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Traditional cultural expressions such as expressions of folklore, Indigenous art and handicrafts and music and performance have received protection under the Australian Copyright Act 1968 (Cth)--albeit to a limited extent. The outcomes of the copyright cases of the 1990s discussed above in Part II make it plain that while individual Indigenous artists can easily be afforded protection under the Act, the communities to which the artist is responsible cannot. What this series of cases demonstrates is a clear inability of Australian copyright law to deal with the collective nature of traditional cultural expressions and knowledge, and reinforces its ineptness to accommodate customary law unless there is a specific provision to allow for it. This clearly emphasises the need for sui generis legislation for the protection of such customary and communal expressions and knowledge. This remains the case even though the folklore provisions of the Copyright Act 1968 (Cth) provided some recognition. These provisions were made available due to the Australia-United States Free Trade Agreement (entered into force on 1 January 2005), and were achieved through the definition of 'live performance'. The performer of the expression of folklore becomes a joint owner with the maker of the sound recording--acquiring moral rights in his/her performance--and is able to exercise performers' protection for a live performance. (114) While not a collective right, it does provide some protection for  by the performers --although it must be kept in mind that it is jointly owned with the recorder of the performance.

(TCE – traditional culture expression)

The ECTK of indigenous groups requires positive protection, rather than the negative rights available under western intellectual property laws. The implementation of positive protection would validate and empower indigenous groups, and affirm the value and worth of indigenous ECTK. From a review of indigenous issues in the Australian context alone, it can be seen that ECTK protection cannot be separated from other indigenous issues such as land rights and self-determination, all of which impact upon indigenous cultural identity.65 The implementation of sui generis laws contributes positively towards these social and policy conflicts that continue to concern indigenous people as their role in contemporary society evolves beside the dominant Western societal paradigm.

Consequently, it must be acknowledged as an established fact that current, Eurocentric intellectual property laws provide protection for ECTK that is either insufficient or ad hoc, depending on the facts of the case. It can be seen from the weight of literature and authority on the topic that such protection has been acknowledged as undesirable due to its uncertain application. Indigenous people need reliable and uniform protection to achieve their goals.

Another approach, that has been strongly advocated by some academics and many NGOs, would be the development of a sui generis regime of IPRs, that is, a legal regime “of its own kind” which is specifically adapted to the nature and characteristics of traditional knowledge. A model of sui generis national legislation that would give communities property-like rights over their collective knowledge was developed by the Third World Network (Community Intellectual Rights Act) in 1994.105 Although this approach has received considerable attention in the literature, little progress has been made in terms of actually implementing this kind of protection. The establishment of a sui generis regime poses, many complex conceptual and practical issues. Briefly these are:106 definition of the subject matter of protection; requirements for protection; extent of rights to be conferred (rights to exclude, to obtain a remuneration, to avoid misappropriation); title-holders (individuals/communities); modes of acquisition, including registration; duration; enforcement measures.107 Sui generis literally means “of its own kind” and consists of a set of nationally recognized laws and ways of extending plant variety protection (PVP) other than through patents. TRIPs itself does not define what a sui generis system is or should be.108 Potentially, a sui generis system could be defined and implemented differently from one country to another 109 and the system might be defined to create legal rights that recognize any associated traditional knowledge relating to genetic resources and promote access and benefit sharing. The government may choose to extend protections to genetic resources and/or knowledge to a community in the form of patents, trade secrets, copyrights, farmers’ and breeders’ rights, or another creative form not currently established in the intellectual property regime. 110 In addition, a sui generis system may adopt measures of protection specific to traditional knowledge in order to nullify inappropriate patents. For example, the Andean Community’s Decision 486 states: “patents granted on inventions obtained or developed from genetic resources or traditional knowledge, of which any member state is the country of origin, without presentation of a copy of the proper access contract or license from the community shall be nullified”.111

The interest in sui generis systems-national and international, for protection of TK is a public policy objective that reflects the needs and expectations of communities, particularly traditional knowledge holders. In IPRs, claims for international protection are considered only when national protection exists. The quest for protecting traditional knowledge within the cultures of knowledge traditions bound to IPR systems, as presently developed, is a futile search for a “procrustean bed for an ameboid phenomena” (Viswanathan, 2001). There is no reason to regard a functioning IPR frame as more perfect than one that mirrors a natural process or approximates a synthetic repository for a real flower or butterfly. IPR concepts are useful to describe the innovation tree but there is no reason to mistake concepts for the tree itself. Specification through documentation in a discrete representation can detract from and deny or devalue living processes. The pursuit of validity, standardisation, universalisation, uniqueness, authenticity and historicity are features of IPR regimes. If TK could be adapted to them, there would be no need to ponder over missing markets. The struggles for and against commodification are essentially about acquiring new IPRs. Biopiracy and piracy of traditional knowledge is a global public bad. This may be mitigated if international cooperation replaces the paradigm of ‘external affairs’ with policy-making to internalise externalities at source by recognising and provisioning ‘global public goods’. The recognition of traditional knowledge as a global public good may someday enable an international sui generis system to be operationalised. However, that would need the Convention on Biodiversity and TRIPS to be harmonised to enable WIPO, UNESCO, UNIDO, UNEP, FAO, WORLD BANK, WHO and UNDP to facilitate processes that may otherwise conflict with WTO. An international treaty providing ‘sui generis’ protection to traditional knowledge can be reached through WIPO or UNESCO or WTO but the immediate prospects of doing so are fraught with considerable difficulties.

Traditional Knowledge (TK) plays an important role in the world economy because a wide range of medicinal plants, herbal formulations, and products based on agriculture, forestry, arts and crafts are traded internationally and have considerable economic value. TK is also used as an input into modern industries such as biopharmaceuticals, cosmetics, dyes, pigments, chemicals, textiles, design, pesticides, farming and agro-industries, to mention a few. A large proportion of this value added is captured by companies leveraging their scientific and technological capabilities through trade using worldwide marketing networks. An international consensus on the scope of IPR protection for TK remains elusive. Criteria for coverage and the terms of protection for TK are neither free from controversy, nor imminent. Thus, there is a need to examine the feasibility of ‘sui generis’ 2 protection of traditional knowledge. This is explicitly acknowledged in paragraph 19 of the Doha Ministerial Declaration as one of the important issues to be discussed by the TRIPS Council during the current round of WTO negotiations. If TRIPS is clarified or revised and supplemented to cater to protection of traditional knowledge, or if the WIPO Inter Governmental Committee on traditional knowledge, genetic resources (GR) and folklore, with its renewed mandate of September 2003, succeeds in securing commitments towards an international treaty, a way forward may be established for international consensus on protecting, developing and trading in traditional knowledge. Meanwhile, a number of countries including Brazil, China, India, Panama, Peru, Philippines, Portugal and the African Union countries have taken steps towards the design and development of national ‘sui generis’ protection systems for traditional knowledge.

As we all know, with various examples from the world over, the appropriation and use of traditional knowledge especially as it relates to genetic resources has caused problems especially when intellectual property rights are acquired based on the traditional knowledge. Well-known examples are the Neem, Tumeric, Hoodia, Maca among others. The knowledge from the indigenous and local communities was crucial in subsequent use of these plants in the pharmaceutical field and it is important to acknowledge the same. The panellist in round table 2 also gave examples from their different countries in relation to food, agriculture, and architecture. The existing intellectual property regime may not be the appropriate mechanism for protection but a sui generis system of protection should work for traditional knowledge. The protection sought may be defensive which aims at stopping third parties from acquiring intellectual property rights over traditional knowledge. This may be through a database such as the TKDL in India. Defensive strategies might also be used to protect sacred cultural manifestations, such as sacred symbols or words from being registered as trademarks. Positive protection seeks to grant rights that empower communities to promote their traditional knowledge, control its uses and benefit from its commercial exploitation. Several national laws have adopted this approach but are limited to the country in which the law is passed thus the need for an international instrument.

Several countries have adopted Sui-generis laws for protecting traditional knowledge from patenting. These include South Africa, Peru, Panama, Costa-Rica, Portugal, India and Thailand. A number of countries have decided to develop national legislation to protect traditional knowledge. In addition inter governmental and non-governmental organizations have produced model legislation for interested countries to adopt. In June 2000 Panama has passed a Suigeneris law by name “Panama’s special system for registering the collective rights of indigenous people’s for the protection and defense of their cultural identity and traditional knowledge and setting out other provisions”.8

According to World Intellectual Property Organization (WIPO) the Sui-generis system of Panama actually constitutes the first comprehensive system of protection of traditional knowledge ever adopted in the world.9

There shall be adequate protection available against misappropriation of TK, the reason being that it affects the livelihoods of the TK practitioners. A sui generis legislation shall also ensure opportunity to any person even outside the custodian community for enrichment of TK. However, financial benefits from such exploitation of TK should flow down and reach all the stakeholders. This can only be ensured if knowledge societies are registered and its membership is governed systematically. In order to create such a system, it is to be ensured that TK holders/communities register a "knowledge society" according to the laws of the country. The TK holders/communities shall be recognized as custodians of the said TK only after that. After registering the "knowledge society", they can apply to the appropriate Government (deemed owner of TK) for recognition as custodians. It is the responsibility of the respective state governments to encourage individual practitioners of tK or communities to form knowledge societies. When the custodians are officially recognized, they get the power to manage the TK according to the statute. They are also empowered to market their TK as they deem appropriate, ensuring that any commercial value in it would benefit them first. Government authorities should empower the TKcommunities to obtain Patents on the innovations made by them on the TK and to negotiate with the potential customers. It is also necessary to educate them that no patents could be obtained, within India or abroad, on any TK per se or aggregation thereof, obtained from any region or place, irrespective of whether it is in the custody of a community/ individual or in public domain

(TK – Traditional Knowledge)

GIs are also important intellectual property rights employed to protect intangible cultural heritage. GIs are signs given different terms in national and international norms. They play a similar role to appellations of origin (AOs), in that both GIs and AOs highlight a qualitative link between the relevant product and its place of origin. The link with the place of origin is stronger for AOs, since the quality or characteristics of the product must result exclusively from their geographical origin: raw materials should be sourced in the place of origin, as should the processing of the product. In the case of GIs, a single criterion attributable to geographical origin is sufficient: the production of the raw materials and the development or processing of a GI product do not necessarily have to take place entirely in the defined geographical area. For the sake of simplicity, GIs and AOs will be referred to collectively as GIs, unless indicated differently. The legal instruments and the protection available for GIs vary considerably from one country to another. A sui generis system providing for the registration of GIs exists in some states, e.g., Kenya, Nigeria, South Africa, Egypt, Mexico, Peru, Cuba, India, Pakistan, Mauritius, and Sri Lanka. The most advanced of these sui 34 EUTM Regulation, Article 4(a). 35 ibid Article 4(b). 36 Jeffrey Belson, Certification and Collective Marks (2nd edn, Edward Elgar 2017). 37 EUTM Regulation, Article 74(1). Cross-border safeguarding of intangible cultural heritage 115 generis systems is that of the EU, where GIs (as well as Protected Designations of Origin (hereinafter PDOs)38 and Traditional Speciality Guaranteed (hereinafter TSGs))39 are regulated by the EU Regulation No 1151/2012 (QS Regulation).40 The registration of EU GIs gives rise to a unitary intellectual property right (overriding any national rules on domestic GIs) covering the entire EU territory (Article 118(2) TFEU).41 The exhaustive nature of the QS Regulation distinguishes it from other EU Regulations on unitary EU intellectual property rights, e.g., the EUTM Regulation, the Regulation on Community Designs,42 and the Regulation on Community Plant Variety Rights.43 In fact, according to these Regulations, the interested parties may choose to register an EU trade mark according to the EU Regulation or a national trade mark based on the domestic legislation(s) in force in the member state(s) of registration.44 In contrast, interested parties can only register their GIs in the EU, based on the QS Regulation, and can no longer register a national GI in a single member state.

Other countries have modified existing IP regimes or have created sui generis schemes to deal with specific indigenous peoples. Perhaps most boldly, New Zealand has amended its trademarks laws to protect indigenous designs, requiring the government to veto any application for marks whose use or registration would offend a significant portion of the community, legislation that has the practical effect of preventing trademarks incorporating Maori sacred designs. 111 Other countries including [*527] Panama, Nigeria, Tunisia, and the Philippines have passed “copyright-like’ laws allowing, inter alia, collective ownership of sacred indigenous objects, fee distribution to communities whose folklore serves as a source for creative works, and the criminalization of “international distortion” and misuses of folklore. 112

Third, questions of indigenous rights and traditional knowledge have caught the attention of the United Nations, the World Intellectual Property Organization, and the Organizational of American States. For instance, the widely-debated UNESCO treaty on intangible heritage explicitly includes “representations” and “cultural spaces,” and is aimed at “integrating” the physical and the intangible managing the “grey area’ between the two, including local input into resource management. 113 The Protocol of San Salvador addresses similar issues, though the document concentrates on concerns of just compensation and access to knowledge more so than its counterparts. 114 Finally, and perhaps the most significantly, traditional knowledge was singled out for potential WTO regulation under the TRIPS agreement during the Doha round, suggesting the possibility of more aggressive enforcement (e.g. fines and retaliatory trade measures, rather than the purely normative force derived from proclamations by other international institutions). 115

While a sui generis system of protection and databases allow nation-states to exercise some order of protection, those systems still require TK to become perceptible under the Western constructs of law and understanding. A sui generis system of protection of TK within the scope of global IP needs definitions, objectives, identification of the subject matter, legality of material, registrations, exceptions and limitations, and duration of protection to be clearly defined in order to be legitimized and enforceable. While IPR aims to commodify certain parts of TK, specifically the parts that can be traded and sold, a sui generis system of protection may be able to protect TK that exists outside of the Western construct of IP. A sui generis system of protection is used in protecting intangible property and granting rights to those who have original claim to knowledge, or proprietary rights. The sui generis system of protection of TK may provide exclusive rights in an attempt to provide fairness and equity from neo-liberal market forces to primarily Indigenous peoples []. The holistic and unique character of TK under a sui generis system allows for specialized measures or laws to be created exclusively to address the special characteristics of specific subject matter.

In addition to the variety of legal constructions for the protection of TK is the development and expansion of national and an international database. However, this presents a variety of issues in many countries of the Global South as they do not have intensive internal technological and scientific capacity to adapt and transform knowledge production to fit within what would be protected under current IPR frameworks []. Additional issues arise where TK-holders and the State intersect, as well as between TK-holders and researchers.

If one invokes an expanded version of standard intellectual property law, negative protection can easily be obtained. The crucial expansions are recognizing prior foreign use, as well as publication, as part of prior art that blocks patents and creating registries of traditional knowledge (published or used) whose availability facilitates the blocking of patents. Positive protection is harder to obtain on this approach, because many of the features of traditional knowledge— e.g., its not being invented by a specific individual or group at a specific time in a specific inventive step—might block the issuing of traditional patents. But one could create a sui generis system of intellectual property rights that would be designed to accommodate the special features of traditional knowledge. Such a sui generis system either could be incorporated into national intellectual property laws or could be based in a special international regime.

As Professor Anaya articulates and the authors of this special issue of JIPLP varyingly contemplate, the similarities between the inadequacies of the protection of tangible rights of indigenous peoples (eg indigenous land rights) and that of their intangible rights protection (including IPRs) tend to stem from a common source – the failure to acknowledge the “inherent logic of indigenous peoples’ world views”.2 Perhaps the solutions lie not just in finding ways to include indigenous IPRs in current IPR regimes, but through the facilitation of an entire paradigm shift to capture the nuances of these issues both effectively and precisely. How, for instance, can indigenous IPRs be valued commercially, and how may adequate compensation models be developed in exchange for the commercial use of these rights? A key to increasing the recognition of the inherent value of indigenous IPRs within their traditional cultural settings may lie in developing methods to properly value this worth in tangible terms. What seems necessary is a model to adequately measure the significance of indigenous IPRs, starting at the source (the indigenous community), and finding ways of translating this value into benefit systems that can be returned to the communities from which the IPRs were sourced. Hence recognition is attributed to the crucial part these IPRs play within the cultures from which they are derived.

6. The commons in the IP field The Commons Theory has gained noticeable interest in all types of property, among which IP is a peculiar and interesting one to debate on. In particular, the question that the legal literature has been asking right now is whether, in the light of the Commons, the idea of property is still needed to increase creation and innovation, the two most important aspects that jusitifed IP in the frst place.110 The utilitarian argument, by emphasizing the utility of intellectual products for the society as a whole,111 is the one according to which, without IP, the creation would result in intellectual products that are non-exclusive and non-rival.112 Users would access the product without paying its price, ie free-riding on it (non-exclusivity), and the resource would be used without depriving anyone else of such a use (non-rivalry).113 In this way the creator is contributing to the welfare of the entire society, but if she cannot recoup her investment, there would be a lack of incentive that ultimately results in a block of innovation and creation.114 To avoid this situation, IP, as private property in general, is introduced to correct the market failure that would derive from the use of only public goods. It is true that in case of intellectual products there would not be that depletion of physical resources that Garrett refers to in his ‘The Tragedy of the Commons’.115 However, according to this line of thought, without incentives given by IP, there would be an underproduction of works and inventions,which is always an ineffciency of the market.116

This type of conventional argument cannot be entirely accepted anymore: it is clear that in some communities, from painters to open-source developers, creativity is widespread without the implementation of IP, in the so-called ‘negative spaces’, due to non-economic factors in place that incentivize creative efforts.117 In fact, in creative industries—where usually IP would dominate—Commons, that are intended as resources that lack exclusivity, are consistently present, as evidenced, among others, by the author Dusollier.118 The author states that Commons in the IP field can derive from the delineation of the exclusivity granted by copyright and patent, which is mostly public domain and exceptions/limitations.119 Moreover, considering that sometimes authors and inventors decide to opt-out entirely from exclusivity to encourage the sharing and dissemination (as non-economic motivators) of their intellectual products,120 Commons can be the result of private ordering initiatives, such as open-source software, Creative Commons or open-source patenting.121 The issue is that, since all these instruments that represent Commons, are completely different from each other, if the same defnition is used for all of them, confusion might rise in relation to what a proper Commons in the IP context is.122 Therefore, it would be preferable to clarify these different categories of Commons before moving forward.

Having clarifed that the vaccine and other life-saving treatments meet the conditions to be considered Commons, there is the need to assess what particular category of IP Commons these goods belong to, and in this assessment the advantages and disadvantages of each Commons, analysed in the previous section, must be considered. If the vaccine was part of the public domain, no IP holder would have an exclusive right in it, resulting in an unconditional freedom to use the vaccine. However, there would be an issue of enforceability, since the public domain is without controls and legal enforcement, and this would lead to a risk of underuse or overuse of this resource, by resulting impossible to manage the resource itself. A similar situation would arise if the vaccine was recognized as an exception/limitation to the patent regime: on the one hand, there would not be any exclusivity, and on the other hand, the enforceability would be implemented only as a defence against an alleged patent infringement. Therefore, the cases where this Commons is enforceable would be extremely limited. Lastly, perhaps the most suitable Commons for the vaccine and other life-saving treatments would be an open innovation instrument, such as IP pledges or patent pools, and this is actually what already occurred during the pandemic with regard to some diagnostics and treatments against Covid-19, as evidenced in Section 6. However, it has been already noticed that these instruments are based on private ordering initiatives, and thus on the will of the IP holder. It is far from certain that the owner of patents related to the vaccine would be willing to share such a technology with everyone in the form of a binding pledge. Therefore, also the open innovation instrument does not seem to be the optimal solution for a normative ‘commonization’ of the vaccine against Covid-19 and other life-saving treatments.

3. The international context: the ineffectiveness of TRIPS compulsory licence and WTO waiver.

There is a consistent number of authors, including Dinwoodie and Dreyfuss, according to which the significance of the TRIPS Agreement is decreasing internationally,39 due to the following indicators: the response to emerging technological trends offered by new IPs treaties, such as the World Intellectual Property Organization (WIPO) Treaties; the enactment of new free trade agreements (FTAs), concluded by the USA and European Union (EU), where provisions usually deviate from the TRIPS rules; the US willingness to retaliate in case the implementation of TRIPS is too consistent; and the limited use of the WTO dispute settlement system to deal with TRIPS-generated disputes.40 Without going into a detailed analysis, it will be seen that all these aspects contribute to the ineffectiveness of a very important instrument provided in TRIPS: the compulsory licence.41 This is ‘a state-granted license issued to a third party to manufacture and produce a patented invention without the patent owner’s consent’.42

5. The search for an effective GHS The second most relevant reason why the theorization of a Commons for the Covid-19 vaccine and other life-saving treatments should be pursued is the achievement of a GHS system. GHS has not a proper definition, but it has always been approached from two opposite perspectives: on the one hand, state and national security which prioritizes national safety, and on the other hand, through a more holistic point of view, security of the entire humanity, beyond national borders.87 This lack of clarity is evidenced in how the world was highly unprepared to face the Covid-19 virus and all the consequences that derived from it.88 Therefore, there is the need to take a position on what GHS really means. This can be done by critically assessing two aspects of the pandemic that amplified issues of inequality, nationalism and private interests: the restrictive measures commonly defined as lockdowns (including stay-at-home orders, shelter-in-place orders, economic shutdown),89 and, more relevant for the purposes of this paper, the vaccine’s development and distribution. With regard to the first phenomenon, the impact of the restrictive measures, although consistent across the world, has been highly dependent on the country involved. The most drastic effects can be found in low- and middle-income countries (LMICs) where the lockdown led to a limitation of access to essential public health services, such as the treatment of the Human Immunodefciency Virus.90 Moreover, considering that all the health facilities were deeply focused on testing, treating and preventing Covid-19, in LMICs there was a 10 per cent decline of sexual and reproductive health services only in 2020, specifically in relation to the use of contraceptives, services for pregnancy-related and new-born care and abortions.91 Other than these serious health-related issues, there is evidence that state authorities started to implement intimidation, violence and imprisonment against part of the population, not due to violations of the restrictive measures, but only because they were political opponents and marginalized communities.92

The only instrument that could put an end to all the restrictive measures and their devastating consequences is the vaccine, which was finally introduced at the end of 2020. However, the real success of this pharmaceutical depended (and still depends) only on its equitable access and rapid distribution on a global scale, and unfortunately this was not the case. A sense of vaccine nationalism took over at the end of 2020, with all the wealthy countries that started to pre-order vaccine quantities beyond their own needs, arriving to cover 300 per cent of the population.93 Developing countries, despite the fact that their own citizens were part to the trials for Covid-19 vaccines, were being excluded from this massive distribution.94 This naturally resulted in missing the target set by the World Health Organization (WHO) to fully vaccinate 40 per cent of the population in every country by the end of 2021.95 Therefore, as it can be easily noticed, the goal of ensuring a GHS that is human security-centric and equity-based, especially in terms of equitable access and distribution of vaccines, is far from being accomplished.

Naturally, there could still be the conviction that governments, when it comes to implementing this inclusive right, would find the firm opposition of the private industry. However, since nowadays companies around the globe must ensure corporate social responsibility (CSR), they have been already implementing ethical sources initiatives (ESIs) by formally and/or informally sourcing processes in an ethical and socially responsible way.158 And these initiatives, such as guaranteeing transparency in the supply chain, have been shown to be beneficial not only for the society at large—as they were initially thought—but also for the companies themselves, through a positive reaction of the stock market and increase of operating performance.159 Therefore, from the perspective of private companies, the enforcement of the inclusive right for vaccines and other life-saving treatments would be an additional and innovative way to conduct an ESI and accomplish CSR. Moreover, it should not be forgotten that it is the private industry itself, which has been implementing community driven approaches that lean towards inclusivity. For instance, in the biotech field, the technological platform Molecular provides researchers with ‘real-time global sourcing of ideas, capital, and know-how’.160 Another example, briefy mentioned in Section 6, could be the synthetic biology feld that is now embracing an ethos of openness through several commons-based institutions [eg Synthetic Biology Engineering Research Center (SynBERC)].161

In conclusion, the current scenario is changing, not only from the public but also from the more private perspective, and there is the need to embrace that change, to embrace that inclusivity and turn it into something useful for the society as a whole. The inclusive right that has been theorized in this section can constitute a good normative starting point.

4. The great paradox: public funding but private properties Before introducing the concept of inclusive right and enforceability of Commons, it should be argued why the vaccine against Covid-19 should be considered a Commons in the first place. The first reason, investigated in this section, is the public funding contribution.

The Covid-19 pandemic resulted in drastic economic and social dislocation.66 Given this unprecedented situation, countries all around the world—including the EU, UK, Germany, Canada, and USA—started to accelerate the development and manufacture of treatments and vaccines, by allocating in total $9 billion of research funding from the beginning of the pandemic to the half of 2020, most of the times to private companies.67 By addressing the USA as an example, it can be immediately understood how the public funding have been extremely important for the R&D of every instrument (vaccines, therapeutics, etc …) needed to defeat the virus. The USA alone contributed with 35 per cent of all the public funding, focusing it mostly on a domestic level, through large grants allocated to US-based pharmaceutical companies.68 Even before the pandemic, the public commitment in pharmaceutical R&D has always been consistent in the USA. With an annual budget of $30 billion, the US National Institutes of Health (NIH) is the world’s largest single funder research in the life sciences, providing one-third of the biomedical R&D in the USA overall, and most of the funding for the basic biomedical research.69 Despite the substantial investment made by the government, and ultimately by the public at large as taxpayers, the property of the vaccines and treatments still belongs to the pharmaceutical companies that allegedly developed them. For instance, with regard to the mRNA technology implemented in the vaccines manufactured by Moderna and BioNTech/Pfzer that own the relative patents, as observed in Section 2, the NIH publicly funded 174publications in PubMed (PMID) in relation to this type of vaccines, a number which equals to 23 per cent of the total amount of 767 PMID.70

There is one last option to consider. It is now sufficiently clear that, at least in the IP feld, there is no grand unifed theory of Commons.151 However, all Commons—from public domain to open innovation instruments—have one constant feature which is inclusivity, and this should be taken into high consideration.152 It has been already ascertained that until now IP has always been focused on exclusivity, and not on the spaces of inclusivity that nonetheless have been present in the IP context in the form of public domain, exceptions/limitations and open innovation instruments as negative spaces. This perspective should change, in the sense that the private and public dichotomy, which has constituted the foundation of IP, should be replaced with a more complex combination of rights and privileges.153 This does not mean to abolish IP completely, but to achieve a harmonization between IP and the Commons. If this harmonization is to be achieved, the inclusivity feature should be conceived not only as a static aspect of Commons but also as something that is normatively relevant.154 Hence, inclusivity should have normative consequences. In particular, users of a work or invention, whether it is in the public domain, it constitutes an exception/limitation to copyright or patent law, or it is delivered through an open innovation instrument, should always be able to enforce and manage that Commons, specifically in the form of inclusivity.155 Therefore, the main idea proposed by Dusollier—and applied in this paper for the Covid-19 vaccine and other life-saving treatments—is that there should be an actual ‘inclusive right’ that would constitute an effective remedy or enforcement for the Commons, for the negative space. This right would be extremely useful for the public domain and exceptions/limitations that are almost impossible to implement, but also in the open innovation schemes where usually the users’ rights are enforceable only against the licensor or IP holder.156 When there is a right, a correspondent duty arises. Indeed, the correlative of the inclusivity right would be a duty on everyone else to not interfere with the inclusivity. Considering all these aspects, a sui generis inclusive right should have the following characteristics:

1. It shall never exclude another person enjoying the same inclusive right.