Maria Isabel Manley

Maria Isabel Manley (Marie) leads Sidley’s Life Sciences team in London and is widely recognized as a leading authority on EU and UK regulatory law. She advises start-ups and global life sciences companies on a full range of contentious and non-contentious regulatory matters, including high-stakes (“bet-the-company”) cases, investigations, and judicial challenges.

Marie’s clients span the pharmaceutical, biotechnology, medical devices, ATMP, chemicals, cosmetics, and food sectors. She has deep expertise in the full life cycle of medicinal products, advising on the optimization of IP and regulatory rights — including regulatory data protection, marketing exclusivity, paediatric extensions, and supplementary protection certificates (SPCs) — as well as on advertising, product liability, competition, and market access issues. She regularly represents and advises clients in their engagement with NICE and NHS England on Health Technology Assessments, helping to articulate the value proposition of innovative medicines and leveraging real-world evidence (RWE) to support reimbursement applications. Marie has also successfully represented pharmaceutical companies before the European Medicines Agency (EMA) in matters relating to orphan drug status and paediatric extensions.

A seasoned litigator, Marie has acted in a number of landmark cases before the EU and English courts up to the Supreme Court, including a high-profile matter recognized in The Lawyer’s Top 20 Cases (2021–2022) and awarded “Impact Case of the Year” at the LMG Life Sciences Awards (2022, 2025) and Managing IP Awards (2022). She has also represented leading pharmaceutical companies before key regulatory authorities including the European Commission, EMA, MHRA, NICE, and the UK Department of Health. She has extensive experience coordinating complex, multi-jurisdictional litigation across the EU/EEA and globally.

Beyond her client work, Marie is a frequent speaker on EU pharmaceutical and regulatory law and the co-author and co-editor of Navigating European Pharmaceutical Law (Oxford University Press, 2015).