With the Food & Drug Administration’s recent approval of the first biosimilar in the United States and continued changes in the litigation landscape, biotech innovators and biosimilar developers face increasingly complex antitrust and intellectual property issues. Bates White provides pharmaceuticals, life sciences, biotechnology, and medical devices manufacturers with strategic guidance and economic expertise that helps illuminate the complicated markets in which these products are sold.
Our team has extensive litigation and consulting experience addressing complex issues related to a biologic’s life cycle. Our professionals analyze pricing, utilization, reimbursement, and market trends and evaluate the impact of new products, patent expiration, and the entry of biosimilars. The Healthcare and Life Sciences practice combines industry expertise and rigorous analytic approaches to develop and support expert opinions on topics including antitrust damages, irreparable harm, commercial success, among others. Our experts also have an extensive track record of testimony and publications providing timely and objective insights into biotechnology markets.
- Provided consulting expertise for a global life sciences company to evaluate the economics of biosimilar entry in the United States and key international markets. The focus was on market penetration and pricing of medicines entering under a new regulatory framework for biosimilars.
- Retained by a multinational life sciences company to provide economic insight into the market for biologic and non-biologic oncology products. Bates White conducted an analysis examining current trends in biologic pricing, utilization, and reimbursement across nearly 30 countries.
- Engaged by a trade organization representing the global innovative biopharmaceutical industry to analyze the US oncology market and provide a long-term projection of overall spending. The analysis focuses on evaluating past trends in cancer care and forecasting spending in view of looming patent expirations and the impact of biosimilars.
- In Teva v. Amgen, supported Professor Tomas Philipson of The University of Chicago in his application of the four eBay factors regarding patent infringement in the market for biosimilar pharmaceuticals. Working on behalf of Amgen, Dr. Philipson’s analysis supported an injunction to prevent Teva from launching its infringing drug, Neutroval. A court-approved settlement enjoined Teva from introducing Neutroval into the United States until one month before the relevant patents were due to expire.
- In Amgen v. Sanofi, supported Professor Ernst Berndt of the Massachusetts Institute of Technology in his application of the four eBay factors after Sanofi’s biologic Praluent was found to infringe on patents related to Amgen’s biologic Repatha. Among other topics, Dr. Berndt discussed the importance of intellectual property rights in providing the necessary incentives to develop new biologic treatments. A decision on a permanent injunction is expected by the end of 2016.