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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: https://doi.org/10.1093jiplp/jpae044,” ALB]

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 license to the former patent holder for their follow-on inventions.19 In this context, it is possible to identify a specifc 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 fling 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 identifed, 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 signifcantly. 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 frst patent pools in history identifed 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.

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