Featured Experts
Sean Nicholson
Professor, Department of Economics,
Professor, Brooks School of Public Policy,
Cornell University;
Senior Advisor, Cornerstone Research
Margaret K. Kyle
Chair in Intellectual Property and Markets for Technology,
MINES ParisTech
Iain M. Cockburn
Richard C. Shipley Professor in Management,
Questrom School of Business,
Boston University
Darius Lakdawalla
Quintiles Chair in Pharmaceutical Development and Regulatory Innovation, School of Pharmacy,
Professor, Sol Price School of Public Policy,
Chief Scientific Officer, Leonard D. Schaeffer Center for Health Policy and Economics,
University of Southern California
Alice Chen
Associate Professor,
Sol Price School of Public Policy;
Director of the Value of Life Sciences Innovation Program,
Leonard D. Schaeffer Center for Health Policy and Economics,
University of Southern California
David C. Chan Jr.
Chancellor’s Chair and Professor,
Robinson Life Science, Business, and Entrepreneurship Program,
Haas School of Business, University of California, Berkeley;
Staff Physician, Codirector, Center for Policy Evaluation,
Department of Veterans Affairs
Featured Case Experience
In matters alleging patent infringement by a biosimilar entrant, Cornerstone Research and an affiliated expert have examined damages resulting from the entry of a biosimilar version of a blockbuster biologic drug.
To assess lost profits, Cornerstone Research and the expert modeled the impact of biosimilar entry on the price and volume of the reference biologic drug in the actual and “but-for” worlds.
- When evaluating price erosion for the biologic drug, we analyzed factors affecting price negotiations between the biologic drug manufacturer and public and private third-party payors, hospitals, and physician clinics. For one of the matters, the price erosion analysis also took into account the possibility that, in the “but-for” world, the biosimilar drug would gain regulatory approval for only some of the indications that the reference biologic drug was approved to treat.
- The lost volume analysis built upon the observed gradual acceptance of the biosimilar drug by physicians, patients, and payors, and distinguished between treatment-naïve and continuing patients to reflect differences in biosimilar acceptance.
In addition to lost profits analyses, we have also examined reasonable royalties under the Georgia-Pacific framework and assessed the value of the first-mover advantage in the context of the biosimilar manufacturer’s incentives to enter into a hypothetical negotiation.
A leading manufacturer of high-technology medical devices retained Cornerstone Research and an affiliated expert to evaluate the patent infringement damages claims of the plaintiff, another manufacturer of such devices.
Based on an analysis of how hospitals select medical devices, we found that hospital purchasing decisions would not have changed significantly and thus the defendant’s sales would not have been lower absent the alleged infringement. We also showed that the plaintiff did not compete in all of the same geographic markets as the defendant, and therefore, could not have lost sales in those markets. Given the magnitude of lost sales that the plaintiff claimed, we also concluded that the plaintiff would have been unable to produce the additional devices without costly investment in new production capacity.
We also used evidence on the cost of developing an alternate non-infringing technology to determine an upper bound on the royalty rate that the defendant would have agreed to pay for the use of the plaintiff’s technology.
Cornerstone Research supported a health economist to analyze the loss in value of a drug in development due to the advantage that the manufacturer of a competing drug in development obtained by allegedly stealing trade secrets.
Two pharmaceutical manufacturers were collaborating on a novel drug in the early stages of development. The plaintiff alleged that the defendant stole the plaintiff’s trade secrets, annulled the collaboration, and clandestinely developed a competing drug. The plaintiff also claimed that knowledge of trade secrets gave the defendant a head start in developing its own drug.
Defense counsel retained Cornerstone Research and an affiliated expert to analyze the loss in value of the plaintiff’s drug due to the defendant’s alleged head start and to evaluate the damages estimated by the plaintiff’s expert. We analyzed the various drivers of value for the plaintiff’s drug, such as projected sales, marketing expenditures, research and development expenses, cost of capital, and timing of launch of competing drugs.
As defendants in Hatch-Waxman litigation increasingly rely on “blocking patent” arguments, Cornerstone Research and affiliated experts have examined assertions of “blocking patents” by generic companies. We have also reviewed the applicability of the “blocking patent” framework offered in the Acorda Therapeutics v. Roxane Laboratories decision in a variety of settings.
In multiple matters, our affiliated experts have opined on the relevance of alleged “blocking patents” to the evaluation of the nexus between the claimed patented inventions and the drug’s commercial success. They have also testified on the regulatory environment that governs follow-on research by third parties in the presence of alleged “blocking patents” as well as the economic mechanisms and incentives for conducting follow-on research in the presence of such patents.
In pharmaceutical patent litigation, Cornerstone Research and affiliated experts commonly evaluate whether generic, biosimilar, or competitor entry would impose irreparable harm on the patent holder and whether the full extent of such harm can be estimated with a reasonable degree of economic certainty and adequately compensated through monetary damages.
To do so, we assess the extent to which entry may lead to price erosion and/or loss of volume or market share for branded or reference biologic drugs, driven by pharmacy substitution, payer incentives, pricing and reimbursement mechanisms, and physician prescribing behavior. We also consider the effects on formulary positioning and potential loss of an early-mover advantage, evaluating whether these effects are reversible. And we account for the broader economic impacts, including adverse effects on specialized labor and relationship capital, as well as incentives and ability to finance future research and development efforts, to inform whether injunctive relief may be warranted.
