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Maria Isabel Manley

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

Biography What others say


Maria Isabel is a partner and head of the Regulatory Department.  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). 

Maria Isabel has represented a number of the world’s leading pharmaceutical companies in litigation before the national and the European 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 (NICE), and the Department of Health. In 2013/14, she has been involved in the hottest EU pharma cases including representing Shire before the General Court on a Paediatric extension and then successfully before the commission; representing AstraZeneca before the CJEU on a SPC matter; and intervening in the AbbVie and InterMune cases on behalf of EFPIA and PhRMA (the EU and US pharma industry associations). Maria Isabel successfully represented Clinuvel Pharmaceuticals before the EMA for a breakthrough drug. She also successfully represented Laboratoires CTRS in proceedings before the General Court against the European Commission for its refusal to grant a marketing authorisation for CTRS’ orphan medicinal product. This case is of great importance for the industry as the Court ruled on fundamental issues at stake regarding the pharmaceutical legal framework. Maria Isabel is currently representing Seattle Genetics Inc. before the CJEU in an SPC case as well as Les Laboratoires Servier against the Commission Decision alleging a breach of competition rules. She also has extensive experience in co-ordinating EU and overseas litigation.

Maria Isabel is a regular speaker at public conferences and has extensively published for major life science publications.  She is Chairperson of the Legal Affairs Community for the Drug Industry Association (DIA), a member of the Association of British Healthcare Industries (ABHI) and actively participates in the Legal Issues and Compliance Committee.

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.


Credentials
  • 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
Recommended for
  • Life Sciences - Women in Business Law (2015)
  • Fourth Edition of Best Lawyers in the United Kingdom in the practice area of Life Sciences Law (2015)
  • Top Ranked - Chambers UK (2015)
  • Life Sciences: Regulatory (Key Individual) - Chambers and Partners (2014/2013/2012)
  • Life Sciences-Regulatory – IP and Product Liability – Who’s Who Legal (2013)
  • London Top 100, London Top 50 Women and EU Law - Super Lawyers UK (2013)
  • Commercial, IP & Regulatory - The Lawyer Hot 100 (2012)
     

Marie Manley and her team are the best regulatory litigators I have ever worked with.  Their understanding of the pharmaceutical industry and knowledge of the pharmaceutical legal framework, coupled with their creativity and passion, makes them a source of invaluable support.  A true winning team!” - Antoine Ferry, CEO of Laboratoires CTRS, 2015

"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

Maria Isabel Manley is considered one of the leading regulatory lawyers in the UK, with sources describing her as "a leading expert" in the area.” Chambers and Partners 2014

“It has also developed strong regulatory capabilities, with the ‘charismatic and tenacious’ Maria Isabel ManleyThe Legal 500 2014

"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