People

Bruce S. Manheim, Jr.

Partner

Bruce-Manheim.jpg
Bruce Manheim represents life science companies on a wide array of matters, including regulatory issues before the Food and Drug Administration and other agencies, life cycle management strategies for pharmaceuticals, GMP compliance matters, government and internal investigations, administrative agency litigation, valuation and diligence on life science transactions, and environmental compliance issues involving biotech products. Mr. Manheim has also developed special knowledge on issues surrounding research, development and commercialization of products under the Biodiversity Convention and Nagoya Protocol.

Mr. Manheim holds graduate degrees in both science and law, and brings a multidisciplinary approach to the complex issues at the forefront of today's life sciences industry. He also shares a special understanding of the manner in which in-house counsel grapple with issues confronting life science companies. He spent almost a year on a secondment as acting general counsel of a major business unit of a large medical device company. Mr. Manheim frequently counsels life science clients based outside of the United States on FDA regulatory issues and related matters.

Mr. Manheim has extensive experience representing clients on matters involving drugs, biologics, devices, cosmetics, supplements and other food products. Mr. Manheim assists clients on biosimilars and Hatch-Waxman exclusivity issues, leads internal investigations and compliance assessments, and works closely with attorneys from the Litigation/Controversy Department on civil and criminal investigations. He has filed numerous petitions with FDA and served as lead counsel in litigation challenging FDA and other federal agency actions.

Mr. Manheim was formerly a partner in the Life Sciences Group at Ropes & Gray for more than 10 years. Before that, he served as counsel and partner at a boutique FDA law firm for a decade. Prior to entering private practice, Mr. Manheim worked for many years as a senior attorney-scientist at the Environmental Defense Fund, where his practice focused on public health and environmental issues arising within both domestic and international legal frameworks.

Honors & Awards

  • Selected by his peers for inclusion in the 2014-2017 editions of the Best Lawyers in America for his work in FDA law
  • Recommended in the 2017 edition of The Legal 500 United States for Healthcare: Life Sciences
  • Recognized in the 2012, 2013 and 2014 editions of Chambers USA: America's Leading Lawyers for Business for Healthcare: Pharmaceutical/Medical Products Regulatory
  • National Law Journal 2011 “Champion Award” for Upholding the Legal Profession's Core Values Through Public Service, Pro Bono Efforts and Advocacy for Civil Liberties

Speaking Engagements

Mr. Manheim has recently made the following presentations:

  • The Nagoya Protocol and the Plant Treaty: A Practical Perspective to Compliance and the Development of ABS Agreements, Presentation at the ASHS 2015 Annual Conference, New Orleans, LA (August 2015)
  • An Ounce of Prevention is Worth a Pound of Cure: Responding to the Government's Increased Reliance on the Park Doctrine and OIG Exclusion of Corporate Officers, Presentation at AdvaMed2011, Washington, (September 2011) 
  • Biosimilars: Building the Path Forward, Presentation at the FDA/CMS Summit, Washington, (December 2011)
    Biosimilars in Mergers, Licensing and Collaboration Arrangements, Presentation to the First C5 Forum, London (January 2012)
  • U.S. FDA Regulation of Drugs and Biologics: Legal Overview and Case Studies, Presentation to the Korea Pharmaceutical Manufacturers Association, Seoul (April 2012)
  • Reducing Regulatory Risks in Transactions: Key Actions and Best Practices, Presentation at the Deloitte Touche Tohmatsu Life Sciences Seminar, Tokyo (September 2012)
  • Biosimilars in the United States: The Emerging Regulatory Framework, Presentation to the Japan Pharmaceutical Legal Affairs Association, Tokyo (September 2012)
  • Utilizing the Biosimilar Approval Pathway to Gain Access to the World’s Most Lucrative Pharmaceutical Market, Presentation to the Second C5 Forum, Munich (December 2012)

Recent Highlights

Mr. Manheim’s recent experience includes the following matters:

FDA Regulatory Matters

  • Assisted a major biotechnology company with numerous legal and legislative issues surrounding the development and implementation of the biosimilars legislation.
  • Submitted citizen petitions, and assisted in preparation for Advisory Committee meetings, on various issues involving approval of generic versions of complex products.

Investigations and Compliance Assessments

  • Conducted an internal investigation of GMP and promotional issues surrounding a biologic product with black box warnings concerning immunogenicity.
  • Assisted in the defense of the chairman of a medical device company in a government enforcement investigation involving allegations of improper marketing of devices.
  • Led a post-acquisition investigation and analysis of a pharmaceutical company’s marketing practices and compliance protocols.

Transactional Activities

  • Conducted diligence and prepare an evaluation of the value of a target company in connection with its acquisition by a large pharmaceutical firm.  
  • Counseled a large medical device company on various issues surrounding royalty agreements, consulting agreements and grant agreements.

Biodiversity Compliance Audits

  • Assisted a major pharmaceutical company on compliance issues and access-benefit sharing agreements arising under the Biodiversity Convention.
  • Conducted a biodiversity compliance assessment of, and developed internal compliance procedures for, the research division of an international food and nutrition company.

Professional Activities

Since entering private practice, Mr. Manheim has continued to pursue his interest in pro bono matters involving significant public policy issues. He successfully represented the Brady Campaign to Prevent Gun Violence in a lawsuit striking down a federal rule that would have allowed loaded and concealed guns in national parks and wildlife refuges. (Brady Campaign to Prevent Gun Violence v. Salazar) He currently serves as co-lead counsel to the chapters of three national medical organizations in First Amendment litigation challenging a Florida law barring physicians from asking their patients about firearm safety. (Wollschlaeger v. Farmer)

Publications & News

View

August 16, 2017

WilmerHale Lawyers Named Among the 2018 Best Lawyers in America®, Nine Recognized as Lawyers of the Year

Best Lawyers in America®—the oldest and most respected peer-review publication in the legal industry—recognizes 107 WilmerHale lawyers and names nine partners as Lawyers of the Year in its 24th edition.

July 24, 2017

WilmerHale Reps Emergent BioSolutions in $96M Acquisition of GlaxoSmithKline Anthrax Drug

Emergent BioSolutions announced it would acquire a drug for treating inhaled anthrax from pharmaceutical giant GlaxoSmithKline in an all-cash deal worth up to $96 million.

May 18, 2017

Nations Press for International Restrictions to Govern Genetic Sequence Data

As various nations consider application of international ABS requirements to GSD, research organizations and synthetic biology companies should closely follow these developments to determine how they may impact their use of GSD. Moreover, those accessing GSD should consider, if possible, the extent to which unilateral ABS agreements requirements may govern their use of such information.

February 14, 2017

WilmerHale Counsels Cynosure in $1.65B Acquisition by Hologic

The WilmerHale team on the transaction was led by Hal Leibowitz and Jason Kropp and included Andrew Bonnes, Kim Wethly, Leon Greenfield, Bruce Manheim, Steve Barrett, Laura Schneider, Amy Null, Julie Hogan Rodgers, Ciara Baker, Davis Sluis, Caroline Dotolo and Alex Civetta.

November 17, 2016

Rise of digital DNA raises biopiracy fears

Bruce Manheim is quoted in this article published in Science magazine. The article describes how the use of digital DNA may be regulated by various nations under the Nagoya Protocol and may lead to allegations of biopiracy.

November 8, 2016

Regulation of Synthetic Biology Under the Nagoya Protocol

An article by Bruce Manheim, published in Nature Biotechnology, considers whether digital sequence information from genetic resources in foreign countries will be subject to the access and benefit-sharing requirements of the Nagoya Protocol and other international agreements.

October 12, 2016

Freedom to Utilize Genetic Resources? The Nagoya Protocol Two Years Later

An article by Bruce Manheim, published as a WilmerHale Client Alert and republished by Intellectual Property Watch and Asia IP, discusses the Nagoya Protocol and how over the past two years—as various nations have adopted new provider and user measures—the Protocol's legal framework has begun to coalesce into an international regulatory scheme governing access to and use of genetic resources for research and development.

August 15, 2016

WilmerHale Lawyers Named Among the 2017 Best Lawyers in America®, Six Recognized as Lawyers of the Year

Best Lawyers in America®—a respected peer-review publication in the legal industry—recognizes 101 WilmerHale lawyers and names six partners as Lawyers of the Year in its 23rd edition.

August 11, 2016

"Follow-On Biologics": Ensuring Continued Innovation in the Biotechnology Industry

An article co-authored by Bruce Manheim, published by Health Affairs (Vol. 25, No. 2, 2006), discusses new protein products that will likely need more market protection than what is provided to new drug products.

January 14, 2016

Epizyme Inc. Closes Follow-On Offering

WilmerHale represented Epizyme Inc. in its follow-on offering announced on January 12, 2016.

Practices

Skip Navigation Links.

Education

JD, cum laude, Georgetown University Law Center, 1988

MSL, Public Policy, cum laude, Vermont Law School, 1981

MA, Biology, cum laude, Claremont Graduate University, 1978

BA, Biology, cum laude, Pomona College, 1977

Bar Admissions

District of Columbia

California

Skip Navigation Links.