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/Healthcare Regulation 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/Healthcare Regulation 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; consumer protection issues; and the application of the antitrust laws to and mergers and joint ventures involving regulated industries, particularly pharmaceuticals, 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 regulation 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 and biologics, food additives, GRAS substances and packaging, medical devices, and dietary supplements; FTC, DOJ, and state investigations; Hatch-Waxman matters; and Centers for Medicare and Medicaid Services healthcare regulatory matters. He has assisted with numerous life sciences transactions, including product acquisitions and licensing.

Mr. Mahinka has published nearly 70 articles on antitrust and FDA/healthcare regulation matters. He is a co-author of Life Sciences Mergers and Acquisitions (2008), and Winning Antitrust Strategies (2004), and of the ABA Antitrust Section's forthcoming Pharmaceutical Antitrust Handbook, and the Food and Drug Law Institute's forthcoming 2nd ed. of Fundamentals of Law and Regulation.

Mr. Mahinka has presented nearly 70 speeches on antitrust and FDA/ healthcare regulatory 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 Washington Legal Foundation, the Regulatory Affairs Professionals Society, IHOKEN (the Japanese pharmaceutical industry lawyers' association), and the Edison Electric Institute.

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.