Life Sciences

NERA’s global team of economic, statistical, and data experts works with many of the world’s leading pharmaceutical and biotechnology firms, regulators, tax authorities, and other entities to provide expert analysis and testimony across a number of disciplines. 

Antitrust and Competition

In the past three years alone, NERA has represented clients in over 50 antitrust and competition matters involving pharmaceutical and biotechnology companies, including investigations before US and EU regulatory authorities, cases involving reverse payments, civil lawsuits alleging anticompetitive behavior, and pre-merger economic analysis and consulting. Our economists are well-versed in the unique competitive and regulatory issues faced by companies in the pharmaceutical and biotechnology industries and are deeply experienced in conducting the unbiased economic and statistical analysis and rigorous econometric modeling necessary to provide thoughtfully considered, highly defensible expert reports and testimony. Select examples of recent matters include:

• Analyzed potential antitrust liability and damages resulting from alleged monopolization in an over-the-counter medication market
• Assisted pharmaceutical clients before US competition authorities during merger investigations
• Provided expert analysis and testimony in a class action antitrust lawsuit against a global pharmaceutical company under Federal Rule 23 involving commonality, typicality, and the predominance of common questions related to liability and damages
• Analyzed the compatibility of dual-pricing schemes for the distribution of pharmaceutical products in the EU
• Provided expert analysis and testimony regarding class certification in a matter involving reverse payments

Intellectual Property

Over the past three years, NERA’s intellectual property economists, survey experts, and social scientists have represented clients in more than 100 matters involving branded and generic pharmaceuticals,  over-the-counter medications, and dietary supplements. Below are examples of recent matters:

• Appraised the value of intellectual property assets, determined reasonable royalty rates, and quantified damages in numerous patent infringement cases
• Provided analysis of claims for damages relating to delayed market entry of generic  pharmaceutical manufacturers under Section 8 of the Canadian Patented Medicines (Notice of Compliance) Regulations
• Provided survey evidence (including survey design and analysis of results) for class action lawsuits resulting from an alleged data breach
• Designed surveys and analyzed results in matters alleging false advertising in the dietary supplements industry
• Assisted counsel with a US Supreme Court brief relating to the economic effects of a potential stay of entry of a generic pharmaceutical
• Provided commercial success analysis for pharmaceutical clients in Hatch-Waxman ANDA matters
• Analyzed the likelihood of irreparable harm in matters being considered for preliminary and permanent injunctions

Product Liability and Mass Torts

NERA experts have been analyzing personal injury and product liability issues for almost 15 years, assisting companies with projects related to product recalls, damages claims, insurance disputes, mergers and acquisitions and consumer class actions.  Examples of recent matters include:

• Provided testimony in an insurance dispute involving whether the claims being made against a pharmaceutical company were related to on-label or off-label warnings
• Forecasted future liabilities related to personal injury claims arising from the historical use of beauty products
• Allocated claims to insurers in pharmaceutical litigation, providing advice on how to structure settlements to maximize payments available under existing insurance policies and forecasting future claims for continuing litigation with third and fourth tier insurers once primary insurer limits were exhausted

Securities

NERA is widely recognized as a leading provider of economic and financial analysis in securities and finance matters. Our experts work with pharmaceutical and biotechnology companies, directors and offices, regulators, and other entities in bet-the-company matters including mass torts, shareholder class actions, white collar criminal and regulatory enforcement actions, and commercial disputes. Examples of recent matters include:

• Provided analysis of materiality, loss causation, and damages for a cross-border (US-Canada) shareholder class action lawsuit
• Represented a client in a 10b-5 case involving a biotechnology company with an orphan drug in the pipeline
• Designed, conducted, and reviewed results of a survey in a false advertising class action lawsuit of a food supplement manufacturer

Transfer Pricing

NERA’s global Transfer Pricing Practice provides clients in the pharmaceutical, biotechnology, cosmetics, and biologics industries with expert analysis, valuation support, and advice. Our experts frequently represent clients in matters before national and international tax authorities, serve as expert witnesses in litigation and arbitration, and provide guidance to regulatory bodies responsible for domestic and global tax policy. Examples of recent matters include:

• Provided an expert testimony in tax controversy proceedings involving a multinational pharmaceutical company
• Prepared documentation for compliance with the terms of a cost sharing arrangement for a biotechnology research company
• Advised a biopharmaceutical company expanding to the US on an optimal arrangement for the intangibles ownership that takes into account the group’s operating model
• Represented a European medical supply company in a tax audit challenging the level of interest rate applicable to a convertible bond held by the parent company
• Prepared documentation of “arm’s length  charges” for intercompany transactions among the American and European operations of a pharmaceutical and beauty supply company
• Reviewed and prepared a report regarding intercompany transactions of intangibles and tangible products for a global biotechnology company
• Performed a benchmarking study for distribution, marketing, and manufacturing activities of a pharmaceutical wholesaler