Over the last decade, the number of inventions in this emerging field has expanded rapidly. Cell and tissue therapies hold enormous potential and the first wave of products has only recently emerged. Our Biotechnology team has supported numerous clients in this exciting area from preliminary in vitro experiments to product commercialisation.
Cells and tissues pose unique IP challenges because they are dynamic, living systems, with especially complex structures even relative to other biologics. Their production often requires sophisticated methods. Effectively protecting and defending innovations in this area requires not only specialist technical knowledge, but also an understanding of the patentability issues specific to this field, and an awareness of the relevant regulatory frameworks. This type of technology often creates additional complexities in the areas of due diligence, FTO and SPCs.
Our Biotechnology team includes specialists that have years of experience working in this field, having supported companies that pioneered some of the first commercially available cell therapies. For example, we worked with a company for over a decade on the first EMA approved allogeneic adult stem cell therapy product. We have advised on a diverse range of other technologies in this area, including stem cell-derived therapies for inflammatory and metabolic disorders, CAR-T cells, iPS cells, genetically modified animals as well as inventions involving live bacterial biotherapeutics and fungi.