Morgan Lewis

Related News

01/14/15 Life Sciences Group Of The Year: Morgan Lewis, Law360
Our Life Sciences team's work with Merck & Co. on its consumer products division sale to Bayer AG earned the firm a spot among Law360’s Life Sciences Groups of the Year.
01/02/15 Life Sciences Cases To Watch In 2015, Law360
Life Sciences partner Stephen Paul Mahinka is quoted regarding a case involving a brand-name drug manufacturer’s ability to extend the life of its patent.
10/16/14 White House Holds Back on Ralls Appeal, The Deal Pipeline (read the article)
Antitrust partner Stephen Paul Mahinka is quoted regarding the administration's decision to forgo a Supreme Court appeal.
View all news
Photo of  Stephen Paul Mahinka

practice accolades

FDA

Named the Healthcare Pricing and Reimbursement Firm of the Year by LMG Life Sciences (2013)

Ranked the second-largest U.S. healthcare law firm by Modern Healthcare (2012–2013)

Recognized as a top 10 law firm within the Life Sciences Regulatory Super League by The Practical Law Company (PLC) (2012)

Listed as Recommended in PLC's Life Sciences Multi-Jurisdictional Guide (2012)

honors + affiliations

Trustee, Gettysburg College

Former Trustee, Johns Hopkins University

Legal Media Group, LMG Life Sciences Guide Hall of Fame Inductee (2013)

Member, Law360 Life Sciences Editorial Advisory Board (2013–2014)

Former Member, Editorial Advisory Board, Food and Drug Law Journal

Former Executive Editor, Harvard International Law Journal

Listed, Who’s Who Legal:  Life Sciences -- Regulatory (2014)

Listed, Thomson Reuters SuperLawyers Washington, D.C. Food and Drugs (2014)

Listed, Best Lawyers in America – FDA Law (2014–2015)

Listed, Legal Media Group, LMG Life Sciences Guide “Life Sciences Star” FDA and Non-IP Litigation and Enforcement (20132014)

Recommended in Practical Law Company, PLC Life Sciences Multi-Jurisdictional Guide Regulatory  and Competition/Antitrust (2012)

Recommended in Practical Law Company, PLC Competition and Cartel Leniency Multi-Jurisdictional Guide (2012)

Recommended in Practical Law Company, PLC Which Lawyer? Yearbook – Life Sciences: Competition/Antitrust; Life Sciences: Regulatory; and Competition/Antitrust (2012)

Listed, EuroMoney Expert Guide to Leading Practitioners: China Competition and Antitrust (2011)

Former Chair, American Bar Association, Antitrust Law Section, Committee on Labor Exemptions

AV rated by Martindale-Hubbell

bar admissions

  • District of Columbia
print profile

Stephen Paul Mahinka
Partner


Email: smahinka@morganlewis.com
Washington, D.C.
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
United States
Phone: +1.202.739.5205
Fax: +1.202.739.3001

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.

education

  • Johns Hopkins University, B.A., Phi Beta Kappa
  • Harvard Law School, J.D.