Genome editing is a breakthrough technology. These gene editing systems can lower barriers to entry historically enjoyed by major companies, which have been sustained by high costs of innovation. It can enable a disruptive reduction in cost for the development of consumer-centric products. It holds immense potential to enable a robust community of researchers to leverage the natural genetic diversity of plants and realize traits such as drought tolerance, disease resistance, or nutrient levels in a fraction of the time required for traditional plant breeding approaches to trait development.
Few would disagree that the precision and efficiency of genome editing lowers R&D costs and reduces time to market, leveling the playing field for innovation beyond those few companies with the largest R&D budgets. However, uncertainty about the intellectual property landscape surrounding CRISPR/Cas9 – currently the most widely used technology enabling this paradigm shift – perpetuates a barrier to entry for innovators wishing to utilize this technology for the advancement of the industry and society.
We recently published an article in Nature Biotechnology arguing that current claims surrounding Cas9 enzymes are improperly broad, potentially limiting innovation in the field of genome editing. The arguments are based on current Federal Circuit opinions, Examiner Guidelines for examining sequence related applications, and our own experience with prosecution in the US Patent and Trademark Office. The patent system was designed to “promote the useful sciences.” In exchange for disclosing or teaching others how to make and use the claimed invention, the patent holder is rewarded with a period of exclusivity. The patent laws were designed to ensure that the scope of protection was commensurate in scope with the teaching of the patent specification. If the scope of exclusive rights is too broad; patents, or uncertainty surrounding them, can stifle follow-on innovation.
As a company designed to empower organizations of any size to access and leverage the most advanced genomics science to drive crop performance, we have built an operating system that includes a suite of tools, including a novel family of genome editing nucleases for use in plants (termed CRISPR 2.0), distinct from the Cas9 family. These nucleases demonstrate distinct advantages in higher plants compared to other genome editing tools. We have shared these technologies with leading scientists at NC State University, Boyce Thompson Institute (a non-profit institution associated with Cornell University), Washington State University, and the Donald Danforth Plant Science Center. We have also made this technology available on a non-exclusive basis to commercial partners for the incorporation of a wide range of traits that improve crop sustainability and nutrition.
Genome editing is one of the most powerful technologies our generation has seen. As responsible stewards of the environment and in the interest of societal advancement, we need to ensure that the capabilities enabled by this technology are not unnecessarily restricted. With correct application of the laws and cooperation among the business and research community, we can all be a part of the solution.