Stephen Paul Mahinka

Partner

Stephen Paul Mahinka is the chair of Morgan Lewis's interdisciplinary Life Sciences Practice. He also is a member of both the Antitrust Practice and the FDA and Healthcare Practice. The firm's Life Sciences Practice, one of the nation's largest, is consistently ranked among the world's 20 leading practices in ^PLC Cross-border Quarterly's yearly life sciences review. Mr. Mahinka has practiced in both the antitrust and FDA/healthcare areas throughout his career, and is the founder of the firm's FDA and Healthcare Practice and a former head of the firm's Antitrust 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; 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. As part of his competition practice, he has made numerous filings to the Committee on Foreign Investment in the United States (CFIUS) concerning transfers of national security and critical infrastructure assets to foreign purchasers.

In the FDA/healthcare 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, food and food additives, GRAS substances and packaging, medical devices, and dietary supplements; FTC, DOJ, and state investigations; Hatch-Waxman matters; and regulatory and transactional matters regarding healthcare service providers. He has assisted with numerous life sciences transactions, including acquisitions, collaborations, and licensing.

Mr. Mahinka has published nearly 70 articles on antitrust and FDA/healthcare matters. He is a co-author of Life Sciences Mergers and Acquisitions (Aspatore, 2008), of Food and Drug Law and Regulation (Food and Drug Law Institute, 2008), and of Winning Antitrust Strategies (Aspatore, 2004), and a contributing author of the ABA Antitrust Section's Pharmaceutical Industry Antitrust Handbook (2009).

Mr. Mahinka has presented nearly 70 speeches on antitrust and FDA/healthcare 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.