Clients draw on our deep knowledge of the life sciences industry—its institutional structure, its competitive environment, and its regulatory framework. Our experience spans a spectrum of cases, including antitrust, intellectual property, reimbursement disputes, product misrepresentation, securities, and breach of contract. Our staff and experts provide strategic advice, rigorous analysis, and persuasive testimony. From initial strategy through deposition and trial, clients have used our findings in hundreds of matters involving the life sciences industry.

View Selected Experts

Our extensive network includes top experts from academia and industry.

Our extensive network includes top experts from academia and industry.

Margaret K. Kyle

Chair in Intellectual Property and Markets for Technology,
MINES ParisTech

Margaret Kyle is a noted authority on competition, intellectual property (IP), and innovation, with extensive multinational experience with life sciences and healthcare topics.

Professor Kyle has been retained as an expert witness in multiple matters and has significant testifying experience, including at trial. She has provided testimony on a range of issues, including damages related to alleged product misrepresentation, pricing of pharmaceutical products, and nascent competition. The global Women@Competition platform named Professor Kyle among forty notable women competition professionals in their forties.

In her academic work, Professor Kyle has examined the impact of antitrust, trade, and IP policies on R&D investment, innovation, and competition. In particular, Professor Kyle has substantive experience with issues related to pricing of pharmaceutical products, R&D productivity, new product distribution, and competition between branded and generic pharmaceutical products. In addition, she has written about antitrust merger enforcement issues in pharmaceutical markets, with applications to other dynamic markets characterized by innovation. In the context of COVID-19, she has analyzed how incentives can promote the development of new medical technologies and advance the rapid manufacture of tests and treatments.

Professor Kyle’s previous positions include visiting professor of strategy at Northwestern University’s Kellogg School of Management; visiting scholar at the Center for the Study of Income and Productivity at the U.S. Federal Reserve Bank of San Francisco; professor at the Toulouse School of Economics; assistant professor at the London Business School, Duke University, and Carnegie Mellon University; and visiting professor at the University of Hong Kong.

Professor Kyle consults to policy entities in the United States, Europe, and the UK on competition, economics, and innovation topics. She is a member of DG Competition’s Economic Advisory Group on Competition Policy. At France’s Conseil National de Productivité, which advises the French Prime Minister and the Minister of Economic Affairs, she is one of eleven independent academic economists analyzing the country’s productivity and competitiveness, particularly issues linked to the Euro Zone. She coauthored a note on policies to encourage pharmaceutical innovation for France’s Conseil d’Analyse Économique. In the UK, Professor Kyle serves on the Research Committee for the Office of Health Economics.

Professor Kyle has coauthored chapters in the Handbook of Health Economics, the Oxford Handbook of the Economics of the Biopharmaceutical Industry, and Elsevier’s Encyclopedia of Health Economics. Her academic papers have been published in leading economics, strategy, and health policy journals. She is associate editor of the International Journal of Industrial Organization. Professor Kyle has been invited to speak at numerous conferences on issues such as nascent competition, reverse payment patent settlements, and excessive pricing.

Our extensive network includes top experts from academia and industry.

Iain M. Cockburn

Richard C. Shipley Professor in Management,
Questrom School of Business,
Boston University

Iain Cockburn specializes in competition and innovation in the life sciences, software, and information technology industries. He has provided expert testimony in intellectual property, breach of contract, product misrepresentation, and antitrust matters, addressing class certification, merits, and damages issues. Professor Cockburn’s expert testimony has covered a range of industries, including robotics, smartphones, medical devices, diagnostic testing, online auctions, cloud computing services, and oil well equipment. He has particular expertise in pharmaceuticals and biotechnology.

On pharmaceutical matters, Professor Cockburn’s expert work has covered topics that include pricing, the impact of marketing on prescribing, off-label promotion, Medicare and Medicaid reimbursement, competition between brand and generic products, reasonable royalties, and valuation issues associated with licensing and collaboration agreements.

The author or co-author of multiple book chapters, Professor Cockburn has also published articles in leading journals, including the American Economic Review, the RAND Journal of Economics, and Health Affairs. A frequent speaker on intellectual property and business strategy topics, he has presented his research at numerous academic conferences, and in policy briefings to government agencies in Canada, the United Kingdom, and the United States. Professor Cockburn is a research associate at the National Bureau of Economic Research.

Professor Cockburn has been honored with several awards for teaching and research excellence. He is the chair of the Strategy & Innovation Department at Boston University. Prior to joining the faculty of Boston University, he served as the VanDusen Professor of Business Administration in the Faculty of Commerce at the University of British Columbia. He has also been a visiting scholar at Harvard University and the MIT Sloan School of Management.

Our extensive network includes top experts from academia and industry.

Darius Lakdawalla

Quintiles Chair in Pharmaceutical Development and Regulatory Innovation,
Professor, School of Pharmacy,
Professor, Sol Price School of Public Policy,
Director of Research, Leonard D. Schaeffer Center for Health Policy and Economics,
University of Southern California

Darius Lakdawalla is a leading authority on pharmaceutical economics. Professor Lakdawalla focuses on topics related to health economics and health policy, including the value and determinants of medical innovation, the economics of health insurance and risks to health, and the industrial organization of healthcare markets. He has particular expertise with issues involving pharmaceutical industry policy, prescription drug insurance coverage and reimbursement, and alternative payment models for pharmaceuticals.

Professor Lakdawalla has served as a consulting expert in life sciences and healthcare litigation in both state and federal courts, where he addressed liability and damages issues. He has quantified the impact of pharmaceutical marketing on drug sales, analyzed irreparable harm due to patent infringement, and estimated damages related to Medicare Part D reimbursement and optimal use of medical services. Professor Lakdawalla also has years of experience providing business consulting services to major pharmaceutical companies.

An award-winning researcher, Professor Lakdawalla has published articles in leading economics, medical, and health policy journals, including the American Economic ReviewHealth Affairs, and the Journal of the American Medical Association. His article “Economics of the Pharmaceutical Industry” was published in the Journal of Economic Literature. He has also coauthored chapters in the Handbook of Health EconomicsThe Oxford Handbook of the Economics of the Biopharmaceutical Industry, and The Elgar Companion to Health Economics (2nd edition), among others.

In addition to serving on several editorial boards, Professor Lakdawalla is associate editor for the American Journal of Health Economics and the Journal of Health Economics. He previously served as associate editor for the Review of Economics and Statistics, and as an expert panelist for the National Academy of Medicine. Professor Lakdawalla is a research associate at the National Bureau of Economic Research (NBER).

For more than a decade, Professor Lakdawalla has taught courses on health economics and policy, as well as health management. Prior to joining USC, he served as senior economist and director of research at the RAND Corporation’s Bing Center for Health Economics.

Our extensive network includes top experts from academia and industry.

Sean Nicholson

Professor, Department of Economics,
Professor, Brooks School of Public Policy,
Director, Sloan Program in Health Administration,
Cornell University;
Senior Advisor, Cornerstone Research

Sean Nicholson specializes in the analysis of pharmaceutical competition, innovation, and pricing. In pharmaceutical and healthcare matters, Professor Nicholson has provided expert testimony related to antitrust and competition, product misrepresentation, fraudulent pricing, patent infringement, trade secrets, and breach of contract. He has testified at trial in federal and state court and before the International Trade Commission.

Professor Nicholson is currently conducting research in three areas: the causes of regional variations in medical spending, the value of new medical technologies, and innovation in the pharmaceutical and biotechnology industries.

Professor Nicholson teaches in the Department of Policy Analysis and Management at Cornell University. He is also a research associate at the National Bureau of Economic Research. Professor Nicholson has served as an associate editor of Health Economics and as a research director of the Upstate Health Research Network. His research has been published in the New England Journal of Medicine, the Journal of Health Economics, and the Handbook of Health Economics, among many publications. He also cosigned an amicus brief submitted to the U.S. Supreme Court in FTC v. Actavis.

Before joining the faculty at Cornell University in 2004, Professor Nicholson taught as an assistant professor of Health Care Systems at the Wharton School of the University of Pennsylvania. He has received several awards for his teaching.

Life Sciences Capabilities

Cornerstone Research’s staff and experts have conducted extensive research on pharmaceutical markets and have a deep understanding of the institutions and regulations that govern pharmaceutical competition. We have worked with life sciences clients to address:

  • Price-fixing claims
  • Reverse payment settlements
  • Life-cycle management strategies or “product hopping”
  • Monopolization and collusion claims involving allegations of delayed generic entry
  • Mergers and acquisitions
  • Predatory and discriminatory pricing
  • Exclusionary practices
  • Class certification

Life Sciences firms are often the target of False Claims Act allegations of unlawful marketing and sales practices, improper pricing, and violations of the Anti-Kickback Statute. During the investigation and litigation phases of these matters, we work with clients to identify and analyze the information needed to assess liability, damages, and penalties.

Breach of contract disputes often require detailed valuation analyses to assess damages. In addition to assessing commercially reasonable efforts and damages, we have helped clients evaluate such diverse issues as:

  • Early stage uncertainty–risk in the R&D process
  • Economic implications of generic entry
  • Impact of changes in therapeutic alternatives space
  • Effect of product life-cycle management techniques
  • Reasonableness of commercial efforts

Our staff and experts draw on their extensive knowledge of pharmaceutical and medical device markets to estimate lost profits, reasonable royalties, and the value of innovative technologies in patent infringement and trade secret matters. Attorneys and companies also engage us in Hatch-Waxman litigation, litigation involving biosimilars, and inter partes reviews to assess commercial success and irreparable harm.

We work closely with clients to evaluate class certification, causation, injury, and damages in cases involving allegations of product misrepresentation and ERISA violations. Our experts have addressed improper marketing allegations such as overstated efficacy and failure to disclose safety risks as well as alleged ERISA violations such inadequate drug coverage by health plans.

In securities litigation, clients draw on our expertise in finance, accounting, economics, and biostatistics along with our knowledge of the competitive and regulatory environments that impact life sciences firms. Attorneys and corporations often retain us when facing government investigations or private litigation to address class certification, evaluate loss causation, and estimate damages. Our experience includes matters related to:

  • Announcements of FDA approval decisions
  • Publication of clinical trial results
  • Accounting treatment of expected penalties for off-label marketing
  • Withdrawal of a blockbuster drug from the market for safety reasons
  • Value of Pharmacy Benefit Manager contracts in a pharmacy merger

Featured Cases

Featured Publications

19 May 2022

Intersection of Intellectual Property and Competition Policy in Recent Cases

The authors discuss high-profile cases in the EU and US that concern IP rights and competition policy.

23 August 2021

Why Curve-Fitting Cannot Be Used to Show Causation or Estimate Impact

Iain Cockburn discusses the problems with curve-fitting methodology in economic analysis in this Westlaw article.

9 August 2021

Evaluating Innovation Theories of Harm in Merger Review: Economic Frameworks and Difficulties

The authors discuss recent life science cases that deal with innovation theories of harm, and what economic models can be useful in reviewing propo...

8 July 2021

Cornerstone Research Staff and Experts Submit Comments to Multilateral Pharmaceutical Merger Task Force

Comments emphasize the need for the FTC to consider the varied effects of mergers on innovation.

22 July 2020

COVID-19 Implications for Pharmaceutical Litigation

Darius Lakdawalla of the University of Southern California discusses the economics of pharmaceutical markets and the impacts of COVID-19 from the m...

23 June 2020

2020 IAM Guide to Leading Patent Professionals

Intellectual Asset Management (IAM) names Henry Grabowski of Duke University and Matthew Lynde of Cornerstone Research in its annual list of leadin...

How can we help you?

For more information or assistance with a specific matter, please contact us.