John R. Manthei

Chair, Health Care & Life Sciences Practice at Latham & Watkins LLP

John R. Manthei

John R. Manthei

Chair, Health Care & Life Sciences Practice at Latham & Watkins LLP

Biography

John R. Manthei is a partner in the Washington, D.C. office of Latham & Watkins and serves as global Co-chair and Washington, D.C. Chair of the Healthcare and Life Sciences Practice. His practice focuses on regulatory matters involving the Food and Drug Administration (FDA) for the medical device, pharmaceutical, biotechnology and dietary supplement industries.

Mr. Manthei’s practice includes assisting clients with all aspects of the FDA-regulated product life cycle, including, among others:


Pre-market development



FDA product submissions



Development of market exclusivity strategies



Drafting and negotiation of both US and international clinical trial agreements



FDA and Federal Trade Commission (FTC) regulation of marketing and promotion of products



Quality System Regulation and Good Manufacturing Practice requirements (including assisting in third-party audits and drafting SOPs)



FDA inspections



Recalls



FDA and Drug Enforcement Administration (DEA) export and import requirements



Civil and criminal compliance and enforcement

Prior to joining Latham, Mr. Manthei served as Majority Counsel for the US House of Representatives’ Committee on Energy and Commerce (1998-2000). In this capacity, he counseled the Full Commerce Committee, the Health and Environment, and Oversight and Investigations Subcommittee Chairmen, as well as the House Leadership on matters relating to the FDA and legislation concerning the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, and the Controlled Substances Act. Since 2000, Mr. Manthei has represented the pharmaceutical, biotechnology and medical device industries as counsel in nearly every major FDA legislative initiative. He has also testified before Congress on several occasions involving FDA and DEA regulatory and enforcement matters.

Mr. Manthei serves as outside FDA counsel to the Medical Device Manufacturers Association (MDMA) and is a former member of the Food & Drug Law Institute’s Advisory Committee for Drugs and Biologics. Mr. Manthei has been repeatedly recognized as a leading FDA attorney in Chambers USA: America’s Leading Lawyers for Business (2010 – 2015). In addition, Mr. Manthei has been recognized as a Leading Life Sciences Industry Lawyer in The Legal 500 US (2012 – 2015), as one of “Washington's Best Lawyers” by Washingtonian magazine (2013) and as “Life Sciences Industry Star” by Euromoney and LMG Life Sciences (2012 – 2014). In 2006, he was named as one of the “Top 40 Lawyers Under 40” by Washingtonian magazine, and has been recognized in Who’s Who in America, Who’s Who in American Law, Who’s Who International, and Who’s Who Legal: Lifesciences.

Mr. Manthei has authored numerous articles and has been a featured speaker and lecturer on FDA regulatory and enforcement matters at events sponsored by the Pharmaceutical Research and Manufacturers Association (PhRMA), the Biotechnology Industry Organization (BIO), AdvaMed, MDMA, BioCom, BayBio, the Food and Drug Law Institute (FDLI), the American Health Lawyers Association (AHLA), GMA, Harvard University, Stanford University and MIT, among others. Mr. Manthei also serves on the editorial boards of BNA’s Medical Device Law & Industry Report and LifeSciencesLaw 360.

In addition, Mr. Manthei has been quoted in CBS News, Washington Post, CNN, USA Today, CNBC, Boston Globe, San Francisco Chronicle, Forbes, Business Week and other leading national and international business journals on FDA regulatory, enforcement, and policy matters.

Some of Mr. Manthei’s recent publications include:

“The Regulation of Follow-On Biologics: FDA Authority and Implementation,” FDLI Publications (January 2014)
“Off Label Promotion: New FDA Standards and Guidance,” Medical Devices Law & Industry Report, Bloomberg News (April 2014)
“The Food and Drug Administration Safety and Innovation Act of 2012: Assessing the Impact on the Pharmaceutical and Biotechnology Industries,” BNA’s Pharmaceutical Law and Industry Report (August 2012)
“The Food and Drug Administration Safety and Innovation Act of 2012: Assessing the Impact on the Medical Device Industry,” BNA’s Medical Device Law and Industry Report (August 2012)
“Maintaining Eligibility for FDA Small Business Waivers Is Not So Simple: Practical Considerations for Structuring Investments in Emerging Pharmaceutical Companies in Light of SBA’s Restrictive Policies,” FDLI Update (September/October 2011)
“Medical Device Reform is (Almost) Here: FDA Announces Action Items for Improving the Agency’s 510(k) Premarket Clearance Process,” Medical Devices Law & Industry Report (March 2011)
“A Brave New World: The U.S. Food and Drug Administration's Newfound Authority for Regulation of Follow-on Biologics,” Bloomberg Law Reports (May 2010)
“What to Think About When Considering an Overseas Clinical Trial Program,” BioWorld Perspectives (March 2009)
“Exclusivity Strategies in the United States and European Union,” FDLI Update (May 2009)


May 2014
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Intellectual Property and Regulatory Issues Facing Biotech Leaders Today

Menlo Park, CA

Presentation looks at how biotechnology-related inventions may or may not qualify as patentable subject matter, the scope and boundaries of the FDA “safe harbor” exception to patent infringement, and the future of “biosimilar” drug approval and regulation under the biologics Price Competition and Innovation Act.

Overview
RelSci Relationships

2240

Number of Boards

2

Number of Awards

1

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Partner at Latham & Watkins LLP

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Office Managing Partner, San Francisco at Latham & Watkins LLP

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Partner at Latham & Watkins LLP

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Partner at Latham & Watkins LLP

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Managing Partner at Latham & Watkins LLP

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Partner at Latham & Watkins LLP

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Global Chair, International Tax Practice at Latham & Watkins LLP

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Partner at Latham & Watkins LLP

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Of Counsel at Latham & Watkins LLP

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Office Managing Partner at Latham & Watkins LLP

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John R. Manthei
Chair, Health Care & Life Sciences Practice at Latham & Watkins LLP
Education
JD
Class of 1994

The University of Wisconsin Law School is located on historic Bascom Hill in the heart of the beautiful UW–Madison campus. It boasts a renowned faculty, an extensive curriculum and a dynamic student body. As part of a world-class university located in the state’s capital, the Law School also offers an unparalleled wealth of experiences beyond its walls. An extensive curriculum places emphasis on the dynamics of the law—how the law relates to social change and to society as a whole—while at the same time stressing skill development. In addition to nationally recognized programs in several substantive areas, the Law School also has one of the largest clinical programs in the country. UW Law School offers many dual degree programs , concentrations and certificate programs. With a focus on skills-based learning, our students graduate practice-ready and prepared for success. Most UW Law School students are pursuing a J.D. (Juris Doctor) degree, while many others are earning an LL.M. (Master of Laws) or the S.J.D. (Doctor of Juridical Science). The UW Law School's nationally recognized faculty and staff work together to provide an outstanding learning environment for our students. Our faculty and staff come from a wide range of backgrounds and bring varying experiences, views and approaches to the Law School. They are inspired by the UW’s distinctive law-in-action approach, and they are committed to helping students develop into confident, successful lawyers.

BA
Class of 1990

Miami University is one of the oldest public universities in the country, made possible by an ordinance signed by President George Washington in 1795. Chartered in 1809, Miami welcomed its first students in 1824. Miami's reputation grew as quickly as its enrollment, and it became known as the "Yale of the West" for its ambitious liberal arts curriculum. Today, Miami consistently ranks among the nation's top public universities for the quality of teaching and overall student experience. One of Miami University's most famous graduates was Benjamin Harrison, who later became a President of the United States. Professor William Holmes McGuffey revolutionized the education of generations of Americans when he conducted research for his Eclectic Readers series while teaching at Miami from 1826 to 1836. The "mother of fraternities," Miami was the founding site of four national fraternities: Beta Theta Pi, Phi Delta Theta, Sigma Chi, and Phi Kappa Tau; as well as Delta Zeta sorority.

Career History
Chair, Health Care & Life Sciences Practice
Current

Latham & Watkins LLP is a full-service law firm. The firm offers services in the areas of finance, litigation, tax, banking, life sciences, private equity, real estate, government relations, employment law, and outsourcing. The firm practices in a spectrum of transactional, litigation, corporate, and regulatory areas. Latham & Watkins was established in 1934 and is based in New York, New York.

Majority Counsel
1998 - 2000

The Committee on Energy and Commerce, the oldest standing legislative committee in the U.S. House of Representatives, is vested with the broadest jurisdiction of any congressional authorizing committee. Today it has responsibility for the nation's telecommunications, consumer protection, food and drug safety, public health research, environmental quality, energy policy, and interstate and foreign commerce. It oversees multiple cabinet-level Departments and independent agencies, including the Departments of Energy, Health and Human Services, Commerce, and Transportation, as well as the Environmental Protection Agency, the Federal Trade Commission, the Food and Drug Administration, and the Federal Communications Commission.

Boards & Committees
Director
Tenure Unconfirmed

PROVIDE GRANTS TO THE DISTRICT OF COLUMBIA, VIRGINIA AND MARYLAND SCHOOL SYSTEMS FOR CRITICAL AND IMMEDIATE ASSISTANCE TO CHILDREN IN NEED.

Political Donations
$1,000
2011

Founder at Young Guns Program

$500
2009

Former Governor of Virginia

$1,000
2003
Transactions
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Vifor Pharma AG purchases Relypsa, Inc.

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Merck & Co., Inc. purchases Afferent Pharmaceuticals, Inc. from Domain Associates LLC, Pappas Capital LLC, Roche Ventures, New Leaf Venture Partners LLC, Third Rock Ventures LLC

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Allergan Plc purchases AqueSys, Inc. from SV Health Investors LLP, Rho Ventures, The Innovation Factory LLC, Accuitive Medical Ventures LLC, Longitude Capital Management Co. LLC

Awards & Honors
2013
Washingtonian Magazine - Top Lawyers, FDA Lawyers
Other Affiliations
This web site is not endorsed by, directly affiliated with, maintained, authorized, or sponsored by John R. Manthei. The use of any trade name or trademark is for identification and reference purposes only and does not imply any association with the trademark holder. The Presence of John R. Manthei's profile does not indicate a business or promotional relationship of any kind between RelSci and John R. Manthei.