Introduction
The pharmaceutical patent system is broken. This is not an overly controversial statement in a market that regularly sees medicines launched at over US$3 million per patient, that has created significant disparities in the availability of COVID-19 vaccines across the globe, and that is at the origin of an accelerating antimicrobial crisis. A large number of commentators have come to the same conclusion, compiling long lists of ills that beset the contemporary pharmaceutical innovation and market system: lack of innovation and other market failures around neglected diseases, regulatory capture and revolving doors between regulators and pharmaceutical giants, the aggressive marketing of pain and other medicines, and attempted corruption of healthcare staff and patient groups.Reference Baker 1 Many of these structural problems are caused by the sheer power and financial might of “Big Pharma,” an industry that has seen its market size quadruple in the past decades from around US$400 billion in 2000 to a current estimate of US$1.6 trillion, with research productivity distinctly falling behind in growth rates.Reference Mikulic 2
Rather than adding to this increasingly forceful indictment, this paper seeks to accomplish two complementary goals. My first objective is to connect many of the “symptoms” of the arguably ailing pharmaceutical system to the temporality of patenting, which I understand, in short, to tie a specific past, determined by a particular narrative around pharmaceutical R&D expenditure, to a predetermined future — a 20-year patent monopoly that allows amortization of these investments. As I will argue, this future is in fact doubly predetermined: at least at a narrative level, it is a consequence of “past” investments to be recouped, but it is also built on a particular “future perfect,” where current promises to maintain the status quo determine the course of action of future innovators and investors. This double predetermination of the future, in my reading, has succeeded in cutting short any meaningful debate around large-scale change in pharmaceutical markets. While this temporality is often implicit in many critiques of pharmaceutical business practices,Reference Kang, Birch and Muniesa 3 I argue that only a thorough understanding of the peculiar temporality of pharmaceutical patents allows us to engage with the second objective of this paper. This second objective is to devise a set of principles and practices that can break with the current temporality of pharmaceutical markets and, on this basis, sketch a new social contract for our pharmaceutical innovation system. Thus, rather than stopping at diagnosis, I extend my analysis to a set of principles that opens up an alternative temporal economy of pharmaceuticals. Doing so may ultimately allow us to better take into account the multiple temporalities that exist in this space, chiefly among them patients’ own temporalities, which typically get overridden by the peculiar timelines of the innovation-patenting-monopoly-profits-market sequence.Reference Bruckner Johansen, Geiger and Wadmann 4
The Temporal Bind of the Pharmaceutical Patent System
As many readers of this journal are aware, pharmaceuticals were excluded from the patent system in many jurisdictions for the longest time. Where pharmaceuticals were patentable, such as the US, this inclusion often remained a controversial one.Reference Gaudillière 5 In many debates around the patentability of pharmaceuticals, the benefits of incentivizing high-cost innovation were raised as a bulwark against arguments in favor of public health and a freely circulating knowledge commons. Debates have continued to the present day, with positions seemingly getting more entrenched.
These controversies point to the fundamental balancing act that shapes pharmaceutical markets, usually referred to as the “patent bargain”: a social contract in which the social costs of granting a patent are traded against its purported benefits.Reference Biagioli 6 Those benefits are usually seen in the disclosure of innovative activity around patentable subject matter (compounds, methods, and processes), which is weighed against a temporary protection from competition. 7 This protection lasts, at least in theory, 20 years from the moment a patent is filed — though this period is known to be somewhat elastic, as I will explain below. Thus, the patent bargain attaches a temporal point zero — the moment when a patent is filed — to a predetermined future: the multi-year period during which the patent holder essentially enjoys a market monopoly. But this bargain also encompasses a past in which the innovator invested financial and other resources into the research and development of medicines, which, according to the standard argument for patents, can only be amortized through keeping competitors out of the market. Thus, the balance that the patent bargain seeks to strike welds together two temporalities: a past in which investments have been made and a future in which they can be recouped and reinvested (see Figure 1). If we follow the standard argument of the patent bargain, these temporalities are materially tied: “upstream” innovation only happens because it is incentivized by the promise of a lucrative downstream medicines market, with the patent moment as the temporal and factual linchpin between these two stages.
The embedded temporalities of the standard patent bargain.
In the “golden age” of vertically integrated pharmaceutical firms, research and innovation may have indeed taken place in the same firm that eventually also marketed the resulting medicines, indicating a more direct link between financial investment in innovation upstream and downstream market amortization. Yet in an age where pharmaceutical innovation predominantly takes place in often complex innovation networks involving smaller biotechnology companies, public research institutes, public-private partnerships, and a myriad of other players, the link between these upstream and downstream temporalities becomes much less obvious.Reference Geiger and Bourgeron 8 With the breakup of vertically integrated innovation, the patent bargain, in fact, increasingly ties two markets together: an upstream R&D market for innovation and intellectual property (IP), and a downstream market where medicines are marketed and sold. This situation has opened the door to the assetization of pharmaceutical IP.Reference Bourgeron and Geiger 9
Birch and Muniesa define assetization as the conversion of scientific knowledge or legal and other practices into “identifiable and alienable property” that “can be owned … and capitalized as a revenue stream.”Reference Birch and Muniesa 10 Importantly, when patents become assets, “the value of patents as assets derives from the projected exchange value of the patent as a property right rather than the actual or anticipated use value of the patented invention.” 11 This “asset condition” means that the valuation of pharmaceutical patents typically relies on a discounted cashflow calculation that takes into account projected future income through licensing or the sale of the patent.Reference Doganova 12 Such a future-oriented valuation necessarily includes a speculative dimension in predicting the state of future markets. Concretely, then, what is traded “upstream” in these markets for pharmaceutical IP assets is no longer the “downstream” promise of a market for medicines but rather the potential to cash in on the patent-as-asset through monopoly powers. In extreme cases such as defensive patenting or patent trolling (when non-practicing entities buy up patents for the sole purposes of blocking competitor innovation or speculating on IP), upstream IP markets in fact prevent innovations from reaching downstream markets.
This fact brings us back to the potential societal win of the patent bargain. At a societal level, patent-enabled monopolies are associated with expectations that the resulting innovative medicines are made available, accessible, and affordable to patients on behalf of the broader public, who is incurring the cost of the patent bargain. Of course, none of these expectations are enforceable.Reference Geiger and Bourgeron 13 Accordingly, many of the “misfires”Reference Geiger and Gross 14 or market failures that plague the pharmaceutical political economy are related to the pharmaceutical industry exploiting this implicit temporality of the patent bargain. In the upstream R&D market, these failures include investing in areas that hold strong promises for lucrative future markets rather than in areas of greatest societal need; using patent rents for stock buybacks or shareholder payouts rather than reinvesting them in innovative activity; or withdrawing R&D funding in favor of buying up late-stage patented innovation as assets. 15 Temporal downstream tactics typically revolve around the prolongation of the downstream monopoly through a veritable temporal toolkit, which typically includes: (i) “pay for delay”: paying generic manufacturers to delay their entry into the market; (ii) “evergreening”: layering secondary patents on primary chemical compound patents, filed at later points; (iii) “product hopping”, that is, creating and marketing a reformulated and newly patented version of an already-existing medicine; (iv) in the US, gaming the citizen petition process, which consists of delaying a pending generic application by filing “concerns” — a process meant for “concerned citizens” but often utilized by corporations; and (v) exploitation of existing regulatory exclusivities in order to extend monopoly periods beyond patent expirations, such as the EU’s ten-year market exclusivity for orphan drugs or its eight-year data exclusivity.Reference Feldman 16 Clearly, the societal costs of the patent bargain become greater and the potential benefits more diluted when patents-as-assets are traded in two temporally interlinked markets.
So far, I have argued that the standard argument for pharmaceutical patents creates a particular narrative temporality where an imagined past investment in a market for innovation needs to be recouped through a future market monopoly.Reference Sertkaya 17 Yet the proponents of pharmaceutical patents also base their arguments on another type of future. This future is a promissory and much more ill-defined one, in which imaginary innovators weigh up the pros and cons of investing in pharmaceutical R&D; a future in which these innovators may be swayed to invest in the development of lifesaving medicines only if past promises of monopoly rents will continue to materialize into the future. Those promissories point to a narrative future where the past has to repeat itself to entice innovators to engage in the pharmaceutical social contract, essentially creating an eternal return of the status quo in which the industry positions itself as the only path to providing life-saving medicines. It is particularly this second, promissory future that is often brought to bear when industry representatives raise the specter of the “chilling” effects of any interference in the patent system on future R&D investments. Tracing the case of the EU Pharmaceutical Sector Inquiry of 2009, Geiger and Finch have demonstrated how this narrative of a “chilled” future devoid of pharmaceutical R&D acted as a rallying point for pharmaceutical patent proponents to thwart stronger regulatory oversight. 18 It also acts as a point of reference that cannot be defeated: as the specter of a barren R&D pipeline is a future-oriented one, it can never be proven wrong. As we shall see below, it can only be refuted by creating what Geiger and Finch called “counter-narratives”: sketching alternative futures.
Thus, the patent system and the social contract that has discursively supported it draw an explicit link between a particular past, where investments were made by private entities that need to be recouped, and a future that serves as a springboard for future R&D investments. Any interference, so the narrative goes, risks drying up this R&D investment monopoly market cycle. In this narrative, other pasts are erased, including any innovation that happened in or was financed by public institutions, as are other possible futures; including innovation systems that are unmoored from market monopolies, such as pharmaceutical commons, which may provide the same or even a better level of health attainment than what is possible in the current market structure. Importantly, a singular dominant innovation narrative of a future colonized by the past also erases the temporalities of other stakeholders: those of patients in particular, who may require innovation at a much faster rate than pharmaceutical investment cycles foresee, or those of regulators, who may wish to pursue alternative timelines that foster stronger global synchronicity.Reference Geiger, Prainsack and Wagenaar 19 By eclipsing these other temporalities, patent proponents ensure that the one singular temporality, depicted in Figure 1, seems all but inevitable.
The Temporalities of mRNA Vaccines
The case of the mRNA vaccine technology illustrates the peculiar temporalities enabled by the pharmaceutical patenting system and the many ruptures rendered invisible in industry narratives. The timeline of the technology that allowed mRNA vaccines to become a critical lever to end the COVID-19 pandemic dates back to the early 1960s, when messenger ribonucleic acid (mRNA) was first discovered. It took scientists twenty years to synthesize mRNA and to discover that synthetic mRNA could be used to make proteins to trigger specific immune responses, turning cells into “medicine-making factories.”Reference Veugelers 20 Yet, despite the emergent potential of mRNA technology to become what is known as a platform technology — that is, a flexible toolkit for a vast range of diseases — the technology was generally seen as unstable throughout the 1990s and early 2000s,Reference Dolgin 21 and funding to drive the technology forward proved challenging to obtain. Unresolved scientific questions included how to carry mRNA into human cells and how to make the proteins stable enough to trigger the body’s immune response. The discovery of lipid nanoparticles solved the first problem, and the second puzzle was solved by Katalin Karikó and Paul Weissman in 2005 while working to develop a vaccine against HIV. After years of struggling to find funding for their mRNA research, their invention was patented by the University of Pennsylvania and later licensed to the company Cellscript.
The first patents associated with these cumulative discoveries in university laboratories opened up the next chapter in mRNA’s history: the emergence of spinouts and biotech startups, dedicated to bringing mRNA-based medicines to market. In Germany, Curevac was founded in 2000 and BioNTech in 2007, while US-based Moderna was founded in 2010. Karikó and Weissman started their own company, but it failed to reach a licensing agreement for a core process technology and ceased operations. Several other biotech firms specializing in mRNA technology emerged around the same time. All were funded by a mix of private (mainly venture) capital, philanthropic grants and public funders. 22 Notably, while the conventional vaccine market in the early 2000s was essentially divided among four large pharmaceutical firms (GSK, Merck, Sanofi, and Pfizer), “Big Pharma” did not get involved in mRNA technology until much later — Pfizer, for instance, entered into a partnership with BioNTech in 2018. At that time, several patent and licensing infringement claims were already being fought out in the courts between these biotech startups.Reference Adekola 23
By the time the COVID-19 pandemic was declared by the World Health Organization (WHO) in early 2020, mRNA research had progressed for over forty years, mainly in university labs and spinouts with strong collaborative ties to public research institutes. It was only when mRNA research slowly revealed its potential as a new pharmaceutical platform technology that larger biotech firms, and much later “Big Pharma,” became interested and involved. Even then, the “bargain” struck between continuing public investments in R&D and “downstream” medicines markets proved to be a murky one: while the first market-ready application of the technology was as an Ebola vaccine, it was never rolled out; this particular market did not seem lucrative enough for private patent holders.Reference Beyrer 24
As is well known, mRNA’s trajectory changed radically in the course of the year 2020. Lavish public funding — particularly through the US$18 billion budget of Operation Warp Speed — helped to condense into less than a year an R&D process that would normally take up to ten years. Totaling advance purchase agreements and direct funding, the overall public contribution to accelerate mRNA vaccine development in the US alone is estimated at over US$31 billion.Reference Lalani 25 The compressed timeframe was also enabled by ad hoc changes in the institutional frameworks that accompany drugs innovation. From clinical trial design and animal studies, through to ethics reviews and regulatory authorizations, every single stage was institutionally reshaped to fast-track emergent mRNA vaccines — often despite ethical concerns.Reference Beretta and Marelli 26 BioNTech’s vaccine received emergency authorizations in December 2020 in the US, UK and EU, only days before Moderna’s vaccine received these authorizations. 27
From a temporal perspective, this unprecedented contraction of R&D timeframes, facilitated by public financing and institutional enablement, now means that the future of mRNA technology is already colonized. First, because the patents associated with the COVID-19 mRNA vaccines now command a much longer market monopoly than is the case for other vaccines or medicines, which are usually in development for about half of the patent’s lifespan.Reference Florio 28 Second, because many of the patents enabled through the pandemic-necessitated “warp speed” were deliberately broad, particularly regarding mRNA delivery technology, and may extend to a substantially larger pharmaceutical domain than just SARS viruses.Reference Shores 29 The technology is currently in trials in fields as diverse as oncology, HIV, and inflammatory diseases, and it is reportedly even tested in models for a “universal” influenza vaccine.Reference Lim 30
While the societal benefits of speed-to-market in the case of the COVID-19 pandemic are evident — mRNA vaccines contributed greatly toward the reopening of normal societal functions and preventing further deaths — the mRNA market that came to be also betrayed significant access-to-medicines and health equality issues. For the first two years of the vaccine’s availability, an essentially unvaccinated Global South waited behind a virtually fully vaccinated Global North for their place in the vaccine purchasing line. Moderna and BioNTech both refused to help retool or train potential vaccine manufacturers in lower and middle-income countries, arguably because the technology was too complex for rapid tech transfer — a fact that was disputed by many expert commentators.Reference Geiger and Gross 31 Moreover, both firms refused to license their technology to the COVID-19 Technology Access Pool (CTAP), a patent pool modelled on the Geneva Medicines Patent Pool, which allows for voluntary tech transfer to generic manufacturers in lower income countries.Reference Geiger and McMahon 32 And though Moderna made a pledge not to enforce its patents as long as the pandemic lasted, neither firm engaged in the WHO’s South Africa-based mRNA Tech Transfer Hub, a hub-and-spoke research facility that seeks to expand mRNA technology and know-how to all parts of the globe (more below). Given that the patent landscape of mRNA technologies has been cemented down for the foreseeable future, this inequity is likely to repeat itself: The technology is now largely in the hands of a small set of firms worldwide — by 2022, Moderna reportedly already held around 323 patents across 62 patent families, with BioNTech assigned around 245 across 46 families.Reference Li 33
Financially, the race for monopoly rights for the mRNA-as-asset technology paid off: Moderna grew its turnover from US$60 million in 2019 to just under US$20 billion in 2022, while BioNTech increased its revenue from around US$100 million in 2019 to over US$17 billion in 2022. 34 The mRNA platform technology, meanwhile, is predicted to lead to unprecedented advances in a broad field of applications in the years to comeReference Ankrah 35 — at least for those who can gain access to these innovations.
Are These Temporalities Inevitable?
The vignette above serves to illustrate two points: the first is that the actual timeline of mRNA discovery and market access is much longer and more diverse than what the dominant public narrative suggested. mRNA’s past consisted of a multi-branched and uneven patchwork of labs, funders and researchers, often located in public institutions or at least with roots in public research bodies (as in the case of the two BioNTech founders, who had both held significant EU funding), all with their own timings and future expectations. As in many previous cases, Big Pharma only entered the scene late in the day, at a point in time when market-ready drugs were already at the starting line and R&D risk was all but eliminated. 36 The standard patent bargain argument, of a singular temporality of high-risk innovation recompensed through patent ownership and an associated market monopoly, barely if at all holds up in these situations. Given that all major advances around the technology were made in public institutions, neither does the argument that the current system is irreplaceable — that without patents, innovation like this would simply not happen. While we can never tell what an alternative future in 2021 would have looked like had mRNA expertise remained fully in public hands, it only stands to reason that with the same capital injections, universities and public research labs would have succeeded in achieving similar breakthroughs.
Toward a New Temporal Political Economy of Pharmaceuticals
As we have seen, there is considerable financial gain in perpetuating the narrative linkage between the currently prevailing pasts and futures of pharmaceutical innovation. Combating these future-colonizing narratives is only possible by creating a strong counter-narrative of a new temporal political economy of pharmaceuticals, one in which the future is not held hostage to an eternal return of the past. I see four complementary strategies as playing a major role in building such a new political economy. The first two strategies are compatible with the existing patent system but would nonetheless have significant implications on the future timelines, particularly of speculative technologies such as mRNA. The first strategy consists of more temporally-conscious policymaking, which would enforce timelines that privilege public needs ahead of private patent holders’ commercial desires. The second strategy revolves around significantly narrowing the scope of pharmaceutical patents granted. Together, both strategies would serve to limit the proportion of global future health needs that are hostage to shareholder assetization objectives. The third strategy more decisively breaks with the current temporalities of the patent bargain and carries its intent in its name: delinkage. Delinkage represents the idea of a material and temporal decoupling of the upstream and downstream markets through incentivizing R&D and innovation efforts through means other than monopoly rents. Lastly, the fourth and most incisive strategy is to disrupt the asset condition of pharmaceutical patents — the essential connector between the upstream and downstream markets — through strategies of pharmaceutical “commoning”: the communal governance of innovation pipelines and manufacturing and distribution chains, which could prevent patent accumulation in the upstream stages and the downstream accumulation of profits. I will expand on each of these four strategies briefly in turn.
Temporally Conscious Policymaking
The first strategy can and should be implemented immediately as it does not interfere with the normal functioning of the patent system: making health regulations more temporally sensitive. As I have argued with colleagues elsewhere, it is vital that in cases of health emergencies such as pandemics the world can act “as one” to foster synchronicity and a sense of solidarity. 37 To enable this within a context where the future is already predetermined by the past is a difficult but not impossible undertaking for policymakers. The negotiations around the International Health Regulations (IHR) and the Pandemic Agreement over the past years have represented unique opportunities to build temporal sensitivity into global health regulations. This could be achieved either by taking much more seriously the notion of timeliness, a notion that has been repeatedly invoked in the discussion drafts that led up to the recent Pandemic Agreement, or by replacing this rather unspecific notion with the more specific one of global synchronicity. Synchronicity in pandemic policymaking would allow regulators to put in abeyance any attempts by private firms to enforce the normal patent rules on “downstream” markets when global societal need is greatest. Enforcing global synchronicity through temporally sensitive pandemic regulations would allow future regulators to overturn refusals such as those by Moderna and BioNTech to share their technologies with vaccine manufacturers that were ready to manufacture mRNA vaccines to help distribution bottlenecks. While such a policy move may not prevent future hostage-taking of pharmaceutical markets through claims that the high costs for innovation need to be recouped, it would at least represent a way to increase the societal gains of the patent bargain in moments of greatest need — and do so in a way that would institute a synchronized, solidaristic temporality in health emergencies across the global community.
Decolonizing the Future Through Narrower Patents
We now turn to the issue of overly broad patents. The fact that broad patents enable patent holders to “own the future” has already been highlighted by Seth Shulman in 1999.Reference Shulman 38 Yet it appears that this 25-year-old critique has failed to effect any change in patent practices. To wit, in the aftermath of the COVID-19 pandemic and the windfall profits it enabled for BioNTech/Pfizer and Moderna, a patent lawsuit was filed in August 2022. In it, Moderna accused BioNTech/Pfizer of patent infringement for mRNA patents issued between 2010 and 2016, a time when parts of the technology were still developed through National Institutes of Health funding and other public efforts. In this lawsuit, Moderna claimed that these prior patents covered some of the fundamental principles of mRNA technology used in BioNTech/Pfizer’s COVID-19 vaccine Comirnaty, suing for significant compensation and potentially also limiting competitors’ future use of these patents. In response, BioNTech/Pfizer launched its own legal challenge, claiming that Moderna’s patents were based on shared knowledge and overly broad. With this, they accused their adversary of monopolizing a field of fundamental technology. In a further defensive move, BioNTech/Pfizer then launched an Inter Partes Review with the US Patent and Trademark Office (USPTO) in August 2023, challenging the validity of Moderna’s patents on the grounds mentioned above (that the patents were overly broad and based on prior art).Reference Kurt 39 A similar move in 2023 at the European Patent Office (EPO) yielded mixed results: one of Moderna’s patents (the ‘565 patent) was invalidated, while another crucial one (the ‘949 patent) was maintained in May 2024 in what commentators have called a “modest win” for Moderna.Reference Becker 40 In a simultaneous multi-year long dispute out of courts between Moderna and the National Institutes of Health (NIH), a first agreement has seen Moderna pay US$400 million to the NIH for a crucial patent over the spike technology of mRNA vaccines filed by a combination of researchers from the NIH, the Scripps Institute in California and the University of Dartmouth in 2017. A second dispute remains unsettled at the time of writing, with Moderna being notably slower to acknowledge the contributions of shared and publicly funded knowledge to their own technology than other vaccine manufacturers.Reference Morten 41 BioNTech too has had to agree to a combined US$1.26 billion settlement with the NIH and the University of Pennsylvania over mRNA royalties for two major patents.Reference Bratulic 42
These legal battles indicate room for maneuvering for patent offices to prevent too much of a slice of the future being colonized by particular narratives of the past. Much has been written about how patent offices have turned into commercial entities and about the dearth of attention patent officers can devote to any one patent.Reference Parthasarathy 43 While I acknowledge the financial and time constraints that patent offices operate under, and often in increasingly politically volatile contexts, each patent decision paves an almost unchangeable path for a 20-year future, and the broader granted patents are, the more of this future is at play. At a minimum, I would call for patent offices to fully assume their responsibility toward a future that needs to be left as open as possible for societal benefit to occur. The granting of narrow and highly specific patents would contribute significantly to this openness.
Delinking Patents from their Asset Condition
The third strategy to decolonize the future from patents that are used primarily as assets leads us more decisively into a new temporal political economy of pharmaceutical markets: delinkage. For access to medicines activists, the term delinkage primarily refers to detaching the final market price of drugs from the supposed need to recoup unsubstantiated R&D costs. They call for governments to redirect the price premiums paid to pharmaceutical monopolists for medicines into incentive funds that would more directly target innovation efforts. In my interpretation, the concept of delinkage contains an explicitly temporal core: if pursued, this strategy would break or at least fundamentally challenge the narrative connection between “upstream” innovation markets and “downstream” market monopolies. To “contain” upstream R&D markets and stop them from overdetermining future medicine markets, delinkage would incentivize pharmaceutical innovation through mechanisms other than the promise of future market monopolies. They would provide targeted incentives for R&D and facilitate competition in the R&D markets themselves, but crucially without the promise of monopoly, thus preventing IP assets from welding together upstream and downstream markets. Delinkage mechanisms include prize bonds, innovation vouchers, or innovation funds, aimed at specific areas of pharmaceutical need. Firms would be able to compete for these incentives based on a set of key deliverables around the proposed innovation’s impact on global health. Once a medicine has been developed through these mechanisms “upstream,” it would be made available patent-free in a downstream market in which multiple generic manufacturers can compete against each other on the basis of distribution, access or price. Small-scale experiments in delinkage have been conducted for over a decade: the Bill and Melinda Gates Foundation-funded not-for-profit organization Grand Challenges, for instance, aims at solving key global health and development problems through innovation grants. It has thus far offered almost 4,000 individual grants for pharmaceutical innovation projects across 122 countries. 44 Endeavoring to test delinkage mechanisms at scale, the Health Impact Fund (HIF) is currently seeking funding for the first large-scale proof-of-concept pilot to foster new therapies for neglected diseases. At full scale, the HIF would allocate a recurring monetary pool of international tax revenues, government contributions, and philanthropic funding to innovators. These innovators would then conduct the R&D of specific products and commit to selling them at a cost no higher than the cost of manufacturing or licensing them out to contract manufacturers. Through pay-for-performance contracts, the HIF would hold back a portion of the allocated finances until equitable access and therapeutic benefit can be ascertained. 45 In the case of COVID-19 vaccines, early ideas around the ACT-A Covid Accelerator COVAX mechanism in fact contained proposals for a global joint innovation fund through which innovating entities could be financed. However, these proposals did not foresee a full delinkage between those funds and later patents. They also remained largely theoretical, while COVAX became a vehicle for vaccine distribution only — and arguably did not function too well in that capacity either. 46
Pharmaceutical Commons
The final strategy leading toward a new temporal political economy of pharmaceuticals consists of introducing a distinct commons element to unlink upstream and downstream markets. A commons approach to pharmaceutical innovation would entail a reorientation of the upstream-downstream chain away from financial profits and toward the common good, in the form of non-competitive, non-market mechanisms broadly based on commons principles: mutuality, a needs-based agenda, fair in distributing risk and benefits, and accountable.Reference Geiger and Kleinhout-Vliek 47 It would require, first of all, a strengthening of public bodies in more firmly directing pharmaceutical innovation toward areas of greatest need and in financing public research entities to carry out this innovation. A 2023 report for the European Parliament’s Science and Technology Options Assessment (STOA) Panel in fact recommended such a reawakening of the “entrepreneurial state” in pharmaceutical innovation and production.Reference Mazzucato 48 Crucially, however, these public bodies would then not yield the space to private investors assetizing the resulting intellectual property but rather keep innovation circulating in the public domain through collective governance mechanisms, including sharing and fair use licenses. Further development, manufacturing, and distribution too would be orchestrated by public bodies, with these processes involving not-for-profit entities and commercial firms where these are best placed to fulfil a role in the pharmaceutical commons, with financial or in-kind compensation on their actual contribution to getting medicines to patients — rather than a speculative, mostly narrative, and fully promissory reward in an unchanging present.
Public commons-private pharmaceutical innovation exists in many differently forms already; one of the most prominent examples is the Drugs for Neglected Diseases initiative (DNDi), an initiative founded in 2003 from Médecins Sans Frontières’ Nobel Peace Prize with a triple mission of discovering, developing, and delivering drugs for the most neglected diseases to the most neglected patients, including Chagas, sleeping sickness, dengue, or leishmaniasis. DNDi sees itself as a “conductor of a virtual orchestra,” drawing on a wide range of expertise, including that of private firms, and it is wedded to a paradigm that centers on open access to knowledge. Its IP policy and all negotiations with potential partners are guided by the need to ensure affordability and access to drugs and the desire to develop medicines as public goods. 49 Prefiguring current debates by two decades, DNDi’s IP policy also embraces delinkage principles — that is, separating out the cost for and incentivization toward R&D from patents and any profits from the final product. While it is often portrayed as a model for a commons-based pharma regime, critiques raised against the initiative reflect the difficulties of maintaining a commons when partnering with private entities that will continuously seek to reappropriate commons-based knowledge for their own profit.Reference Lezaun and Montgomery 50
In the case of COVID-19, the WHO’s mRNA hub founded in mid-2021 represents a notable transnational attempt at infusing commons-based thinking into this highly-assetized market. In the WHO’s words, “The Hub and partners create a global common good for the benefit of all by providing a range of services along the entire vaccine value chain.” 51 The hub is located at the pharmaceutical for-profit research firm Afrigen in South Africa, with various spokes across lower and middle-income countries. The initiative is dedicated to training vaccine manufacturers in producing mRNA vaccines and sharing knowledge around this technology, enabling mRNA innovation to thrive. Accordingly, the hub’s first project was to reverse-engineer Moderna’s COVID-19 vaccine, made feasible at the time by Moderna’s pledge not to enforce patent rights for the duration of the pandemic but since obstructed by Moderna’s attempts at stopping the further diffusion of this technology. Unlike a full pharmaceutical commons, the WHO hub works largely within the current market system but seeks to upskill manufacturers and innovators for future medical technology needs. Thus, in the temporality argument put forward in this paper, the hub works at least partly toward decolonizing the future from a present where mRNA technology has been fully enclosed by a handful of private entities located in high-income countries. In this particular case, the term “decolonizing” may also be understood in its more commonly-used sense: the hub explicitly seeks to foster and upskill pharmaceutical innovation and manufacturing in lower- and middle-income countries and to lower these countries’ dependence on firms located in high-income countries for vaccines and other essential health technologies.Reference Geiger and Conlan 52 Arguably, though, by playing within the rules of the patent-based political economy, the mRNA hub has not yet managed to break the future of mRNA technology completely free from its market-based captors.Reference Herder and Benavides 53
Conclusion
As of 2023, more than 15,000 patents related to mRNA technology had been granted around the world, and doubtless thousands more have been filed.Reference Wang 54 These patents contain the building blocks for mRNA vaccines against HIV, tuberculosis, certain forms of cancer, sickle cell disease, and many others. In the current system, this knowledge, based on decades of shared foundational research conducted in knowledge commons, is now locked up for close to 20 years for patent holders to assetize as they see fit. In fact, due to the government injections of financing and the removal of red tape during COVID-19, our mRNA future is even more strongly colonized by private interests than other pharmaceutical markets. mRNA platform technology is a case where the future truly is a hostage to a past — but a past that only selectively highlights what is to be taken into account.
It will likely remain a moot point whether our current global patent system is “too big to fail” 55 or whether pharmaceutical innovation without patents is indeed “preferable, profitable, and practicable.”Reference Radder and Smiers 56 This paper intervenes in this debate by calling for a much more temporally sensitive understanding of pharmaceutical innovation, financing, and governance. If there is such a thing as a patent bargain, it is important to lay open the implicit temporalities in this bargain, and it is high time to assert alternative narratives. Rather than engaging with pharmaceutical representatives in the same tired arguments over what it really costs to innovate and what medicines prices might represent “value for money,” I suggest that we collectively switch our attention to these new narratives, built around a new temporal political economy of pharmaceuticals. In that temporal economy, pharmaceutical innovation on the one hand and manufacturing and distribution on the other are seen as what they functionally are: as two interdependent markets, but markets that can be materially and financially separated and individually regulated, to maximize their individual contribution to the common good.
Acknowledgements
Thank you to the Special Symposium Editors, Dr. Mina Hosseini and Prof. Imelda Maher, for organizing the workshop giving rise to this paper and the ensuing Special Symposium. I am indebted to Dr. Tineke Kleinhout-Vliek for editorial assistance and long conversations about the issues raised in this paper. Research leading to this paper was funded by the European Research Council under the European Union’s Horizon 2020 research and innovation programme (grant agreement No 771217). This symposium was co-funded by the European Union’s Horizon Europe Marie Skłodowska-Curie Actions programme under grant agreement No. 101061575 and the UCD Sutherland School of Law. The views and opinions expressed are, however, those of the author only and do not necessarily reflect those of the European Union or the European Research Executive Agency. Neither the European Union nor the Agency can be held responsible for them.
Competing interests
The author confirms that she has no conflict of interest in writing this article. She is a member of the WHO Technical Advisory Group (TAG) on pharmaceutical pricing policies and a member of the civil society group Access to Medicines Ireland. She does not receive any gratuities as part of these roles. This article expresses only the author’s personal views.
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