Navigating Intellectual Property in Cell & Gene Therapy - Beyond CRISPR

Introduction

Cell and gene therapy (‘CGT’) is advancing at extraordinary speed, with concepts that were science fiction only a few years ago now becoming serious therapeutic strategies. Approaches targeting cancer, cardiovascular disease and even one-time curative treatments for rare genetic disorders are rapidly moving toward clinical reality.

This momentum, originally catalysed by the arrival of CRISPR-based gene editing, has reshaped how therapies are developed and communicated. Research outputs are increasingly appearing first in non-peer-reviewed channels, start-ups are forming earlier in the clinical pathway and development models are becoming faster and more iterative than traditional pharma routes. At the same time, the IP landscape is becoming more complex. While CRISPR remains central, newer areas such as allogeneic cell therapies, in vivo cell editing, immune-evasive cell engineering, target site selection and delivery systems now demand equally careful attention. Recent start-up activity, including initiatives such as Azalea Therapeutics co-founded in late 2025 by Jennifer Doudna and others, highlights how quickly the field is expanding beyond first-generation CRISPR frameworks.

Alongside this rapid innovation comes significant risk: freedom-to-operate challenges, fragmented patent landscapes and the possibility of overlooked IP constraints that can jeopardise translation from lab to clinic. These risks can be substantially reduced through early, structured IP strategy, particularly when navigating CRISPR-related rights alongside adjacent technologies that may ultimately determine clinical viability and commercial success.

This new virtual classroom seminar provides a practical foundation in CGT intellectual property strategy in Europe, focusing on how to move from therapeutic promise to therapeutic reality. It is designed for anyone involved in CGT development, including patent professionals, tech transfer teams, life sciences investors and start-up business leaders. A basic understanding of patenting and publicly known CGT technologies is assumed.

What You Will Learn

This live and interactive course will cover the following:

• Timing of patent filings in cell and gene therapy (‘CGT’), taking into account recent EPO Board of Appeal case law, with particular focus on securing valid priority for CGT-related claims, including decisions addressing non-viral delivery systems
• Practical coordination of IP strategy with funding and development milestones, including how to align patent filing decisions with cash flow constraints and the progression of CGT technologies from academic research into clinical trials
• Freedom-to-operate (‘FTO’) considerations in Europe, including analysis of therapeutic development exemptions, remaining infringement risks and lessons from recent US litigation (e.g. Blue Allele v Intellia Therapeutics)
• Overview of the current CRISPR IP licensing landscape, highlighting key stakeholders, licensing frameworks and ongoing constraints affecting commercial deployment
• Emerging high-value patent areas at the EPO and within PCT applications relevant to CGT, including CRISPR alternatives, engineering of allogeneic cell therapies and delivery technologies for in vivo targeting

Recording of live sessions: Soon after the Learn Live session has taken place you will be able to go back and access the recording - should you wish to revisit the material discussed.