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In this chapter, we will explore several real-world case studies that highlight the tension between intellectual property (IP) protection and access to life-saving medicines. These case studies offer a nuanced perspective on how patent laws, international agreements like the WTO’s TRIPS Agreement, and other intellectual property rights impact global health outcomes.
The cases include the HIV/AIDS crisis, the development and distribution of Covid-19 vaccines, and the complexities surrounding biologic drugs. These examples illustrate both the successes and limitations of the current system, providing a foundation for discussing potential reforms in later chapters.
Case Study 1: HIV/AIDS Medication and the Doha Declaration
The HIV/AIDS crisis of the late 20th century was a turning point in the global discussion about access to medicines, especially in LMICs. At the height of the crisis, antiretroviral (ARV) treatments, which could significantly extend the lives of people living with HIV/AIDS, were priced at around $10,000 per patient per year. This cost was prohibitively high for the majority of patients in LMICs, particularly in sub-Saharan Africa, where the epidemic was most severe. This case study illustrates how the Doha Declaration on the TRIPS Agreement and Public Health enabled the use of compulsory licensing to expand access to life-saving medicines.
The Role of Patents in the HIV/AIDS Crisis
At the onset of the crisis, multinational pharmaceutical companies held patents on the most effective ARV therapies. As the crisis worsened, public health advocates criticized the high prices of these drugs, arguing that patent protections were preventing millions from accessing life-saving treatments. In response to growing pressure from civil society, governments, and international organizations, the WTO convened a meeting in 2001 that led to the adoption of the Doha Declaration on the TRIPS Agreement and Public Health.
The Doha Declaration clarified that WTO members have the right to use the TRIPS Agreement’s flexibilities, including compulsory licensing, to protect public health. It emphasized that TRIPS should not prevent countries from taking measures to ensure access to medicines in public health emergencies. The Declaration marked a significant victory for public health advocates and LMICs seeking to produce or import cheaper generic versions of patented ARVs.
Compulsory Licensing in Practice
Following the Doha Declaration, several countries, including Brazil and Thailand, issued compulsory licenses to produce or import generic ARVs. This significantly lowered the cost of treatment and expanded access to millions of people living with HIV/AIDS. For instance, Brazil’s compulsory licensing policy allowed the government to negotiate significantly lower prices for ARVs, which contributed to the country’s successful HIV/AIDS treatment program.
Moreover, pharmaceutical companies began to respond to the pressure by offering discounts on patented ARVs or entering into voluntary licensing agreements with generic manufacturers. The price of ARVs dropped from $10,000 per patient per year in the late 1990s to less than $100 per patient per year by the mid-2000s, dramatically increasing access to treatment.
Lessons Learned
The HIV/AIDS crisis demonstrated the power of TRIPS flexibilities, such as compulsory licensing, to expand access to essential medicines in public health emergencies. However, it also highlighted the limitations of this approach. The process of issuing compulsory licenses can be slow and bureaucratic, often requiring negotiations with patent holders, which can delay access to urgently needed treatments. Moreover, pharmaceutical companies and high-income countries, such as the United States and members of the European Union, have sometimes exerted political pressure on countries attempting to use compulsory licensing, further complicating the process.
Case Study 2: Covid-19 Vaccines and the TRIPS Waiver Proposal
The Covid-19 pandemic presented unprecedented challenges to global public health and exposed significant inequities in the distribution of vaccines and treatments. While vaccines were developed in record time, thanks in part to innovative technologies like mRNA, access to these vaccines was highly unequal. High-income countries were able to secure the bulk of early vaccine supplies through advance purchase agreements, leaving many LMICs without sufficient doses. This case study examines the impact of intellectual property protection on Covid-19 vaccine distribution and the ongoing debate over the proposed TRIPS waiver.
The Development of Covid-19 Vaccines
The rapid development of Covid-19 vaccines was a remarkable scientific achievement, driven by public and private sector investment. However, the initial distribution of these vaccines was marked by stark inequities. By mid-2021, high-income countries had administered the majority of available doses, while many LMICs struggled to vaccinate even a small portion of their populations. This disparity was partly due to the patent protections on Covid-19 vaccines, which limited the ability of LMICs to produce their own doses or source them from alternative suppliers.
The TRIPS Waiver Proposal
In response to the inequitable distribution of vaccines, India and South Africa proposed a temporary waiver of certain provisions of the TRIPS Agreement in October 2020. The waiver aimed to allow WTO member states to suspend IP protections for Covid-19 vaccines, treatments, and diagnostics for the duration of the pandemic. Proponents of the waiver argued that it would remove legal barriers to the local manufacturing of vaccines and treatments, particularly in LMICs, thereby increasing global supply and accelerating the end of the pandemic.
However, the waiver proposal faced strong opposition from several high-income countries, including the United States (initially), the European Union, and the United Kingdom, as well as major pharmaceutical companies. Opponents argued that the waiver would undermine incentives for innovation and that the real barriers to vaccine distribution were related to supply chain issues and manufacturing capacity, not intellectual property.
COVAX and the Challenges of Equitable Distribution
The COVAX initiative, co-led by Gavi, the Vaccine Alliance, the WHO, and the Coalition for Epidemic Preparedness Innovations (CEPI), was designed to ensure equitable access to Covid-19 vaccines, particularly for LMICs. While COVAX was successful in delivering vaccines to many countries, it faced significant challenges, including insufficient funding and supply shortages, which hindered its ability to meet global demand.
Lessons from the Covid-19 Vaccine Rollout
The Covid-19 vaccine case highlights the complex relationship between intellectual property, global health, and manufacturing capacity. While patent protection did not create the sole barrier to vaccine access, it contributed to the inequities by limiting the ability of LMICs to produce their own vaccines. Moreover, the debate over the TRIPS waiver exposed the limitations of the existing IP system in responding to global health emergencies. The waiver proposal remains a contentious issue, with ongoing negotiations within the WTO, and its outcome will have significant implications for future pandemics.
Case Study 3: Biologic Drugs and Patent Thickets
Biologic drugs, which are derived from living organisms, represent some of the most advanced and expensive treatments available today. These drugs are used to treat conditions such as cancer, autoimmune diseases, and genetic disorders. However, the patent landscape for biologics is far more complex than for traditional small-molecule drugs, creating additional barriers to the production of affordable biosimilars (generic versions of biologics). This case study explores how patent thickets have been used to extend the market exclusivity of biologic drugs, preventing competition and driving up costs.
The Rise of Biologic Drugs
Biologic drugs have revolutionized the treatment of many serious diseases, offering targeted therapies that can be more effective than traditional treatments. However, biologics are significantly more expensive to develop and produce, and this is reflected in their market prices. For example, Humira (adalimumab), a biologic used to treat autoimmune conditions like rheumatoid arthritis, has been one of the best-selling drugs globally, but its cost can exceed $50,000 per patient per year in the United States.
Patent Thickets and Evergreening
To protect their market exclusivity, pharmaceutical companies often file multiple patents on various aspects of a biologic drug, a practice known as evergreening. These secondary patents can cover new formulations, dosing regimens, delivery mechanisms, or even slight modifications in the manufacturing process. The result is a patent thicket, a dense web of overlapping patents that can extend exclusivity beyond the original 20-year patent term.
For instance, AbbVie, the manufacturer of Humira, has filed over 100 patents on the drug in the United States, effectively delaying the entry of biosimilar competitors until at least 2023, even though the original patent expired in 2016. This extended exclusivity has allowed AbbVie to continue charging high prices, limiting access to the drug for patients in LMICs and driving up healthcare costs in high-income countries.
Barriers to Biosimilar Entry
Even when biosimilar manufacturers manage to navigate patent thickets, the development and regulatory approval process for biosimilars is far more complex than for small-molecule generics. Biologic drugs are large, complex molecules that are more difficult to replicate, and biosimilars must undergo rigorous testing to demonstrate that they are sufficiently similar to the original biologic. This complexity, combined with the legal challenges posed by patent thickets, has delayed the introduction of biosimilars and kept prices high.
Lessons from Biologics
The case of biologic drugs and patent thickets demonstrates how the current IP system can be manipulated to extend market exclusivity, creating significant barriers to competition and access to affordable treatments. It highlights the need for reform in the way patents are granted and enforced, particularly for biologics, where the public health implications of delayed access are profound.
Summary of Practical Implications
The case studies presented in this chapter illustrate the practical impact of patent protection on global health. While patents play a crucial role in incentivizing innovation, they can also create significant barriers to access, particularly in LMICs. The HIV/AIDS crisis showed the potential for TRIPS flexibilities, like compulsory licensing, to expand access to life-saving medicines, but also revealed the limitations of these mechanisms in practice. The Covid-19 pandemic exposed the limitations of the global IP system in responding to urgent health crises and highlighted the need for more flexible, equitable solutions. Finally, the case of biologic drugs and patent thickets demonstrates how the strategic use of patents can extend market exclusivity, delaying access to affordable treatments.
In the next chapter, we will explore legal and ethical perspectives on balancing pharmaceutical innovation with the global right to health, and propose potential reforms to the existing system to better address global health challenges.
