maintain high prices insulated from market competition,Footnote ¹¹ not only in the markets where the drugs were originally developed, but also in poor countries with extreme levels of inequality. This means that, in such poor countries, either most of the population is left without access to modern medicine, or there is a tremendous burden on the budget of the government to buy such drugs, sometimes at prices higher than in the countries of origin. In the second scenario a substantial part of the country’s tax revenue is transferred abroad to pay for patented pharmaceuticals instead of supporting a more general health policy.

Concerning the right to health, it is slightly easier to define the orthodox and heterodox approaches. Fredman analyzes how the right to health is understood in different jurisdictions, examining the substantive content given to the right to health and how this determines the duties of the State.Footnote ¹² Fredman identifies three different approaches relating to the right to health. However, for clarity, I will here present them as four different legal treatments of the matter. The first, second, and third approaches, as detailed here, I consider as part of the orthodoxy. The fourth approach, incorporating the right to equality in the access to health care, I will define as the heterodoxy.

The first approach prevails in jurisdictions with no express constitutional right to health. This would include most developed countries, such as the United States, the United Kingdom, and many countries that followed the Westminster constitutional model of parliamentary democracy, along with most of continental Europe.

The second approach applies in jurisdictions where the right to health is not clearly provided for in the constitution but courts have held that the right to health is implied, derived from other rights that are constitutionally protected. Apex courts in India and Canada, along with the European Court of Human Rights, have provided examples of such departures from the orthodox approach to the right to health. The Indian Constitution includes language related to health in Article 47 of the “Directive Principles of Social Policy,” but does not expressly provide for a right that is enforceable in courts.Footnote ¹³ In the case of the Canadian Charter of Rights and Freedoms and the European Convention on Human Rights (ECHR) there are no explicit references to health or the right to health.Footnote ¹⁴ Despite that, Fredman shows that courts in India and Canada, as well as the European Court of Human Rights, have derived aspects of the right to health from other rights, such as the right to life and personal integrity.Footnote ¹⁵ This intermediate approach shall still be regarded as orthodox since it does not regard the right to health as independently actionable before the courts but only as a consideration that informs decisions based on other grounds.

The third approach includes jurisdictions with an express right to health in their human rights instrumentsFootnote ¹⁶ but which recognize the right as a purely individual right. There are several ways in which an express right to health might be understood. It could be an individually justiciable right to medication or other medical intervention for individual illness. Alternatively, the right to health could be based on a broader framework which includes, for example, a right to access to health care or a right to be healthy that is implemented through public policy and collective enforcement.Footnote ¹⁷ The orthodox approach would be the individualistic one. For instance, in the case of limited access to medication, the individualistic approach favors litigation by individuals to force governments to buy pharmaceutical products. This approach favors the interests of pharmaceutical companies, preventing governments from having any bargaining power to negotiate the prices of such patented products. Also, it ends up having a negative distributive effect, since the haves typically gain more from mechanisms that rely on individual litigation than the have-nots. Hence, free drug distribution would benefit the middle classes and exclude the poorest of the poor.Footnote ¹⁸ Taking into account my own previous investigation of the litigation for the free distribution of pharmaceutical products in Brazil, based on the right to health, I would include Brazil in this third category.

What I previously concluded, studying the case of Brazil, is that this approach, based on formal equality before the law and favoring individual cases, ends up benefiting wealthier individuals in the urban middle classes, since those would be the ones with greater access to private medical and legal resources to support individual litigation.Footnote ¹⁹ Even if such an individualistic approach does not necessarily favor the super-wealthy individuals but only the middle-classes, in highly unequal countries, such as Brazil, because the middle-class is a small group, privileging those individuals to the detriment of the much larger group of poor people has a tremendously negative distributive effect.Footnote ²⁰ Those effects usually go unnoticed, since underprivileged individuals suffer quietly, forgotten by the mass and social media.

I recognize that this third approach might be better described as the ultra-orthodox approach, more than just a variation of orthodoxy.Footnote ²¹ This would require further analysis of other jurisdictions where ultra-orthodoxy might also be present in order to support this hypothesis, and in the further sections of this chapter I will attempt to offer more subsidies that may ground such an endeavor.

The fourth approach protects the human right to health based on a principle of material equality, departing from the more formalistic approach implemented through individual litigation. This approach would focus on how public policies are implemented and would include statistical analysis of, for example, access to specific treatments. In general, violations of the right would be brought to the courts by means of collective actions, such as direct constitutional challenges or class actions. I call this view the heterodox approach to the right to health because it only recognizes the right to health as an actionable constitutional right when it is applied with a positive distributive effect, meaning, for the benefit of the poorest individuals in society and not just the ruling elites and middle classes.Footnote ²² The heterodox approach to a right to health already recognizes, from a methodological point of departure, that individuals or groups might be marginalized because of their race, age, gender, disability, religion, and, as a result, will have disadvantages in access to justice and health care.Footnote ²³

A decision from the Colombian Constitutional Court offers a striking example of the heterodox approach to the right to health. In this case, decided in 2008, the Constitutional Court of Colombia ordered a massive restructuring of the country’s health system, providing that “courts can enforce access to health goods and services as a matter of fundamental rights.”Footnote ²⁴ The case collected 22 tutelasFootnote ²⁵ selected to demonstrate the systemic problems in the Colombian health system that had led to the overuse of the tutela. Instead of only granting relief to individuals, the court demanded a more extensive reform of the health system in order to grant access to healthcare to the poorest individuals in Colombian society. The success of the case lies not in putting the constitutional court in the position of implementing public policies, but in preventing the kind of individual litigation over the right to health that became endemic in countries such as Brazil.

In the field of constitutional law, legal orthodoxy is characterized by neoformalism,Footnote ²⁶ as described by Duncan Kennedy, which appeals “to supposedly transcendent, but also positively enacted values in constitutions or treaties, against the status quo.”Footnote ²⁷ Moreover, the neoformalism “is unreflective in a way diametrically opposite to policy analysis.”Footnote ²⁸ Hence, the orthodox approach to the right to health is in line with this broader approach to orthodox constitutionalism in the sense that it favors individual and not collective litigation.

The central aspect of constitutional law orthodoxy is the focus on the analysis of general principles. Ronald Dworkin, from an Anglo-Saxon perspective, and Robert Alexy, from a German perspective, are authors who exemplify this turn toward formalism and who “focus on law application,” especially on “legal reasoning and the justification of judicial decisions.”Footnote ²⁹ Insofar as they remain concerned with either the application of “abstract principles directly, without any intermediation, to any given specific problem” as “the best way to reason about questions of rights,”Footnote ³⁰ as in Dworkin’s approach, or harmonizing the application of principles with rationality, as in the case of Alexy’s theories of argumentation and principles,Footnote ³¹ their perspective appears to neglect completely, or at least not sufficiently value,Footnote ³² distributive consequences of the interpretation of constitutional law. In this respect, Dworkin’s and Alexy’s works exemplify the orthodox approach to constitutional law, which focuses on a formalistic and supposedly neutral balancing of principles, instead of adopting as a guiding methodology the distributive analysis of how constitutional rights are applied in practice.

By contrast, the heterodox approach to constitutional law can be seen in the paradigm of “transformative constitutionalism,” first introduced by Karl Klare in his analysis of certain decisions of the South-African constitutional court.Footnote ³³ The concept means a “project of constitutional enactment, interpretation and enforcement”Footnote ³⁴ directed to a “large-scale, egalitarian social transformation,” being, thus, not neutral, but “frankly intended to carry a positive valence, to connote a social good.”Footnote ³⁵ This project is aimed at “transforming a country’s political and social institutions and power relationships in a democratic, participatory, and egalitarian direction.”Footnote ³⁶

At the time he coined the term, Karl Klare used it “to describe both what South African constitutionalism” was at the time “and what it ought to be” in the future.Footnote ³⁷ South Africa had adopted “a Constitution with massively egalitarian commitments.”Footnote ³⁸ These would be, however, only “progressive aspirations” if the lawyers did not engage in harmonizing judicial method and legal interpretation with the Constitution’s rules.Footnote ³⁹ In spite of the Constitution’s potential, the dominant legal culture in South Africa, which was regarded by Klare as formalistic,Footnote ⁴⁰ liberal,Footnote ⁴¹ and lacking a “strong tradition of substantive political discussion and contestation through the medium of legal discourses,”Footnote ⁴² could represent a barrier to a transformative project focused on the distributional effects of constitutional adjudication.Footnote ⁴³

According to Klare, the text of the South African Constitution, rather than being liberal,Footnote ⁴⁴ was focused on social concerns and redistributive policies.Footnote ⁴⁵ As he emphasized, “the Constitution contains a pervasive and overriding commitment to equality, specifically comprehending a substantive (redistributive), not just formal, conception of equality.”Footnote ⁴⁶ This approach assumed that the South African legal system could not be “neutral with respect to the distribution of social and economic power and of opportunities for people to experience self-realization.”Footnote ⁴⁷ Consequently, the courts ought not to be reluctant to interrogate its distributive consequences in all aspects of economic life,Footnote ⁴⁸ including, as a result, the right to property, contractual rights, and torts regimes.

Based on this understanding of what orthodoxy and heterodoxy mean with regards to the constitutional right to health, I will discuss whether this form of transformative constitutionalism may be applicable to the Brazilian constitution and if the Brazilian Supreme Court adopted such a doctrine in ADI 5529.Footnote ⁴⁹ However, in order to set the stage for this discussion I must first present the details of the decision itself. With this in mind, we now turn to the debate regarding how Section 40 of the Brazilian Patent and Trademark Law came to exemplify what I will characterize as legal ultra-orthodoxy.

8.3 Ultra-orthodoxy in Brazilian Intellectual Property Law

I have already defined ultra-orthodoxy as the adoption of radically neo-liberal legal institutions in developing countries as a result of the lobbying efforts of industries with substantial economic power. The main characteristic of ultra-orthodox institutions is that they are not mere transplants of legislation and case law existing in Europe and the United States. They are truly radicalized versions of such legal institutions. When I say radicalized, I mean regarding their distributive effects. Hence, those ultra-orthodox institutions have, on face value, characteristics that increase their negative distributive effects. I believe that this phenomenon is substantially different from what has been documented in the literature on legal transplants,Footnote ⁵⁰ since in this literature there is usually the expectation that legal institutions will be relatively similar with regards to their distributional effects. In this section, I will argue that the Brazilian Patent and Trademark Law provides at least two outstanding examples of ultra-orthodoxy: the provisions on patent extensions and the so-called pipeline regime. In order to demonstrate how those examples were developed, I will provide the context in which the Brazilian Patent and Trademark Law was approved by the Brazilian Congress, in the mist of the neo-liberal reforms of the 1990s, and of the legislative process involving what I regard as the ultra-orthodox features of such statute.

The current status of legal orthodoxy in intellectual property rights, the right to health and constitutional law in general is the result of a historical process of economic and legal transformations that erupted after the end of the Cold War that I will generally describe here as the neoliberal reforms. Despite its prevalence in the debates regarding legal reform in developing countries, neoliberalism can only be correctly understood as a construction of a specific historical context,Footnote ⁵¹ in which, with the fall of the Soviet Union and the end of the Cold War, the focus on integrating countries previously excluded from the process of economic globalization, such as Eastern European and Latin American countries, became central to the international public debate.Footnote ⁵²

Central to the debate was the so-called Washington Consensus, a list, made in 1989, of ten policy actions that were supposedly “desirable in just about all the Latin American countries.”Footnote ⁵³ Its pillars were the “consensus on democracy and elections,” “free trade,” and “open markets.”Footnote ⁵⁴ Those policies were based, however, as Joseph E. Stiglitz once asserted, “on a simplistic model of the market economy”Footnote ⁵⁵ in which there was no need for governmental intervention to achieve perfect market functioning. That is why these policies of the Washington Consensus were designated as neoliberal.Footnote ⁵⁶ The concept of deregulation, which appeared frequently in the neoliberal discourse was, according to John Williamson, used in the sense of a facilitation of the entry of new companies in a country through the “abolition of barriers.”Footnote ⁵⁷ It was also argued that an excess of government regulation could be harmful to small businesses and might even encourage corruption.Footnote ⁵⁸ The whole list was perhaps better labeled a “Liberalization Consensus.” The policies were not free choices of the democracies in Latin America, as the term “consensus” might suggest, but impositions from Washington. This neoliberal model, imposed on Latin American countries without regard for their interests and their political, social, and historical peculiarities, failed to be implemented successfully.Footnote ⁵⁹

Establishment of an intellectual property rights regime was not a component of the original “Washington Consensus” but it later became a cornerstone of the effort to facilitate business entry in the Global South. Nonetheless, few areas of law have a more secure place in the canon of orthodoxy than intellectual property law. In the context of intellectual property law, for a country to follow a neoliberal or orthodox approach it has to adhere fully to the World Trade Organization’s TRIPs model, which, according to Hans Löfgren and Owain David Williams, “marked the highpoint of neoliberalism.”Footnote ⁶⁰

Brazil’s Patent and Trademark Law created an exceptional intellectual property regime even more protective of the interests of transnational businesses than the TRIPS’s regime. The head of Section 40 provides that patents for invention shall, as a general rule, be valid for a period of twenty years counted from the filing date. Up until this point, the Brazilian statute only followed the standard provisions of the TRIPS Agreements. The innovation came in its sole paragraph, which created an exception for the terms provided in the head of the Section (caput). The sole paragraph provided that the term of the patent should not be less than ten years, counted from the date of grant, except in cases where the Brazilian National Institute of Industrial Property (Instituto Nacional da Propriedade Industrial) (INPI), the Brazilian patents and trademarks office, was unable to carry out the substantive examination of the application due to proven judicial conflict or force majeure.

Hence, if the INPI were to take, for example, almost twenty years to grant the patent, the total term of the patent would be thirty years. No other patent regime in the world had an equivalent provision, both among countries in the Global North and Global South.Footnote ⁶¹ Extensions in other jurisdictions are granted for only a few months, taking into consideration, for example, any real delay that the approval proceedings might have caused to taking the product into the market. No other patent law regime provides an automatic extension, much less of a minimum period of ten years.

I do not believe that the extraordinary character of the sole paragraph Section 40 can be explained only by the asymmetry of political power in the international arena between Brazil and developed countries or as a result of a lack of understanding on the part of Brazilian lawmakers. Brazil has one of the most sophisticated professional diplomatic bodies in the world, with substantial experience in multilateral organizations. Moreover, unlike most other countries in the Global South, Brazil has a very sizable economy, which grants it considerable bargaining power in international arenas, even when acting alone. Nor can it be said that Brazilian authorities were misled and that they had no idea that the patent system in Brazil was divergent. As a Brazilian diplomat recognized at the time, the “additional privileges” granted by the Brazilian Congress to patent holdersFootnote ⁶² mostly favored foreign companies since, at the time, Brazil did not have a highly sophisticated research and development environment in the local private sector.

Local pharmaceutical companies were aware of the likely effects of Section 40 of the Brazilian Intellectual Property Statute and opposed its adoption. According to a speech in Congress from Dante Alário Junior, former President of the Association of National Pharmaceutical Laboratories, patent terms would be, if the bill was approved as it was proposed at the time, exactly “as the transnationals want”Footnote ⁶³ and, consequently, would just unnecessarily increase “the time of the foreign private monopoly, which would not benefit Brazil at all.”Footnote ⁶⁴ The Federation of Industries of the State of São Paulo (FIESP) observed that these terms were “excessive,” “creating a reserved market for too long,” which could “discourage technological renewal.”Footnote ⁶⁵ In particular, FIESP believed that the automatic extension of patent terms due to eventual delay on the review process, which would later be enshrined in Section 40 of the Brazilian Intellectual Property Statute, should be eliminated.Footnote ⁶⁶

The automatic extension of the patent term provided by the sole paragraph of Section 40 was not even the aspect of the Patent and Trademark Law that ignited the most active public debates. Another controversial issue was the so-called pipeline provision, which became Sections 230 and 231 of the Patent and Trademark Law. The “pipeline” system allowed holders of foreign patents to register their patents in Brazil and obtain protection for the remaining period of validity under foreign law, despite the fact that such patents were in the public domain under the previously existing Brazilian legislation.Footnote ⁶⁷ This mechanism was not provided for in the TRIPS agreements and was peculiar to the Brazilian legal system. It caused a great deal of concern among local public health specialists,Footnote ⁶⁸ since it was estimated that 340 medicines that were not previously protected by patents in Brazil would be suddenly granted protection.

It was clear that protecting pipeline patents would cause a sudden and drastic increase in the prices of Brazilian pharmaceuticals.Footnote ⁶⁹ According to Cassandra M. Sweet, referring to a study from Tahir Amin,Footnote ⁷⁰ “total deposits through the pipeline system resulted in 1,182 applications (45% from the US, 13% from the UK, 10% from Germany, 9.6% from Japan, and 7.7% from France), over 700 (or well over half) were granted.”Footnote ⁷¹ Consequently, Brazil had to pay “between 704% and 5,622% more for” some of these medicines “than it would have spent on equivalent generic medicines.”Footnote ⁷² In gross values, from 2001 to 2007, it was estimated that Brazil paid “between US$420 and US$519 million more, when compared with the reference prices from the World Health Organization or Doctors without Borders, respectively.”Footnote ⁷³ These are striking numbers for a poor and unequal country. It was not without reason that pipeline patents were, throughout the discussion of the bill in Brazil, called “abject and despicable”Footnote ⁷⁴ as well as a “legal aberration.”Footnote ⁷⁵

The pipeline provisions were challenged before the Brazilian courts almost immediately after they were enacted. On April 24, 2009, the Federal Attorney General, urged on by the National Federation of Pharmacists and the Brazilian Network for the Integration of Peoples,Footnote ⁷⁶ proposed before the Federal Supreme Court a direct action for the declaration of unconstitutionality of Articles 230 and 231 of the Patent and Trademark Law, which, as mentioned, provided for pipeline patents.Footnote ⁷⁷ The Supreme Court, however, failed to rule promptly on that matter and all “pipeline” patents expired without being challenged.

The fact that the Intellectual Property Law was approved by Congress over the objections of local elites might be explained by the fact that it was supported by substantial lobbying activity from foreign actors. At the time, Brazil was facing political pressure from the United States,Footnote ⁷⁸ which had companies holding a large number of patents to be protected. Fernando Henrique Cardoso, the then President of Brazil, even assured a US trade official, according to Folha de São Paulo, a Brazilian newspaper, that the bill met “85% of the demands of the international community.”Footnote ⁷⁹ In parallel, Interfarma, the association of the international pharmaceutical industry located in Brazil, dedicated to following parliamentary activities, among other things, participated actively in the discussion of the bill.Footnote ⁸⁰ According to Laymert Garcia dos Santos, there was even speculation that the bill was originally drafted by Interfarma.Footnote ⁸¹ Unfortunately, the Brazilian political system does not regulate lobbying and so it is not possible to analyze the amounts different interest groups invested in lobbying around the adoption of the Patent and Trademark Law.

The automatic patent extension and the pipeline provisions of Brazil’s Patent and Trademark Law are examples of ultra-orthodoxy, in contrast to the orthodoxy embodied in the terms of the TRIPS agreements. As used here, this concept refers to radical interpretations of nonliberal legal institutions that threaten to have negative distributive effects when implemented in countries in the Global South with high levels of inequality. As such, ultra-orthodoxy leads to worse distributive effects than simply importing or transplanting orthodox legal institutions in accordance with the Washington Consensus.

8.4 The Brazilian Supreme Court Ruling on Patent Extensions

This section will consider the Brazilian Supreme Court’s response to the ultra-orthodox patent extension provisions of the Patent and Trademark Law to evaluate if it deviated from the traditional orthodox approach by incorporating the distributive effects of private law in its decision on the ADI 5529, and, as a result, if such a ruling may be an example of legal heterodoxy. Kevin Davis and Mariana Pargendler have discussed in detail “how courts in select developing countries have recently diverged from orthodoxy and begun to embrace heterodoxy,” using, for instance, “contract law to reduce inequality.”Footnote ⁸² Davis and Pargendler define heterodoxy as divergence from institutional arrangements in countries in the Global North, a subset of which involve divergences adopted by courts and motivated by concerns about economic inequality.

The exceptional patent extension regime adopted by Brazil diverges from models favored in the Global North but in other respects fits awkwardly with Davis and Pargendler’s conception of heterodoxy. I characterize the Brazilian regime as an example of ultra-orthodoxy because, even though it involves a departure from legal standards imported from the Global North, it does not have the heterodox feature of attempting to reduce or adapt to the effects of high economic inequality.

This section will consider whether the ruling by the Brazilian Supreme Court which declared the sole paragraph of Section 40 of the Brazilian Patent and Trademark Law unconstitutionalFootnote ⁸³ should be regarded as an example of legal heterodoxy, in the sense used by Davis and Pargendler. Some features of this ruling could be regarded as “heterodox,” such as the attention paid to distributive concerns, the interpretation of the right to health as a human right that should be interpreted collectively, the value given to independent academic opinions, not funded by any of the interested industries (the international pharmaceutical industry and the local generic drugs industry), and, lastly, the attention paid to comparative law, particularly involving other countries from the Global South.Footnote ⁸⁴ At the same time, it could be argued that the Supreme Court’s decision does not qualify as heterodox since its results represent only a return to the TRIPS standard – the sole paragraph of Section 40, being a “TRIPS-plus mechanism.”Footnote ⁸⁵ Hence, the ruling of the court in favor of considering Section 40 unconstitutional would only put the Brazilian system in the “orthodox” category, by complying with the TRIPS agreement, which, as described in Section 8.2, represents orthodoxy in intellectual property law. The Court’s position might be seen in that light as a repudiation of only those exaggerated aspects of legal ultra-orthodoxy. A more detailed assessment of the arguments presented by the opinion of the court may enlighten this discussion.

First, the opinion of the Rapporteur of the case, Justice Dias Toffoli, makes it clear that the decision was based on the right to healthFootnote ⁸⁶ in the midst of a global pandemicFootnote ⁸⁷, which highlighted “the damage resulting from an undue and unconstitutional exclusivity.”Footnote ⁸⁸ Many Justices, besides Justice Toffoli, also endorsed consideration of evidence based on comparative law.Footnote ⁸⁹ As summarized in the headnote of the decision, the Court concluded that the sole paragraph of Section 40 “does not derive from the TRIPS Agreement; nor does it find a parallel in other jurisdictions, in which the additional exclusivity rights follow a logic essentially different from that adopted by the Brazilian legislation, having a reduced application, being limited to specific cases and not being automatic rights.”Footnote ⁹⁰

In reaching these conclusions, the court took into consideration research produced by the Law and Poverty Group of the University of São Paulo Law School, coordinated by Professor Calixto Salomão Filho and me. The report was prepared based on the work of several highly dedicated and talented students, without financial support from any of the parties involved in the litigation, including the foreign pharmaceutical industry (arguing against the declaration of unconstitutionality) and the Brazilian producers of generic pharmaceuticals (in favor). The report adopted an approach that is unusual in constitutional argument, focusing mainly on a comparative perspective with a strong empirical approach. Typically, the Brazilian Supreme Court, like other constitutional courts, refuses to ground its decisions on comparative law analysis because of sovereignty concerns. The Brazilian Interdisciplinary AIDS Association (ABIA), the first organization to make a statement as amicus curiae in the lawsuit, filed the report with the court on December 16, 2020.

The Law and Poverty Group’s study included an analysis of process of extension of patents in Brazil and across twenty-nine other jurisdictionsFootnote ⁹¹ and concluded that there was no other legal system in which the extension was automatic for a fixed number of years and operated as set forth in Section 40, sole paragraph.Footnote ⁹² The study represented the most extensive comparative analysis of the matter at the time. The study also concluded that there were no grounds for the argument that the provision was adopted by Brazil as a response to “an obligation under the TRIPS Agreement.”Footnote ⁹³ The study found that, in all cases in which a country allowed the extension of patent terms due to delays in the approval process, it imposed at the same time a series of limitations. As mentioned in the previous section, such countries take into consideration the testing period of new drugs required by health authorities and if the delay in the approval caused a delay in taking the medicaments to the market. If there is no actual delay or if the cause cannot be singled out as being related to the approval process by the patent office, or even if the party concurred in the delay in any form, such elements may prevent the granting or reduce the extension period. The study demonstrated that such detailed analysis in other jurisdictions usually resulted in insignificant increases in the patent terms, of only a few months, for example. The Brazilian provision, on the contrary, had no limitations based on the specificities of the case, which meant that Brazil ended up having the longest effective patent terms of all the jurisdictions studied.Footnote ⁹⁴

This initial finding led the Law and Poverty Group to take a step further in the research and identify not only the applicable law in each jurisdiction but also the average effective duration of the patent terms, to determine whether differences in the legal framework created differences in practice. The results of the survey were absolutely striking. When comparing the effective term of the ten longest-lasting patents in the pharmaceutical sector with comparable patents in other jurisdictions, the difference is clear: “while the average term of the ten Brazilian patents indicated is 29.61 years, their counterparts in the other countries present average protection a little longer than the twenty years suggested by the TRIPS agreement.”Footnote ⁹⁵ In general, as highlighted by Mário André Machado Cabral, in his review of the court ruling and the study of the Law and Poverty Research Group, “the average patent term in Brazil is 24.305 years. This is the highest average term among the BRICS countries (Brazil, Russia, India, China and South Africa), Latin American countries, as well as the six countries with the highest average terms (Brazil, Switzerland, Italy, UK, US and Sweden).”Footnote ⁹⁶ The study did not identify one single country in which the average surpassed twenty-one years, meaning that, in all other countries that adopted any kind of extension mechanism, such extensions did not surpass a few months on average. In Brazil it surpassed the TRIPS agreements term of twenty years by more than four years. This meant that Brazilian customers were paying monopolistic prices for, or being excluded from access to, patented products for many years after those patents were in the public domain in other jurisdictions. The study also included many jurisdictions in the Global South, breaking with the traditional approach in comparative law of looking only for standards from countries in the Global North. Based on this overwhelming evidence, several of the Supreme Court justices stressed how extremely the country’s patent system was tilted in favor of global monopolies and against the poorest of the poor.Footnote ⁹⁷

The study of the Law and Poverty Group concluded that these excessively long patent terms – which were also indeterminate, since the rule imposed no limits upon extensions after the patent was grantedFootnote ⁹⁸ – created disincentives to innovation since it prevented investments in new products based on technologies that would otherwise have been in the public domain.Footnote ⁹⁹ Furthermore, by granting exclusive privileges in an indeterminate manner, the rule also violated the constitutional provision on free competition.Footnote ¹⁰⁰ The study further concluded that, especially in the context of the COVID-19 pandemic, the rule interfered, without justification, with the population’s access to health, since it influenced the price and, consequently, access to medicines.

In its references to the study by the Law and Poverty Group, the justices of the Supreme Court highlighted two aspects of the study in ways that may be regarded as heterodox. First, Justice Lewandowski emphasized that the research was “disinterested,”Footnote ¹⁰¹ recognizing that the report was carried out by a public university without resources from any of the industries involved in the litigation and in the legislative process that proceeded it. He affirmed emphatically: “I understand that the conclusions of the empirical and disinterested research of the Law and Poverty Group leave no room for doubt as to the total dysfunctionality and inadequacy of the device under analysis.”Footnote ¹⁰²

Second, in his opinion, Justice Dias Toffoli regarded the study as “extremely relevant” because of its comparative analysisFootnote ¹⁰³ and devoted an entire page of his opinion to quoting excerpts from the research focused on comparative law issues, which included countries in the Global South.Footnote ¹⁰⁴ Right after this analysis, Justice Dias Toffoli concluded: “In other words, the term provided for in the sole paragraph, Section 40, is not justified.”Footnote ¹⁰⁵ Other Justices also emphasized the comparative law aspect in their opinions. Judge Nunes Marques, quoting from the report, stressed that “the average effective term of pharmaceutical patents in Brazil is the longest even in comparison with countries in the BRICS group.”Footnote ¹⁰⁶ This breaks the mold with regard to orthodox constitutional analysis, which usually understands matters of constitutional law to concern only domestic matters, refusing to rely upon comparative law arguments.

Justice Dias Toffoli also emphasized in his opinion the impact of the patent term extension on the Brazilian National Health System (SUS) – one of the largest public health systems in the world – and the pharmaceutical industry.Footnote ¹⁰⁷ In his guiding opinion he citedFootnote ¹⁰⁸ a study from the Institute of Economics of the Federal University of Rio de Janeiro, added to the case files by the Brazilian Interdisciplinary AIDS Association, and also quoted by the Attorney General,Footnote ¹⁰⁹ which claimed that the Ministry of Health spent “about 1.9 billion [reais] per year on just nine drugs whose patents would have expired between 2010 and 2019.”Footnote ¹¹⁰ Similarly, Justice Lewandowski pointed out, based on the data from the research of the Law and Poverty Group, that the rule had a “major impact” on public health.Footnote ¹¹¹

Justice Dias Toffoli was well aware of the importance of the ruling for the foreign pharmaceutical industry. He noted that Interfarma, the lobbying organization of the international pharmaceutical companies which participated intensively in the lawmaking process, as described above, also participated in the legal proceeding before the Supreme Court as amicus curiae and filed opinions in defense of its interests.Footnote ¹¹² He made it clear that the sole paragraph of Section 40 of the Patent and Trademark Law was unconstitutional in great part because of “the undue extension of the term of effectiveness of pharmaceutical patents,” creating an unjustified privilege for the private interest of one group “to the detriment of the collectivity, having an extreme impact on the provision of public health services in the country and, consequently, going against the constitutional right to health (art. 196 of the 1988 Constitution).”Footnote ¹¹³ This recognition by the court that the decision would affect interest groups and that there was a distributional matter to be resolved among those interest groups is another feature of the ruling which suggests it represents a step in the direction of a heterodox approach to constitutional adjudication.

The opinion of Justice Toffoli adopted the language and methodology of the heterodox interpretation of the right to health, described in Section 8.2. He interpreted the right to health as a right to be protected by means of public policies rather than individual litigation, since the individuals who were being hurt by the patent extensions were not even part of the proceedings. This represented a clear departure from approaches to the right to health previously favored by the Brazilian Supreme Court. This was further clarified by the modulation decision, in which the court explained certain aspects of the main decision. The Brazilian Supreme Court developed this methodology of ruling constitutional cases first on the merits and then issuing a supplementary decision to decide on procedural matters such as the time in which the decision will be effective. The Brazilian Supreme Court refers to this process as “modulation” (modulação) of the ruling of unconstitutionality. In the ADI5529, Justice Toffoli provided in his modulation decision that, while the ruling generally would be applicable only to new patent filings, in the case of patents of pharmaceutical products it also would apply to patents filed before the ruling. This decision was also followed by the majority of the court.Footnote ¹¹⁴

The analysis of the right to health in the leading opinion was intertwined with distributive concerns, reflecting an unprecedented adherence to a transformative constitutionalist approach. Citing the Law and Poverty Group’s report, Justice Rapporteur Dias Toffoli stressed that, since Brazil was a developing country, the effects on poor people who were excluded from access to treatments due to the high costs for medicines were particularly harsh.Footnote ¹¹⁵ Consequently, the public health system enshrined in the Constitution would be severely affected and harmed, especially in relation to those who depend on the system “to ensure their physical integrity and their survival.”Footnote ¹¹⁶

The extent to which the opinions of Justice Dias Toffoli and the Justices who concurred with him were based on distributive concerns was evident in the headnote of the ruling prepared by the Court. The headnote’s summary of the main rulings in the case focused mainly on its distributive aspects. It noted, for example, that the Court relied upon the idea of the “social function of intellectual property,” according to which property rights concern “the community and the development of the country.”Footnote ¹¹⁷ The extension of patent terms would, therefore, be “unfair and unconstitutional,” as it privileged “private interest to the detriment of the community,”Footnote ¹¹⁸ affecting access to medicines and the rights of competitors, consumers and those “who depend on the Unified Health System to guarantee their physical integrity and survival.”Footnote ¹¹⁹ The Court also noted, as consequences of the extension of the terms, that there would be an “arbitrary increase in profits, deepening the inequality between economic agents and transforming what was justifiable and reasonable into something unconstitutional, thus constituting an offense to the social function of intellectual property,” “free competition,” and “consumer protection.”Footnote ¹²⁰

The individual opinions provided more details regarding the reasoning of the Court on distributive matters. Justice Lewandowski noted that the rule hinders “overcoming poverty, contributes to Brazil’s technological backwardness and discourages development” “in favor of multinational companies that obtain benefits” in Brazil “that they cannot achieve either in their countries of origin or in any other nation in the world.”Footnote ¹²¹

The Court also took into account the fact that the case took place against the backdrop of a pandemic. Justice Toffoli stressed this factor when granting a provisional remedy in the case.Footnote ¹²² The Court agreed with this perspective, emphasizing, in the words of the headnote, that the burden on “public authorities” and “society” had become even more serious and urgent “in view of the international health emergency resulting from the COVID-19 pandemic.”Footnote ¹²³

As expected, the decision was not unanimous. Some of the dissenting opinions offered arguments in support of the “ultra-orthodox” legal approach. This was clear in the opinion of Justice Luiz Fux, who affirmed that he was inclined toward “analyzing the Law under the prism of economic analysis, of systemic risk, of ‘Brazil Risk’, of investor flight.”Footnote ¹²⁴ He argued, if the rule was found unconstitutional, Brazil would face systemic risk, because contracts would be breached, and investors would be caught by surprise.Footnote ¹²⁵ According to him, quoting Richard A. Posner,Footnote ¹²⁶ such systematic consequences should not be underestimated by a judge. Justice Fux presented these arguments in a very formalistic manner, without citing empirical evidence to support his claims. The absence of empirical support was particularly striking considering the evidence submitted by the Law and Poverty Group showing that no other country in the world had a legal regime for patent extension similar to the Brazilian one. It is not reasonable to mention “investor flight” when even the countries with the largest pharmaceutical industries, such as the United States, Germany, and Switzerland, placed substantially greater restrictions on patent extensions than Brazil.

Justice Fux’s reference to the economic analysis of lawFootnote ¹²⁷ provided his opinion with a scientific veneer, and he emphasized the foreign pharmaceutical companies’ economic argument that longer patent terms would stimulate innovation by rewarding investment in inventions, however, without any empirical evidence. This exemplifies the “ultra-orthodox” approach because it bases its reasoning on what may be regarded as neo-liberal arguments. The generic use of economic analysis of law by Brazilian courts usually overlooks the fact that application of economic analysis of law by courts in the United States and Europe generally requires empirical analysis. In the case at hand, empirical work was required to determine the costs and benefits of such extraordinarily long patent terms, the benefits of potential innovation, and the potential costs to the right to health of the general population. The parties opposed to the declaration of unconstitutionality never presented such an analysis, and, as a result, Justice Fux relied only upon a theoretical approach. On the other hand, as mentioned in the beginning of this section, several amicus curiae reports presented data related to the costs of such patents to the health of the Brazilian population.Footnote ¹²⁸ This led him to conclude that the only solution to the effects of the patent terms on health would be the mechanism of compulsory license, which would be less drastic than a ruling of unconstitutionality.Footnote ¹²⁹

Following a similar approach, Justice Barroso also drew attention to the “systemic effects of decisions.”Footnote ¹³⁰ In response to the evidence based on comparative law, he pointed out that cross-country differences may be justified by the fact that each country deals with its own circumstances.Footnote ¹³¹ In this respect, Justice Barroso also resonated orthodox constitutional law, calling for the balancing of principles following Dworkin’s and Alexy’s approach, arguing that a decision only on the grounds of its distributive effect could break the equilibrium of the constitutional system and that principles related to the protection of intellectual property rights should also be taken into consideration.

The common feature in the opinions of Justices Fux and Barroso is that they failed to support their arguments with any empirical evidence to counter the studies by public universities that grounded the opinions by the majority. This also highlights the normative and antiscientific bent of supporters of ultra-orthodox legal arrangements. It has been a feature of law and economics in certain parts of the Global South that general concepts become dogmas, abandoning the idea that such arguments need to be based on scientific evidence. The fact that “a” patent system, well adapted to a particular economy, “may” further development does not mean that “any” and “all” patent systems will further economic development. There is no rule about it and finding a response to such a question would require detailed research.

Dissenting opinions often say more about the actual thinking of the court than the leading opinion itself. In this case, since the dissenting opinions were so clearly aligned with what I described as “ultra-orthodoxy,” it is difficult not to recognize that the court’s ruling is more about repudiating legal reforms with excessively negative distributive effects than about taking a more proactive role in supervising the implementation of public policies, whether in the public health or in the patent systems. In any case, this ruling already qualifies as one of the “most important decisions” in the history of the Brazilian Supreme Court,Footnote ¹³² and certainly “the case of most relevance and impact” on intellectual property law in the country, as noted by Justice Nunes Marques.Footnote ¹³³ It was also, in my opinion, the most important decision by any court in the world on health and intellectual property rights in the midst of the global pandemic, particularly for recognizing the distributive effects of the patent system and overcoming the traditional divide between public and private law in this area. By bridging that divide, the court challenges an important pillar of orthodox law and economics and neo-liberal thinking, namely the ideas that distributive matters are only of concern for public law, to be dealt with exclusively through tax and transfer policies, and that private law should not be changed on account of negative distributive effects.Footnote ¹³⁴ The decision set a landmark by being the first Supreme Court ruling to adopt a clearly heterodox discourse, with its focus on distributive matters, its public policy-based approach to the right to health, and extensive use of comparative law with a focus on Global South countries.

It would be unfortunate if this decision ended up being understood as an isolated case, motivated only by the context of the pandemic. After all, the COVID-19 pandemic only highlightedFootnote ¹³⁵ certain processes of deterioration of human rights protection caused by the global economic system that must be corrected by increasing the focus on distributive effects of the legal private order. The relevance of the case in the future as a true “heterodox” decision will depend on the willingness of the Supreme Court to apply the core aspects of the ruling in other cases, making it a true precedent on preventing the worst negative distributive effects of ultra-orthodox approaches to private law in Brazil. It will also depend on the capacity of scholars and judges in Brazil to recognize the transformative potential of the new heterodox approach to private law scholarship and adjudication, for which this ruling might be only a starting point. The chapter has the purpose of serving as a first step in this intellectual endeavor.

8.5 The Backlash against the Ruling

The Supreme Court’s ruling on ADI 5529 has generated backlash, by which I mean attempts to circumvent its effects.Footnote ¹³⁶ Backlash may take many forms, including sham litigation to prevent competitors from beginning to produce generic drugs; filing a web of patent applications with similar names and descriptions, to confuse competitors; attempting to delay public procurement of generic drugs; and lobbying for new legislative initiatives in Congress. This section considers evidence of such backlash, the possibility that it could render the Supreme Court’s ruling ineffective, and whether that would undermine the ruling’s importance as a heterodox precedent.

The first evidence of backlash appeared in the Brazilian Congress. Three months after the Court’s ruling, Congress repealed the sole paragraph of Section 40.Footnote ¹³⁷ The repeal took place through the approval of Law 14,195/2021,Footnote ¹³⁸ later informally known as the “doing business law,” which generally addressed the process of company formation and other corporate law matters unrelated to intellectual property.

The decision to repeal a provision that had already been declared unconstitutional by the Supreme Court was, at least, puzzling. It is implausible that Congress’s motivation was simply to do a “clean up” of the Patent and Trademark Law. It is reasonable to suspect that Congress was motivated by the lobbying of foreign pharmaceutical companies. But, again, to what end?

The explanation might lie in the fact that the repeal creates legal uncertainty. The uncertainty regards the effectiveness of the ruling by the Supreme Court, and in particular its decision (set out in the modulation decision) that the ruling would apply retroactively to pharmaceutical patents filed in the past, not only to new ones. Hence, the legal uncertainty created by the repeal of the sole paragraph of Section 40 of the Patent and Trademark Law is the following: what should be now applied: (i) the Court’s modulation decision, including the holding that the ruling would put into the public domain patents already filed for pharmaceutical products, or (ii) ordinarily applicable rules regarding the temporal scope of legislation, which could be interpreted to mean that the change in the law would be applied only to patents filed after the sole paragraph of Section 40 of Federal Law No 9,279/1996 was repealed, meaning that previously filed pharmaceutical patents would be protected?

In my opinion, the repeal of Section 40, sole paragraph, of the Brazilian Patent and Trademark Law should not be interpreted as having limited the effects of the ruling by the Supreme Court because, according to the tenets of separation of powers, Congress could not change the law to circumvent the effects of a decision by the Supreme Court. However, other legal scholars, judges, and lawyers could have different opinions on the matter, creating legal uncertainty. The well-established scholarship on sham litigation demonstrates that all that it requires is legal uncertainty.Footnote ¹³⁹ Private parties involved in such litigation are only buying time. To delay the production of generic drugs is already a major victory since it creates a de facto extension of patents. In the case of Brazil, it might be decades before this matter is settled by the Supreme Court, unless the court is challenged to take a more active role in the process.

It is unclear if the repeal was a result of lobbying by foreign pharmaceutical companies. Again, the lack of transparency in Brazilian legislative proceedings plays a part. The information that is publicly available shows that the original proposal to repeal the sole paragraph of Section 40 of the Patent and Trademark Law predates the ruling of the Supreme Court on the matter by a few months. A bill proposing the amendment of the Patent and Trademark Law was introduced in the final stages of the litigation, when it was clear that the Court would soon issue its opinion.Footnote ¹⁴⁰ It was introduced by a member of Congress from a conservative party.

However, Congress approved the repeal only after the ruling of the Supreme Court and Congress’ members used the Supreme Court’s ruling as grounds to justify their support for the repeal.Footnote ¹⁴¹ It was a formal justification, since there is no public record of relevant debates in Congress about that repeal and opposition was modest.Footnote ¹⁴²

There is more evidence of looming backlash. Numerous pharmaceutical companies initiated legal proceedings with the aim of extending the duration of individual patents, thereby preventing the manufacturing of generic drugs.Footnote ¹⁴³ By May 2023, thirty-nine lawsuits had already been filed by pharmaceutical companies seeking patent extensions.Footnote ¹⁴⁴ The pharmaceutical companies argued, for example, that the INPI unreasonably postponed the patent application evaluation process, resulting in financial losses by curtailing the time during which the companies could enjoy exclusivity. They argued that this issue could be remedied by prolonging the patent terms, a course of action that the Supreme Court ruling on the ADI 5529 explicitly declared unconstitutional,Footnote ¹⁴⁵ since it was the exact purpose of the extension of patents provided by law. The claim is wrong on its face value. These lawsuits are requesting lower court judges to grant the companies the same kinds of extensions contemplated by the unconstitutional provision based on general equity arguments, which are not admissible in cases in which there is a specific law that regulates patent rights. Clearly wrong arguments presented to courts like that are the hallmark of sham litigation. One strategy is to file several claims with bogus legal grounds under the belief that at least some lower court judges without sufficient information or knowledge of the matter will make mistakes, such as granting injunctions. In this case, what the pharmaceutical companies are requesting from the lower courts is to create caselaw that is directly contrary to a ruling of the Supreme Court. Even if the cases end up being decided against the international pharmaceutical companies, injunctions may be issued. Lawsuits in Brazil may take several years to have a final decision so obtaining an injunction may be a major victory, since it has the practical effect of extending the patent.

According to a survey conducted by Grupo Farma Brasil, all cases that reached the Appellate Courts resulted in the denial of patent extension requests. However, injunctions were issued in a few cases granting the international pharmaceutical companies the right to keep their patents while the case is decided without appeal. Such injunctions are also experiencing high rates of rejection – only 20 percent have been granted.Footnote ¹⁴⁶ Nonetheless, the fact that injunctions were granted in about 20 percent of the cases is already astonishing and, as discussed, considering that those cases may take decades to have a decision that is not subject to appeal given the slowness of Brazilian courts, the injunction itself may represent a definitive victory with regard to certain patents. It will be important to keep track of the progress of these cases through the Brazilian courts.

In the years to come, we will see whether the Supreme Court’s decision in ADI 5529 was effective in terms of increasing distribution of generic drugs to the Brazilian population. If backlash prevents the decision from having a positive distributive effect then we may infer that ultra-orthodoxy is a feature of the entire Brazilian legal system rather than of specific legal provisions. In that case, the role of courts and scholarship will be to identify the elements and sources of this ultra-orthodoxy.

8.6 Conclusion

The aspects of the Brazilian patent law regime that were declared unconstitutional by the Brazilian Supreme Court in ADI 5529 due to their negative distributive effects represented a phenomenon that I have labeled ultra-orthodoxy. Section 40, sole paragraph, of the Brazilian Patent and Trademark Law did not simply follow the orthodox approach, implementing rules provided in the TRIPs agreement, but in fact adopted a hyperbolic version of it. The negative distributive effects of such an arrangement are undeniable, since it was determined that Brazilian patents were extended, on average, for about four more years than all other jurisdictions in the world. As a consequence, pharmaceutical companies could charge monopolistic prices for their patented products in Brazil while such technologies were already in the public domain elsewhere. This chapter has demonstrated that the ruling by the Brazilian Supreme Court in ADI 5529 was grounded on the understanding that the patent extension mechanism provided by Section 40, sole paragraph, of the Brazilian Patent and Trademark Law was an outlier with no parallel in any other jurisdictions around the world, and that this had negative distributive effects for the Brazilian population, violating, most significantly, the right to health with regards to access to medicines. No other country in the world, as emphasized by the Brazilian Supreme Court, allowed such a long period of monopolistic exploitation of innovation. The main innovation of this ruling by the Supreme Court, in a departure from its own precedents, was to treat negative distributive effects as grounds for the declaration of unconstitutionality of a private law reform. In doing so, the Court rejected orthodox approaches, according to which courts should not engage in the analysis of the distributive effects of private law arrangements, since distribution should be accomplished through public law.

There are several heterodox elements of the Supreme Court ruling on ADI 5529. The first and foremost is its clear adoption of distributive analysis as grounds for declaring private law institutions unconstitutional, breaking with the neoliberal orthodoxy as incorporated in the canons of economic analysis of law. Second, the Brazilian Supreme Court made extensive use of comparative law and empirical analysis, including analysis of not only jurisdictions from the Global North but also from the Global South. Third, the Supreme Court made substantial use of amicus opinions which were regarded as independent of the economic interests at stake, coming mainly from research institutes located in Brazilian public universities. This aspect of the decision responds to the concern that distribution of wealth might also affect the way that expert opinions are presented to the court in high-stake cases. Last, but not least, the court clearly evaluated private law institutions in light of their impact on public interests and regarded them as means to implement social and economic rights such as the right to health. All these elements, grounded in the use of distributive analysis, put the ruling on ADI 5529 in the pantheon of significant heterodox precedents, not only in Brazil but also internationally.

The case also generated substantial backlash, including sham litigation designed to prevent competitors from producing generic drugs. The fact that this backlash may mute the potentially beneficial distributive effects sought by the Supreme Court in no measure reduces the relevance of the case and its heterodox character.