Legal Claims toward SARS-CoV-2 Complementary DNA Integrated into the Human Genome

Abstract

Recent independent results by Zhang et al. (Reverse-transcribed SARS-CoV-2 RNA can integrate into the genome of cultured human cells and can be expressed in patient-derived tissues. Proc. Natl. Acad. Sci. U. S. A. 118, e2105968118, 2021) and by Briggs et al. (Assessment of potential SARS-CoV-2 virus integration into human genome reveals no significant impact on RT-qPCR COVID-19 testing. Proc. Natl. Acad. Sci. U. S. A. 118, e2113065118, 2021) suggest that LINE1-mediated retrotransposition and integration of the SARS-CoV-2 genome, by means of recombinant complementary DNA, into the host genomes of SARS-CoV-2 infected humans are detectable with standard PCR diagnostic methods. On this background, a new and far-reaching patent for a SARS-CoV-2 reverse genetic system (published 30 September 2021 as US patent US2021024532W and World Intellectual Property Organization WO2021195596A2, https://worldwide.espacenet.com/patent/search?q=pn%3DWO2021195596A2) with legal claims toward artificial SARS-CoV-2 complementary DNA and its sequence variants in host cells is briefly discussed. It is argued that this might pose historically a unique situation, where genomes of living persons may have become both the targets of recombination with artificial DNA and the objects of emerging patent claims. This situation and its potential implications need an open and transparent public discussion.

Note:
Funding: None to declare.

Declaration of Interests: None to declare.

Keywords: SARS-CoV-2, rerotransposition, genome integration, human genome, international patent law