Researching genetics can be complicated, the regulations and IP issues surrounding them can be even more so.
Decisions requiring IP and regulatory guidance are deeply embedded from early discovery through post-launch phases of product development. IP strategy needs to be tied to business goals, directed to the specific R&D pipeline, and evergreen. Due to the fact that all organisms are not treated the same, and the asynchronous nature of the global regulatory framework, careful planning of timing and projected costs to secure needed regulatory approvals is essential.
Join Cassie Edgar, Partner and Biotech Attorney at McKee, Voorhees & Sease who will share how appropriate intellectual property and regulatory counsel is critical for organizations developing products using gene editing technology.
What You Will Learn
- Working with gene editing technology poses unique intellectual property and regulatory challenges, from the R&D discovery through post-launch phases of the product development lifecycle
- The current regulatory framework is product specific, currently morphing and complicated by global trade issues
- To be most effective, intellectual property strategy needs to be tied to business goals, and focused on developing offensive and defensive positions beyond the traditional “is it patentable” lens