In this article, Cellistic's Head of IP, Sergei Kurkin, addresses the critical intellectual property (IP) considerations in the rapidly evolving field of gene editing for cell therapies, including induced pluripotent stem cell (iPSC) derived therapies. The two main elements of IP strategy highlighted are:
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Freedom to Operate (FTO): Ensuring that the use of a technology does not infringe on existing patents.
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Protecting Innovation: Securing patents for new technologies to safeguard them from being copied.
Key points include:
- Gene Editing Technologies: Traditional methods like TALENs and ZFNs are established, but newer CRISPR technology offers faster and more efficient gene editing. However, CRISPR faces complex IP and licensing issues.
- CRISPR Developments: Cas9 was the first CRISPR system adapted for gene editing in eukaryotic cells, leading to patent disputes. Cas12a is a newer system with fewer patents but also has licensing complexities. Further innovations include alternative CRISPR systems and AI-enhanced gene editing tools.
- Gene Editing Applications: The focus is on specific gene deletions and insertions while avoiding off-target effects. Patents are often around improvements in targeting precision.
- Immune Evasion: Research aims to create gene edits that prevent immune responses in patients. Newer combinations of genetic modifications are being protected to enhance safety and efficacy.
- IP Strategy: Continuous monitoring and filing new patents are crucial. This maintains exclusivity, attracts partners and investors, and navigates the complex gene editing IP landscape.
Author: Sergei Kurkin, PhD
