Covington & Burling opened its first European office in 1988 and now has approximately 80 lawyers in London and Brussels. The European food and drug practice group includes more than twenty-five lawyers, who are qualified in various EU Member States, and several research assistants with law or science degrees. Collectively, the lawyers and other staff speak the main languages of the European Union, and the offices maintain extensive collections of EU and national regulatory materials.
The group has advised hundreds of companies and trade associations, including many of the major multinational pharmaceutical manufacturers, biotechnology companies, and major producers of medical devices, cosmetics, foods, food additives, food packaging, dietary supplements, pesticides and specialty chemicals, and other consumer products. The offices handle regulatory matters before the European Commission, the European Medicines Agency, and national regulatory agencies in the European Union, and they provide extensive regulatory advice to individual clients. The European offices also handle public policy, litigation, trademark, international tax, compliance, and corporate and commercial matters for food and drug industry clients. The European offices are closely integrated with the Washington and Beijing offices, so they can provide clients with coordinated advice on multinational matters and immediate access to all of the firm’s facilities and staff.
Representative Matters
- We have actively participated in the development of key pharmaceutical legislation in Europe, including the Orphan Medicines Regulation, the 2004 revision of the EC pharmaceutical legislation, the Paediatrics Regulation, the Pharmaceutical Penalties Regulation, the Advanced Therapy Medicinal Products Regulation, and recent major amendments to the general legislation on medicinal products, including changes in the rules on drug safety reporting.
- We are counsel to Pharmaceutical Research and Manufacturers of America (PhRMA) in Europe on various legislative and policy issues, and we have advised the European Federation of Pharmaceutical Industries and Associations and trade associations of the pharmaceutical industry in EU member states.
- We successfully defended a pre-market approval in Olivieri v. Commission (T-326/99), the first legal challenge of an EC approval for a medicine before the EC Court of First Instance.
- We represented Merck in MSD v. Commission (Case T 273/03). The EC Court annulled a decision of the Commission harmonizing the labeling for Renitec.
- We represented Shire and Janssen-Cilag before the English High Court and the European Court of Justice in Generics (UK) Ltd. v. Licensing Authority (2009), which held that a drug product approved in an EU candidate member state before its accession to the Union could not later be used as the reference product for a generic marketing authorization application in an EU member state. This is one of the few recent decisions of the European courts favoring the interests of innovative pharmaceutical manufacturers in the interpretation of the EU generic drug rules, and it remains highly relevant because of the numerous Eastern European countries that have entered the Union in recent years.
- We advise various pharmaceutical companies with respect to life cycle management planning.
- Our European offices have provided coordinated regulatory advice to multiple companies in the post-merger integration of manufacturing and sales operations for pharmaceutical and medical device companies in Europe and numerous jurisdictions around the world.
Accolades
- PLC Cross-border Super League
- Ranked 1st in the Life Sciences Regulatory Super League (2004-2011)
- Ranked 1st in the Life Sciences Industry Super League (2005-2009)
- PLC - Life Sciences, Which Law Firm? (2011)
- Leading: Regulatory firm, EU, USA, and England
- Chambers UK (2011)
- Life Sciences
- Life Sciences: Regulatory/Compliance
- Life Sciences: Regulatory/Compliance - Richard Kingham and Grant Castle
- Chambers Global (2011)
- Life Sciences
- Life Sciences: Regulatory/Compliance
- Life Sciences: Regulatory/Compliance - Grant Castle and Richard Kingham
- Legal 500 UK (2010)
- Pharmaceuticals and Biotechnology
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