Patent power in biomedical innovation: Technology governance in biomodifying technologies

Abstract

Biomedical innovation is often rewarded by exclusive proprietary rights such as patents. In the case of gene editing, induced pluripotent stem cells, and three‐dimensional (3D) bioprinting (here described as biomodifying technologies), the limitations of the patent system come into stark relief, generating both technical and political doubts. Generally, political and technological limitations are supposed to be solved with so‐called good governance, based on some principles. We focus on three of such governance principles (participation, accountability, and transparency) to show how they have been weakened, instead of strengthened, by the current patent system. We demonstrate that although patent applications are submitted by both public and private players, the latter have imposed a growing dominance in gene editing, induced pluripotent stem cells, and 3D bioprinting, disseminating their aggressive and exclusive strategies. As a consequence, a logic of experimentality tends to prevail where the three fundamental governance principles fail to be enacted.

Editorial: Regulation and governance of gene editing technologies (CRISPR, etc.)

“…The preceding 40-plus years of research and commercial activity with genetic engineering technologies also served to identify a considerable range of applications or suggest new avenues for development where CRISPR might improve on existing genetic modification practices. Accordingly, global research on gene editing, as indicated by the number of publications (Asquer and Krachkovskaya, 2021;Zhou et al, 2021) and patent filings (Bicudo et al, 2022), has demonstrated a steep increase since 2012. From being a niche research interest, gene editing must now be considered a field of international scientific, commercial, and increasingly, public interest (Martin et al, 2020).…”

“…Whilst not an application per se, the patent rights to CRISPR/cas9 have also been subject to a protracted dispute (Sherkow, 2017;Panagopoulos and Sideri, 2021), while the patenting strategy of the CRISPR patent holders has also been subject to ethical critique for its potential impacts on innovation (Feeney et al, 2018;Panagopoulos and Sideri, 2021;Bicudo et al, 2022). This is an illustrative, rather than an exhaustive list, but it is sufficient to evoke the range of governance and regulatory challenges raised by the advent of gene editing technology, which also form the basis for this thematic collection.…”