Marie Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law. She represents development-stage, specialty and established global life sciences companies in a broad spectrum of matters, both contentious and non-contentious, including bet-the-company regulatory matters, investigations and court challenges. Marie advises clients in the pharmaceutical, biotechnology, medical devices, chemicals, cosmetics and food sectors in proceedings before both national and European courts and the regulatory agencies in the UK and across Europe. She has particular experience on issues arising during the life cycle of medicinal products, including optimization of IP regulatory rights, advertising, product liability, competition and market access issues (namely representing and advising clients in their interaction with NICE and NHS England). Marie also has experience in advising life sciences companies in commercializing e-health and m-health products in the EU, including advising on their compliance with the EU legal framework and market access issues.
Marie has represented a number of the world’s leading pharmaceutical and life sciences companies in litigation before the EU and English Courts, as well as before the regulatory authorities, including the European Commission, the European and UK medicines authorities (EMA and MHRA), the National Institute for Health and Clinical Excellence and the Department of Health. She has extensive experience in coordinating multi-jurisdictional litigation throughout the EU/EEA and overseas.
