Maria Isabel Manley

Partner
marie.manley@bristows.com
+44 (0)20 7400 8000



LLB Swiss Law, Lausanne University
LLM in European law, Lausanne University
LLM in International Law, Columbia University School of Law, New York
Postgraduate Diploma in EU Competition Law, King's College, London 
Qualified 1998 (New York)
Qualified 2003 (England and Wales)
Partner 2005
 
Maria Isabel Manley is a partner and head of the Regulatory Department at Bristows.  Maria Isabel specialises in IP matters with a particular focus on European and UK regulatory and competition law in the bio-pharmaceutical, chemical, medical devices, cosmetics and food sectors.  She advises on a broad spectrum of matters, both contentious and non-contentious, that arise in the conduct of a pharmaceutical or a biotechnology business (in particular those arising in the context of the life cycle management of medicinal products, including advertising and product liability).

She has represented a number of the world’s leading pharmaceutical companies in litigation before the European and the English Courts.  For example, she represented Novartis before the ECJ regarding the interpretation of the SPC Regulation. She also successfully represented Servier Laboratories Limited before the NICE Appeal Panel and before the English Court of Appeal for Judicial Review on part of that decision (the NICE guidelines now have to be reviewed to take into account all sub-groups of patients). She is currently representing a pharma company before the General Court regarding the Commission’s refusal to grant a Marketing Authorisation for an orphan drug. She also regularly represents pharmaceutical companies before UK and EU institutions (EMA, MHRA, NICE, DOH and the European Commission) as well as the PMCPA.  For example, she is currently representing a leading pharma company under investigation by the EU Competition Commission as well as representing them in an action before the English Courts. She is also experienced in coordinating EU and overseas litigation.

Maria Isabel has an international background having 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

Directory Credentials
 
Recommended for:

• London Top 100, London Top 50 Women and EU Law - Super Lawyers UK (2013)
• Commercial, IP & Regulatory - The Lawyer Hot 100 (2012)
• Life Sciences: Regulatory (Key Individual) - Chambers and Partners (2013/2012)
• Life Sciences - Best Lawyers UK (2012)
• Life Sciences: Regulatory - PLC Which Lawyer (2012)
• Pharmaceuticals and Biotechnology (Leading Individual) - The Legal 500 (2012/2011)

"The 'superb'  Maria Isabel Manley is commended for her leadership of instructions concerning the National Institute for Clinical Excellence (NICE) and the Medical and Health products Regulatory Authority (MHRA), and for her handling of mandates involving EU and competition regulations." - Chambers and Partners 2013

"Bristows’ regulatory team, led by Maria Isabel Manley, has ‘the technical and commercial acumen to secure a competitive advantage’." - The Legal 500 2012

“Maria Isabel Manley is known as a ‘hugely user-friendly lawyer’ with expertise in life sciences regulation, EU law and judicial reviews.” – Chambers and Partners 2012

“Regulatory practice head Maria Isabel Manley is ‘enthusiastic, pragmatic and aggressive when needed'. She successfully represented Servier Laboratories in its landmark Court of Appeal case against NICE.” – The Legal 500 2011

Finalist for Regulatory Team of the Year - Legal Business Awards 2011

"Maria Isabel Manley impresses interviewees with her knowledge of EU regulation. She successfully represented Servier in the Court of Appeal, leading to the National Institute for Health & Clinical Excellence (NICE) being ordered to make a fresh decision regarding an osteoporosis treatment, strontium ranelate." - Chambers and Partners 2011

"Maria Isabel Manley is 'innovative in her approach to European regulatory law and not afraid to try a creative approach to protect our rights when necessary'. She advises clients throughout the pharmaceutical, biotech and medical device industries." - Chambers and Partners 2010

"Bristows is strong in patent litigation, and Maria Isabel Manley is regarded as one of the leading regulatory life sciences lawyers in the UK. She advised Servier Laboratories in its successful landmark Court of Appeal case against NICE, and also acted for Servier in the second-ever judicial review of a NICE decision" - Legal 500 2010