Life Sciences Corporate Disputes
In recent years, the health care industry has experienced an increasing number of black box warnings and drug withdrawals, widely publicized litigation involving drug safety, and government investigations of alleged off-label promotion of prescription drugs. Patent challenges and issues related to generic entry have also received considerable attention. In this environment, the strategies pursued by brand manufacturers may be vulnerable to a variety of legal challenges.
Our experience in health economics and outcomes research, epidemiology, modeling and analytics, market access and commercial strategy, and health care policy has proven highly valuable in our expert litigation work. We have in-depth knowledge of health care data sources, access to proprietary data, and experience in analyzing data from clinical trials, FDA spontaneous reports, health insurance claims, third-party market research, and patient medical records. Our academic and in-house experts have provided strategic assistance to counsel at key points in litigation, including pretrial discovery, settlement negotiations, and trial preparation.
Our Capabilities
Intellectual Property Valuation
Determination of the economic value of patents, proprietary technologies, and licensing agreements in patent and trade secret–related disputes, including cases involving blockbuster drugs, medical devices, and pharmaceutical and biotech innovations (e.g., platform technologies, manufacturing processes) at different stages of development
Contractual Disputes and Supplier Relationships
Evaluation of commercial reasonableness of agreements and allegations of breach of contract (e.g., use of commercially reasonable efforts) in co-development and co-marketing agreements, pricing structures, and supply chain economics among health care and life sciences firms
Damages and Financial Impact
Quantification of lost profits, reasonable royalties, unjust enrichment, and economic harm in high-stakes litigation between companies within the health care and life sciences industries
Tortious Interference and Corporate Raiding
Analysis of allegations of intentional disruptions of contractual or business relationships and improper solicitation of employees or business relationships
Payer-Provider, Claims Handling and Payment, and Pricing/Coverage Disputes
Analysis of reimbursement structures, contract compliance, and disputes over medical necessity and service payments; evaluation of claim administration, denials, and practices and disputes over formulary placement and pricing strategies for pharmaceuticals and medical devices
Scientific & Statistical Experts
Providing in-depth analyses of technologies, research and development processes, clinical trials, efficacy and safety data, and manufacturing issues in disputes involving pharmaceutical and biotech assets and medical devices
Regulatory Experts
Offering insights into regulatory approval and compliance processes in life sciences litigation, including in the US, Europe, and Asia
Licensing and Business Alliance Experts
Analyzing licensing agreements, technology transfers, and revenue/cost-sharing disputes related to life sciences collaborations, including joint ventures and university partnerships
Former Life Sciences Industry Executives
Evaluating strategic, commercial, and operational considerations in disputes involving business practices, partnerships, and competitive conduct, including analyses of the feasibility, costs, and risks associated with pharmaceutical and biotech innovation, investment, and product launches
Intellectual Property Valuation Experts
Assessing the economic value of patents, trademarks, and proprietary technology in litigation and arbitration
Economic and Damages Experts
Providing lost profits, reasonable royalty, and unjust enrichment calculations; competitive analysis; and insights into the economics of innovation
