Roundtable 2: The Best-Laid Schemes of Mice and Human Cells: Why Building a Defensible Patent Portfolio is Critical for Advanced Therapies

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

Chaired by:

Deborah Sterling, Ph.D. Director, Biotechnology & Chemical Practice Group, Sterne, Kessler, Goldstein & Fox

&

Paul Ainsworth, Director, Trial & Appellate Practice , Sterne, Kessler, Goldstein & Fox

*Limited Capacity closed discussion - 10 personnel