IP Considerations For Gene Editing In The Cell Therapy Space

By Sergei Kurkin, PhD, European Patent Attorney, Head of Intellectual Property

Gene editing technologies, such as CRISPR, are revolutionizing cell therapy development by allowing targeted modifications to cells for more effective disease treatment. However, companies must navigate the complex world of intellectual property (IP) to ensure they don't infringe on existing patents and protect their own innovations. While older gene editing technologies like TALENs and ZFNs have clearer patent landscapes, CRISPR technologies have faced legal disputes and complex licensing arrangements. The recent discovery of Cas12a-based CRISPR systems provides an alternative, but a few broad patents still dominate the IP landscape. In response, companies are exploring alternative CRISPR systems and modifications to existing technologies, such as STAR-CRISPR optimized for gene editing in cell therapy applications. Additionally, companies are focused on improving the safety and efficiency of gene edits and avoiding off-target effects. Immune-evasion gene edits are also being explored to prevent immune responses. Many of these ideas and technologies have been patented by academic institutions and licensed by biotechnology companies for further development.

To protect allogeneic cell therapies, it is crucial to monitor the IP landscape and file patent applications for advancements. This stepwise approach allows for the protection of new improvements as they are identified. Some applicants may abandon older patent filings that no longer cover their pursued technology, but many maintain multiple filings to ensure freedom to operate and prevent others from claiming the space. Monitoring key players in the field and the life of patent applications is vital for an effective IP strategy in this technology. Finding the right balance between navigating existing IP rights and filing patent applications is necessary to maintain exclusivity while developing innovative cell therapies. The specific IP strategy depends on the business model and technologies used for therapeutic product generation. By staying informed and proactive in IP protection, companies can secure their position in the rapidly evolving field of gene editing and cell therapy.