Covington’s Life Sciences Industry Group integrates the firm’s extensive transactional, regulatory and intellectual property experience to meet the specialized needs of life sciences companies. The lawyers in this group have substantial cross-disciplinary experience in these practice areas, as well as significant international experience in the major pharmaceutical markets, including practice experience in the European Union and Japan. This multi-disciplinary and multi-jurisdictional approach enables us to quickly assimilate our clients’ regulatory, intellectual property and commercial goals, identify potential issues and, as appropriate, develop creative and novel approaches to maximize value for our clients. When problems arise, we are able to help clients respond quickly to achieve efficient and cost-effective solutions.
However, our experience extends beyond the traditional legal services offered by other firms. The life sciences industry operates at the nexus of a host of unique regulatory, intellectual property and commercial considerations that vary from jurisdiction to jurisdiction. Bringing a drug from the laboratory to the marketplace involves considerable time and expense, requiring an innovator to navigate numerous complex and interrelated legal and business requirements. We advise clients throughout a product’s life cycle to facilitate efficient and effective research and development, and successful launch and commercialization, as well as to maximize the product’s franchise; our "life cycle management" approach integrates regulatory and marketing strategies, including follow-on products, over-the-counter conversion, and patent and trademark protection. We have particular experience in advising clients on the interplay among the regulatory and patent opportunities presented by the Hatch-Waxman Act.
The firm provides a full range of transactional and advisory services to pharmaceutical, biotechnology, medical device, veterinary and agricultural companies in the United States and abroad. Our clients include many of the major national and multinational pharmaceutical companies as well as a wide array of biotechnology, diagnostic and medical device companies, ranging from start-up ventures to industry leaders. We also represent the leading trade associations representing these industries, namely: the Pharmaceutical Research and Manufacturers of America (PhRMA), the National Pharmaceutical Council (NPC), the Consumer Healthcare Products Association (CHPA), and the Animal Health Institute (AHI).
Representative Matters
- We represented a coalition of vaccine and drug manufacturers in legislative proceedings in the last session of Congress that led to the enactment of provisions to limit liability for drugs and vaccines for avian flu.
- We are assisting trade associations in negotiating new legislation to govern emerging technologies, such as gene therapy, cell processing, and pharmacogenetics in the European Union, and we regularly advise companies on strategies to bring their products to the market in the United States and Europe.
- We are advising companies and trade associations on policy matters relating to the development of procedures for approval of follow-on versions of biotechnology products for which patents have expired in the United States and Europe.
- In recent years we have handled a diverse range of transactions for a large number of pharmaceutical and biotechnology clients, including Abbott Laboratories, Acorda Therapeutics, Astellas, AstraZeneca, Biosynexus, Bristol-Myers Squibb, CoTherix, Eisai, Emergent Biosolutions, Encysive, Genzyme, Gilead Sciences, GlaxoSmithKline, GPC Biotech, ImClone, King Pharmaceuticals, Medarex, Memory, Merck, Johnson & Johnson, Pfizer, Riotech (UK), Schering-Plough, SkyePharma, Solazyme, Wyeth, and others.
- We presently serve as national coordinating counsel for Hoffmann-La Roche Inc. in product liability litigation, national coordinating counsel for Purdue Pharma in antitrust and consumer protection litigation, and national coordinating counsel in all pharmaceutical products liability litigation for the Consumer Healthcare Products Association (CHPA), the Washington, DC based trade association for nonprescription drug manufacturers.
Accolades
- Law360’s "Practice Group of the Year," Health (2011)
- 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)
- The Practical Law Company (PLC) - Life Sciences, Which Law Firm? (2006-2009)
- Leading: Regulatory firm, EU and USA
- Highly Recommended: Regulatory firm, England
- Leading: Commercial & Partnering, USA
- Highly Recommended: Commercial & Partnering, England
- Leading: Government Enforcement & Investigations, USA
- Highly Recommended: Competition/Antitrust, EU
- Highly Recommended: Regulatory Medical Devices, USA
- Recommended: Corporate, USA, England
- Highly Recommended: Product Liability, England
- Recommended: Product Liability, USA
- Recognized: Intellectual Property, USA
- The Practical Law Company (PLC) - Life Sciences, Which Lawyer? (2009)
- Commercial & Partnering: John Hurvitz, Emily Leonard, Lucinda Osborne, Daniel Pavin, and Jim Snipes
- Competition/Antitrust: Georg Berrisch and David Hull
- Corporate: James Beery, Bruce Bennett, and Ellen Corenswet
- Government Enforcement and Investigations: Ethan Posner, Geoffrey Hobart, and Mark Lynch
- Intellectual Property: Paul Berman
- Regulatory: Peter Barton Hutt, Peter Bogaert, Grant Castle, Richard Kingham, Michael Labson, Eugene Lambert, and Peter Safir
- Regulatory Medical Devices: Ellen Flannery
- Chambers USA - America's Leading Business Lawyers (2011)
- Life Sciences
- Life Sciences: Corporate/Commercial - John Hurvitz, Emily Leonard and James Snipes
- Life Sciences: Regulatory/Compliance - Richard Kingham
- Life Sciences (CA)
- Life Sciences: Corporate/Commercial (CA) - Amy Toro and James Snipes
- Healthcare: Pharmaceutical/Medical Products Regulatory (DC)
- Healthcare: Pharmaceutical/Medical Products Regulatory (DC) - Scott Cunningham, Ellen Flannery, Peter Hutt, Richard Kingham, Michael Labson and Peter Safir
- Chambers UK (2011)
- Life Sciences
- Life Sciences, Product Liability
- Life Sciences, Regulatory
- Life Sciences, Regulatory, Leading Individuals: Grant Castle and Richard Kingham
- Product Liability, Mainly Defendant
- Product Liability, Food
- Chambers Global (2011)
- Life Sciences
- Life Sciences: Regulatory/Compliance
- Life Sciences: Regulatory/Compliance - Grant Castle and Richard Kingham
- Legal 500 EMEA (2011)
- EU Regulatory, Pharmaceuticals and Biotechnology
- Legal 500 UK (2011)
- Pharmaceuticals and Biotechnology
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