2.1 The Intellectual Property Challenges

IPRs are at the core of the mRNA hub's activities. The MPP is to assist, with its expertise in intellectual property management, by providing analysis and defining and negotiating terms and conditions of eventual agreements.Footnote ³⁹ The intellectual property arrangement is that Afrigen will grant MPP a non-exclusive license to utilize its data and inventions to achieve the goals of the initiative.Footnote ⁴⁰ Under this understanding, the MPP is authorized to share the program data with the WHO and third parties.Footnote ⁴¹ The MPP will then enter into an agreement with the spokes whereby it grants each spoke a non-exclusive license to develop and commercialize ‘products’ based on the technology developed by the hub.Footnote ⁴² Each spoke will in turn grant to MPP and other spokes a non-exclusive license to any data or inventions it develops based on the technology transferred by the hub.Footnote ⁴³

The key issue regarding the intellectual property arrangement is that MPP and WHO do not guarantee freedom to operate in the spoke's territory and export markets. Instead, they only provide an intellectual property landscape analysis at the spoke's country level. Consequently, the responsibility of confirming the actual status and scope of patents/claims filed and/or granted in the spoke's country lies with the spokes. Section 10.2 of the mRNA Vaccines Technology Transfer template agreement between MPP and the spokes is very clear on this point:

The above provision, while understandable due to the territoriality of intellectual property law, suggests that the spokes need to be aware of and take into account any existing patents or IPRs in their territory that could impact the activities of the initiative as a whole. The complexity of this understanding has already become apparent. For instance, the mRNA hub (Afrigen) located in Cape Town has already been accused of infringing on Moderna's patent for the mRNA COVID-19 vaccine which is currently in force in South Africa.Footnote ⁴⁴ In response to the accusation, the MPP stated that its model of public health licensing relies on the voluntary participation of intellectual property holders, and, thus, it has no intention of engaging in any patent infringement.Footnote ⁴⁵ While it is true that Moderna did not grant a license to the MPP for the hub's activities, MPP has stated that it relied on two grounds to justify its continued use of Moderna's mRNA technology without consent.Footnote ⁴⁶ First, is that the patent law in South Africa contains a research exception provision authorizing R&D activities in the country, regardless of any patent situation.Footnote ⁴⁷ Second, is that Moderna has committed not to enforce its COVID-19-related patents against low- and middle-income countries developing vaccines to combat the pandemic.Footnote ⁴⁸

Both of these justifications are thin, if not without merit. First, far from having an all-encompassing experimental use/research exception, South Africa's Patent Act only contains a narrow regulatory review exception – that is, the exception is limited to the purposes of applying for regulatory/marketing approval – that is specifically limited to non-commercial use. Section 69A of the South African patent law reads:

This is a contradistinction to an actual experimental use/research exception, an example of which is Article 47(3) of the Indian Patent Act which subjects the grant of a patent to the condition that:

It is generally assumed that Article 47(3) falls within the scope of Article 30 of the TRIPS Agreement, a broadly worded provision allowing WTO Members to provide exceptions to the patent owner's exclusive rights, provided that such exceptions are limited, do not unreasonably conflict with a normal exploitation of the patent, and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.Footnote ⁴⁹

Moreover, while it is true to Moderna had committed to not enforcing its COVID-19 related patents against those making vaccines intended to combat the pandemic, the commitment was temporal in nature and limited to ‘while the pandemic continues’. With COVID-19 ceasing to be a pandemic, the commitment would have been no longer in place. To its credit, however, Moderna recently voluntarily pledged ‘to never enforce patents related to its COVID-19 vaccines against companies manufacturing in or for the 92 low- and middle-income countries in the Gavi COVAX Advance Market Commitment (AMC), provided that the manufactured vaccines are solely for use in the AMC 92 countries’.Footnote ⁵⁰ Moderna subsequently confirmed that the mRNA hub comes within the scope of the pledge.Footnote ⁵¹

Nevertheless, the aforementioned situation generates uncertainty and emphasizes a noteworthy challenge concerning intellectual property for both the hub and the spokes as the initiative advances and begins researching into other diseases and viruses beyond SARS-CoV-2 (COVID-19). This challenge becomes even more intricate due to the complex nature of mRNA technologies, which encompass various patentable aspects such as mRNA sequences, modified nucleotides or bases, delivery systems, manufacturing processes, and therapeutic applications.

It is worth emphasizing that a large part of the uncertainty is not the result of the international legal framework but from inaction at the domestic level and the failure to make use of existing flexibilities in TRIPS. That such research can be conducted in a more secure manner is proof, contrary to the often widely held notion that TRIPS flexibilities are not workable, that they are indeed potent and can be used when needed.

While the underlying reasoning behind the research exception is to facilitate experimentation and research on existing patented technologies thereby advancing the objectives of the patent system, the scope of the exemption varies widely between and among WTO Members whose domestic legislation contains such an exception. In certain jurisdictions, the exception is defined narrowly, while in others it is relatively broad.Footnote ⁵² There have been limited efforts thus far to establish a standardized and widely shared best practices approach across countries, possibly due to the existing differences and challenges associated with such harmonization.

To avoid guard against litigation and unnecessarily narrow interpretation of the exception, the mRNA hub and the countries/regions where the spokes are located should carefully draft an experimental use provision that clarifies the extent to which research and other public health-related activities are exempted from patent infringement liability. A broad provision, perhaps following the Indian example, will ensure that the delineations of the experimental use exemption are clear and wide enough to cover issues such as permitted acts, products, submissions in other jurisdictions, temporal limitations, and limitations to generics or a broader exception employing models that match broad research, public domain, and competition policies in their country.Footnote ⁵³ In the absence of a clear experimental use exemption, the activities of the mRNA hub may likely incur unnecessary costs and societal costs, which include possible adverse effects on competition within the mRNA technology space and public health.

2.2 Freedom to Operate

As highlighted in the previous section, the sustainability of the mRNA hub-spoke model is not without intellectual property obstacles. Its freedom to operate would undoubtedly be (in fact is) threatened by, among other reasons, the apparent reluctance of key biotech companies in the mRNA space to support the initiative. This threat is further aggravated by the growing landscape of mRNA patents. Currently, several companies hold patent portfolios on various components of mRNA technology.Footnote ⁵⁴ Some notable examples include Moderna, BioNTech, CureVac, Arcturus Therapeutics, Alnylam Pharmaceuticals, Translate Bio, Sanofi, GlaxoSmithKline, Pfizer, and Johnson & Johnson.Footnote ⁵⁵ These companies have filed for and been granted multiple claim types that define the boundaries of protected mRNA inventions, covering aspects such as the mRNA sequence itself, the delivery system for mRNA vaccines, the dosage regimen, the medical uses, and the manufacturing processes in many jurisdictions.Footnote ⁵⁶ Recent research analyzing mRNA vaccine patent landscape reveals increasing number of applications in a host of countries, including the United States, China, Japan, the European Patent Office (EPO), South Korea, Australia, India, and South Africa.Footnote ⁵⁷

Moderna, whose technology the mRNA hub reverse-engineered and produced, did not voluntarily license its technology to the hub. Despite Moderna having filed and been granted several mRNA patents in South Africa, it refused to cooperate and share technology with the hub, likening the replica vaccine produced to a ‘copy of a Louis Vuitton handbag’.Footnote ⁵⁸ Instead, Moderna is investing $US500 million in developing a production facility of its own in Kenya.Footnote ⁵⁹ While the activity of Moderna in Kenya is laudable to the extent that it would expand the existing supply source for mRNA-based products, its implication on the mRNA hub's business model is still unclear.

That said, the mRNA patent landscape has been described as a complex and dense ‘jungle,’ resulting in what is known as a ‘patent thicket’ – a collection of partially overlapping patent rights that require those seeking to commercialize the technology to obtain permission from multiple rights holders.Footnote ⁶⁰ This situation is similar to the concept of the ‘anticommons,’ where ownership rights are fragmented among multiple parties, making it difficult to coordinate usage rights necessary to utilize a technology. While the assumption that more patents promote innovation is debatable, a high concentration of patents in the mRNA technology field is likely to discourage the hub's efforts to facilitate technology diffusion and follow-on innovation.Footnote ⁶¹

Patent thickets and anticommons have long been on the policy radar. Previous studies have identified factors that can lead to ‘bargaining failure’, including high transaction costs due to fragmented patent ownership and stacking licenses, as well as information asymmetries and uncertainties about the scope of patent protection.Footnote ⁶² High transaction costs arise not only due to the multiplicity of rights holders but also because of complex freedom-to-operate searches and rights clearance procedures. Licensing mRNA technology patents, given the complexity of the patent landscape, clearly falls into this category and could affect the goal of making affordable mRNA-based vaccines and therapeutics available in low- and middle-income countries. Even when licensing agreements are reached, the terms could include ‘reach-through’ provisions. The term ‘reach-through’ licensing agreements, also known as ‘stacking licenses,’ describes situations where the owner of an ‘upstream’ technology patent requires a share of the economic benefits generated through the downstream use of the licensed technology.Footnote ⁶³ This exercise of bargaining power makes licensing unappealing to potential licensees (the spokes in this instance), as it allows the patent owner to claim a share in the economic benefits generated downstream under contractual terms. These conditions are likely to result in higher prices for the final products, affecting the hub's goals and sustainability.

Furthermore, in discussions on mRNA patents, one often encounters critical arguments regarding the ‘too broad’ scope of patent protection afforded to mRNA technologies.Footnote ⁶⁴ Researchers contend that ‘extremely broad claims surrounding mRNA technologies have the potential to stifle innovation in the field’ and that uncertainty about the ‘intellectual property landscape surrounding the technology more generally presents a barrier to entry for researchers and technology developers wishing to explore the technology in their experimental systems of choice.’Footnote ⁶⁵ The argument concerning an ‘unduly’ broad patent scope raises a different concern: whether what is claimed within a patent is commensurate with the actual contribution to the technological state of the art. As Lord Justice Jacob once observed,

The question of whether mRNA patents might claim ‘more than invented’ should be examined in terms of the sufficiency-of-disclosure requirement. Overall, granting broad claims in the field of mRNA technology could potentially give patent owners excessive control, which may hinder further innovation and competition. Therefore, patent offices must uphold the integrity and effectiveness of the patent system by conducting thorough examinations. A meticulous examination of patent examination no doubt, plays a critical role in ensuring that patents are only granted for genuine inventions that meet the legal requirements for patentability and public policy objectives.Footnote ⁶⁷

Here again, South Africa's regulations are lacking as it is a non-examining country – that is to say, there is no patent examination in South Africa. Instead, a complete (and formally valid) patent application will lead to the granting of a patent without any check on whether the substantive requirements of patentability are met. The patent will be presumed valid until proven otherwise and may be subject to revocation based on an objection by a third party. Such a process is inimical to controlling excesses, ensuring only ‘good’ patents are granted and encouraging experimentation and technological development. However, it is important to acknowledge that patent offices in most less-developed countries encounter various challenges, such as limited human resources for examination, a surge in patent applications across diverse technical fields, backlogs, and the pressure to process applications promptly.Footnote ⁶⁸ To address these issues, the countries/regions where the spokes are located could explore entering agreements to outsource examination tasks to more resourceful patent offices or put in place regional patent examination mechanisms that would ensure that their flexibility under the TRIPS Agreement are safeguarded and effectively maintained.

3.1 Patent Law and Policy in the Balance

Against the background of the issues identified in previous sections, the question remains whether intellectual property is a problem or a solution. There are no simple answers to this question: finding the solutions will be a matter of continuing dialogue and cooperation, both within the international community on the policy plane and at a practical level on the part of each spoke. The task of assessing the complex factual situation, and of sifting through a welter of policy options, is immense, necessitating widespread collaboration and the pooling of diverse expertise. In addition, leveraging and utilizing all the flexibilities provided within the international intellectual property framework would also help ensure that the hub delivers on its mandate.Footnote ⁶⁹

Before commencing manufacturing operations for a particular vaccine, the spokes would need to determine whether any specific patents might present a business risk (that is, patent infringement liability) in the country where their products would be manufactured or sold. Evaluating patent risk is a standard business assessment routinely undertaken by pharmaceutical enterprises, including generic product manufacturers in middle-income countries (such as India). That said, whether patent law is viewed as a problem or a solution would primarily depend on the perspective taken, either an informed and strategic view or a reactive one. The essential logic of the patent system is often portrayed as a ‘balance’: an optimal balance that respects the private interests of those investing resources in the development of new technologies and that promotes the broader public interest in seeing these new technologies emerge not only as abstract scientific publications but as effective, proven technologies that are actually disseminated to the broader public, for overall welfare outcomes.Footnote ⁷⁰ Achieving this idea of ‘balance’ is complex in the context of the mRNA technology transfer hub; but, broadly speaking, the complexity can be neatly navigated by addressing some key pre-patent grant and post-patent grant issues for mRNA technologies.

In the pre-grant phase for mRNA technologies, the primary concern of the countries and regions where the spokes are located should be to ensure that the patents granted are in the public interest, as defined by the ‘patentability’ criteria.Footnote ⁷¹ These would ensure that mRNA patents are only granted for technologies that are genuine additions to existing technological knowledge (i.e., ‘novel’), involve a significant advancement in their technical field (i.e., ‘inventive’ or ‘non-obvious’), and are practically useful (i.e., have ‘utility’ or ‘industrial applicability’).Footnote ⁷² For mRNA technologies, the patent offices must particularly ensure that the patent applications describe the invention in enough detail for someone skilled in the field to replicate it, which is what makes patent information systems valuable. The scope of the patent rights claimed should not exceed the new technology disclosed in the patent, and patent offices should narrow claims during the application phase to ensure that patent rights are limited to their proper scope.Footnote ⁷³ While these criteria are generally known in patent law, the key to an effective patent system is ensuring that issued patents conform to them in practice, which requires maintaining high standards of ‘patent quality’, From a South African standpoint, the absence of thorough patent examination creates opportunities for potential ‘misuse’.Footnote ⁷⁴ For instance, a major multinational company could file numerous patents in South Africa for a highly sought-after or groundbreaking technology without having to demonstrate to the South African Patent Office that these inventions deserve patent protection.Footnote ⁷⁵ This failing of the domestic legislation could allow a tactic that could negatively affect the mRNA hub. Given that most of the recipient countries may lack substantial patent examination frameworks, they may consider outsourcing their examination processes in this regard.Footnote ⁷⁶

After a patent is granted for mRNA technologies, post-grant considerations become important as the technologies enter into a broader legal and regulatory environment. The focus should then shift toward how the patent owners can appropriately exercise their exclusive patent rights, and what remedies can be implemented to serve the public interest. Given that mRNA technologies are typically packaged together from several sourcesFootnote ⁷⁷ and licensed through a range of arrangements and structures, regulators may scrutinize how a patent holder licenses technology, particularly for publicly funded or public sector institutions that hold key patents on valuable technologies which are of strong public interest. Post-grant questions that must be answered with regard to mRNA technologies for instance should include determining appropriate licensing structures and intellectual property management strategies to promote the dissemination of the technologies, establishing exceptions and limitations to patent law to safeguard the public interest, and interventions that override exclusive patent rights to address anticompetitive practices and other abuses of patent rights.

3.2 Patents, Technology Transfer, and the mRNA Hub

The role of patents in facilitating the transfer of technology is cardinal to attaining the objectives of the mRNA hub initiative. This role encompasses various aspects, such as international law, economics, policy context, innovation, competition policy, and ethical considerations.Footnote ⁷⁸ Although the role is intricate, some general observations can be made when considering the mRNA technology transfer hub.

First, a mRNA technology patent does not inherently impede technology transfer. The success of technology transfer would depend on how the exclusive rights granted by a patent are utilized, the jurisdictions where the patent can be enforced, and how these rights are incorporated into suitable mechanisms for technology transfer. For instance, contrary to the notion that intellectual property impeded the transfer of mRNA vaccine technologies during the COVID-19 pandemic, what we actually saw was the critical role intellectual property played in facilitating voluntary licensing agreements and technology transfer for mRNA technologies. Several critical collaborations and partnerships that helped to end the pandemic would not have occurred without intellectual property protection. Lonza would not have partnered with Moderna to produce the active ingredient for Moderna's vaccine, Pfizer and BioNTech would not have collaborated, and Oxford University and AstraZeneca would not have engaged in manufacturing partnerships and licensing agreements in various regions including India.Footnote ⁷⁹ These examples show that intellectual property does not inherently hinder technology transfer but rather that it could facilitate it.

Conversely, the absence of enforceable patent rights in a particular country does not automatically guarantee technology transfer. For example, least-developed countries are not obligated to protect patents under the TRIPS Agreement until 2034.Footnote ⁸⁰ While the absence of patents in these jurisdictions should theoretically suggests that mRNA technologies can be exploited without fear of patent infringement, most least-developed countries often lack the infrastructure and technical know-how needed to reverse engineer patented technologies.Footnote ⁸¹ In this case, the problem shifts from the realm of intellectual property to non-intellectual property barriers to technology transfer, manufacturing, and access.

That being said, the transparency of the patent system, if effectively utilized, can facilitate technology transfer in the context of the mRNA hub. By monitoring technological advancements and trends, the patent system can track new players, geographical shifts, and the relative involvement of public and private sector entities.Footnote ⁸² Moreover, it can help prevent redundant research and development efforts, promote technological leapfrogging and cumulative development, and aid in structuring technology transfer agreements that incentivize the inclusion of improvements, know-how, and related technologies.Footnote ⁸³

While patents alone do not guarantee technology transfer, their effective utilization, in conjunction with transparent systems and appropriate strategies, can help enhance the mRNA hub's sustainability. In any case, the importance of know-how and ensuring the voluntary involvement of right holders in the technology transfer process is integral to the sustainability of the hub. In the course of research and development, vaccine developers accumulate considerable know-how necessary for vaccine manufacturing. Such know-how is usually not disclosed in patents or patent applications, related scientific publications or assessment reports of drug authorities. They are often transferred under non-disclosure agreements. Not getting the cooperation of the rights holders within the mRNA space would deprive the spokes of key manufacturing know-how for vaccine manufacturing. Hence, the imperative of rights holders cooperation is not just to ensure access to know-how but to also avoid intellectual property litigations.

Overall, the role of patents in technology transfer is intricate and multi-dimensional. It is important to dispel the assumption that obtaining a patent is a standalone method for technology transfer. Patents are employed in various ways to transfer technology based on the specific requirements of effective technology transfer. These methods include leveraging access to related technologies from different sources, promoting an open licensing structure, implementing cross-licensing arrangements, and bundling patented technology with non-patented elements such as manufacturing know-how, commercial information, or regulatory approval dossiers.Footnote ⁸⁴ A synergetic consideration of these interrelated factors will help in charting a sustainable future for the mRNA hub and its spokes going forward.

3.3 The Boundaries of Compulsory Licenses

The TRIPS Agreement permits the issuance of compulsory licenses under certain circumstances to allow third-party use of the patent without the authorization of the rights holder. This exception has been the subject of controversy since the inception of the TRIPS Agreement, and the exact contours of these exceptions have yet to be fully defined.Footnote ⁸⁵ The various types of compulsory licenses are, for example, the third-party initiated compulsory license, government use compulsory license, compulsory license of related patents, and compulsory license for export of pharmaceuticals. For the mRNA hub-spoke model, if voluntary licensing fails and the parties cannot come to an agreement on reasonable licensing terms within a reasonable period, the legal option of compulsory licensing for dependent patents or third-party-initiated compulsory license may be considered.

As described in the previous section, the use of mRNA technologies often requires additional technologies such as delivery systems, which means that patent dependencies are likely to occur frequently. In cases where a later invention cannot be used without infringing an ‘upstream’ mRNA patent, the user would need to obtain a license from the relevant patent holder(s).Footnote ⁸⁶ As a precondition for obtaining a compulsory license in a case of patent dependency, the TRIPS Agreement requires that the later invention constitutes ‘an important technical advance of considerable economic significance in relation to the invention claimed in the first patent’.Footnote ⁸⁷ Overall, the effectiveness of this type of compulsory license as an instrument of access does not appear straightforward, as it depends on several factors such as the interpretation of the standard for an important technical advance and the willingness of patent holders to grant voluntary licenses. While the lack of its practical use suggests that the provision may not have been applied in any jurisdiction, one might hypothesize that the very existence of the provision could be a factor contributing to the patent holders willingness to grant a voluntary license and engage in cross-licensing agreements. Platform technologies, such as mRNA technology, generally encourage dependent patent holders to collaborate and engage in voluntary cross-licensing.Footnote ⁸⁸ Through the establishment of cross-licensing agreements for interdependent patents, companies can encourage collaboration, stimulate innovation, and facilitate growth for platform technologies. This approach ultimately leads to the expansion of market reach and returns, thereby reducing the necessity for compulsory licenses for interdependent patents.

In addition, as mRNA technology has great potential to address basic societal needs, such as public health, there is a possibility of implementing a compulsory license based on public interest, particularly in LMICs. However, the effectiveness of such a license would depend on how it is implemented under national law, the availability of local manufacturing technology, and the accessibility of technical know-how. As important as compulsory licenses may seem, they will usually not suffice without a comprehensive and effective transfer of know-how, which is essential to make use of patented technology. Accordingly, for ‘medicinal products based on known methods, such as the use of small-molecule drugs or traditional vaccines using particles of a virus, a compulsory license may provide a ready-to-deploy mechanism for production and distribution’.Footnote ⁸⁹ In contrast, in the case of mRNA-based vaccines, replicating the technical teaching underlying a patent ‘without access to the related know-how is by no means trivial’.Footnote ⁹⁰ This makes compulsory licenses less relevant to the production of mRNA-based vaccines.

Therefore, compulsory licensing cannot be viewed as an immediate solution due to its exceptional nature and case-by-case assessment.Footnote ⁹¹ These issues notwithstanding, in practice it is often the threat to issue a compulsory license (as opposed to the actual use) that serves an important purpose as it is a key bargaining chip for countries negotiating purchases from pharmaceutical companies.Footnote ⁹² The mRNA hub and spoke model could therefore increase the credibility of threats to issue a compulsory license by the spokes, serving as an effective instrument against which voluntary licenses may be negotiated. For this reason, and although imperfect, a compulsory license may play a supportive role in the wider effort to drive local production by the spokes through the mRNA hub.

3.4 Mitigating the Impact of Licensing Fees

Given the bourgeoning mRNA patent landscape, the impact of patent licensing fees on the price of vaccines and therapeutics manufactured by the hub can be significant. The payments that might have to be made and factored into the total cost of the manufactured products, could include an upfront ‘technology access’ license fee, milestone payments, and/or royalties calculated as a percentage of sales revenue. As such, spokes would need to ensure that the payments required in exchange for any license grant will not impact their ability to offer the final product at an affordable price for the final product. An option in this regard is the guideline provided in section 6.4 of the mRNA vaccine technology transfer agreement which states that:

Making a reasonable effort to negotiate a license to MPP will bring the technology into the pool for use by other spokes and the hub. Another option that could be considered is the possibility of negotiating lower royalty rates for sales or public sector purchases to help support a lower pricing strategy and the hub's goal of reducing the cost of vaccination.Footnote ⁹⁴ While several studies provide a comprehensive overview of measures to disseminate mRNA technologies (compulsory licenses, waivers, etc.),Footnote ⁹⁵ there remains a dearth of research on licensing practices in this field. In general, one could project that licensing practices within the complex mRNA space would be unfavourable to the mRNA hub's business environment and potentially could demotivate the spokes. Therefore, more comprehensive research on the functioning of access to mRNA technologies, through voluntary contracts in the context of the mRNA hub I,s necessary.

4.1 Regional Coordination

Several key regional strategic activities would have to be prioritized in order to achieve the objectives set forth by the mRNA Technology Transfer Hub. First, is the need for the harmonization of regulatory standards and processes across countries to be supplied by the spokes. This alignment would reduce unnecessary barriers and ensure consistent quality control, safety standards, and regulatory compliance when distributing mRNA-based vaccines or therapeutics across borders.Footnote ⁹⁶ Another critical aspect is the need to harmonize the public health-related TRIPS flexibilities within the national laws of the spoke and their regional target markets. This would involve incorporating provisions that safeguard public health interests and promote access to affordable medicines.Footnote ⁹⁷

For instance, Article 27 of the TRIPS Agreement provides ample room for Members to tailor their laws to meet specific needs and objectives and provide the meaning and scope of each of the criteria for patentability. The recommended approach for the spoke countries is to embrace strict rules that fully respect prevailing international standards (including the granting of second medical use patents) but could also guard against over-protection and interests that run counter to those of the goals of the mRNA hub.Footnote ⁹⁸ Clear guidelines on the definition of patentability criteria in a manner that extends protection to genuine innovations only while also rewarding R&D investments should be put in place.Footnote ⁹⁹

For a compulsory license, as noted in the previous section, it is the threat of its use that would be a valuable bargaining chip for extracting concessions from the rights holder in the context of the mRNA hub.Footnote ¹⁰⁰ Hence, spoke countries should have compulsory license provisions in place in order to be in a better position to threaten its use when such need arises. An example is to provide that a compulsory licence may be issued if the invention, though capable of being worked in the country, is not being worked on a commercial scale and there is no satisfactory reason for non-working. The legality of local working requirements – domestic provisions that allow the grant of a compulsory licence when a patent is not ‘worked’ in that country – are questionable under Article 27 of the TRIPS Agreement, which prohibits discrimination as to ‘whether products are imported or locally produced’.Footnote ¹⁰¹ However, the consistency of the provision has never been tested in dispute settlement, and there is no evidence that WTO Members maintaining local working requirements are concerned about any inconsistency with the TRIPS Agreement.Footnote ¹⁰²

For parallel importation, an unrestricted international exhaustion regime is highly recommended. Hence, patent laws must be clear and unequivocal in this regard. International exhaustion can benefit by helping facilitate the importation of patented products from the cheapest market in order to assist in meeting prevailing health needs.Footnote ¹⁰³ As simple as this recommendation is, the parallel importation of pharmaceuticals is controversial and complex. spokes must be mindful of other issues beyond trade, including health policies, consumer protection, and medical regulations.Footnote ¹⁰⁴ National marketing approval for pharmaceutical products, labelling laws, import authorizations, and other formalities make use an unrestricted regime even more complicated in practice. Footnote ¹⁰⁵ The ecosystem of parallel trade in pharmaceuticals is beyond the scope of this paper, but from an intellectual property perspective, the international exhaustion regime is a viable way to facilitate access to pharmaceuticals for low-income countries. Overall, there would be a need to establish a regionally streamlined approach to patent protection in a manner that ensures that mRNA technology developers receive a consistent scope of patent rights across the hub's network.Footnote ¹⁰⁶

4.2 Fulfilling Developed Countries' Obligations under TRIPS

During the negotiations leading to the adoption of the TRIPS Agreement, less developed countries were reluctant to adopt and embed in their national intellectual property laws the minimum standards established by the international agreement.Footnote ¹⁰⁷ This reservation is borne out of two factors. First, as less developed countries lack the technological infrastructure needed for ground-breaking inventions, they saw no reason to offer protection to such innovations. Second, offering such minimum protection would preclude them from (in theory) enjoying the myriad of opportunities, which come with a lax, laissez-faire regime such as technology transfer and local technological development. Negotiations were complicated and difficult, but ultimately less developed countries agreed to incorporate intellectual property into the multilateral trading system in exchange for several trade concessions, most notably in the form of enhanced agricultural access to developed country markets. That being said, less developed countries were successful in negotiating for the inclusion of most of the provisions of the so-called ‘B Text’ and embedding flexibilities in the agreement.Footnote ¹⁰⁸

One such concession is Articles 67 and 66.2 of TRIPS Agreement.Footnote ¹⁰⁹ Article 66.2 stipulates that high-income countries ‘shall provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to least-developed country Members in order to enable them to create a sound and viable technological base.’Footnote ¹¹⁰ Article 67 deals essentially with the obligation of developed countries to facilitate the preparation of laws and regulations that are TRIPS-compliant, establish or restructure national intellectual property offices, provide financial assistance, and train personnel. While Article 67 does not mention the international transfer of technology, its scope is arguably wide enough to cover the means of making Article 66 effective.

However, since TRIPS came into force nearly three decades ago, the implementation of these provisions has remained quite nebulous and controversial.Footnote ¹¹¹ The first challenge with Article 66.2 has been that the developed country's obligation ends with providing incentives. There is no obligation to intervene directly in the transfer of technology. Their role is no more than encouraging private holders of to engage in business partnerships with local firms in developing countries. Gervais noted that the ability of developed state governments to foster technology transfer is usually limited by two factors: that governments do not own the vast majority of the available technologies; and that they cannot compel the private sector to transfer the technologies.Footnote ¹¹² Thus, the incentives provided by developed country governments can only serve the purpose of promoting, encouraging, and facilitating technology transfer projects in least-developed countries.

The second challenge is the lack of clarity regarding how the obligations should be fulfilled and to what end. The letter of the law has been said to offer scant guidance on questions such as how many incentives, and how much technology transfer is enough? From how many developed countries to how many LDCs? For how long? Who decides?

The mRNA hub may present a viable opportunity to bring some clarity to these obligations. With the mRNA hub, the provisions of Articles 66.2 and 67 may have taken a distinct character and there should no longer be any ambiguity or lack of clarity as the mRNA hub mirrors what the negotiators of the TRIPS agreement must have envisaged during TRIPS negotiations. If developed countries were to endorse the efforts of the hub (as seems to be the case), they could offer financial support in the form of grants, subsidies, and tax benefits to pharmaceutical companies that collaborate with mRNA hub. By doing so, these countries would be fulfilling their obligations to facilitate the development of a sustainable technological foundation in least-developed countries as outlined in Article 66.2 of the TRIPS Agreement.Footnote ¹¹³ Of particular significance in this context is the potential for the governments representing the holders of patents to be willing to make patented technology accessible through buy-outs, patent pools, or geographically segmented licensing arrangements while also providing financial support.

Furthermore, the ongoing negotiations for the WHO pandemic treaty may present a significant opportunity to reinforce the fundamental objectives and principles of the TRIPS Agreement within the international community and to implement them for a more equitable management and sharing of intellectual property and know-how necessary for pandemic preparedness and response.Footnote ¹¹⁴ While there are concerns regarding whether and to what extent the treaty would be legally binding and/or have a strong enforcement mechanisms,Footnote ¹¹⁵ its primary objective aligns with that of the mRNA hub – promoting a comprehensive approach to enhancing national, regional, and global capacities and resilience against future pandemics.Footnote ¹¹⁶ If effectively leveraged, the treaty could offer a fresh opportunity to put technology transfer and the sharing of intellectual property at the heart of global pandemic preparedness.