Landscape of Genome Editing Technology Patents in the European Patent Office with a Focus on CRISPR-Related Opposition Proceedings

Abstract

In technologies for editing genomic DNA, cellular repair mechanisms are employed which facilitate manipulation of the genomic DNA. When a double-stranded DNA break is introduced at specific sites in the genome, the cellular repair mechanism takes over and facilitates targeted genome editing via non-homologous end-joining (NHEJ), thereby creating so-called insertion or deletion mutations (indels) at the cleaved target site. Alternatively, if a suitable donor polynucleotide is present, the donor can be integrated at the cleaved target site in the genome via homology-directed repair. In the last decades, four major DNA cutting tools were developed that paved the way for successful genome editing, i.e., meganucleases, zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and clustered regularly interspaced short palindromic repeats (CRISPR)/CRISPR-associated protein 9 (Cas9) (CRISPR-Cas9) systems. Patent protection for each one of these genome editing tools was obtained at the European Patent Office (EPO). In the last decade, since its elucidation in 2012, several parties tried to obtain broad patent protection for CRISPR-Cas9. This article focuses on the genome editing tools, patents that were granted for these technologies and, particularly, on opposition proceedings regarding CRISPR-Cas9 patents that relate to CRISPR-Cas9-mediated genome editing.