Morgan Lewis

Related Events

10/10/14 14th Annual Regional Biotech Conference Doylestown, PA
Jeffry S. Mann and Stephen P. Mahinka, presenters
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Related News

08/25/14 Morgan Lewis Represents APM Terminals North America in Sale of Pioneer U.S. Container Terminal
Morgan Lewis advised leading international port terminal operator APM Terminals North America Inc. in the sale of its state-of-the-art container terminal in Portsmouth, Virginia.
07/24/14 Biosimilars Clarity Coming as FDA Eyes Sandoz Application, Law360
FDA partner Stephen Paul Mahinka is quoted regarding the FDA's landmark decision that should answer how copycat products will be named and deemed interchangeable with their branded counterparts.
07/15/14 DC Circuit Rebuke Could Shake Up CFIUS Review Process, Law360
Antitrust partner Stephen Paul Mahinka is quoted regarding the D.C. Circuit's decision to resurrect the first-ever challenge to the Committee on Foreign Investment in the United States review process.
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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

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 (21st ed, 2014)

Listed, Legal Media Group, LMG Life Sciences Guide “Life Sciences Star” -- FDA and Non-IP Litigation and Enforcement (2013)

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 合伙人


Email: smahinka@morganlewis.com
Washington, D.C.
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
United States of America
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.

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.