Law360: Economics Of Harm From Biologic-Biosimilar Competition
For more than two decades and despite the Biologics Price Competition and Innovation Act of 2009, the Hatch-Waxman brand-generic disputes have dominated the...
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Michal A. Malkiewicz is an expert in applying economics, finance, statistics, and survey research methods to complex litigation and commercial disputes, intellectual property, and investigations. He has given testimony at depositions and before US state and federal courts, international arbitration panels, and administrative law judges.
Mr. Malkiewicz applies his expertise to assist law firms, businesses, regulatory agencies, individuals, and other clients in international arbitration, US litigation, and investigations. He has been retained as an expert witness in patent, copyright, and trademark infringement, false advertising, breach of contract, misappropriation of trade secrets, defamation, competition and antitrust, tortious interference, unfair import, unfair competition, and disputes, among others. For more than 15 years, Mr. Malkiewicz has been conducting antitrust and competition, commercial success, quantum of damages, economic causation, irreparable harm, monetary relief, likelihood of confusion, public interest, survey, and valuation analyses, among others.
Mr. Malkiewicz has evaluated harm, damages, competition, monetary relief, and other economic questions under the Uniform Commercial Code, the United Nations Convention on Contracts for the International Sale of Goods, the Anti-Kickback Statute, the Biologic Price Competition and Innovation Act, the Clayton Act, the Copyright Law of the United States, the Defend Trade Secrets Act, the False Claims Act, the Hatch-Waxman Act, the Lanham Act, the Sherman Act, the Telephone Consumer Protection Act, and the Uniform Trade Secrets Act, and numerous other laws, acts, and statutes.
In intellectual property disputes, Mr. Malkiewicz addressed lost profits, price erosion, reasonable royalty, profit disgorgement, unjust enrichment, injunctive relief, and likelihood of confusion factors; analyzed issues arising in the context of Standard Essential Patents and interpretation of Fair, Reasonable, and Non-Discriminatory commitments and rates; and evaluated commercial success of patented products, including in Paragraph IV Certification disputes over Abbreviated New Drug Applications before US district courts. He has also performed economic analyses and testified in Section 337 unfair import investigations before the US International Trade Commission.
Mr. Malkiewicz’s expertise includes development and analysis of consumer and other surveys and other marketing analytics tools; use of Monte Carlo simulations to validate valuation models; and econometric forecasting of future and but-for financial performance. He has extensive experience in matters involving US pharmaceutical and medical devices off-label promotion investigations; econometric analyses of complex data; and valuation of intangible assets for acquisition, licensing (inbound and outbound), and investment and financing/securitization purposes in the US and Europe.
Mr. Malkiewicz taught economics and finance to graduate students at the Institute of Social Sciences and Humanities and serves as an economics research thesis examiner at the School of Advanced Studies at Tyumen State University, Russian Federation. He has published and presented in the areas of consumer surveys, economics, and finance and served as an economic expert witness in courses offered by the National Institute for Trial Advocacy and with the Jerome Mirza Trial Academy at the University of Illinois College of Law, among others. Mr. Malkiewicz is a co-author of a chapter in the Litigation Services Handbook, a popular reference manual for financial expert witnesses.
Prior to consulting, Mr. Malkiewicz worked as a survey researcher at the National Opinion Research Center and as an economic research assistant to the Honorable Richard A. Posner, who at the time was a Judge on the United States Court of Appeals for the Seventh Circuit.