On the issue of compounding drugs in pharmacies pursuant to physicians' prescriptions using a patented invention

This chapter focuses on the perceived shortcomings of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) seen from the perspective of the demandeurs for strengthened intellectual property (IP) protection in the TRIPS negotiations and the subsequent gains made in bilateral and plurilateral free trade agreements (FTAs). The comment concludes that the IP chapters of FTAs throw light on what the two major demandeurs for stronger IP protection, namely the European Union (EU) and the United States (US), did not obtain in the TRIPS negotiations. It also draws attention to certain perceived shortcomings of TRIPS from the perspective of those with mainly defensive interests, but some offensive interests, namely most developing countries. The EU and US agreements are only used to illustrate these points, not to provide a comprehensive understanding of these FTAs. An attempt is made to unravel the puzzle of why developing countries seek and accept FTAs with TRIPS-plus IP chapters, what effect FTAs could have in multilateral IP negotiations on the positions of developing countries that are party to FTAs, and whether or not there is asymmetry in such FTA negotiations. Overall, this chapter concludes that the TRIPS Agreement does appear more balanced when seen from the perspective of the more recent bilateral or regional FTAs concluded by the EU and US.

When the Uruguay Rounds concluded in 1994, many countries signed on to the trade agreements creating the World Trade Organization (WTO) in hopes of benefiting from a system of trade rules “dedicated to open, fair and undistorted competition” (1). WTO members also undertook to implement the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Developing countries, major development agencies and civil society raised concerns over whether TRIPS might limit access to affordable, essential medicines. The Doha Declaration on the TRIPS Agree-ment and Public Health, adopted at the WTO ministerial conference in 2001, responded to these concerns: it empha-sized that the TRIPS Agreement should not stand in the way of member govern-ments acting to protect public health and affirmed governments’ right to use the Agreement’s flexibilities (2).Oliveira et al. (pp. 815–821) pro-vide insight into the flexibilities under TRIPS that provide public health safe-guards and how they are coming under challenge despite the Doha Declaration. Their article on the implementation of TRIPS in Latin America and the Carib-bean gives a snapshot of the key areas where TRIPS flexibilities important for public health must be reflected in a country’s national legislation. Their work is particularly timely because negotiations for the Central American Free Trade Agreement (CAFTA) have been concluded (though the Agreement is not yet ratified), while efforts to move forward a United States free trade agree-ment (FTA) with Andean countries and the Free Trade Area of the Americas continue.These FTAs have sought to curtail the flexibilities under TRIPS, such as compulsory licensing or parallel imports. Have they, though, placed at risk the potential role of generic competition or weakened public sector negotiating leverage? To highlight an area of growing concern, the United States has prioritized the creation or expansion of “exclusive rights” over pharmaceutical test data in FTA negotiations (3). Under Article 39.3 of the TRIPS Agreement, WTO mem-bers must protect test data, submitted to national drug regulatory authorities for pharmaceutical registration, against “unfair commercial use”. While TRIPS does not specify how this is to be done, the United States has insisted in the FTA negotiations that countries provide at least five years of data exclusivity. Instead of generic competitors submitting bio-equivalence data, they must repeat costly tests for marketing approval, which may deter generic entry. This may also raise ethical questions, as generic manufac-turers would be forced to repeat human subject trials on drugs known to be bioequivalent.Data exclusivity provisions apply whether or not a medicine is patented, but the most serious impact is likely to be on drugs that are not under patent. In such cases, data exclusivity will create a “patent-like” barrier that will prevent generic entry during the entire period of exclusivity (4). If a drug is patented, the government could issue a compul-sory licence to overcome the patent bar-rier, but data exclusivity might prevent its market approval. This is the possible situation emerging under the CAFTA, where data exclusivity rules may delay generic competition effectively for up to ten years (5). Such FTAs are not only TRIPS-plus, but may also go beyond requirements under United States law.As developing countries seek lower barriers to their agricultural exports and greater foreign direct investment, can TRIPS flexibilities be safeguarded? How can the playing field for negotiations be levelled? First, developing countries should refuse to accept TRIPS-plus provisions in FTAs. Barring this, they should avail themselves of what the United States practises under government use provisions through non-voluntary licences and what other countries do to prevent patent abuse (6). Secondly, developing country governments deserve fair access to independent, technical assistance and counsel of their own choosing in these negotiations. In recent Andean FTA negotiations, this basic principle of fairness was undermined when the United States delegation prevented the Colombian Government from seating an adviser at the negotiation table. Ministries of trade should also ensure representation of ministries of health in negotiations that will affect public health and ac-cess to medicines. Thirdly, the public health community should insist that evidence be provided and results tracked to document whether the promised gains or the potential public health risks from stronger IPR protection are realized. The reciprocal benefits of technology transfer should be as measurable as the United States monitoring of TRIPS compliance under the Section 301 “watch list”.Finally, regional economic blocs might consider collective approaches to applying the use of public health safe-guards under TRIPS as they have for ne-gotiating price reductions and procuring pharmaceuticals. Ten countries in Latin America banded together to reduce the price of antiretroviral drugs and HIV di-agnostic tests with agreements from both originator and generic manufacturers (7). Such regional groups might benefit from exercising coordinated use of the public health safeguards under TRIPS (8).The paper by Oliveira and her col-leagues provides a useful starting frame-work for flexibilities under TRIPS, but a framework for fairness will require more. Only by taking into account the concerns of public health in trade agree-ments will we ensure that all countries have a fair deal for the future. O

Patently robbing the poor to serve the rich

The existence of standard essential patents (SEPs)—and the associated litigation—has potentially disruptive consequences for the manufacture, marketing and distribution of complex products that incorporate many patented standards, for example, information and communication technology (ICT) products such as smartphones that incorporate a camera, video, web browser, wireless communications, text messaging, and so on, as well as an increasing number of ‘connected’ Internet of Things products such as wearable devices and ‘smart home’ devices. Indeed, SEP owners may use the patent enforcement system to prevent implementers of these technologies from bringing to market competing products that use the same standards. As is known, this raises concerns about competition in the market and the need to maintain interoperability to ensure the development of the ICT industry. One of the legal tools which can be used by implementers to (try to) neutralise SEP holders' anticompetitive behaviours is the ‘antisuit injunction’ (ASI). ASIs are not uncommon in common law jurisdictions while they are foreign to civil law countries within the European Union (EU). ASIs are particularly useful to SEP implementers when patent holders disrespect their commitment to license their patents on a FRAND basis. For example, a judge who is in the process of assessing whether the SEP owner complies with FRAND terms may at the same time grant an ASI to stop the patentee taking patent infringement actions in other jurisdictions until the FRAND litigation has been concluded. In February 2022, the EU filed a complaint at the World Trade Organization (WTO), arguing that China's use of ASIs prevents EU‐based companies from properly protecting their SEPs. Indeed, ASIs have recently been granted in several Chinese disputes, including in Huawei v Conversant and Xiaomi v. InterDigital. More specifically, China's Supreme People's Court held that Chinese courts can use ASIs to prevent SEP owners from filing disputes in any foreign courts to enforce their patents; and that anyone who does not comply with the injunction should be fined €130,000 per day. In the WTO case the EU notes that such a case law jeopardises innovation and growth in Europe, ‘effectively depriving European technology companies of the possibility to exercise and enforce the rights that give them a technological edge’. From a legal perspective, according to the EU, China's conduct is in violation of various Trade‐Related Aspects of Intellectual Property Rights (TRIPS) provisions, including Article 28 which grants exclusive rights to patent owners. The paper focuses on this EU–China WTO/TRIPS dispute and more generally, on the relevance of ASIs within SEP cases.

At the end of 2002, the United States rejected a compromise proposal aimed at giving developing countries without local manufacturing capacities access to affordable life-saving drugs. At a December meeting at the World Trade Organization (WTO) in Geneva, negotiators of several of the 144 WTO expressed their regret about the failure to reach an agreement by the intended deadline, which was the end of last year. Eduardo Perez Motta, Chairman of the WTO Trade-related Aspects of Intellectual Property Rights (TRIPS) Council and author of the compromise proposal, even apologized to sufferers from diseases in the developing world for the failure to come up with a viable solution. Meanwhile, in an attempt to reinvigorate the stalled negotiations, European Union (EU) Trade Commissioner Pascal Lamy put forward another compromise solution. bone of contention is the export of generic versions of drugs protected by patent to developing countries that lack manufacturing capacity to produce the generics themselves. At their fourth conference in Doha, Qatar, in November 2001, WTO ministers adopted a Declaration on TRIPS and public health. agreement, usually referred to as the Doha Declaration, allowed poor countries to produce urgently needed drugs even if the drugs in question are under patent protection, a procedure known as compulsory licensing. Even back then, however, WTO negotiators admitted there was a shortcoming in the Doha Declaration: the contentious paragraph 6 the Declaration bluntly states that members with insufficient or no manufacturing capacity could face difficulties in making effective use of compulsory licensing ... We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002. This is because, according to TRIPS guidelines, drugs made under compulsory licence are intended predominantly for the domestic market, that is, not for export. But the recent TRIPS Council meeting failed to deliver one, even though a compromise proposal, drafted and circulated by Perez Motta, was on the table. At the end of lengthy argument, the United States was the only country that refused to endorse the proposal. US delegation considered the compromise--which did not restrict the range of diseases covered--to be too broad in scope, and insisted that instead the agreement should be limited to drugs for HIV/AIDS, malaria, tuberculosis and similarly infectious epidemics. According to a statement by the United States trade representative Robert Zoellick, issued on 20 December, such a focus on infectious diseases would reflect the original intentions of the Doha Declaration. That is not the way Ellen T'Hoen of Medecins sans Frontieres (MSF) sees it. Already in Doha the United States tried to limit the scope of diseases, she pointed out. None of those proposals of theirs made it through those negotiations. As a matter of fact, paragraph 4 of the Doha Declaration is very clear about this point: no limits [in terms of disease range]. In a way these attempts open up the whole Doha Declaration again. For T'Hoen the latest developments represent a tragic U-turn in the health-trade debate. T'Hoen is not alone in her critique. Celine Charveriat of Oxfam says: The fact that the European Union and the United States argued that developing countries should not have access to affordable generic drugs for asthma and diabetes, which kill and debilitate millions in these countries, proves that profits still come before people's lives and that the WTO has powers totally beyond its competence. …

The compatibility of the U.S. fair use doctrine with international treaty norms has been questioned many times over the years by European and even American commentators. Does the fair use limitation on copyright’s exclusive rights comport with the “three-step test” that regulates the permissible scope of exceptions in national copyright laws under Article 9(2) of the Berne Convention for the Protection of Literary and Artistic Works and in Article 13 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)? This test requires copyright exceptions to be for “certain special cases” and to neither interfere with “a normal exploitation” of protected works nor “unreasonably prejudice the legitimate interests” of authors and other rights holders. Those who doubt its compatibility mostly point to the generality of the U.S. fair use provision and its seeming case-by-case indeterminacy to argue its failure to pass the first step of the test. This paper makes two main points in support of its thesis that the U.S. fair use limitation is indeed compatible with the three-step test. First, the U.S. fair use doctrine was accepted as consistent with the three-step test when the U.S. joined the Berne Convention in 1989. Its statutory embodiment recites several specific criteria that provide guidance to its interpretation, and the fair use caselaw has evolved to refine the types of special cases to which it applies, in accord with the first step of the test. Many functions served by the U.S. fair use doctrine are achieved elsewhere through specific exceptions. Because fair use cases carefully assess harms of challenged uses to markets for protected works and other legitimate interests, the fair use doctrine satisfies the second and third steps of the test. Second, the U.S. fair use doctrine has remained consistent with the three-step test since the U.S. agreed to abide by the TRIPS Agreement when it joined the World Trade Organization (WTO) in 1994. Several developments in recent years, including a proliferation of fair use and similar flexible copyright exceptions in the international arena and a fair-use-friendly provision in the Trans-Pacific Partnership agreement, signal a more receptive attitude internationally towards flexible, open-ended limits on copyright’s exclusive rights, particularly in light of extraordinary technological advancements in the digital age. These developments reinforce the paper’s conclusion that the U.S. fair use doctrine satisfies the TRIPS three-step test, notwithstanding certain recent criticisms. While we agree that it is conceivable that a particular overbroad appellate court decision applying the fair use doctrine could be challenged, we argue that none of the recent critiques of fair use decisions is sound or put the U.S. in danger of not complying with its international obligations.

Patent protection versus public health

Hope as well as fear was running wild when in 1995 the multilateral trading system incorporated the protection of intellectual property (IP) rights. As one author put it, “the [IP] component of the WTO [World Trade Organization] Agreement represented a revolution in international intellectual property law.” This article provides a reality check 15 years after the fact with a particular focus on how the WTO performed in terms of settling IP disputes under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It compares conventional expectations associated with the creation of TRIPS and WTO dispute settlement to (i) the number and types of TRIPS disputes actually filed and decided, (ii) institutional and substantive decisions and interpretations reached by WTO panels and the Appellate Body in their application of the TRIPS agreement and, finally, (iii) the status of implementation of adverse WTO rulings under TRIPS. The article offers a number of hypotheses that may explain these descriptive results centered on (i) the rather unique features of WTO dispute settlement, (ii) the TRIPS Agreement itself as compared to other trade agreements and (iii) an escalating cycle of IP-skepticism, due in no small part to the hard-line position taken by many IP industries themselves, and culminating in the 2001 Doha Declaration on TRIPS and Public Health which confirmed and slightly expanded TRIPS flexibilities in the context of the access to essential medicines debate. The core message of this article is that based on 15 years of operation both the hopes and fears traditionally linked to TRIPS and WTO dispute settlement, not just in 1995 but to this day, were and continue to be largely exaggerated. TRIPS as conventionally portrayed by many is in this sense “the dog that barked but did not bite”. A caveat to this core message is, however, that it says something about the role and impact of formal dispute settlement under TRIPS, less about the broader changes brought about by the TRIPS agreement, in particular, sweeping (and often costly) legislative amendments in many developing countries, monitoring through the TRIPS Council and bargaining “in the shadow” of TRIPS both to weaken and to strengthen global IP protection (be it in the Doha Declaration on TRIPS and Public Health, certain preferential trade agreements, WIPO or the WHO).

The role of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, within the public health landscape of African states cannot be understood as a static image. Rather, TRIPS is about transformations. In the previous chapters, I have introduced some of these transformations as enacted through the movements generated by the implementation of TRIPS – or at times, their unexpected lack of movement. I have then questioned how the influence of pharmaceutical patents can be explored aside from their role as legal regulation, through their action within markets, and in particular in markets that are still heavily influenced by past and current forms of imperialism. Here, I reflect on the changes, innovations and transformations that have occurred within the public health context of Djibouti and Ghana in recent years, and in particular those that can be viewed as a reflection of the broader movements generated by TRIPS at the global level. My starting point here is that TRIPS can only be explored fully if we also engage with the various global movements that is has produced or been entangled with. The analysis provided in Chapter 2 is built upon in this chapter, and I start from the understanding of TRIPS as a complex assemblage that has come to produce and become entangled into the access to medicines campaign and its different effects. I explore two main issues here: first, I look at some of ways in which medicines and diseases have become reshaped in Ghana and Djibouti following the new global emphasis on access to affordable medicines. I then turn specifically to AIDS, as a site in which the complexity of the coproductive processes linking TRIPS and disease can be explored in more specific depth. I argue throughout that these movements and transformations need to be considered carefully if we wish to understand the full extent of the relationship between public health and intellectual property (IP). This approach is both informed by my theoretical conceptualization of TRIPS and by the entanglement of TRIPS, IP and recent global programmes in the discourses of participants to this research. In their views, discussions of IP were inherently linked to a broader questioning of the movements that animate the landscape of disease and treatment that they engaged with on a day-to-day basis. TRIPS is an event that happens in many places, that generates changes in many networks, that is embedded in multiple actions and practices, and, in order to understand what it ‘does’ in Djibouti or in Ghana, it is essential to have a clearer idea of the effects it has in these many other places, and the indirect repercussions this has on these localized contexts.

In this chapter, I consider one dimension of the translation of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, by following its translation as a set of prescriptions – as a set of official rules carried on paper, expected to have a predefined impact – in Djibouti and Ghana. I use the term prescription here with the meaning that is given to it within actor-network theory (ANT), when looking at technologies, to reflect the idea that any technology (including here legal technologies) comes with a script that carries, amongst other things, a series of expectations on its ability to generate actions from others (Akrich and Latour, 1992). I question here the impact that TRIPS as a set of rules is having on local legislation, and how the specific contexts of Djibouti and Ghana have responded to the expectations attached to TRIPS. In doing so, I therefore analyse what are commonly referred to as 'implementation' issues, and engage with the particularities of the networks at play, and in particular the links between the translation of intellectual property (IP) and local forms of expertise (Barrett, 2004). The nature of TRIPS as textual material is central to this analysis, and this chapter seeks to demonstrate the series of socio-technical translations that occur when the text of TRIPS and its embedded prescriptions interact with legal institutions in Djibouti and Ghana. This chapter constitutes only a prelude to unpacking the complexity of TRIPS, and of IP, in the rest of this study. But questioning this process of translation is also important for emphasizing the complexity of the process of translation from global law to local practices, systematically explored in the literature in this field. Importantly, the chapter also interrogates the travels of TRIPS into Djibouti and Ghana, by returning to their first entry points in the networks of IP – or what would become so under the influence of TRIPS. I am predominantly concerned here with exploring how those in charge of translating TRIPS initially responded to this new actor and, consequently, in the different realities adopted by TRIPS as it travelled to those two remote locations. Many other questions raised by the translation of rules into practice are explored in the next chapter, but these are best understood with a clear introduction to what implementing a complex legal text such as TRIPS in Djibouti and Ghana means in terms of process.

THE COMMON COMMERCIAL POLICY Since a few years, the European Union (EU) has taken several initiatives to promote and protect innovation. According to the European Commission, innovation is the prerequisite for the competitiveness of the European industries and businesses and, furthermore, for growth and employment. Thus, innovation has been given a central place in the Lisbon strategy which influences national and European policies and actions. In this context, intellectual property rights (IPRs) enforcement has become a priority in fighting counterfeiting and piracy which have increased in a worrisome way. The achievement of the single market is the first legal basis to organize a uniform system of IPRs by creating titles that coexist with national ones. But, in the context of globalization, the EU does also deal with external trade policy as part of the external aspects of the Lisbon strategy. The interface between external trade and IPRs appeared in 1986 in the framework of the Uruguay Round. But, at that time, the European Community had no competence on this subject. The Amsterdam and Nice treaties tried to give it the competence in the commercial aspects of intellectual property. Such initiative resulted in a lack of visibility, as its competence was shared with the Member States. As the Lisbon treaty has clarified its competences, the European Union has now an exclusive competence in the commercial aspects of intellectual property and the Council can act by a qualified majority to conclude agreements on this subject. Without waiting the entry into force of the Lisbon treaty, the European Commission has decided that IPRs were one of the new growth sectors that the EU would include in the foundations of its common commercial policy. The EU maintains its commitment to multilateralism and is involved in the Doha Round which tries to improve the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement in line with development priorities. In that context, the UE has a unique status of full member next to its member states and tries to get a better protection of geographical indications. But, as the negotiations face strong oppositions between the parties on the agricultural subject, the European Commission has decided, through free trade agreements (FTAs) to get stronger and stricter provisions on IPRs. By concluding FTAs, the EU seeks to obtain extended engagements than in the multilateral context. This is also a way for the UE to export its own standards of IPRs protection. Bilateralism is considered a complement to multilateralism and the European Commission wants to use the same tools as its “competitors”, such as the United States. On the basis of several criterias, it has identified countries which could become its trading partners through FTAs. The study of the recent agreements between the EU and the Cariforum group and with South Korea reveal deeper engagements from the EU’s trading partners to provide an IP protection similar to the one in the EU. Furthermore, since 2007, negotiations are engaged with ASEAN and India which have qualified as priorities for the conclusion of new generations of FTAs. The European Commission seems to be all the more determined to improve through bilateral cooperation the enforcement of IPRs as the “Europe 2020” strategy maintains the priority on innovation and the end of the Doha Round is not predictable in a middle term. But this position may not be conformed to the EU’s international objectives.

In accordance with its mandate to ensure the production and trade of better and competitively priced goods and services around the world, the World Trade Organization has to enforce several multilateral agreements, one of which is that on the Trade-Related Aspects of Intellectual Property Rights (TRIPS). Geared towards protecting the intellectual property rights (IPR) of inventors and authors on goods traded worldwide, TRIPS sets minimum standards of IPR protection, which member countries can legislate. Due to the difficulty in estimating the impact of TRIPS on agriculture, it has spawned spirited debates among its proponents and critics since its implementation in 1995. Unfortunately, the bases of arguments from both sides about the impact of TRIPS on global goods trade in general, and on agricultural trade in particular, have been anecdotal. Although some economists have tried to develop models to analyze the impact of TRIPS on trade, their findings have been inconclusive. The same holds true as well with respect to the expected impact of TRIPS on agricultural trade and development. This paper examines the legal provisions of TRIPS and their implications on Asian agricultural trade and development. It also discusses other issues—not addressed by TRIPS but attributed to it, such as agriculture R&D, bio-piracy, traditional knowledge and folklore, and plant breeder's rights—whose links to TRIPS have not been established by evidence, or are, at best, anecdotal. Documenting a specific application of TRIPS, the paper highlights the experience of the Philippines in the testing and commercialization of Bt corn, an agricultural biotechnology product developed and commercialized after TRIPS had gone into effect. The Philippine Bt corn experience provides some evidence that TRIPS and agricultural biotechnology—given the conducive environment of TRIPS-compliant domestic IPR laws, bio-safety policy regulations, information and education campaigns, and research and development—can have a positive impact on agricultural trade and development, even in a developing and agricultural country like the Philippines. Based on the analysis of the current impact of TRIPS on Asian agricultural trade and development, and the Bt corn experience of the Philippines, the paper proposes an Asian agenda for member countries, by which they can effectively deal with, and benefit from TRIPS.

In accordance with its mandate to ensure the production and trade of better and competitively priced goods and services around the world, the World Trade Organization has to enforce several multilateral agreements, one of which is that on the Trade-Related Aspects of Intellectual Property Rights (TRIPS). Geared towards protecting the intellectual property rights (IPR) of inventors and authors on goods traded worldwide, TRIPS sets minimum standards of IPR protection, which member countries can legislate. Due to the difficulty in estimating the impact of TRIPS on agriculture, it has spawned spirited debates among its proponents and critics since its implementation in 1995. Unfortunately, the bases of arguments from both sides about the impact of TRIPS on global goods trade in general, and on agricultural trade in particular, have been anecdotal. Although some economists have tried to develop models to analyze the impact of TRIPS on trade, their findings have been inconclusive. The same holds true as well with respect to the expected impact of TRIPS on agricultural trade and development. This paper examines the legal provisions of TRIPS and their implications on Asian agricultural trade and development. It also discusses other issues—not addressed by TRIPS but attributed to it, such as agriculture R&D, "bio-piracy", traditional knowledge and folklore, and plant breeder's rights—whose links to TRIPS have not been established by evidence, or are, at best, anecdotal. Documenting a specific application of TRIPS, the paper highlights the experience of the Philippines in the testing and commercialization of Bt corn, an agricultural biotechnology product developed and commercialized after TRIPS had gone into effect. The Philippine Bt corn experience provides some evidence that TRIPS and agricultural biotechnology—given the conducive environment of TRIPS-compliant domestic IPR laws, bio-safety policy regulations, information and education campaigns, and research and development—can have a positive impact on agricultural trade and development, even in a developing and agricultural country like the Philippines. Based on the analysis of the current impact of TRIPS on Asian agricultural trade and development, and the Bt corn experience of the Philippines, the paper proposes an Asian agenda for member countries, by which they can effectively deal with, and benefit from TRIPS.

Priorities for the COVID-19 pandemic at the start of 2021: statement of the Lancet COVID-19 Commission

Regulating intellectual property (IP) with free trade agreements (FTAs), economic partnership agreements (EPAs), and even multi-party IP measures may be politically and procedurally easier for the European Union (EU) than regulating the same subject matter internally. IP chapters included in trade agreements falling under the EU’s exclusive Common Commercial Policy (CCP) competence could become a particularly attractive instrument to regulate IP. The EU’s exclusive CCP competence now covers “commercial aspects of intellectual property” and is likely broader than the EU’s internal exclusive competence to legislate IP. The EU could thus resort to its exclusive CCP competence and extensively regulate IP through trade treaties. Moreover, the FTAs, EPAs, and new multi-party IP measures assume constitutional functions not possible for internal legislative acts of the EU by guiding the interpretations of EU secondary law and by enabling its judicial review. As the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) lacks the capacity for direct effect and judicial review, the IP chapters of the FTAs and EPAs as well as new multi-party IP measures could change the constitutional landscape of the EU’s IP law in a significant manner.