Marie Manley

Partner at Sidley Austin

Speaker

MARIA ISABEL 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.

Marie is currently representing:

• Astellas Pharma before the Court of Justice of the European Union (CJEU) in relation to the interpretation of the Synthon case (C-557/16).
• Les Laboratoires Servier before the EU General Court against a European Commission decision alleging a breach of competition rules (T-691/14).
• Les Laboratoires Servier in UK parallel proceedings brought by the health authorities in England, Wales, Scotland and Northern Ireland seeking damages for an alleged over-spend of medicine as a result of an alleged breach of competition rules.

Marie recently acted in two appeals before the UK Supreme Court and a month-long trial before the High Court, winning the 2022 LMG Life Sciences “Impact Case of the Year” and the 2022 Managing IP awards “UK Impact Case of the Year.” Marie is recognized as a leader in her field, including a Band 1 ranking in Chambers UK (since 2011) and Chambers Europe 2020 for Life Sciences: Regulatory, as well as recommendations in Who’s Who Legal and Best Lawyers (since 2009). She is also ranked as “Leading Individual” for Life Sciences and Healthcare by the Legal 500 UK 2023. Marie was featured in the LMG “UK Life Science Stars” (2015), Super Lawyers “London Top 100” and “London Top 50 Women” (2015/2013), and The Lawyer “Hot 100” list (2012). Who’s Who Legal 2018 ranked her as one of the Top 5 “Thought Leaders” in Europe for Life Sciences. Marie has also been named a “Thought Leader – Global Elite” for Life Sciences in Who’s Who Legal: Thought Leaders 2023.

Marie also won the 2019 LMG “Women in Business Law Award” for “Best in Life Sciences” and more recently, Marie was recognized as “Lawyer of the Year” in Life Sciences Law by Best Lawyers 2021. Other recent praise for her client service and legal acumen includes:

• “Marie Manley leads the team. She is very hands on and a real fighter for her clients’ interests. She has extremely in-depth knowledge of the life sciences sector from a regulatory and patent perspective, as well as being right at the cutting edge of competition law in this area.” “This is a great team. They really know the life sciences sector inside out, in addition to being great and flexible lawyers and litigators. I have worked with them on quite gruelling projects and the team at Sidley methodically pulled the task apart and found all the right points. They are first rate.” (Legal 500 UK 2023)
• “Marie Manley is quite simply peerless in her field. A great strategist with a deep knowledge of regulatory matters and a joy to work with. Great practical advice. ” (Legal 500 UK 2023)
• “Marie Manley is an outstanding lawyer from a technical perspective but what makes her different is the personality that she brings to her interactions with me as an in-house lawyer and my business colleagues. ” (Legal 500 UK 2023)
• Marie is claimed to provide “Unrivalled insight into the pharmaceutical and medical device regulatory framework in the EU. ” (Legal 500 UK 2023)
• “Marie Manley is the consigliere for all critical pharma-regulatory work." “A regulatory powerhouse who provides pragmatic and commercially savvy advice." (Chambers UK 2022)
• Clients say “She grasps difficult concepts quickly, and can convey them to others and apply them to the concrete demands of the business. She is highly respected across the market for her magisterial knowledge of European pharmacovigilance, product compliance and agency investigations.” (Chambers UK 2021)
• Marie is described by clients as “bringing a very practical approach to advice.” (Chambers Europe 2020)
• Maria is one of Europe’s leading minds when it comes to life sciences-related regulatory matters. She is “a huge asset to the firm and a tenacious litigator who clients love.” (Who’s Who Legal: Thought Leaders 2019)
• “Maria Manley … is a ‘standout lawyer in the regulatory space’ who is internationally renowned in the area. One impressed source notes: ‘She is a real leader in the life sciences sector.’’” (Who’s Who Legal 2018)
• “Maria Manley is a much-admired regulatory expert concerned primarily with contentious matters associated with European market authorisation processes. Interviewees say: ‘She is a superb practitioner.’” (Chambers UK 2018)
• “Market sources report that the London-based Maria Isabel Manley … is ‘brilliant on a European level.’” (Chambers Europe 2018)
• “Interviewees say that London-based Maria Isabel Manley is ‘clearly a regulatory guru and an expert in the field. She really prepares well and knows her stuff.’ She attracts significant praise for her work on ECJ litigation testing the extent of patent protection afforded to orphan drugs or the duration of regulatory data protection.” (Chambers Europe 2017)
• “The ‘very creative and resourceful’ Maria Isabel Manley is particularly distinguished for her “exceptional knowledge of the European regulatory framework.” (Chambers UK 2017)
• “Clients praise her ‘sharp mind’ and describe her as ‘a powerhouse in the European regulatory field’.” (Chambers UK 2016)
• “Maria Isabel Manley is a ‘truly outstanding regulatory lawyer.’ She is recognised as ‘insightful’, ‘user-friendly’ and ‘technically proficient’ by pharmaceutical and biotechnology companies operating in the UK and Europe.” (Who’s Who Legal 2015)

Prior to joining Sidley in 2018, Marie was a partner and head of the regulatory department at a major UK law firm. She has previously worked in Switzerland, New York and Brussels.

She is fluent in English, French and Spanish and has a working knowledge of German, Italian and Catalan.