Navigating the CRISPR Cas9 Patent Landscape: An IP Strategy Guide

Navigating the CRISPR Cas9 Patent Landscape: An IP Strategy Guide

The advent of CRISPR Cas9 technology has revolutionised gene editing, triggering a complex web of intellectual property (IP) disputes and opportunities. This article provides an overview of the CRISPR Cas9 patent landscape and offers strategic insights for companies operating in this space, drawing from recent developments and expert opinions.

The CRISPR Cas9 Patent Thicket

The CRISPR Cas9 field is marked by ongoing legal battles among key players like the University of California, University of Vienna, Emmanuelle Charpentier (collectively known as CVC), and the Broad Institute (including Harvard University and the Massachusetts Institute of Technology). These disputes primarily revolve around the foundational patents protecting the use of Cas9, particularly in eukaryotic cells.

• Key Players:
  • CVC: Owns foundational patents and licenses them through ERS Genomics (for non-human therapeutic uses) and CRISPR Therapeutics (for human therapeutics).
  • Broad Institute: Holds patents, especially for Cas9 use in eukaryotic cells, licensed exclusively to Editas Medicine.
  • ToolGen and Sigma-Aldrich: Other innovators with significant patent holdings in the CRISPR space.

IP Strategy Considerations for CRISPR Cas9

Given the intricate patent landscape, companies must adopt a nimble and well-informed IP strategy to navigate potential risks and capitalise on opportunities. Here are key considerations:

• Licensing:
  • Secure Necessary Licenses: Evaluate the specific application of CRISPR Cas9 and secure licenses from relevant patent holders. At a minimum, a license from CVC is needed if using the CRISPR Cas9 cleavage complex with single-guide RNA.
  • Bilateral Agreements: Given the complexity, bilateral licensing agreements are more likely than patent pools. Vertex Pharmaceuticals' deal with Editas Medicines post-Casgevy approval exemplifies this approach.
  • Licensing Focus: Some entities are ramping up licensing efforts. Editas, for instance, has a team focused on licensing its patents to businesses developing Cas9 therapeutics.
  • Dynamic Communication: It's important to communicate effectively and educate market players, clarifying confusions arising from ongoing legal disputes.
• Patent Enforcement:
  • Vigilance: Patent owners are increasingly focused on protecting their IP and licensees from unfair competition.
  • Potential Litigation: The first US approval of a CRISPR Cas9 therapeutic (exa-cel) is likely to spur litigation among rights holders.
  • Protecting Patents: Those involved feel strongly about protecting their patents. ERS Genomics is very willing to litigate.
• Freedom to Operate:
  • Conduct Thorough Analysis: Perform comprehensive freedom-to-operate searches to ensure new products or services do not infringe on existing patents.
• Patent Strategy:
  • "Whitespace": Identify the whitespaces to file valuable patents in more niche industry applications where AI has not yet made its value clear. The much larger space of niche applications will yield a great number of strategically valuable patents in the years to come.
  • Proactive Strategy: Given the fast pace of technological advancement, it's important to build a proactive patent strategy to provide strong, defensible positions and establish a market advantage.
• Due Diligence:
  • Verify Licenses: Confirm that suppliers have the necessary licenses before obtaining reagents in the CRISPR space.
  • Understand Limitations: Adhere to label licenses, especially regarding commercial use.

Key Considerations

• Early Engagement: Address patent matters early to avoid potentially higher costs later.
• Impact of AI: There are large language model models that create three-dimensional outputs, impacting the medical devices, 3D printing, life sciences and material science industries. The non-functional appearance of the three-dimensional outputs can be also be protected by design patents.
• Research Exemptions: Understand that research-use exemptions for patents vary globally and may not cover all activities.

Conclusion

The CRISPR Cas9 patent landscape is complex and evolving. Companies must proactively manage IP risks and opportunities. A strategic approach that includes securing necessary licenses, enforcing patents, conducting thorough freedom-to-operate analysis, and staying informed about legal and technological developments is essential for success in this revolutionary field.

‍