Can you patent the sun? Towards a sui generis inclusive right to manage the relationship between intellectual property and Commons

Abstract

This paper, by adopting the Covid-19 vaccine as a case study, argues that some pharmaceutical drugs should be considered as Commons, ie goods that are managed and owned by the public at large, and not as private property—exclusivity—of pharmaceutical companies. The reasons of such a strong argument are, on the one side, the conspicuous public-funding contribution to develop Covid-19 vaccines and other essential life-saving treatments, and, on the other side, the search for a human and equity-oriented Global Health Security.
It is true that, from a legal perspective, vaccines can be patented, leading to questionable practices in the pharmaceutical industry, such as patent thickets. However, an alternative and fairer path, which would result in the theorization of a Commons for the vaccine, can be pursued. In particular, the actual types of Commons in the IP law field—the public domain, exceptions/limitations to patents and open innovation instruments such as IP pledges—present some issues in relation to enforceability. By forwarding the concept of ‘negative spaces’ to the patent realm, these spaces should not only claim to not enforce IP but also be able to ‘enforce that non-enforcement’.
Therefore, this paper, by building on the work of the author Dusollier, advances the idea that from the inclusivity, which is the typical feature of every Commons, a sui generis inclusive right can be envisaged and applied in the context of the vaccine, by rethinking the relationship between IP and Commons.

1. Introduction

Although the Covid-19 pandemic seems now a far memory, it is important to not forget that experience. An experience that ultimately impacted so many aspects of our life, from working remotely to wearing a mask, to the realization that, in front of a serious disease on a global scale, the concepts and ideas that no one has ever thought to challenge need to be rediscussed under a new perspective. One of these discussions relates to the complicated relationship between exclusivity and inclusivity, private property and public good, IP and Commons.

When in 1955 the journalist Edward R Murrow asked Jonas Salk, the inventor of the polio vaccine, who owned the patent for that pharmaceutical product, the scientist replied ‘The people, I would say. There is no patent. Could you patent the sun?’.¹ This question nowadays could be slightly reformulated as ‘Should you patent the sun?’. This sums up the main argument of this paper: some pharmaceutical drugs should be considered as Commons, ie goods that are managed and owned by the public at large, and not as private property—exclusivity—of pharmaceutical companies. Thus, at least in relation to the vaccine and any other life-saving treatments against the spread of highly contagious diseases on a global scale (such as Covid-19), a renovated balance between IP and the Commons Theory must be pursued.

This paper will implement a normative approach to assess the reasons of such a strong argument: on the one side, the conspicuous public funding contribution to develop the Covid-19 vaccines, and, on the other side, the search for a human and equity-oriented Global Health Security (GHS). It is true that for now, from a legal perspective, vaccines can be patented (‘how the law is’) but this does not mean that the law cannot be modified (‘how the law should be’). Indeed, it should always be remembered that law must keep pace with the society. Therefore, if the needs of the society change—as it occurred during the Covid-19 pandemic—law must change and evolve as well, and this paper can offer a theoretical and normative direction to follow.

In particular, Section 2 briefly introduces the mRNA technology as the main example and case study to assess the patentability of vaccines in Europe and the USA, given the influence of these regions and the impact of their pharmaceutical industries worldwide. Moreover, this section explores a specific and problematic issue—patent thickets—in the context of complex technology industries such as the pharmaceutical one.

Section 3 discusses two international initiatives, compulsory licensing provided in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement² and the waiver for Covid-19 vaccine technologies adopted by the World Trade Organization (WTO).³ In particular, the section argues that these instruments are not suitable to face the issue of patented vaccines in the midst of a pandemic or a global emergency.

Section 4 starts going into the core of this paper’s argument, by addressing the first reason why the vaccine against Covid-19 should be considered as a Commons. Although the governments all around the world invested substantial public funding in the Research & Development (R&D) of treatments, diagnostics and vaccines against Covid-19, the pharmaceuticals derived from that R&D belong to private companies. Considering the lack of international legal instruments in this regard, two legislative initiatives in the USA that attempt to solve this contradiction are assessed, although their effects seem not so encouraging.

The Section 5 illustrates the second reason why vaccines and other life-saving medicines should be Commons, which is the achievement of an efficient GHS system, that is human and equity-oriented, and not focused only on the wealth and security of each country nationals. It is argued that there are many instruments through which this GHS can be implemented, such as the theorization of vaccines and other life-saving treatments as Commons.

The Section 6 addresses the Commons Theory in the field of IP, stating that the Commons in this context can assume three different connotations: public domain, exceptions/limitations to copyright and patent, and open innovation. These three types of Commons are illustrated by underlying their respective advantages and disadvantages.

Section 7 of this work applies this Theory of Commons in the context of the vaccine against Covid-19 and other life-saving treatments, by highlighting all the benefits that would derive from it. In particular, it is assessed that, from a normative perspective, an effective way to implement, manage and enforce such a Commons is a sui generis ‘inclusive right’, first theorized by the scholar Dusollier. This right can constitute a good starting point for the implementation of legislation related to the Covid-19 vaccine and any other life-saving treatments that could be identified as Commons, leading to a reconsideration of the relationship itself between IP and Commons.

2. mRNA vaccines: from lawful patentability to problematic thickets

With the success of the recent mRNA vaccines manufactured by Moderna and BioNTech/Pfizer against Covid-19, the mRNA technology gained a huge attention worldwide, although this method has more distant origins in producing vaccines. The idea of genetic—DNA and RNA—vaccines started to be developed many years ago, but until the late 2000s there was not so much trust in using RNA to implement new vaccines, because of its instability, the inefficiency in vivo delivery and the risk of substantial inflammatory responses.⁴ Lately, from 2010 onwards, some fundamental innovations in the study of RNA made it possible to solve those issues. In particular, the progresses are related to the ability of engineering messenger RNA (mRNA) sequences, the enactment of effective methods that lead to the safe and reliable production of mRNA, and the improvement of techniques to efficiently deliver mRNA vaccines.⁵

These innovative nucleic acid vaccines are an improvement of the former recombinant vector vaccines,⁶ considering that, instead of inserting the DNA plasmid into a bacterial or mammalian cell to then purify the antigenic result, these vaccines can be immediately administered into the patient where the antigen is produced in her own cells.⁷ This viral antigen, that is produced by the patient’s cells in situ, stimulates an immune response. Therefore, on the one hand, immunity against the original virus is generated, and on the other hand, the security of the vaccine recipient is not compromised.⁸ With regard to the manufacturing process, these mRNA vaccines are easier and faster to produce than the recombinant vector vaccines, and this was an extremely important aspect during the pandemic, where the timing of the virus response to the vaccine needed to be reduced as much as possible, because of the elevated virality and related fatalities. As a matter of fact, when the sequence that encodes an immunogen is discovered, the vaccines can be produced within a few weeks.⁹ This can result useful especially in case a new virus strain is identified, or a new mutation occurs in a known virus. Moreover, multiple mRNAs encoding different antigens can be combined in a single immunization, leading to a multi-antigenic approach that constitutes an optimal solution to assemble multimeric protein complexes directly in the host cells, and thus to obtain a universal vaccine against influenza.¹⁰

Given the importance of this ground-breaking technology, it should come as no surprise that every time an invention related to it is developed obtains patent protection. For instance, Moderna has been patenting every mRNA technology and delivery instrument that is essential for mRNA therapeutics and vaccines.¹¹ However, the patentability of vaccines in general largely depends on their composition, given that these products can have many forms¹² For instance, the vaccine against smallpox, which led to the first mass vaccination in history, was realized through an injection of pus from a milk maid that had been exposed to cowpox, and thus it would not deserve patentability.¹³ However it is pretty clear that nowadays there are vaccines that contain living or non-living matter that have been altered to have a synthetic result suitable for inoculation, such as the recombinant vectors.¹⁴ And following the legal rationale according to which a product of nature can be patented only when it solves a certain technical problem and is implemented in an artificial way,¹⁵ this type of vaccines can be patentable, since they contain modified pathogens or modified DNA. For instance, the flu vaccine, which is deemed to need regular updates every year, requires months of work in state-of-the-art laboratories.¹⁶ The same applies for mRNA vaccines. It is true that they are based on something that it is present in the human body—mRNA—and the viral antigen in this case is produced in the cells of the patient. However, the final product involves, as already underlined, years of experimentation and development to engineer mRNA sequences, and to allow them to function in a way that they are useful for human purposes. This is the reason why it is defined mRNA technology, with this last term indicating something that is in fact artificial. Therefore, under US and European Patent Convention (EPC) law most of the vaccines are clearly patentable. However, the reflection that this paper sets out to make, by adopting a normative approach, is the following: is it fair and reasonable that vaccines are patentable?

Answering this question requires an evident but important premise: innovation nowadays is reputed to be cumulative in its nature,¹⁷ since it is seen as a scientific pyramid, where each scientist adds a block to a certain creation.¹⁸ In this constant R&D, typically the new inventor cannot simply recognize credits to the previous one in form of citation, but the patent system would require each new manufacturer to demand a licence to the former patent holder for their follow-on inventions.¹⁹ In this context, it is possible to identify a specific phenomenon called ‘patent thickets’ that can be explained as ‘a dense web of overlapping intellectual property rights that a company must hack its way through in order to actually commercialize new technology’.²⁰ This phenomenon is mostly present in complex technology industries, meaning a type of technology which includes different components that can be assembled to result in different products (‘modular’), and these products consist of a multitude of these different components (‘complex’).²¹ Given this complexity, as there are overlaps in the functionality of different components, there is an overlap in the patents granted for those components, and if the patents are granted to different firms, the patent thickets arise.²² And these thickets could trigger a ‘vicious cycle’. In fact, in certain industries, it is difficult to identify all the granted patents, to assess the claims in every patent and to avoid the overlaps, and the owners of these technologies have no intentions to arrest the production of innovative products, due to the presence of existing thickets.²³ The consequence is that companies are prompt to filing hundreds of patents each year to avoid patent infringement and to be in a more convenient trade position if and when negotiations take place. The result is more patent thickets.

Biotechnology, which includes vaccine R&D, is one of the industries that mostly involve patent thickets.²⁴ As stated above, although they are based on natural elements, such as mRNA, vaccines require the constant human intervention for every step that leads to their production. And different patents are granted for one specific vaccine to protect this complex technology on different levels.²⁵ A finalized vaccine product is constituted by various components, and each of them may be covered by different patents. In particular, a vaccine can be formed by an antigen, an adjuvant and an excipient, which are respectively covered by more than one patent.²⁶ For instance, when a novel antigen is identified, there can be the patentability of the nucleic acid level, the protein level and the expression technology, which would all receive a distinctive protection than the one towards adjuvants and vehicle technologies.²⁷ Not only the vaccine per se but also its medical application can receive a distinct patent protection,²⁸ with regard to, for instance, a new delivery device, a novel vaccine combination with various substances, a new dosage or a different target group.²⁹ Therefore, probably a single vaccine manufacturer is not the holder of all the patents for that product and the relative medical applications.

With regard to how the problem of patent thickets can be solved in complex technologies, the opinions diverge significantly. According to some authors, such as Jacob, this problem of patent thickets is a direct and natural malfunctioning of the patent system, and thus nothing can really be done to solve it if the patent system itself is not improved somehow.³⁰ In a certain way, it is patent law itself that authorizes the application of patent thickets. Both in the EPC and the US legislation, every single invention can be patentable, as long as it is new,³¹ non-obvious³² and industrially applicable,³³ and the level of contribution of each invention to the composition of a complex technology is not relevant. Other authors, including Gurgula, believe that there has been at least one example in history where the patent thickets issue has been solved through private mechanisms (instead of radical reforms of the patent system): the ‘Sewing Machine War’.³⁴ In the nineteenth century, the sewing machine was considered a complex technology and, as such, was not made by one manufacturer. Many inventors made a lot of experimentation and were granted hundreds of patents for each essential component of that invention.³⁵ This led to the ‘Sewing Machine War’, since it became impossible to manufacture one of these machines without incurring in multiple patent infringements.³⁶ This problem was not overcome by new laws concerning the patent system, but by the patent holders exercising in a more collaborative way the rights of use and disposition attributed through their patents, leading to one of the first patent pools in history identified as ‘Sewing Machine Combination’.³⁷ Gurgula argues that even nowadays there is this need of coordination among patent owners, in the forms of patent pools and cross-licensing.³⁸ However, it is important to take into consideration that the implementation of these mechanisms is left to the will of the patent holders, that most of the time are not so inclined to collaborate with their competitors, especially in the pharmaceutical industry. The phenomenon of patent thickets illustrates only one of the harmful effects of the existence of patents in vaccines. Hence, a solution should be envisaged, and that solution would be the non-subsistence of patents and introduction of a Commons, instead, for the vaccines and other life-saving medicines, as it will be discussed in Sections 6 and 7.

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

This instrument was one of the main controversial aspects for the ratification of TRIPS. As it can be easily imagined, on the one side, developed countries desired stronger protection for patented inventions.⁴³ On the other side, developing countries preferred easier access to patented technologies, and thus a wider application of compulsory licences.⁴⁴ The final compromise can be found in Article 31 entitled ‘Other Use Without Authorization of the Right Holder’ which gives the countries ample discretion in using compulsory licence. However, there are some conditions that must be satisfied to apply this instrument, including, among others: (i) that the authorization of this instrument should be assessed on its specific merits; (ii) that the government and the right holder should attempt to negotiate a voluntary licence on reasonable commercial terms, although in a situation of emergency—such as the current pandemic—this condition can be waived, provided that nevertheless the patent holder is notified as soon as reasonably possible; (iii) that the licence must be ‘predominantly for the supply of the domestic market’; (iv) that the government must grant ‘adequate remuneration’ to the patent owner.⁴⁵ As easily noticed, some of these conditions can prove particularly burdensome when it comes to the application of the licence. Therefore, a second type of compulsory licence, situated in Article 31bis, is considered a waiver of the instrument contained in Article 31. In particular, this second instrument enables countries, which do not have the capacity to produce generic substitutes of patented pharmaceuticals under the domestic compulsory licences, to import the substitutes from countries that have the capacity to manufacture them, without risking the intrusion of the patent holder.⁴⁶ It was the crisis due to the AIDS pandemic in South Africa that led to the adoption of the Doha Declaration on the TRIPS Agreement and Public Health which recognized that ‘WTO Members with insufficient or no manufacturing capacities [of pharmaceuticals] could face difficulties in effective[ly] us[ing] compulsory licensing under the TRIPS Agreement’.⁴⁷ Hence, the amendment to Article 31 was enacted to improve access to essential medicines worldwide.

Notwithstanding the great expectations for the use of compulsory licences to address public health problems that mostly affected developing countries, these instruments proved to be not particularly effective for three main reasons, identified by Harris. First, the special compulsory licence system in Article 31bis is not flexible enough for both the exporting and importing countries.⁴⁸ For instance, when Canada and Rwanda, respectively as the exporting and importing countries, attempted to implement the waiver, Apotex, which was the manufacturer of the generic AIDS medicine destinated to Rwanda, declared that the process was too cumbersome and involved huge costs with few incentives.⁴⁹ And the complications were mostly caused by the long negotiations between Apotex and the patent holders.⁵⁰ It is clear here that, despite the willingness of a country to take certain actions, the rightsholders can still play a relevant role, since they often require consistent incentives for the concession of IP rights. The second reason why compulsory licence in TRIPS is reputed to be ineffective is that, as in the case of the implementation of TRIPS in general, some countries fear retaliation from other countries and their pharmaceutical companies.⁵¹ As an example, when in Thailand the national government decided to issue a compulsory licence under Article 31 to produce antiretroviral drugs, USA and EU censored the country, and the pharmaceutical company Abbott decided not to licence some of its products in Thailand.⁵² States, on the one hand, do not want to antagonize pharmaceutical companies that bring jobs and investment in their territories, and, on the other hand, they prefer to not destabilize political relations with major regions of the world, such as USA and EU.⁵³ Last reason for the inefficiency and scarce application of Articles 31 and 31bis is once again similar to the one related to the inefficiencies of TRIPS in general; namely, the obligations contained in bilateral agreements may limit the application of the compulsory licence mechanisms.⁵⁴ For instance, in the several FTAs stipulated by the USA with least-developed and developing countries,⁵⁵ there are provisions that allow the use of compulsory licences to obtain generic medications only when certain conditions are met. These include the exclusivity of the data generated by the patent holder to the holder themselves, or a prior notification to or a consent by the patent owner to issue the compulsory licence for their invention.⁵⁶

Also by taking into account these difficulties to implement compulsory licence mechanisms, a specific instrument, which has been implemented on the international level in an attempt to ease the access to vaccines during and after the pandemic, is the TRIPS waiver on Covid-19 vaccines. The approval of this waiver has had a very troublesome process. Originally, the proposal by India and South Africa to internationally waive obligations of TRIPS, namely all the IP rights, to make Covid technologies—especially vaccines—publicly available for all the world did not receive a positive respond and was blocked in October 2020. When the two proposing countries renewed this request of a general waiver of patent rights in March 2021, this time supported by over 80 developing countries, developed countries, such as USA, EU, Japan, Canada and Switzerland continued to block it, asserting that the existing compulsory licences mechanisms provided in TRIPS are suitable to guarantee enough supply of vaccines and treatments around the world. Only later on, in May 2021, the USA changed its policy, when it announced support to the proposed temporary waiver of IP rights on Covid-19 technologies.⁵⁷ The final compromise can now be found in the 12th Ministerial Conference Decision [WT/L/1141; WT/MIN(22)/30] adopted on 17 June 2022.⁵⁸ The significant issue is that this waiver applies only in relation to ‘the use of the subject matter of a patent required for the production and supply of Covid-19 vaccines […] to the extent necessary to address the Covid-19 pandemic’.⁵⁹ Despite a commitment to decide on the extension of the waiver to any Covid-19 diagnostics and therapeutics,⁶⁰ the deadline for such decision—originally scheduled for 17 December 2022—has been extended indefinitely.⁶¹ And no decision has been made so far.⁶² One the one side, some developing countries rightly push for such extension, by arguing that the current waiver is not enough to allow the access to life-saving medicines against Covid-19 and to face future pandemics and health challenges.⁶³ On the other side, WTO members that are developed countries, advocated for caution on the extension to therapeutics and diagnostics, by also underlining the lack of evidence on the correlation between strong IP rights and weak access to Covid-19 technologies.⁶⁴ It is difficult to say how this situation will be solved. However, a simple waiver—even with an extension to any Covid-19 technology—might not be enough. Instead of suspending rights, it is important to introduce international measures that, one side, provide technology and knowledge transfer, and, on the other side, they guarantee enforcement of such transfer.⁶⁵ The inclusive right that is proposed in this paper goes into that direction by taking always into high consideration that open access should not only be advocated but also be implemented.

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/Pfizer that own the relative patents, as observed in Section 2, the NIH publicly funded 174 publications 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

Despite the total lack of international instruments to address the issue of fair recognition of each contribution to a specific invention, there is one legislative example—it will be seen whether it is effective or not—thanks to which the public efforts in developing and manufacturing pharmaceuticals can be recognized in the USA: the Bayh–Dole Act, approved by the Congress in 1980 to facilitate the US technological innovation.⁷¹ This legislation allows the government to apply so-called ‘march-in’ rights, which give the possibility of granting a licence to a company to develop an invention protected by patents but financed through public funding, even against the will of the patent holder.⁷² More specifically, at first, the government can require the contractor or successors in title to grant a ‘nonexclusive, partially exclusive, or exclusive license’.⁷³ If the patent owner refuses to grant it, the government will grant the licence itself.⁷⁴ However, strict criteria must be complied with if the government wants to implement this ‘march-in’ mechanism. These rights can only cover inventions that are ‘conceived or first actually reduced to practice in the performance of work under a funding agreement’.⁷⁵ This is a first noticeable obstacle, since the government often provides only indirect contributions to the specific technology and the related drug development, by for instance identifying bio-makers or analysing certain diseases.⁷⁶ In addition, there are four circumstances under which these march-in rights can be exercised; the most relevant of which states that the action must be taken when there is a necessity ‘to alleviate health or safety needs’.⁷⁷ This provision seems to be quite broad and unclear, and some authors, such as Kapczynski, have observed that it does not solve the problem of excessive pricing,⁷⁸ a problem that instead is likely to occur especially in the start of a pandemic where the demand for medical help is quite high, and the offer is not that consistent. Therefore, it is no surprise that these march-in rights have never been properly applied in the 40 year plus history of the Bayh–Dole Act, and the main reason of the various denials was exactly that the drug pricing was not so excessive as to trigger the march-in mechanism, in the sense that this was not considered a prerogative to accomplish health or safety needs.⁷⁹

Considering the ineffectiveness of this legislative act, the question now is whether there is a more effective way to recognize the government contribution to the development of vaccines and treatments against Covid-19. If a system of fair pricing is to be implemented, some authors believe that one of the most important factors in defining such fair price is the accounting of the public funding, in the sense that, once the government reduces R&D cost and risk, its investment is directly part of the input in the development of the drug, and the price should represent such input.⁸⁰ Once again in the USA, an enacted law allows the government to override a patent and purchase the invention covered by that patent at a competitive price.⁸¹ Patent holders should be entitled to a reasonable compensation by taking into account a variety of aspects, including any licence terms and R&D investments made by the patent holder.⁸² In the pharmaceutical context, this provision has been used in 2001, when, during the anthrax scare after the 9/11 terroristic attack, a proposal was made to import generic versions of the antibiotic ciprofloxacin, and this led the patent holder in that situation, the company Bayer, to cut its price.⁸³ Therefore, through this provision the government can have a consistent leverage for the reduction of a drug price, either through voluntary agreement with the patent holder or generic procurement.⁸⁴ Although this legal instrument seems to have a better effect in terms of recognizing the public funding contribution than the Bayh–Dole Act, there are some aspects which remain quite debatable. It is true that the process is straightforward, and patent holders cannot prevent the federal procurement agents to accept bids to contracts and to not consider the status of the patent. However, it should not be forgotten that the rightsholders are still entitled to sue for compensation before, at the first instance, the Court of Federal Claims,⁸⁵ and this would definitely pose a first obstacle to the process.⁸⁶ Lastly, from a more political point of view, it is highly difficult to imagine that the US government would implement this mechanism by going systematically against the interests of the patent holders. Hence, this provision has not been recently applied in the pharmaceutical context. Perhaps a more radical intervention would be needed, and an inclusive right for vaccine and other life-saving treatments could represent that radical solution.

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 Immunodeficiency 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.

Unfortunately, the activism from the international community, that should ensure, if not the total accomplishment, at least a contribution in reaching a GHS for the vaccines, proved to be not particularly sensitive in this regard. The reference is not only to the limited IP waiver and its complicated history analysed in Section 3 but also to another international instrument through which, if implemented properly, developing nations would have obtained access to vaccines. The reference is to the facility called COVAX at the WHO, funded in a (failed) attempt of showing multilateral solidarity. COVAX was committed to ensure a vaccine contingent of 20 per cent cover of each country’s population, which is a threshold extremely lower than the one (around 60 per cent) required to reach herd immunity and protect the entire world from the virus.⁹⁶ Moreover, similar to what was discussed in Section 3 with regard to the TRIPS compulsory licensing, bilateral agreements and Memorandum of Understanding, between developed countries, LMICs and vaccine manufacturers, allowed the latter to overcome the legal guarantees and requirements of COVAX, also considering that the facility was consistently underfunded.⁹⁷ Considering all these aspects, it can be noticed how this pandemic showed the controversial links between global health, GHS and global inequities, and how such inequities must be reduced in order to achieve this GHS that is more human and equity-oriented.⁹⁸

There are different interventions that can be done to pursue this perspective of GHS. The first one could be prioritizing Covid-19 in health programming.⁹⁹ The prevention and vaccine programs against the virus require the implementation of efficient and strong universal systems, in terms of primary health care-oriented services.¹⁰⁰ Interestingly, practical hints to create such a system can be taken from LMICs that implemented efficient public health strategies, such as integrated programming, contact tracing, and door to door health care, for instance during the epidemic response to Ebola in West Africa.¹⁰¹ Second, there is the need of implementing human rights instruments,¹⁰² especially the International Covenant on Economic, Social and Cultural Rights¹⁰³ and International Covenant on Civil and Political Rights.¹⁰⁴ These international treaties can in fact enforce important rights and state obligations related to the access of life-saving drugs.¹⁰⁵ For instance, other than adopting only a ‘negative’ IP waiver and/or IP exception, it would be important that countries ‘positively’ comply with their international obligations of promoting the right to health and the extension of financial and technical resources to LMICs.¹⁰⁶ Third intervention that can be made to pursue GHS is the adoption of an equity focus in the International Health Regulations (IHR) of the WHO.¹⁰⁷ This legal instrument would require each country to prepare and adhere to pandemic guidelines. However, its core requirements have never received a consistent implementation in most countries, especially LMICs.¹⁰⁸ Therefore, the implementation of the IHR framework, that can allocate global and local accountability, would be central to deal with the inequities of the world. Lastly, there is probably the most relevant intervention for this paper and its argument, which is technology and knowledge transfer.¹⁰⁹ In particular, there is the need to address vaccines and other life-saving treatments as shareable and accessible Commons, through the implementation of an inclusive right which, as mentioned above, would not only guarantee the open access but also enforce it. This is the focus of the following sections.

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 justified IP in the first 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 inefficiency 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 definition 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.

The first Commons is the public domain, that covers those intellectual resources that are not protected, or no longer protected by IP, and in this way, they lack any exclusivity,¹²³ resulting in Commons at the highest grade. In particular, in patents—IP of interest for this paper—public domain results in abstract ideas, discoveries and other excluded subject matter,¹²⁴ inventions that do not satisfy the patentability requirements and inventions that are no longer under patent protection and unregistered inventions. Another way to conceive Commons in the IP context is when there is not a total non-property, as in the case of public domain, but when non-property—whose main aspect is inclusivity—coexists with spaces of property—characterized by exclusivity.¹²⁵ This relates to exceptions and limitations in patents, where, for instance, in the case of private use of the invention there is a general entitlement of inclusivity (as long as the invention is implemented in private), or based on the research exception, there is a Commons reserved to some specific categories of people (researchers). The last form of inclusivity in the IP context is the most recent one and defined as the open innovation movement.¹²⁶ The first type of open innovation was the open software, which is based on ‘the freedom to run and use a program and to copy, modify, improve and redistribute it’.¹²⁷ Open software adopts, as one of its main ‘commandments’, the free redistribution of the source code to everyone.¹²⁸ This open-source concept found acknowledgement not only in the copyright field with, among others, the notorious Creative Commons¹²⁹ but also in the patent context. For instance, the Biological Open Source (BiOS) Licence, developed by the Centre for Applications of Molecular Biology in International Agriculture (CAMBIA), establishes a worldwide, non-exclusive and royalty free right to develop and apply the technology of two patents owned by the centre.¹³⁰ Another example of open innovation in the patent field, that proved to be useful during the Covid-19 pandemic, relates to IP pledges that, although they assume various forms and labels, have as their main goal to make IP (and the knowledge within it) freely available to the public in the form of technological transfer.¹³¹ In particular, IP owners started to gather in organizations and make available their IP rights to users all around the world, without the latter being at risk of committing a patent infringement. These pledges are usually royalty-free, and in some cases—such as the Open Covid Pledge—self-executing, meaning that anyone who is interested can immediately use the IP without additional negotiation or formalities.¹³² Moreover, when there is the risk that the users may charge excessive price for the products that result from the IP freely available to anyone, some pledges—such as the Harvard–Mit–Stanford Pledge—require users to demand ‘fair’ or no more than ‘cost-plus’ prices.¹³³

All these open innovation instruments, from open software to patent pledges, can be considered Commons, in the sense that they are inclusive in sharing and using a specific resource.¹³⁴ However, this category of Commons is different than the ones of public domain and exceptions/limitations. Within the open innovation instruments there can still be some exclusive rights that are, instead, completely absent in the public domain. Taking the IP pledges as the most prominent example, their main subject—knowledge—has been often covered by patents at the outset. Therefore, the inclusivity generated by this particular Commons derives from the exclusivity that the patent owner obtained through patentability. This is not a contradiction, since exclusivity, on which IP is based, is something different than exclusion.¹³⁵ Exclusivity in a certain invention does not entail exclusion of others from using that invention. As a consequence, open innovation instruments are ultimately contracts where the patent owner decides willingly to create inclusive entitlements that are beneficial to the users of that invention.¹³⁶ Some authors, such as Elkin-Koren, are quite critical of the recourse to such instruments, since this would entail to make IP reliable on private-ordering norms—contracts—potentially resulting in the impairment of the balance of different IP regimes.¹³⁷ The specific concern is that market players that own substantial IP would make their assets available to the users under very restrictive terms, probably more restrictive than normal licences, under the false assumption of open innovation.¹³⁸ Although this risk is definitely tangible, it can be argued that most open innovation instruments aim to make any margin of exclusivity impossible, by having a proper ‘self-binding Commons’¹³⁹ that would not allow IP owners to change terms of the contracts in a more restrictive way whenever they wish to. The legal mechanism that would apply in this context is the so-called ‘copyleft’, also defined in the patent context as grant-back, through which if someone wants to improve or modify a specific work or invention, she is required to distribute such modified work or invention under conditions of inclusivity. Hence, any modified work or invention would be included under an open innovation scheme, resulting in a total correspondence between the contract and the IP resource.¹⁴⁰

After assessing each Commons, it is important to highlight their specific advantages and disadvantages. The Commons which is the furthest away from exclusivity would be the public domain, that, on the one hand, allows anyone to use a specific creation unconditionally, but on the other hand, this unlimited use is almost impossible to enforce, since no one that is part of the public could claim and protect her privilege through a legal remedy.¹⁴¹ This lack of enforceability is one of the main reasons why Hardin argues for a ‘Tragedy of the Commons’, according to whom when things are left to the use of the public, they are destined to be overused or underused.¹⁴² A similar issue of enforceability can be found in the context of copyright and patent exceptions. Although in this case the inclusive privilege enjoyed by users for the exception is enforceable, this is possible only as a form of defence when a copyright or patent infringement case occur.¹⁴³ Lastly, open innovation instruments, which originate from exclusive rights, create enforceable contractual rights against the licensor or the IP owner, but only on the condition that the freedoms granted by these Commons are perpetuated through the copyleft or grant-back mechanism.¹⁴⁴ Therefore, the will of the IP owner is still one of the main factors that influence the impact and importance of an open innovation instrument.

The concept of ‘negative spaces’ can be forwarded into the realm of patentability, considering that one of the most active open communities is precisely the one of software developers, whose technology could also in theory be protected through patents in case of computer programs inventions.¹⁴⁵ However, these ‘negative’ spaces, in which Commons ‘reside’ as the only available goods, require a ‘positive’ feature, in the sense that they do not only have to claim unenforceable IP (‘negative’), but they have to find an alternative in order for this inclusiveness to be enforced in some other ways (‘positive’). Therefore, it is time to address the theoretical possibility to include the Covid-19 vaccine and other life-saving treatments within these ‘negative spaces’, on the condition that this Commons could be enforceable through a sui generis inclusive right.

7. The Covid-19 vaccine as commons: the sui generis inclusive right

Across the world there have been important campaigns related to the issue of vaccine access and allocation, such as the Free The Vaccine initiative which demands that ‘Covid-19 diagnostic tools, treatments and vaccines must be available to everyone everywhere’,¹⁴⁶ or academics, including Boschiero, who stated the nature of vaccines as ‘global common/public goods’, despite being currently regulated as ‘private market goods’.¹⁴⁷ The question to be answered now is how this desirable shift to a Commons Regime can be realized from a normative perspective.

The vaccine and other life-saving treatments against Covid-19 should be considered as Commons, since they are compatible with the two important and general features that every Commons should have: the property has to be capable of being monopolized by private owners; the claim of the public should be stronger than the one of private people or entities, in the sense that a certain good would be more efficient and valuable if used by an indefinite and unlimited number of people.¹⁴⁸ Specifically, it has been already discussed that a vaccine is capable of being monopolized by pharmaceutical companies. This is possible from a legal perspective because, although the starting point can be something natural such as mRNA, ultimately in order to develop and produce a vaccine there is the implementation of a complex technology which is made by humans, and thus vaccines can be granted different patents. Moreover, as the second requirement to be ‘commonized’, the vaccine and other life-saving treatments would be more beneficial if accessed and used by the public at large for several reasons that have been discussed throughout this paper. First, only if the vaccine is administered in every corner of the world, there is the chance to end a global pandemic, by reaching a herd immunity and avoiding that some new strains imperil the efficacy of the vaccine itself in the future. As affirmed in an impactful way by Meijer et al, ‘In a pandemic, nobody is safe until everyone is safe’.¹⁴⁹ Second, an equitable access and allocation of vaccines and other life-saving treatments towards the public at large would contribute to institute a GHS that is human and equity-oriented and not just focused on the nationals’ safety. The establishment of such a system would also allow to face future pandemics or serious global issues, such as climate change, in a more efficient and responsible way. Third, it would simply be fair to recognize the efforts that the public itself put in developing and producing these vaccines, since most of R&D in this pandemic—but also beyond—received public funding, and ultimately the contribution of taxpayers. Fourth, the vaccine as a public good perhaps would constitute a symbol against the nationalisms and xenophobia that have been spreading around the world also in this context, since some wealthy countries that have large supplies of vaccines refused to vaccinate migrants and asylum seekers, by prioritizing their nationals.¹⁵⁰ This could lead to the implementation of a GHS which is human and equity-oriented. And it might constitute finally a realization among the developed countries in the West that, although many viral diseases have been eradicated in that part of the world, in least-developed and developing countries there are ongoing health and access issues that need to be tackled and not ignored.

Having clarified 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.

There is one last option to consider. It is now sufficiently clear that, at least in the IP field, there is no grand unified 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:

It shall never exclude another person enjoying the same inclusive right.
It shall preserve the resource and its collective use.
It must be enforced in order to defeat any claim of exclusivity that could hamper the common use.
Any court judgment that recognizes the inclusive right against some claim of exclusivity shall automatically benefit all individuals enjoying a similar inclusive right in the work or invention.
Any legal regime of inclusive rights would be assessed and implemented according to the particular situation concerned.¹⁵⁷

Now, these features would be perfectly compatible if the Commons were the vaccine and other life-saving treatments against Covid-19. The inclusive right for this Commons would have as its normative object the distribution, management and administration of the vaccine and other life-saving treatments against Covid-19. In particular, this inclusive right would never be exercised in a way that can potentially exclude others that enjoy the same right. In contrast, it should be exercised in a way that preserve the Commons—identified as the vaccine and other life-saving treatments—and their collective use. Moreover, this right can be enforced in order to defeat any exclusivity that hampers the common use of the resources, not only when a court dispute arises, but in a comprehensive way. And, in relation to court judgments, these should serve not only as an example of enforcement of such Commons, but, most importantly, these decisions should automatically benefit all individuals enjoying a similar right in those resources, even if those individuals are not directly involved in the case at issue. Lastly, this inclusive right should be implemented according to the particular situation concerned. Instead of necessarily ex ante assigning a category of Commons, this feature confers certain elasticity to the type of Commons that is needed in a specific circumstance. For instance, at the beginning of an emergency situation such as a pandemic, the hypothetical scenario could see having technology and knowledge transfer of vaccines in the form of IP pledges and thus a less intrusive Commons. And later on, governments could decide to enact legislation that would attribute the status of excluded subject matter (public domain) or non-exclusivity of commercialization or production of the vaccine (exception to patentability). However, it is important to clarify that, whether the vaccine is recognized as a public domain, as an exception/limitation, or as an open innovation instrument, the theoretical and normative features of the inclusive right should never be derogated, by finding application in any circumstance. The resource should be regarded as any type of Commons, while the inclusive right would constitute a way to properly enforce that resource.

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, briefly mentioned in Section 6, could be the synthetic biology field 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.

8. Conclusion

This paper has assessed the delicate equilibrium which exists between IP—as an expression of exclusivity—and the Commons—whose main feature is inclusivity—in the context of a pandemic, by adopting a normative approach and introducing the sui generis inclusive right in relation to the vaccine and other life-saving treatments against Covid-19.

First, through a focus on the vaccine and its most recent and innovative mRNA technology, it has been explained that vaccines can be patented from a legal perspective. However, the patentability leads to questionable practices in the pharmaceutical industry, such as patent thickets, which in turn result in damage not only for the patent holders themselves but also for the public at large. Moving to the relevant international level for the regulation of patents and vaccines in the pandemic, it has been noted that the instruments of compulsory licence contained in TRIPS and the vaccine waiver adopted in June 2022 showed a consistent number of flaws in their implementation.

On these bases, this work has pointed out an alternative solution, at least in relation to the Covid-19 vaccine and other life-saving treatments, which is the theorization of a Commons for such invention. The first reason why this direction should be followed is that, since the public funding for the development of the vaccine and any other treatments against the virus was consistent, and there are not proper legal instruments that would recognize such public effort in the context of the privatized pharmaceutical industry, it could be fair to attribute to the public at large the ownership of such resource. Second, there is the need, now more than ever, to pursue a GHS that is human and equity-oriented, considering that this pandemic exacerbated inequalities around the world, with only the richer and developed countries with enough quantities of vaccine for their populations. Patenting of vaccines always has, and always will, have detrimental effects because of the nature of what the invention is trying to do—prevent virality by giving exclusivity. Therefore, this vaccine and other life-saving treatments would satisfy the two requirements that every Commons should have to be defined as such: being potentially owned in a private way; being managed more efficiently by the public at large.

The paper has addressed which exact form of IP Commons this vaccine should have: the public domain, exceptions/limitations to patents or open innovation instruments such as IP pledges. All these three types of Commons present some issues, especially in relation to the aspect of enforceability. By forwarding the concept of ‘negative spaces’ to the patent realm, it should be recognized how these spaces do not only claim to not enforce IP but should be able to respect and ‘enforce that non-enforcement’. This paper, building on the work of Dusollier, has advanced the idea that from the inclusivity, which is the typical feature of every Commons, a sui generis inclusive right can be envisaged and applied in the context of a specific resource that is to be ‘commonized’, by rethinking the relationship between IP and Commons. Although this remains—for now—a theoretical speculation without proper legal grounds, it can represent a good normative starting point to implement legislation in this direction.

It should be remembered that law needs to change according to the new necessities of the society, by offering, as every other science, its contribution to solve problems, especially when they have global implications. This must be done through the involvement of legal researchers, legislators, judges and all the other actors that can offer legal solutions to complex issues, by not only applying the current juridical categories and concepts but also by modifying them based on the concrete situation at issue. Will law succeed in this objective? Time and research will tell.

Acknowledgements

The author would like to thank Amy Thomas for providing precious comments and feedback on the first draft and Roberto Caso for supervising the dissertation that this article is based on.

Footnotes

Brian Palmer, ‘Jonas Salk: Good at Virology, Bad at Economics’ (2014) Slate. Available at https://slate.com/technology/2014/04/the-real-reasons-jonas-salk-didnt-patent-the-polio-vaccine.html (accessed 8 December 2023).

TRIPS, Arts 31–31bis.

World Trade Organization, ‘TRIPS Council Welcomes MC12 TRIPS Waiver Decision, Discusses Possible Extension’. Available at https://www.wto.org/english/news_e/news22_e/trip_08jul22_e.htm (accessed 8 December 2023).

Norbert Pardi et al, ‘Recent Advances in mRNA Vaccine Technology’ (2020) 65 Current Opinion in Immunology 14, 14.

ibid.

A vaccine against Covid-19, manufactured through a recombinant vector, is the vaccine developed by Vaxzevria (former Astrazeneca).

Wim Jiskoot et al, ‘Vaccines’ in Daan JA Crommelin, Robert D Sindelar and Bernd Meibohm (eds) Pharmaceutical Biotechnology: Fundamentals and Applications (Springer International Publishing 2019, Cham, CH) 294.

Emily H Pilkington et al, ‘From Influenza to COVID-19: Lipid Nanoparticle mRNA Vaccines at the Frontiers of Infectious Diseases’ (2021) 131 Acta Biomaterialia 16, 17.

ibid.

Moderna, ‘Moderna’s Patents and Pending Patent Applications’. Available at https://www.modernatx.com/en-US/patents? (accessed 8 December 2023).

Elizabeth Siew-Kuan Ng, ‘Intellectual Property in Vaccine Innovation: Impact of Recent Patent Developments’ in Sunil Thomas (ed) Vaccine Design: Methods and Protocols, Volume 2: Vaccines for Veterinary Diseases (Springer 2016, New York, US) 843.

Palmer (n 1).

See Association for Molecular Pathology v Myriad Genetics [2013] 12 US 398; see also EPC, arts 52(2)(3) and 53.

ibid.

Palmer (n 1).

Olga Gurgula, ‘Strategic Accumulation of Patents in the Pharmaceutical Industry and Patent Thickets in Complex Technologies – Two Different Concepts Sharing Similar Features’ (2017) 48 IIC—International Review of Intellectual Property and Competition Law 385, 387.

Carl Shapiro, ‘Navigating the Patent Thicket: Cross Licenses, Patent Pools, and Standard Setting’ (2000) 1 Innovation Policy and the Economy 119, 120.

ibid.

BH Hall and C Helmers, ‘A Study of Patent Thickets’ (UK Intellectual Property Office 2013) 7.

ibid.

Federal Trade Commission, ‘To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy’ (2003). Available at https://www.ftc.gov/reports/promote-innovation-proper-balance-competition-patent-law-policy (accessed 8 December 2023).

ibid 32: other complex technologies that could be affected by patent thickets are semiconductors, computer software, the Internet and nanotechnology.

Maria MM Mertes and Gerd Stötter, ‘Managing the Patent Thicket and Maximizing Patent Lifetime in Vaccine Technology’ (2010) 6 Human Vaccines 860, 860.

ibid.

European Patent Office, ‘7.1 First or Further Medical Use of Known Products’. Available at https://www.epo.org/en/legal/guidelines-epc/2023/g_vi_7_1.html (accessed 11 December 2023). ‘Where a substance or composition is already known to have been used in a “first medical use”, it may still be patentable under Art. 54(5) for any second or further use in a method according to Art. 53(c), provided that said use is novel and inventive’. In the USA, there is not even an exclusion of patentability of methods for medical treatment, as it is instead provided in EPC, art 53(c). Therefore, the USA is more permissible than the EPC.

Mertes and Stötter (n 25) 860.

Robin Jacob, ‘Patent Thickets: A Paper for the European Patent Office Economic and Scientific Advisory Board Meeting’ (2013) 8 Journal of Intellectual Property Law & Practice 203.

EPC, art 54; 35 USC s 102.

ibid art 56; 35 USC s 103.

ibid art 57; 35 USC s 103.

Gurgula (n 17) 392.

Adam Mossoff, ‘The Rise and Fall of the First American Patent Thicket: The Sewing Machine War of the 1850s’ (2011) 53 Arizona Law Review 194. Available at https://arizonalawreview.org/mossoff/ (accessed 11 December 2023).

ibid.

Gurgula (n 17) 392.

Graeme B Dinwoodie and Rochelle Cooper Dreyfuss, ‘Designing a Global Intellectual Property System Responsive to Change: The WTO, WIPO and Beyond’ (9 November 2009) 1188. Available at https://papers.ssrn.com/abstract=1502262 (accessed 11 December 2023).

Donald Harris, ‘TRIPS After Fifteen Years: Success or Failure, as Measured by Compulsory Licensing’ (2016) 18 Journal of Intellectual Property Law 367, 371.

TRIPS, arts 31 and 31bis.

Harris (n 40) 383.

Daniel J Gervais, The TRIPS Agreement: Drafting History and Analysis (Sweet & Maxwell 2008, London, UK) 15.

ibid 16.

TRIPS, art 31.

ibid art 31bis.

World Trade Organization, ‘WT/MIN(01)/DEC/1’. Available at https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S009-DP.aspx?CatalogueIdList=37246&CurrentCatalogueIdIndex=0 (accessed 11 December 2023).

Harris (n 40) 390–91.

BioSpace, ‘Apotex Inc. Life Saving AIDS Drug for Africa Gets Final Clearance’. Available at https://www.biospace.com/article/apotex-inc-life-saving-aids-drug-for-africa-gets-final-clearance-/ (accessed 11 December 2023).

ibid.

Harris (n 40) 392.

Keith Alcorn, ‘Abbott to Withhold New Drugs from Thailand in Retaliation for Kaletra Compulsory License’ (aidsmap.com, 15 March 2007). Available at https://www.aidsmap.com/news/mar-2007/abbott-withhold-new-drugs-thailand-retaliation-kaletra-compulsory-license (accessed 11 December 2023).

Harris (n 40) 392–93.

ibid 393.

United States Trade Representative, ‘Bilateral and Regional Trade Agreements’. Available at https://ustr.gov/issue-areas/labor/bilateral-and-regional-trade-agreements (accessed 11 December 2023).

Chuan-feng Wu, ‘Raising the Right to Health Concerns within the Framework of International Intellectual Property Law’ (2010) 5 Asian Journal of WTO & International Health Law and Policy 141, 154–55.

Banri Ito, ‘Impacts of the Vaccine Intellectual Property Rights Waiver on Global Supply’ (CEPR, 8 August 2021). Available at https://cepr.org/voxeu/columns/impacts-vaccine-intellectual-property-rights-waiver-global-supply (accessed 12 December 2023).

‘TRIPS Council Welcomes MC12 TRIPS Waiver Decision, Discusses Possible Extension’ (n 3).

World Trade Organization, ‘WT/L/1141; WT/MIN(22)/30’. Available at https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S009-DP.aspx?CatalogueIdList=285740&CurrentCatalogueIdIndex=0 (accessed 12 December 2023).

ibid.

Amalie Holmgaard Mersh, ‘Deadline for COVID-19 Diagnostics, Therapeutics Waiver to Be Extended’ (www.euractiv.com, 21 December 2022). Available at https://www.euractiv.com/section/health-consumers/news/deadline-for-covid-19-diagnostics-therapeutics-waiver-to-be-extended/ (accessed 12 December 2023).

Amalie Holmgaard Mersh, ‘No Decision in Sight on Whether to Extend COVID-19 Vaccine Waiver’ (www.euractiv.com, 2 November 2023). Available at https://www.euractiv.com/section/health-consumers/news/no-decision-in-sight-on-whether-to-extend-covid-19-vaccine-waiver/ (accessed 12 December 2023).

‘TRIPS Council Welcomes MC12 TRIPS Waiver Decision, Discusses Possible Extension’ (n 3).

ibid.

See Rob J Aerts, ‘COVID-19 Vaccines, Patents and an IP Waiver’ (2022) 17 Journal of Intellectual Property Law & Practice 940.

Amy Kapczynski, ‘Realizing Public Rights Through Government Patent Use’ (2021) 49 Journal of Law, Medicine & Ethics 34, 34.

Policy Cures Research, ‘COVID-19 R&D Tracker’. Available at https://www.policycuresresearch.org/covid-19-r-d-tracker/ (accessed 12 December 2023).

ibid.

Danielle Li et al., ‘The Applied Value of Public Investments in Biomedical Research’ (2017) 356 Science 78, 78.

Anthony E Kiszewski et al., ‘NIH Funding for Vaccine Readiness before the COVID-19 Pandemic’ (2021) 39 Vaccine 2458, 2460, Table 1.

35 USC Chapter 18—PATENT RIGHTS IN INVENTIONS MADE WITH FEDERAL ASSISTANCE.

John R Thomas, ‘March-In Rights Under the Bayh-Dole Act’ 7.

35 USC s 203(a).

ibid.

ibid 201(e).

Kapczynski (n 66) 35.

35 USC s 203(a).

Kapczynski (n 66) 35.

Thomas (n 72) 8–9.

Kapczynski (n 66) 36.

28 USC s 1498—Patent and copyright cases.

ibid.

Hannah Brennan et al., ‘A Prescription for Excessive Drug Pricing: Leveraging Government Patent Use for Health’ (2016) 18 Yale Journal of Law & Technology 275, 303.

ibid.

28 USC s 1498.

Kapczynski (n 66) 36.

Annamarie B Šehović, ‘Towards a New Definition of Health Security: A Three-Part Rationale for the Twenty-First Century’ (2020) 15 Global Public Health 1, 1.

Annamarie Bindenagel Šehović and Kaymarlin Govender, ‘Addressing COVID-19 Vulnerabilities: How Do We Achieve Global Health Security in an Inequitable World’ (2021) 16 Global Public Health 1198, 1998.

World Health Organization, ‘Coronavirus Disease (COVID-19): Herd Immunity, Lockdowns and COVID-19’. Available at https://www.who.int/news-room/questions-and-answers/item/herd-immunity-lockdowns-and-covid-19 (accessed 13 December 2023).

World Health Organization, ‘WHO: Access to HIV Medicines Severely Impacted by COVID-19 as AIDS Response Stalls’. Available at https://www.who.int/news/item/06-07-2020-who-access-to-hiv-medicines-severely-impacted-by-covid-19-as-aids-response-stalls (accessed 13 December 2023).

Taylor Riley et al, ‘Estimates of the Potential Impact of the COVID-19 Pandemic on Sexual and Reproductive Health In Low- and Middle-Income Countries’ (2020) 46 International Perspectives on Sexual and Reproductive Health 73, 75.

See Richard A Aborisade, ‘Accounts of Unlawful Use of Force and Misconduct of the Nigerian Police in the Enforcement of COVID-19 Measures’ (2021) 36 Journal of Police and Criminal Psychology 450.

Šehović and Govender (n 88) 1201; David G Legge and Sun Kim, ‘Equitable Access to COVID-19 Vaccines: Cooperation around Research and Production Capacity Is Critical’ (2021) 4 Journal for Peace and Nuclear Disarmament 73, 79–81.

Šehović and Govender (n 88) 1201; Legge and Kim (n 93) 79–81.

Peter Mwai, ‘Covid-19 Vaccinations: African Nations Miss WHO Target’ BBC News (31 December 2021). Available at https://www.bbc.com/news/56100076 (accessed 13 December 2023): ‘Just seven countries on the [African] continent have reached the 40% target’.

Andrew Green, ‘At WTO, a Battle for Access to COVID-19 Vaccines’ (Devex, 15 December 2020). Available at https://www.devex.com/news/sponsored/at-wto-a-battle-for-access-to-covid-19-vaccines-98787 (accessed 13 December 2023).

Šehović and Govender (n 88) 1202; Legge and Kim (n 93) 79–81.

Šehović and Govender (n 88) 1202.

ibid 1204.

100

ibid.

101

ibid.

102

ibid 1203.

103

ICESCR 1966.

104

ICCPR 1966.

105

See ICESCR art 12 that establishes the right of everyone to the highest attainable standard of physical and mental health.

106

Jackie Dugard et al, ‘Mobilising Human Rights to Address Coronavirus Vaccine Apartheid’ (Opinio Juris, 18 February 2021). Available at https://opiniojuris.org/2021/02/18/mobilising-human-rights-to-address-coronavirus-vaccine-apartheid/ (accessed 13 December 2023).

107

Šehović and Govender (n 88) 1203.

108

See Giulio Bartolini, ‘The Failure of “Core Capacities” Under the Who International Health Regulations’ (2021) 70 International & Comparative Law Quarterly 233.

109

ibid.

110

See eg in the field of biotechnology (specifically synthetic biology): Andrew W Torrance, ‘Better to Give Than to Receive: An Uncommon Commons in Synthetic Biology’ in Brett M Frischmann, Katherine J Strandburg and Michael J Madison (eds) Governing Medical Knowledge Commons (CUP 2017, Cambridge, UK) 192–221.

111

Reto Hilty et al, ‘Intellectual Property Justification for Artificial Intelligence’ (11 February 2020) 6. Available at https://papers.ssrn.com/abstract=3539406 (accessed 29 June 2023).

112

Kate Darling and Aaron Perzanowski, Creativity Without Law: Challenging the Assumptions of Intellectual Property (New York University Press 2017, New York, US) 1–2.

113

Richard Watt, Copyright and Economic Theory: Friends Or Foes? (E Elgar 2000, Cheltenham, UK) 4–5.

114

Darling and Perzanowski (n 112) 2.

115

Garrett Hardin, ‘The Tragedy of the Commons’ (1968) 162 Science 1243.

116

Darling and Perzanowski (n 112) 2.

117

ibid 2–3.

118

Séverine Dusollier, ‘The Commons as a Reverse Intellectual Property – from Exclusivity to Inclusivity’ in Helena Howe (ed) Concepts of Property in Intellectual Property Law (CUP 2013, Cambridge, UK) 258.

119

ibid.

120

ibid.

121

Niva Elkin-Koren, ‘What Contracts Cannot Do: The Limits of Private Ordering in Facilitating a Creative Commons’ (2005) 74 Fordham Law Review 398.

122

Dusollier (n 118) 266.

123

ibid 267.

124

See EPC, art 52(2); although in the USA a proper list of non-patentable subject matter is not provided, see 35 USC para 101.

125

Dusollier (n 118) 268.

126

Karen Walsh et al, ‘Intellectual Property Rights and Access in Crisis’ (2021) 52 IIC—International Review of Intellectual Property and Competition Law 379, 386.

127

Dusollier (n 118) 269.

128

Open Source Initiative, ‘The Open Source Definition’ (7 July 2006). Available at https://opensource.org/osd/ (accessed 14 December 2023).

129

Creative Commons, ‘Homepage’. Available at https://creativecommons.org/ (accessed 14 December 2023).

130

Cambia, ‘The CAMBIA BIOS Initiative’. Available at https://cambia.org/bios-landing/the-cambia-bios-initiative/ (accessed 14 December 2023).

131

Jorge L Contreras and others, ‘Pledging Intellectual Property for COVID-19’ (2020) 38 Nature Biotechnology 1146, 1.

132

ibid.

133

ibid 2;

134

Dusollier (n 118) 270.

135

ibid.

136

ibid.

137

Elkin-Koren (n 121) 398.

138

ibid.

139

Amy Kapczynski et al, ‘Addressing Global Health Inequities: An Open Licensing Approach for University Innovations’ (2005) 20 Berkeley Technology Law Journal 1031, 1072.

140

Séverine Dusollier, ‘Sharing Access to Intellectual Property Through Private Ordering’ (2007) 82 Chicago—Kent Law Review 1391, 1414–19.

141

Dusollier (n 118) 277.

142

Hardin (n 115).

143

Dusollier (n 118) 277.

144

ibid.

145

See for more details, eg in the UK and EPC, respectively: Aerotel Ltd v Telco Holdings Ltd & Ors Rev 1 [2006] England and Wales Court of Appeal (Civil Division) EWCA Civ 1371; Programs for computers [2010] Enlarged Board of Appeal G3/08.

146

Free the Vaccine for COVID-19, ‘Free the Vaccine for COVID-19’ (16 May 2022). Available at https://freethevaccine.org/ (accessed 14 December 2023).

147

Nerina Boschiero, ‘COVID-19 Vaccines as Global Common Goods: An Integrated Approach of Ethical, Economic Policy and Intellectual Property Management’ (2022) 22 Global Jurist 177, 16.

148

Carol Rose, ‘The Comedy of the Commons: Custom, Commerce, and Inherently Public Property’ (1986) 53 University of Chicago Law Review 774.

149

Marianne Meijer et al, ‘COVID-19 Vaccines a Global Public Good? Moving Past the Rhetoric and Making Work of Sharing Intellectual Property Rights, Know-How and Technology’ (2021) 31 The European Journal of Public Health 925, 925.

150

Special Reports, ‘Towards a People’s Vaccine Campaign: A Call to Action’ (The Mail & Guardian, 15 January 2021). Available at https://mg.co.za/special-reports/2021-01-15-towards-a-peoples-vaccine-campaign-a-call-to-action/ (accessed 14 December 2023).

151

Yochai Benkler, ‘Between Spanish Huertas and the Open Road: A Tale of Two Commons?’ in Brett M Frischmann, Michael J Madison and Katherine J Strandburg (eds) Governing Knowledge Commons (OUP 2014, Oxford, UK) 69–98.

152

Dusollier (n 118) 279.

153

Julie Cohen, ‘Copyright, Commodification, and Culture: Locating the Public Domain’ in Lucie MCR Guibault and P Brent Hugenholtz (eds) The Future of the Public Domain: Identifying the Commons in Information Law (Kluwer Law International 2006, NL) 165.

154

Dusollier (n 118) 279–80.

155

ibid 280.

156

ibid.

157

ibid.

158

Seongtae Kim and Sangho Chae, ‘Shareholder Value Effects of Ethical Sourcing: Comparing Reactive and Proactive Initiatives’ (2022) 179 Journal of Business Ethics 887, 887; Seongtae Kim et al, ‘Ethical Sourcing: An Analysis of the Literature and Implications for Future Research’ (2018) 152 Journal of Business Ethics 1033, 1033.

159

Kim and Chae (n 158) 887.

160

Molecule Protocol Home, ‘A New Era of Drug Development’. Available at https://www.molecule.xyz/ (accessed 25 March 2024).

161

Torrance (n 110); OpenWetWare, ‘SynBERC’. Available at https://openwetware.org/wiki/SynBERC (accessed 25 March 2024).

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

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Article Contents

Can you patent the sun? Towards a sui generis inclusive right to manage the relationship between intellectual property and Commons

Abstract

1. Introduction

2. mRNA vaccines: from lawful patentability to problematic thickets

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

4. The great paradox: public funding but private properties

5. The search for an effective GHS

6. The commons in the IP field

7. The Covid-19 vaccine as commons: the sui generis inclusive right

8. Conclusion

Acknowledgements

Footnotes

Citations

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Article Contents

Can you patent the sun? Towards a sui generis inclusive right to manage the relationship between intellectual property and Commons

Abstract

1. Introduction

2. mRNA vaccines: from lawful patentability to problematic thickets

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

4. The great paradox: public funding but private properties

5. The search for an effective GHS

6. The commons in the IP field

7. The Covid-19 vaccine as commons: the sui generis inclusive right

8. Conclusion

Acknowledgements

Footnotes

Citations

Views

Altmetric

Email alerts

Citing articles via

Latest

Most Read

Most Cited

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