Morgan Lewis

Related Publications

August 2013 Imperative: Comparative Effectiveness Research, LMG Life Sciences
Pressures by government and private payers on biopharmaceutical companies to establish the value of their products presents the necessity to develop outcomes date which will affect all aspects of the biopharma product lifecycle. (pdf)
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Related Events

Related News

02/21/14 Law360 Invites Nine Morgan Lewis Partners to Serve on its 2014 Editorial Advisory Boards
Morgan Lewis is pleased to announce that nine of its partners representing a broad mix of practice areas have been selected by legal news source Law360 to serve on its 2014 Editorial Advisory Boards.
02/04/14 Morgan Lewis Advises Chiesi on Completed Cornerstone Acquisition
Morgan Lewis served as legal adviser to Chiese on its acquisition of all of the outstanding common shares of Cornerstone Therapeutics.
01/01/14 Life Sciences Cases To Watch In 2014, Law360
Life Sciences partner Stephen Paul Mahinka comments on the FTC v. Cephalon , the FTC's challenge on pay-for-delay agreements restricting generic drug market entry.
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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

LMG Life Sciences Hall of Fame Inductee (2013)

Member, Law360 Life Sciences Editorial Advisory Board (2012–2013)

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

Former Executive Editor, Harvard International Law Journal

Recommended in the Regulatory area in the PLC Life Sciences Multi-Jurisdictional Guide (2012)

Recommended in the Competition/Antitrust area in the PLC Life Sciences Multi-Jurisdictional Guide (2012)

Recommended in the PLC Competition and Cartel Leniency Multi-Jurisdictional Guide (2012) 

Listed as a leading lawyer, Life Sciences: Competition/Antitrust; Recommended, Life Sciences: Regulatory; Recommended, Competition/Antitrust, PLC Which Lawyer? Yearbook 2012

Listed, Legal Media Group's Life Sciences "Life Sciences Star" – FDA and Antitrust (2012–2013)

Listed, International Who's Who of Life Sciences Lawyers (2012–2013)

Listed, Thomson Reuters Super Lawyers Washington, D.C. (2012)

Listed, Washington D.C. & Baltimore's Top Rated Lawyers, Business and Commercial (2012)

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

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

Member, International Association of Privacy Professionals

AV rated by Martindale-Hubbell

bar admissions

  • District of Columbia
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Stephen Paul Mahinka
Partner 合伙人


Email: smahinka@morganlewis.com
Washington, D.C.
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
Phone: 202.739.5205
Fax: 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/healthcare areas throughout his career, and is the founder of the firm's FDA and Healthcare Practice and a former leader of the firm's Antitrust Practice. He is also co-coordinator of the firm's Advertising, Consumer Protection, and Privacy 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/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, biosimilars, food and food additives, GRAS substances and packaging, medical devices, and dietary supplements; FTC, DOJ, and state investigations; Hatch-Waxman matters; FTC, FDA, and state consumer protection matters; joint venture matters regarding healthcare providers; and healthcare reform law issues. 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 transfers of national security and critical infrastructure assets to foreign purchasers. Over the past few years, Mr. Mahinka has obtained clearances for nearly 40 transactions, representing foreign buyers and domestic sellers, in acquisitions, investments, and joint ventures. 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 60 articles on antitrust and FDA/healthcare matters. He is a co-author of Food and Drug Law and Regulation (Food and Drug Law Institute, Second Edition 2011), 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). 

Mr. Mahinka has presented more than 80 speeches on antitrust, FDA/healthcare, 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.

史蒂芬·保罗·马欣卡先生是美国摩根路易斯律师事务所华盛顿特区分所的合伙人。马欣卡先生是该所全球生命科学跨领域业务部的主席,并曾是反垄断业务部的负责人,同时还是食品和药物管理与医疗保健业务部的创始人。

作为其反不竞争业务的一部分,马欣卡先生负责处理本所涉及美国外国投资委员会的业务。在过去几年里,马欣卡先生成功地从美国外国投资委员会获得了对24项以上交易的批准,这些交易涉及来自亚洲和欧洲收购人对美国资产的收购、投资及合资。

马欣卡先生善于处理涉及外国投资委员会和其他相关美国政府部门(如国防安全服务局(Defense Security Service ))的工作,在为解决潜在的外国所有权控制和影响问题,通过与美国政府签订协议作为条件,从而获得对某项拟定交易的批准等方面,具备十分丰富的实战经验。此外,他还协助客户适当地与联邦、州和地方政府的行政与立法官员进行协调,发表公开声明并建立联系,以此作为从外国投资委员会获得对某项拟定交易的批准的部分过程。

马欣卡先生曾任马萨诸塞州上诉法院首席法官的律政书记。

马欣卡先生于1971年毕业于约翰•霍普金斯大学(Johns Hopkins University),是著名的斐陶斐荣誉学会会员(Phi Beta Kappa),并于1974年毕业于哈佛法学院。

education

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