Another Missed Opportunity to Reform Compulsory Licensing and Crown Use in Australia

In 1909, Congress for the first time subjected intellectual property protections to compulsory licensing and rate regulation. A compulsory or statutory license is a legal requirement that mandates that the owner of the intellectual property allow third parties to make reproductions of the protected property, provided the third party pays royalties to the owner. Government sets the prices or royalty amounts to be paid by the third party to the intellectual property owner. When it comes to intellectual property rights secured by the Constitution, only copyright protections have been subjected to pervasive compulsory licensing and rate regulation schemes. Congress has not broadly imposed compulsory licensing and royalty rate regulation on patent rights. This paper therefore focuses primarily on compulsory licensing and rate regulation of musical compositions and sound recordings. As a matter of constitutional principle, imposing compulsory licenses and rate controls on copyrights or patent rights is highly problematic. Compulsory licensing and rate controls are at odds with the Constitution’s philosophic premises regarding the origin of property and the proper role of government. The Founding Fathers and early American constitutionalism regarded intellectual property as arising out of human nature and created through human creative and inventive labor, independently of government. It was the role of government to secure and protect property rights and, when appropriate, to clarify property boundaries. This paper has a special focus on the role of compulsory licensing in the contexts of current proposals relating to music and video programming. It concludes that Congress or agencies should not expand compulsory licensing and rate regulation of copyrighted music and video programming. As new technologies, services, and products emerge in the market, Congress and agencies should respect the exclusive rights of copyright holders in these areas rather than pare back those rights by subjecting them to new restrictions.

When the WTO/TRIPS Agreement entered into force in 1995, around 100 countries had adopted compulsory licensing under national intellectual property law. The compulsory licensing measure can be effective in dealing with situations inhibiting access to medicines, for example when a patent holder fails to use the patent in the granting country or when he or she maintains artificially high prices for patented articles. Despite the significant international development, it remains to be seen how the flexibility margins provided by the TRIPS provisions can be used as safeguards to protect public health interests of the poor countries. Effective mechanisms are also required to support countries that are unable to make effective use of compulsory licensing due to the inefficiency of manufacturing capacity. This chapter examines the problem of using the legal mechanism of compulsory licensing by developing countries. It looks at Thailand’s experiences with the use of compulsory licensing to increase access to medicines. Since the majority of compulsory licences issued around the world are related to pharmaceutical patents, the chapter highlights the use of compulsory licensing in the context of a range of public health responses. It first discusses the use by Thailand of the compulsory government use licensing to increase access to medicines. It also examines international rules on compulsory licensing, including the provisions of the Paris Convention, the TRIPS Agreement, and the Doha Declaration on the TRIPS Agreement and Public Health. Finally, the chapter discusses various legal issues under the Thai Patent Act regarding the compulsory licensing provisions. It also highlights the possible impact, in a broad sense, of the use of legal mechanisms such as compulsory licensing, which aims to effectively maintain fair market competition and dilute the monopoly power of the patent holder.

Copyright collectives are critical to the economic health of the music industry, but they are at a curious crossroads. Collective copyright management is used more extensively in the music business than ever before. Expanded collective copyright management for digital streaming is the centerpiece of the Music Modernization Act (MMA)—the most extensive revision to the Copyright Act in two decades. At the same time, major music publishers, who rely heavily on collective licensing revenue, are on a years-long mission to end collective licensing for certain digital streaming rights. These trends reflect changes that streaming technology has caused in music consumption, distribution, and revenue generation.
 Digital streaming has emerged as the dominant music consumption model, accounting for eighty-three percent of music revenues in the United States in 2020. This rapid rise to dominance naturally has profound implications for the future of music licensing. The licensing needs of streaming service providers are unprecedented in scale. Spotify, for example, currently hosts over 70 million recordings, with more than 60,000 new recordings uploaded every day. Most of these recordings encompass two copyrighted works that must be licensed separately: a copyrighted sound recording and a copyrighted underlying musical composition. Streaming services’ need for such a massive number of licenses highlights the value of collectives that enable streaming services to interface with a manageable number of licensors. It also highlights the importance of blanket licenses that permit spontaneous use of millions of works relatively free from infringement liability.
 At the same time, the importance of collective licensing to copyright owners has decreased in the streaming age. Streaming is a highly concentrated market: Spotify, Apple Music, and Amazon Music together control two-thirds of the global streaming market. Thus, it has never been easier for copyright owners to license a handful of platforms that deliver the lion’s share of revenue. Further, technology has markedly reduced the costs of use-tracking and royalty distribution. All streams are automatically logged, and royalties are automatically distributed based on usage data. As a result, the major record labels often directly license millions of sound recordings to streaming services without using a collective.
 Historically, collective copyright management has been valuable for both copyright owners and users of copyrighted works. The primary advantage is reduced transaction costs. Across the globe, there are millions of music copyright owners and millions of businesses that use copyrighted works. In some cases, individual transactions for large numbers of works would be prohibitively costly for both sides. Collective copyright management creates a one-stop shop for licensors and licensees, drastically reducing transaction costs. Collective copyright management further benefits copyright owners by sharing and thereby reducing administrative and enforcement costs. It further benefits users by reducing potential liability for frequent and spontaneous uses, especially through blanket licensing that empowers licensees to make unlimited use of all works in a licensor’s catalog.
 The major concern with collective licensing has long been the monopoly pricing potential of collective copyright control, especially when collective licensing is combined with blanket licensing. If one entity holds the rights to license the majority of popular songs, it can exact monopoly rents from anyone seeking to use music. Radio stations, streaming services, nightclubs, and other music-centric businesses would have no latitude to seek alternatives if the rights to license the music they need were concentrated in one entity. Music licensing, therefore, has long been a heavily regulated market, controlled through a combination of compulsory licensing regimes, statutory limitations and exceptions to exclusive copyright rights, and competition authority oversight.
 The question is whether such heavy regulation is necessary going forward—or, more to the point, whether collective licensing is necessary going forward. Collective licensing has dominated the music public performance rights market for a century. The two major performance rights organizations (PROs)—American Society of Composers, Authors and Publishers (ASCAP) and Broadcast Music, Inc. (BMI)—offer blanket licenses for millions of works, albeit under strict regulation by the Department of Justice (DOJ) to deter market power abuses. But this model increasingly seems like a vestige of the analog age. Today, there is a relative handful of high-value licensees operating globally. Streaming services have the technological infrastructure to work with a huge number of licensors, unlike the radio stations and nightclubs of yore. Because technology enables nearly frictionless virtual licensing and automated usage tracking and royalty distribution, a plethora of music rights and royalty administration businesses have flourished that are capable of administering direct public performance rights licensing and royalty collection on copyright holders’ behalf. The performance licensing that still involves high transaction costs—licensing of radio stations and brick-and-mortar businesses such as stores, fitness studios, and bars—accounts for less than fifteen percent of PRO revenues. Further, as I discuss in Part IV.B, licensing even in those arenas is vulnerable to disruption.
 The upshot is that music publishers, especially major publishers, are eager to eschew collective licensing in the digital streaming space so they can negotiate higher direct-licensing fees for streaming. As I discuss in Part III.C.3, publishers’ plans have been derailed for the time being by DOJ consent decrees that prohibit PROs from selectively licensing members’ works. Many licensees, on the other hand, are generally satisfied with how collective licensing currently functions in the performance rights space. The two major PROs are so heavily regulated that their blanket license offerings are comparable to compulsory licenses: The PROs’ pricing and licensing discretion is substantially curtailed under rate court and DOJ oversight. Meanwhile, competition from a new PRO (which poaches some of the legacy PROs’ most valuable catalog) and from a burgeoning music rights administration industry adds further pressure, casting doubt on the long-term viability of the legacy PROs. If the legacy PROs deteriorate and publishers seek direct licenses for performance rights, will licensees lobby for a blanket compulsory performance rights license?
 There is precedent for such a compulsory license, as a new compulsory blanket licensing regime came into effect in 2021, mandated by the MMA, for a related right: the right to make and distribute phonorecords of nondramatic musical works, including by means of “digital phonorecord delivery.” In essence, this is a compulsory license for the right to digitally deliver—via download or stream—a copyrighted song encompassed in a sound recording. The MMA also created a new collective—the Mechanical Licensing Collective (MLC) (so-called because the compulsory license covers what was traditionally called the “mechanical right,” or the right to reproduce musical works in formats used for mechanical playback)—to administer the compulsory license. The MMA comes two decades after the creation of another compulsory right prompted by digital streaming: the compulsory right available to “noninteractive” digital music services (essentially, internet radio webcasters and satellite radio broadcasters) to transmit sound recordings. A bespoke licensing collective, SoundExchange, was created to administer that compulsory license as well. In total, the licensing landscape for the U.S. digital music streaming sector involves six collectives: the MLC, SoundExchange, and four PROs. The only licenses in the streaming landscape not administered by licensing collectives are licenses for the use of sound recordings by “interactive” streaming services, such as Apple Music and Spotify. These direct licenses also happen to be by far the most lucrative licenses in the music business.
 The two compulsory streaming licenses of relatively recent vintage (and their respective collectives) seem entrenched for the foreseeable future. However, uncertainty surrounds the future of streaming performance royalties. Will major publishers seek to direct-license streaming performances and withdraw their rights from PROs? Will they seek instead to phase out streaming performance royalties in favor of a single, all-encompassing musical composition royalty stream managed by the MLC? Or will they maintain the status quo: music composition streaming royalties split into performance and mechanical royalties administered and distributed by five or more different collectives. In the long term, the third possibility seems the least likely due to the inefficiencies and lack of flexibility in the current structure. The other possibilities would not be costless, however, as bypassing the PROs for streaming royalties would markedly weaken—if not ruin—the PROs on which publishers would still rely for non-streaming performance royalties.
 In this Article, I examine the present state of collective copyright management and collective licensing in the United States and identify the factors likely to determine the future of collective copyright management due to new usage tracking technology and the rise of digital streaming. In Part I, I lay the terminological groundwork for subsequent discussion by defining and distinguishing the related concepts of collective licensing, direct licensing, compulsory licensing, blanket licensing, and collective copyright management. In Part II, I lay the necessary doctrinal

The challenge of providing access to high-priced patented medicines is a global problem affecting all countries. A decade and a half ago the use of flexibilities contained in the World Trade Organization Agreement on Trade Related Aspects of Intellectual Property Rights, in particular compulsory licensing, was seen as a mechanism to respond to high-price medicines for the treatment of HIV/AIDS in low- and middle-income countries. Today a number of upper-income European Union (EU) Member States are contemplating the use of compulsory licensing in their efforts to reduce expenditure on pharmaceutical products. EU regulation of clinical test data protection and the granting of market exclusivity interfere with the effective use of compulsory licensing by EU Member States and can even prevent access to off-patent medicines because they prohibit registration of generic equivalents.EU pharmaceutical legislation should be amended to allow waivers to data and market exclusivity in cases of public health need and when a compulsory or government use license has been issued. Such an amendment can be modelled after existing waivers in the EU Regulation on compulsory licensing of patents for the manufacture of pharmaceutical products for export to countries with public health problems outside the EU. Allowing a public health/compulsory license exception to data and market exclusivity would bring greater coherence between EC regulation of medicinal products and national provisions on compulsory licensing and ensure that Member States can take measures to protect public health and promote access to medicines for all.

Africa has the highest disease burden in the world and continues to depend on pharmaceutical imports to meet public health needs. As Asian manufacturers of generic medicines begin to operate under a more protectionist intellectual property regime, their ability to manufacture medicines at prices that are affordable to poorer countries is becoming more circumscribed. The Doha Declaration on the TRIPS Agreement and Public Health gives member states of the World Trade Organization (WTO) the right to adopt legislation permitting the use of patented material without authorization by the patent holder, a provision known as "compulsory licensing". For African countries to take full advantage of compulsory licensing they must develop substantial local manufacturing capacity. Because building manufacturing capacity in each African country is daunting and almost illusory, an African free trade area should be developed to serve as a platform not only for the free movement of goods made pursuant to compulsory licences, but also for an economic or financial collaboration towards the development of strong pharmaceutical manufacturing capacity in the continent. Most countries in Africa are in the United Nations list of least developed countries, and this allows them, under WTO law, to refuse to grant patents for pharmaceuticals until 2021. Thus, there is a compelling need for African countries to collaborate to build strong pharmaceutical manufacturing capacity in the continent now, while the current flexibilities in international intellectual property law offer considerable benefits.

Compulsory licensing (CL), provided by the Agreement on Trade-Related Aspects of Intellectual Property Rights, enables countries, including high-income countries, to ensure the protection of public health in the context of stringent intellectual property regimes. This study investigated associations between the time to attempted CL and a series of factors at the drug and country level. We used a dataset of all attempted CL that occurred from 1995 to 2014, calculated the duration as the difference in years between the year of global marketing of a certain drug and the year of attempted CL in a certain country, and applied a nonparametric event history model. We found that the Doha Declaration was quite effective in shortening the time to attempted CL. Additionally, even though global justice movements have encouraged some countries to attempt CL for various medicines since 2012, the time to CL attempts in this period became significantly longer compared to those that occurred immediately after the Doha Declaration. Our findings show that the subject of CL has not successfully expanded to oncology medicines from HIV/AIDS medicines and that recently approved medicines are not yet subjects of CL. Furthermore, our duration model suggests a learning-by-doing effect in attempting CL: previous experience of CL not only triggers CL for the same drugs in other countries but also accelerates CL for other drugs within the country.

Intellectual property rights (IPRs) play an important role in creating incentives for innovations. To strengthen and harmonise global standards of IPRs, the WTO members established the international agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and provided flexibilities for governments to safeguard social benefits of their countries. Compulsory licensing (CL) is one of the flexibilities under TRIPS that enables a government authority to use the licenses of patented medicines without patent-holders’ permission. However, policy makers in many countries are reluctant to use CL to promote access to essential medicines. One explanation is that most countries are worried about the potential implications of using the policy, and they are uncertain about which implementation strategies might help avoid negative consequences. The aim of this PhD thesis is to propose a framework to aid decision-making and implementation of drug policy, focusing on CL under the condition of public non-commercial use and government use of license. This framework is designed to be used as a tool for policy makers in the Thai Ministry of Public Health, suggesting a list of policy elements to help them consider related elements for policy action in making a decision and implementing CL policy in order to minimise negative consequences of the CL. Mixed methods were employed to develop the framework. This study began by developing a preliminary framework based on generic elements of CL policy suggested by inter-governmental organisations. The preliminary framework was strengthened by incorporating lessons learnt from experiences of the former government of Thailand. The implications of CL policy decisions on certain drugs were evaluated in terms of lifetime cost savings compared across different drug types. This allowed the identification of key factors to be included in criteria for drug selection. In addition, the performance of the Thai government in policy implementation was evaluated in order to prioritise areas for improvement. Finally, the contents of the preliminary framework were assessed in terms of applicability to the Thai context. Any additional elements derived from experiences of the former government were used to strengthen the framework. The findings of this study suggest key elements, which should be included in the framework to aid decision-making and implementation of drug policy, focusing on CL policy. 32 elements were identified to be included in the framework. This study also suggests strategies for the decision-making process. Three additional factors are suggested to be incorporated in the drug selection criteria, in order to help policy makers to select the drugs that potentially create the greatest benefits from CL implementation. In addition, this study suggests strategies for the implementation process. The findings help prioritise four implementation areas, which should receive more attention within current CL implementation. This study closes with policy recommendations for the Thai government about the current and future use of CL policy to improve its performance, and also for other countries having the similar context to learn from the Thai experiences.

The compulsory license is a concept that has been an accepted part of American intellectual property ever since the US Copyright Act of 1909. It has been recognized internationally via the Berne Convention for the Protection of Literary and Artistic Works since 1908. US patent law, however, has not paralleled its intellectual property sister copyright; historically compulsory licenses have not been common in the patent field. But change is occurring due to the World Trade Organization’s TRIPS and Doha Declaration which have brought to the international stage what copyright has accepted for more than a century: the compulsory patent license sanctified in international law. Developed countries – that is, patent-rich countries – have an ethical obligation to help those less fortunate. If not, the compulsory license can now be considered as an essential tool readily available in every poor country’s toolkit to help gain access to otherwise inaccessible but desperately needed patented innovation, especially in the area of public health and the accessibility of pharmaceuticals.

The chapter discusses the statutory and treaty basis for compulsory patent licensing, briefly reviews instances in which compulsory licenses have been issued, surveys the economic rationale behind compulsory licensing and compares the potential application of compulsory licensing in essential medicines and climate change mitigation technology.

<p>Although China has already issued laws and regulations on compulsory licensing of pharmaceutical patents, it has not yet implemented specific practices. After the outbreak of “COVID-19”, realistic needs have made it urgent for China to implement compulsory drug patent licensing. Therefore, this study will be based on China’s national conditions, combined with China’s laws and regulations on the compulsory licensing of pharmaceutical patents, and compare specific practices in other countries. Through qualitative analysis, it’s clear that China implements compulsory pharmaceutical patent licensing in three aspects: domestic system, international level, and government responsibility. To analyze the feasibility of China’s drug patent compulsory licensing system and provide suggestions.</p>

The crisis in the music industry has been brought about only in part by the digital revolution. The layering of copyright ownership interests and the complexity of copyright law, particularly as it applies to music, has also played a major role in the inability of the industry to respond to the rapidly evolving ways in which digital works can be distributed and otherwise exploited. After detailing the tangle of legal rights in the music industry and identifying the vested industry players and their respective roles, this article describes the difficulties faced by users of new technology in attempting to comply with the law. These problems may explain, at least in part, the widespread phenomenon of what many in the industry see as infringement on a massive, and global, scale. Without low-transaction-cost solutions and reasonable absolute price for obtaining authorization for the digital activities of millions of users, we see a classic example of market failure. Users respond to this failure by effectively exiting the failed market, completely ignoring the overly cumbersome requirements of the law. This article proposes concrete changes that should be implemented in the Copyright Act. First, the Copyright Act should embrace derivative work independence, eliminating the problems that result from the dual layers of copyright ownership in a final product utilized by downstream listeners. For such a consolidation to be effective in the music industry, however, two additional changes are necessary. First, the compulsory mechanical license for musical works, codified in section 115 of the Copyright Act, must be repealed. Second, sound recording copyright owners must be granted rights equal to those of musical work copyright owners. This package of three changes constitutes a significant modification in the structure of rights in the music industry that would result in a more efficient market for downstream use. The article also recommends that copyright owners be granted a unified right to commercially exploit the copyrighted work, rather than the divisible rights that the Copyright Act currently grants in section 106. In the music industry, copyright owners routinely assign or exclusively license their separate rights to different industry players, dividing these legal entitlements and causing a fractionation of rights in a single copyrighted work. In the digital realm, each of the owners claims that a variety of uses implicates her rights and thus requires her permission. A unified right would take time to influence contracting behavior, but should create vested industry players divided by logical markets rather than clustered around the different statutory rights granted to the copyright owner. Finally, the article explores the problems associated with industry consolidation and the existing and potential mechanisms to reduce the negative effects of the present consolidation. Congress has included provisions in the Copyright Act aimed at curbing potential abuses of monopoly power, such as the compulsory mechanical license. Over time, however, that compulsory license has significantly contributed to the complicated nature of the industry.

Until 2005 some developing countries with pharmaceutical manufacturing capacities especially India used the transitional period allowing local manufacturers to produce and sell generic versions of first-generation ART drugs patented in industrialized countries and originally produced and sold at high prices by Western pharmaceutical companies. Thanks to international competition between generic manufacturers and these companies significant price reductions were achieved for the large majority of these drugs. This was a key factor in the implementation and strengthening of access to AIDS treatment in developing countries and a strategic element in the World Health Organization (WHO) 3by5 plan. However with the end of the extended deadline for TRIPS compliance the scenario is likely to change radically. Considering the end of the transitional period which effectively will prohibit the free manufacture of newer and innovative antiretroviral generations to mark a key episode in the history of the fight against AIDS in developing countries this review will provide an overview of the meaning and consequences of this turning point and to present some of the new challenges of the post-2005 period. (excerpt)

BackgroundRecently, interest in compulsory licensing of pharmaceuticals has been growing regardless of a country’s income- level. We aim to investigate the use of compulsory licensing as a legitimate part of the patent system and tool for the government to utilize by demonstrating that countries with a mature patent system were more likely to utilize compulsory licensing of pharmaceuticals.MethodsWe used a multivariate logistic model to regress attempts to issue compulsory licensing on the characteristics of the intellectual property system, controlling for macro context variables and other explanatory variables at a country level.ResultsA total 139 countries, selected from members of the World Trade Organization, were divided into a CL-attempted group (N = 24) and a non-CL-attempted group (N = 115). An attempt to issue compulsory licensing was associated with population (+) and a dummy variable for other regions, including Europe and North America (−). After controlling for macro context variables, mature intellectual property system was positively associated with attempting compulsory licensing.ConclusionsOur study provided evidence of an association between attempting compulsory licensing and matured patent systems. This finding contradicts our current understanding of compulsory licensing, such as compulsory licensing as a measure to usurp traditional patent systems and sometimes diametrically opposed to the patent system. The findings also suggest a new role of compulsory licensing in current patent systems: compulsory licensing could be a potential alternative or complement to achieve access to medicines in health systems through manufacturing and exporting patented pharmaceuticals.

*Tilleke & Gibbins International Ltd., Supalai Grand Tower, 26th Floor 1011 Rama 3 Road, Chongnonsi, Yannawa, Thailand Tel.: +66 2653 5874 E-mail: siraprapha.r@tilleke.com Government-use compulsory licensing has almost always stirred up controversies and debates with regard to its appropriateness, actual benefits and detriments. Patent owners and advocates of IP protection remain firm on the position that while a country has the right to override patents by issuing compulsory licenses (CLs) in certain limited circumstances, this should be viewed as a last resort, not a preferred method of tackling public health issues. On the other hand, patient rights groups, NGOs and pro-CL governments argue that implementing CLs is in line with international obligations under the WTO framework, which affords member states the right to challenge patents in order to promote access to medicines and resolve public health problems. Although most of the earlier CLs issued in Asia mainly focused on solving health crises relating to HIV/AIDS or other epidemics, Thailand and India began to implement CLs as a means to increase access to drugs whose market prices are regarded as being too costly, including cancer drugs and cardiovascular drugs. This new trend is a slippery slope, and could easily turn into abuse of the patent system beyond what was intended under the WTO framework. Protection of intellectual property, including patents, was specifically recognized by the WTO in the TRIPS Agreement [1]. As an exception to patent rights, Article 31 of the TRIPS Agreement recognized that a member state may grant CLs where necessary, but it also set out a number of conditions and limitations for such government-use CLs. In particular, to provide an opportunity for fair negotiations, Article 31 subparagraph (b) mandated that before a CL is granted, the proposed user must have made efforts to obtain authorization from the patent owner on reasonable commercial terms, and such efforts must have been unsuccessful after a reasonable period of time. An exception is in the case of ‘a national emergency or other circumstances of extreme urgency’, for which a government need not consult with the patent owner in advance of granting the CL; however, the government should notify the patent owner as soon as reasonably practicable thereafter. Article 31 subparagraph (c) also limited the scope and duration of the CLs to the purposes for which they were authorized, and subparagraph (f) further restricted the CLs to the supply of the domestic market. In short, the TRIPS Agreement provides members with compulsory licensing flexibility, but with strong safeguards against an abuse of such power. Subsequently, with the rise of public health problems and issues regarding access to medicines, especially global concerns over the HIV/AIDS epidemic, at

The relevance of scientific research lies in the fact that the article explores the theoretical and legal issues of the compulsory licensing in American and Canadian law. Compulsory licensing is a mechanism that allows the state or third parties to use intellectual property (IP) objects without the consent of the copyright holder, but with compensation. This tool is used to balance the interests of copyright holders and society, especially in cases where IP monopoly may impede access to important technologies, medicines or cultural goods. This article discusses the specifics of US and Canadian compulsory licensing legislation, as well as their practical application.The leading method of researching the problem was the deductive method, which made it possible to study the legal and social nature of the processes of using compulsory licensing in American and Canadian law. The article uses inductive method, method of system scientific analysis, comparative legal and historical methods. The leading method behind the problem is to justify the concept of carefully study of judicial practice (on the example of specific court cases) and legislation of US and Canadian compulsory licensing.The author of the article made the following conclusions. First, the convergence of US and Canadian approaches to compulsory licensing may facilitate more efficient use of this mechanism. Second, U.S. enforcement licensing jurisprudence demonstrates the importance of this tool in protecting competition and the public interest. Examples of court decisions such as United States v. Line Material Co. and eBay Inc. v. MercExchange, L.L.C., illustrate how compulsory licensing can be used to provide access to important technologies and medicines. However, its application comes with certain challenges, such as legal barriers and economic consequences. Further development of judicial practice in this area will depend on global challenges and changes in international law. Third, Canada's enforcement licensing jurisprudence demonstrates the importance of this tool in protecting the public interest, particularly in the area of access to medicines. Examples of court decisions such as Apotex Inc. v. Merck & Co. and Eli Lilly and Co. v. Canada, illustrate how compulsory licensing can be used to provide access to important technologies and medicines. However, its application comes with certain challenges, such as legal barriers and economic consequences.