The United States federal government should abolish patents including via weakening its protection of domestic intellectual property rights in patents via creating an inclusive sui generis right based on preserving biotechnology patent waivers

Cifrodelli 24 [Gabriele, PhD Candidate & Research and Teaching Assistant, University of Glasgow (CREATe Centre), “Can you patent the sun? Towards a sui generis inclusive right to manage the relationship between intellectual property and Commons,” “Journal of Intellectual Property Law & Practice,” 2024, Vol. 00 No. 00, DOI: ,” ALB]

Introduction A

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 modifed (‘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 briefy introduces the mRNA technology as the main example and case study to assess the patentability of vaccines in Europe and the USA, given the infuence 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 identifed as Commons, leading to a reconsideration of the relationship itself between IP and Commons.