2024 Advanced Therapies Europe Conference

Directors Deborah Sterling and Jeremiah Frueauf spoke at the 2024 Advanced Therapies Europe Conference hosted by Phacilitate. Deborah and Jeremiah lead the discussion during the “Roundtable 2: The Best-Laid Schemes of Mice and Human Cells: Why Building a Defensible Patent Portfolio is Critical for Advanced Therapies” session.

IP protects the most important aspects of your advanced therapy medicinal product (ATMP) but the landscape of protection is evolving

• Identify the scope of what can be protected: determine what to protect and what not to protect, when to protect it, and how to protect it
• Establish goals: strategize a forward-looking IP plan that supports business goals and reduces legal uncertainties
• Review your portfolio: assess, reassess, and realign your strategy as needed when R&D progresses and law changes

IP fuels licensing and collaboration is essential in a crowded ATMP field

• Understand breadth and potential of your IP coverage with an eye to investor diligence scrutiny
• IP can draw in collaborators, be a revenue generator, and create opportunity to cross-license in a sea of ATMP delivery technologies
• Common pitfalls with licensing and collaboration – and how to avoid them

IP provides a barrier to market entry; be sure that you are not locked out

• Freedom to operate (FTO) is essential to practice your ATMP and should be at the front of mind through the product development process
• Monitor competitor landscape (both patent portfolios and litigations) to identify potential threats and take proactive measures to address them
• Public disclosure: friend or foe and a means to an end for promoting future FTO