Stephen Paul Mahinka is the chair of Morgan Lewis's Life Sciences and Healthcare Interdisciplinary Group. He also is a member of both the Antitrust Practice and the FDA Practice. The firm's Life Sciences and Healthcare Group, one of the nation's largest, is consistently ranked among the world's leading practices. Mr. Mahinka has practiced in both the antitrust and FDA areas throughout his career, and is the founder of the firm's FDA Practice and a former leader of the firm's Antitrust Practice. He is also co-coordinator of the firm's Advertising and Consumer Protection Practice.
In the antitrust area, Mr. Mahinka's practice includes counseling and litigation concerning mergers, joint ventures, and other collaboration agreements; pricing and price discrimination; marketing and advertising; monopolization; Department of Justice, Federal Trade Commission, and state investigations; FTC and state consumer protection issues; trade associations; the labor-antitrust exemption; and the application of the antitrust laws to regulated industries, particularly life sciences/healthcare and energy. He has testified before government agencies regarding competition issues in both the United States and Canada.
In the FDA area, Mr. Mahinka's practice focuses on regulatory, transactional, and compliance matters throughout the product lifecycle, including approval, acquisition, licensing, marketing, distribution, pricing, and enforcement concerning prescription and OTC drugs, biologics, biosimilars, food and food additives, GRAS substances and packaging, medical devices, and dietary supplements; FTC, DOJ, and state investigations; Hatch-Waxman matters; and FTC, FDA, and state consumer protection matters. He has assisted with numerous life sciences transactions, including acquisitions, collaborations, and licensing.
As part of his competition practice, he has made numerous filings to the Committee on Foreign Investment in the United States (CFIUS) concerning foreign acquisitions of or investments in U.S. national security and critical infrastructure assets. Mr. Mahinka has obtained clearances for nearly 40 transactions, representing foreign buyers and domestic sellers. He has substantial experience with CFIUS and related U.S. government agencies in mitigating Foreign Ownership, Control, and Influence (FOCI) issues that may be presented as conditions to clearance of a proposed transaction.
Mr. Mahinka has published nearly 70 articles on antitrust, FDA, and CFIUS matters. He is a co-author of Food and Drug Law and Regulation (Food and Drug Law Institute, Second Edition 2011 and forthcoming Third Edition), of Life Sciences Mergers and Acquisitions (Aspatore, 2008), and of Winning Antitrust Strategies (Aspatore, 2004), and a contributing author of the ABA Antitrust Section's Pharmaceutical Industry Antitrust Handbook (2009 and forthcoming Second Edition).
Mr. Mahinka has presented more than 80 speeches on antitrust, FDA, and CFIUS matters in the United States and Japan, at programs sponsored by such groups as the Food and Drug Law Institute, the American Bar Association's Section of Antitrust Law, the Biotechnology Industry Organization, the Japan-America Society, the Washington Legal Foundation, the Regulatory Affairs Professionals Society, IHOKEN (the Japanese pharmaceutical industry lawyers' association), and the Edison Electric Institute.
He is a former member of the firm’s Advisory Board and the firm’s Finance Committee and a former vice-chair of the Washington, D.C. office Management Committee.
Mr. Mahinka served as a law clerk to the Chief Justice of the Massachusetts Appeals Court.
Mr. Mahinka is admitted to practice in the District of Columbia.
