Our EU competition team has extensive experience in the life sciences sector, regularly advising companies on the full range of competition law issues, including life cycle management issues, European parallel trade and distribution issues (including co-marketing and co-promotion agreements), collaboration arrangements, IP licensing, and mergers. Our clients include many major 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. In recent years, we have represented clients in major investigations opened by the European Commission in the wake of its inquiry into the pharmaceutical sector, and particularly in connection with late life cycle management and IP strategies.
The life sciences sector operates at the nexus of a host of unique regulatory, intellectual property and commercial considerations that vary from jurisdiction to jurisdiction. The research, development and eventually marketing of life sciences products involves considerable time and expense, requiring an innovator to navigate numerous complex and interrelated legal and business requirements. Our competition law team understands this heavily-regulated sector and is able to advise clients on complex issues in this sector without having to reinvent the wheel.
Our competition law team is an integral part of Covington’s broader Life Sciences Industry Group, which brings together the firm’s extensive transactional, regulatory and intellectual property experience to meet the specialized needs of life sciences companies. 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. The effectiveness of this approach was borne out in the European Commission’s pharmaceutical sector inquiry, during which our competition lawyers were able to work hand-in-hand with our pharma regulatory, IP and government affairs lawyers to develop a holistic strategy on behalf of our clients.
Representative Matters
- Late Life Cycle Management and Patent Settlements – In the past few years, the European Commission has turned its attention to the competition issues raised by late life cycle management strategies, including patent settlements, used by pharma companies to slow the entry of generics onto the market and to get the full value out of their IP rights. It addressed these issues in the context of its inquiry into the pharma sector and has now launched individual cases against companies in order to develop case law in this area. Our EU competition team advised several companies in connection with the sector inquiry, has assisted and continues to assist clients in major investigations opened in the wake of the inquiry, and is continuing to advise clients in developing commercially-practical compliance tools to minimize their competition law exposure in connection with their life cycle management and IP strategies.
- Parallel Trade and Distribution – One of the major issues facing life science companies in Europe concerns “parallel trade” from low-priced countries into high-priced countries. Over the past decade, our EU competition team has been on the forefront of developing effective solutions addressing parallel trade issues facing the pharmaceutical industry, developing a wealth of knowledge on implementation of specific strategies.
- Licensing/R&D Collaborations – We have significant experience navigating the complex competition law rules applicable to licensing and R&D agreements, in order to provide our clients with practical advice compatible with their commercial goals. While each transaction raises its own issues, we typically advise on such threshold issues as whether the parties can even do the deal in the first place – which raises the issue of the relevant market and whether the parties are competitors on that market – as well as issues related to specific provisions of the agreement including territorial and customer restrictions, field of use restrictions, grant-backs and non-competes.
- Mergers – Through our in-depth industry expertise, we assist our life science clients to efficiently obtain merger clearance in European Union and beyond. We also advise clients on their regulatory responses to merger activity by their competitors, in order to ensure that the competitive positions of our clients are not compromised. Past deals in the life sciences sector include mergers in the consumer diagnostics, medical device, oral care, and pharmaceutical industries, amongst others.
- Policy Initiatives – For many years, we have been one of the leading law firms in Brussels helping to ensure that industry’s voice is heard in the EU legislative process and in administrative decision making. We have been active in dozens of legislative campaigns, often involving cutting-edge proposals affecting the life sciences industry.
- Compliance Tools – We have extensive experience assisting clients to develop and improve their competition law compliance efforts, including the implementation of in-person, web-cast, and on-line training programs, tailored to the needs of life science companies, and the creation of practical guidance documents for employees to maximize competition law compliance. We have also conducted workshops for in-house legal teams aimed at providing practical, hands-on experience in handling dawn raids and related enforcement activities. Additionally, in order to help our clients keep costs down, we have worked with them to develop working definitions of the relevant markets for their key products, thereby improving accuracy and consistency and also avoiding unnecessary duplication in our clients’ compliance efforts.
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