Article · Issue One, Michaelmas 2025 – Hilary 2026
Balancing Patents and Public Health
Introduction
A ‘manufacturing-for-export’ exception may be understood as a rule permitting the manufacture and export of a product protected by a patent or supplementary protection certificate to jurisdictions where the invention is off-patent or otherwise unprotected.1
Its compatibility with The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement2 squarely raises the long-debated tension between safeguarding patentees’ exclusive rights and meeting developmental and public-health needs. In pharmaceuticals in particular, such an exception could facilitate timely exports of generics to countries without relevant protection; conversely, IP-exporting states and industry groups caution that it could weaken exclusivity and, with it, innovation incentives.
This essay evaluates whether a manufacturing-for-export exception is permissible under international intellectual property law, drawing on treaty text and structure, post-TRIPS instruments, and case law. It proceeds in four parts. Section I maps the potential benefits and risks. Section II considers the UK’s supplementary protection certificate waiver as an analogy to ‘manufacturing-for-export’ exceptions. Section III focuses on the framework of the TRIPS Agreement and subsequent instruments. Section IV applies that framework to three questions: (1) the consistency of a manufacturing-for-export rule with the wording and structure of TRIPS; (2) how later developments - notably the Doha Declaration3 and Article 31bis4 - bear on the compatibility of the exception; (3) whether any such rule must be sector-specific (e.g., pharmaceuticals) or whether it can be applied across other sectors as well.
I – Benefits and downsides for a ‘manufacturing-for-export’ exception
There are several reasons why a ‘manufacturing-for-export’ exception could be beneficial. Most notably, it could improve global access to essential goods, particularly medicines, by enabling the timely export of affordable generics to countries with limited manufacturing capacity and no relevant patent barriers. Such a pathway would be especially salient for urgent public-health needs in low- and middle-income countries, where treatment gaps persist due to high prices and supply constraints. By permitting clearly defined export-oriented production, the exception could also strengthen and diversify pharmaceutical supply chains and reduce reliance on a small set of producer countries. Additionally, it could lower transaction costs associated with negotiating voluntary licenses or navigating the TRIPS framework for exceptions, particularly for countries with limited legal or negotiating capacity.
Despite the potential benefits, there are however significant counterarguments rooted in concerns about weakening patent protection and the global intellectual property system. First, allowing production in one country solely for sale abroad blurs the territorial boundaries on which patent law rests and complicates cross-border enforcement. It also creates a diversion risk: goods made ‘for export’ can be re-imported or leak into protected markets, shortening the effective exclusivity that helps firms recoup research and development (R&D) in high-income settings. At the system level, such an exception is also likely to be read by major IP-exporting states as a step toward looser patent rules, inviting political pushback from industries that shape trade policy.
II - A COMPARISON WITH THE UK’S SUPPLEMENTARY PROTECTION CERTIFICATE (SPC) WAIVERS The existence of similar exceptions in the UK makes the compatibility of a ‘manufacturing-for-export’ exception with current international legal standards a particularly interesting object of discussion. For instance, the UK adopts EU regulation allowing for a waiver of supplementary protection certificates (SPCs).5 SPCs extend protection for pharmaceutical and plant protection products beyond the standard patent term, compensating for time lost during regulatory approval processes. Through Regulation (EU) 2019/933 amending Regulation (EC) No 469/2009, the EU introduced an SPC “waiver” comprising two elements. First, Article 5(2)(a) lays down the conditions for EU-based manufacturers to produce generic or biosimilar versions of SPC-protected medicines for export to countries where no SPC or patent protection exists. Second, it permits stockpiling so that products can enter the EU market immediately after SPC expiry.6 Framed this way, the SPC waiver seeks to balance innovation incentives with the need to encourage competition and to protect public health goals. The Commission’s impact assessment expected it to level the playing field for manufacturers vis-à-vis countries without SPC-type rights, remove competitive disadvantages, and by enabling export and controlled stockpiling, help lower prices and support the sustainability of health systems.7
The UK’s SPC waiver shows how patent rights and competition law can be balanced to protect legitimate interests, not least those living in countries with a lack of access to medical products. Nonetheless, it is crucial to keep SPC waivers and manufacturing-for-export exceptions distinct. An SPC is a sui generis EU right that extends patent-derived exclusivity for certain medicines and the waiver narrows that right during the SPC term by permitting export manufacturing and limited stockpiling. Crucially, this is with the purpose of “creat[ing] a level playing field between makers established in the Union and third-country makers” which are not disadvantaged by SPCs, according to Recital 9 of the Introductory Text of the Regulation (EU) 2019/933.8 By contrast, a manufacturing-for-export exception would be a direct limitation on patent rights operating during the patent term which effectively gives makers established in the UK an advantage over third-country makers. Hence, a separate assessment of TRIPS-compatibility is required, and the following sections undertake this analysis.
III – Definition of terms and legal basis
The concept of permitting the manufacture and export of a product protected by a patent to importing countries where the invention is not protected by a patent would be, at first instance, non-compliant with Article 28.1 of the TRIPS Agreement (Rights Conferred). The Article states that a patent owner has a number of exclusive rights derived from the patent, including preventing “third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product”.
Correa (2022) highlights two components to the ‘manufacturing-for-export’ exception: an ‘export’ component and a ‘manufacture’ component.9 For the former, he argues that exports are not covered by the patentee exclusive rights as they are outside the scope of Article 28. He also stresses the territorial nature of the right of the patent by referencing decisions of the US Supreme Court such as the Deepsouth Case:10 the patent aims to limit selling by third parties within the territory where the invention is patented. However, when it comes to the manufacture component of the ‘manufacturing-for-export’ exception, this would be non-compliant with Article 28, as it would impede on the exclusive right of ‘making’ of the patentee.
As a consequence, it is worth to analyse whether it would be permissible under Article 30 and Article 31 of the TRIPS Agreement which incorporates a degree of flexibility to the TRIPS Agreement, by allowing for certain exceptions and limitations. Article 30 permits “limited exceptions” to patent rights, provided they do not “unreasonably conflict with a normal exploitation of the patent” or “unreasonably prejudice the legitimate interests of the patent owner.” This provision is significant in assessing whether manufacturing for export could be deemed a “limited exception”. In contrast, Article 31 addresses compulsory licensing, allowing states to authorise use without the patent holder’s consent, subject to conditions such as prior negotiation, adequate remuneration, and predominantly domestic use (Article 31(f)). This provision posed difficulties for countries unable to manufacture pharmaceuticals themselves. As such, the first issue to be assessed will be whether the ‘manufacturing-for-export’ qualifies as an exception under Articles 30 and 31, despite Article 28.1. WTO case law also sheds light on how TRIPS flexibilities are interpreted. As we will observe, the Canada – Patent Protection of Pharmaceutical Products (2000)11 may be instrumental in interpreting the reading of Article 30.
More recent legal developments such as the formal amendment in Article 31bis and the Doha Declaration on TRIPS and Public Health (2001) also inform our understanding of whether a ‘manufacturing-for-export’ exception would be permissible. Under Article 31bis, WTO Members can issue compulsory licences specifically for the manufacture and export of pharmaceutical products to eligible importing countries. This provision includes various procedural safeguards and is to date the only explicit exception under TRIPS allowing export of patented products under compulsory licensing. Similarly, the Doha Declaration on TRIPS and Public Health (2001) clarified that TRIPS should be interpreted in light of public health needs and affirmed the right of WTO members to use TRIPS flexibilities fully.
Lastly, the paper tests the feasibility of a pharmaceutical-only “manufacturing-for-export” exception and its compatibility with TRIPS Article 27.1, which requires patents to be available in all fields of technology and enjoyed without discrimination as to field, place of invention, or import status. It also evaluates the principle of technological neutrality and the risk of legal inconsistencies within the wider WTO framework.
IV – Discussion
A) An interpretation of Articles 30 and 31 of the TRIPS Agreement
The first question to consider is whether the criteria outlined in Article 30 and Article 31 of the TRIPS Agreement would allow for the proposed ‘manufacturing-for-export’ exception, under the current wording of the Agreement as it stands.
Article 30
Article 30 permits WTO Members to introduce “limited exceptions” to the exclusive rights conferred by a patent, provided three conditions are met:
(i) The exception must be limited;
(ii) It must not ‘unreasonably conflict with a normal exploitation of the patent’;
(iii) It must not ‘unreasonably prejudice the legitimate interests of the patent owner.
All three conditions must be interpreted ‘taking account of the legitimate interests of third parties’.
Some considerations on the wording and interpretation
Before discussing the applicability of this exception to manufacturing-for-export exceptions, it is important to address the debate as to its interpretation. Specifically, there is disagreement as to whether these conditions should be regarded as cumulative or not.12 In the WTO Panel decision in Canada – Patent Protection of Pharmaceutical Products (2000), which examined Canada’s regulatory review and stockpiling exceptions, the panel concluded that the three conditions were cumulative.13 However, this contrasts with what is written in the Declaration on Patent Protection, Regulatory Sovereignty under TRIPS, stating instead that the three conditions are not cumulative and that “the three-step test may be understood to require a comprehensive overall assessment rather than a separate and independent assessment of each criterion. Failure to comply with one of the three conditions need not result in the exception being disallowed”.14 As such, further clarification should be provided on the interpretation of the test to better assess whether a ‘manufacture-for-export’ exception would be permissible under Article 30 of TRIPS.
Additionally, there has been disagreement and lack of clarity about the language of the conditions of the three-part test. First, it is unclear what exactly is understood as a ‘limited’ exception; whether this refers to the scope of the exception, its duration, or other features of it.15 Once more, an interpretative reference can be found in the WTO Panel decision in Canada – Patent Protection of Pharmaceutical Products (2000).16 The decision evaluated both the regulatory review exception (or “Bolar”), which permits use of the invention solely to generate data for research and trials, and the stockpiling exception, which allowed manufacture and storage of patented medicines during the last six months of the patent term. The Panel upheld Bolar as a “limited” exception that did not unreasonably conflict with the patent’s normal exploitation but struck down stockpiling as not “limited” and as conflicting with normal exploitation. Stockpiling failed because despite being limited to the last six months, it allowed unlimited volumes and no restriction on destination, creating a commercially significant encroachment on the period in which patentees extract value. In the Panel’s terms, it was not “limited” and it unreasonably conflicted with “normal exploitation”.17
By contrast, the regulatory review exception passed because the permitted acts were strictly confined to what was necessary for regulatory approval, with no commercial use of outputs. The scope of unauthorized acts was small and narrowly bounded, so it did not unreasonably interfere with exploitation. The Panel noted that though regulatory approval processes may require substantial amounts of test production to demonstrate reliable manufacturing, the patent owner’s rights themselves are not impaired any further by the size of such production runs, as long as they are solely for regulatory purposes and no commercial use is made of resulting final products.18
When assessing the language of the second condition of Article 30, there also has been uncertainty about the interpretation of the “normal exploitation” of a patent. In the Canada – Pharmaceuticals case, the panel adopted a broad interpretation, suggesting that “normal exploitation” refers to the commercial activities through which patent holders extract economic value from their patents.
Conversely, other readings of the second condition have also been proposed. Nuno Pires de Carvalho, for example, argues that ‘normal exploitation’ of a patent does not refer to the exploitation of the possible resulting revenues, but rather the right to the invention itself, thus disagreeing with the formulation given by the Panel.19
Applying ‘manufacturing-for-export exception’ to Article 30
However, applying the three conditions in Article 30 to a manufacturing-for-export exception exposes deeper problems.
Seuba et al. (2017) maintain that a manufacturing-for-export rule could satisfy Article 30’s three conditions. First, it is “limited” because it targets a specific act (making) for a specific purpose (export to jurisdictions without relevant protection), with volumes supposedly capped by foreign demand. Second, it does not unreasonably conflict with normal exploitation because patentees earn their core returns at home and domestic rights do not reach foreign markets. Lastly, for any remaining prejudice to patentees’ legitimate interests, these can be tempered by devices such as equitable remuneration.20
Although Seuba et al. (2017)’s view is facially attractive, the Panel in Canada–Pharmaceuticals21 read “limited” as a narrow, purpose-bound curtailment, exemplified by Bolar-type non-commercial testing that does not create saleable inventory.22 Pre-expiry manufacture for export is the opposite: it authorizes commercial scale making during the term, functionally akin to the stockpiling the Panel rejected, thus making it likely that condition 1 on “limited exception” will not be satisfied. Moreover, Solovy & Raju (2017) add that condition 2 on “normal exploitation” includes the option value of keeping the patentee as the exclusive exporter.23 While that may matter where entry is intended, where a patentee opts out of weaker markets the expected foreign revenue is essentially negligible and hence there cannot be said to be any option value. However, this would be difficult to prove, as the subjective intentions of the exclusive exporter will have to be scrutinised. Hence, a manufacturing-for-export rule likely does not fit Article 30’s cumulative test, prompting the application of other mechanisms to allow for such an exception to be put in place.
Applying ‘manufacturing-for-export exception’ to Article 31
Having concluded that a manufacturing-for-export rule does not fit within Article 30’s cumulative test, the analysis must shift to Article 31. Article 31 of the TRIPS Agreement provides a detailed framework for the use of patents without the authorization of the patent holder, primarily through the mechanism of compulsory licensing. The provision establishes several key conditions under which compulsory licensing may be granted, and one of the most important limitations in this context is the requirement that ‘any such use [of the patented invention] shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use’ as outlined in Article 31(f).This provision reflects the underlying principle of compulsory licensing as a tool primarily designed to address domestic public health needs or to remedy anti-competitive behaviour within the domestic market. Consequently, it is unlikely that the manufacturing-for-export exception will be rendered compatible with TRIPS by virtue of Article 31.
B) An interpretation of Post-TRIPS Agreements
Following the direct analysis of the relevant articles of the TRIPS Agreement, it is worth assessing more recent developments that could further inform our interpretation of them, as well as any other grounds under which the exception might be possible. These are mainly Article 31bis and the Doha Declaration.
Article 31bis
Adopted as a waiver in 2003 and formally entered into force in 2017, Article 31bis enables production and export of patented pharmaceuticals under compulsory licences to countries lacking manufacturing capacity.24 This provision is highly specific and includes three procedural safeguards:
(1) the importing country must notify the WTO with proof of its lack of manufacturing capacity;
(2) the exporting country must then issue a compulsory licence;
(3) the products must be clearly identified and not enter other markets.
The very fact that WTO Members adopted a specific waiver and then amended TRIPS could be widely read as evidence that export-oriented manufacture was not covered by the Agreement’s general exception clauses and that such flexibility could not be inferred from Article 30.
However, the complexity of Article 31bis has rendered it largely unused. In 2007, Rwanda requested to import a generic version of a patented drug from Canada under the Article 31bis system.25 Canada issued a compulsory licence, marking the first—and so far, only—use of the provision. Despite being hailed as a success, the process was lengthy and bureaucratically burdensome, discouraging future use. This has reignited debates about whether a broader, more flexible interpretation of Article 30 could better serve public health needs, particularly in low- and middle-income countries.
Additionally, while Article 31bis establishes a formal legal basis for one form of manufacturing-for-export, it is limited to pharmaceuticals, and to circumstances where the importing country cannot manufacture the product itself.
The Doha Declaration
The Doha Declaration on the TRIPS Agreement and Public Health, adopted in 2001,26 is frequently cited as a cornerstone document supporting the use of TRIPS flexibilities to advance public health objectives.
Paragraph 4 says that “the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health” and that the agreement “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all”27. Such wording would confirm a commitment to prioritise common and public interests over private ones, which provides an interpretative lens for Article 30.
However, whether this support extends to allowing a ‘manufacturing-for-export’ exception to patent rights is more contentious. On one hand, the Declaration reaffirms the right of states to use the existing TRIPS flexibilities, such as compulsory licensing (paragraph 5(b)) and the ability to determine national emergencies (paragraph 5(c)).28 These affirmations arguably widen the interpretive scope of Articles 30 and 31,29 potentially creating space for exceptions where export is necessary to meet cross-border health needs. This is especially relevant in the context of insufficient manufacturing capacity in many developing countries—a concern directly addressed through the subsequent Article 31bis mechanism. Yet, this amendment also reveals the Declaration’s limitations: rather than implicitly authorising broader export-oriented exceptions under Article 30, WTO Members opted for a specific legal pathway in Article 31bis, subject to procedural constraints and international notification requirements. The very existence of this amendment may thus be interpreted as evidence that export-oriented flexibilities were not originally covered under TRIPS general exception clauses. Moreover, while the Doha Declaration offers political legitimacy to measures taken in pursuit of public health, it does not override the legal text of TRIPS itself. The Doha Declaration lends normative and contextual weight to a broader reading of TRIPS, but it does not independently authorise a manufacturing-for-export exception. Whether such an exception is permissible still depends on its compatibility with the substantive requirements of the TRIPS provisions it seeks to invoke.
C) Exception limited to pharmaceuticals or extendible to other sectors as well?
Having discussed how a ‘manufacturing-for-export’ exception could breach parts of Articles 30 and 31 TRIPS, it is worth asking whether a sector-limited version, focused on pharmaceuticals, could nonetheless be justified. This is mostly because the pharmaceutical sector is often treated as exceptional because of its public-health implications and the role of trade in access to affordable medicines. Several precedents already reflect this exceptionalism: SPCs restore time lost to marketing authorisation typically for pharmaceuticals and plant-protection products; Article 31 of the TRIPS Agreement allows for compulsory licensing, enabling governments to authorise the production of generic versions of patented medicines without the patent holder’s consent during public health crises; and regionally, the EU permits parallel imports from countries where medicines are priced more affordably and, in defined cases, shortened data-exclusivity to support the faster introduction of generic medicines30.
In light of these precedents, it is worth examining whether a ‘manufacturing-for-export’ exception to patent rights, limited exclusively to the pharmaceutical industry, could be introduced as a legally viable and ethically justifiable mechanism. Such an approach might strike a balance between preserving the rights of patent holders and responding to urgent health and developmental needs in countries where the patented product is not protected, or where patents are not enforced.
However, the legal feasibility of such a sector-specific exception under the TRIPS Agreement remains contentious for the reasons identified above.
Furthermore, limiting a ‘manufacturing-for-export’ exception to a particular sector such as pharmaceuticals raises concerns under Article 27.1 of the TRIPS Agreement, which provides that “patents shall be available for any inventions, whether products or processes, in all fields of technology,” and that patent rights must be “enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.” A sector-specific exception, even with a strong justification such as public health, could be seen as violating the principle of non-discrimination embedded in this provision.
Nonetheless, Canada31 provides a useful precedent to assess the possibility of crafting a limited manufacturing-for-export exception that could possibly operate within the boundaries of the TRIPS Agreement. For instance, if an exception were made with the purpose of assisting in research abroad, or for non-commercial aid in third-world countries, this might be considered a narrowly bounded exception which does not unreasonably interfere with exploitation. Moreover, the exception could place a limit on volumes and destination, providing an argument that such an exception would not constitute a commercially significant encroachment on the period in which patentees extract value.
Conclusion
In conclusion, while the TRIPS Agreement imposes strict conditions on the use of patented inventions, it also leaves room for carefully constructed exceptions that prioritise public health and developmental needs. Read in light of the Doha Paragraph 6 process and the waiver that became Article 31bis, the better view is that export-oriented manufacture was not envisaged under Article 30’s general exception. Nonetheless, Canada provides a useful reference point for the possibility of a narrowly tailored manufacturing-for-export exception—limited to research uses abroad or non-commercial humanitarian supply and constrained by caps on volume and anti-diversion safeguards—so that it does not unreasonably interfere with normal exploitation or amount to a commercially significant encroachment on patentees’ value-extraction period.
Notes
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Neeraj Solovy and Deepali Raju, ‘A Manufacturing for Export Exception to Patent Protection: Advancing Global Health through Access to Medicines’ [2018] 41 Fordham International Law Journal 1393 ↑
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Agreement on Trade - Related Aspects of Intellectual Property Rights (adopted 15 April 1994 ,entered into force 1 January 1995) 1869 UNTS 299 ↑
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WTO, ‘Declaration on the TRIPS Agreement and Public Health’ [2001] WT/MIN(01)/DEC/2 ↑
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WTO, ‘Amendment of the TRIPS Agreement, Article 31bis’ [2005] WT/L/641 ↑
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Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) [2009] OJ L 152/1 ↑
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Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products [2019] OJ L 153/1 ↑
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European Commission, ‘Impact Assessment Accompanying the Proposal for a Regulation amending Regulation’ (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products’ SWD (2018) 240 final ↑
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Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products [2019] OJ L 153/1, recital 9 ↑
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Carlos M Correa, ‘Manufacturing for Export: A TRIPS - Consistent Pro- Competitive Exception’ (2022) 25 Journal of International Economic Law 435 ↑
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Deepsouth Packing Co v Laitram Corp 406 US 518 Pg no.s (1972) ↑
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Panel Report on Canada – Patent Protection of Pharmaceutical Products [2000], WT/DS114/R ↑
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Carlos M Correa, ‘Manufacturing for Export: A TRIPS - Consistent Pro- Competitive Exception’ (2022) 25 Journal of International Economic Law 435 ↑
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Panel Report on Canada – Patent Protection of Pharmaceutical Products [2000], WT/DS114/R ↑
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Max Planck Institute for Innovation and Competition, ‘Declaration on Patent Protection: Regulatory Sovereignty under TRIPS’ [2014] ↑
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Carlos M Correa, ‘Manufacturing for Export: A TRIPS - Consistent Pro- Competitive Exception’ (2022) 25 Journal of International Economic Law 435; Xavier Seuba, Luis Mariano Genovesi and Pedro Roffe, ‘A Manufacturing for Export Exception’ in Bryan Mercurio and Daria Kim (eds), Contemporary Issues in Pharmaceutical Patent Law: Setting the Framework and Exploring Policy Options (Routledge 2017) 161–185. ↑
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Panel Report on Canada – Patent Protection of Pharmaceutical Products [2000], WT/DS114/R ↑
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Ibid para 7.37 ↑
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Ibid para 7.45 ↑
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Nuno Pires de Carvalho, ‘The TRIPS Regime of Patent Rights’ [2002] Kluwer Law International ↑
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Carlos M Correa, ‘Manufacturing for Export: A TRIPS - Consistent Pro- Competitive Exception’ (2022) 25 Journal of International Economic Law 435; Xavier Seuba, Luis Mariano Genovesi and Pedro Roffe, ‘A Manufacturing for Export Exception’ in Bryan Mercurio and Daria Kim (eds), Contemporary Issues in Pharmaceutical Patent Law: Setting the Framework and Exploring Policy Options (Routledge 2017) 161–185. ↑
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Panel Report on Canada – Patent Protection of Pharmaceutical Products [2000], WT/DS114/R ↑
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Ibid ↑
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Neeraj Solovy and Deepali Raju, ‘A Manufacturing for Export Exception to Patent Protection: Advancing Global Health through Access to Medicines’ [2018] 41 Fordham International Law Journal 1393 ↑
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WTO, ‘Amendment of the TRIPS Agreement, Article 31bis’ [2005] WT/L/641 ↑
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WTO Council for TRIPS, ‘Notification under Paragraph 2(a) of the Decision of 30 August 2003: Rwanda’ [2007] IP/N/9/RWA/1 ↑
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WTO, ‘Declaration on the TRIPS Agreement and Public Health’ [2001] WT/MIN(01)/DEC/2 ↑
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Ibid para 4 ↑
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Ibid para 5 ↑
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Agreement on Trade - Related Aspects of Intellectual Property Rights (adopted 15 April 1994,entered into force 1 January 1995) 1869 UNTS 299 ↑
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Council Regulation (EC) 726/2004 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [2004] OJ L136/1_ ↑
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Panel Report on Canada – Patent Protection of Pharmaceutical Products [2000], WT/DS114/R ↑
Cite as
Giulia Cancellaro, ‘Balancing Patents and Public Health’ (2026) 1 OULPR 83