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Bruce S. Manheim, Jr.
Partner
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With almost 30 years of regulatory, legislative and litigation experience in Washington, D.C., Bruce Manheim brings a multidisciplinary approach to the complex array of scientific and legal issues confronting the life sciences industry. Bruce has graduate degrees in both science and law. Prior to joining the firm, he worked as a senior attorney-scientist at the Environmental Defense Fund where, for almost 12 years, he focused on complex legal and scientific issues arising within both domestic and international legal frameworks.
One issue where Bruce has developed considerable expertise centers on research and development of products derived from natural sources. Bruce participated in negotiation of the United Nations Convention on Biological Diversity, which established a legal framework to govern access to a country’s genetic resources and adoption of access and benefit sharing agreements for research and commercialization of such resources. Since adoption of the Biodiversity Convention, Bruce has assisted both pharmaceutical and nutritional companies with matters arising under this international agreement and domestic implementing legislation.
At the same time, Bruce has assisted life science companies on a wide array of other matters. He has served as lead counsel in litigation challenging federal agency actions under the Food and Drug Cosmetic Act and the Freedom of Information Act. He routinely counsels clients on market exclusivity issues involving generic drugs and biosimilars, frequently in close cooperation with the firm’s intellectual property group. Bruce also leads internal investigations and conducts compliance assessments, and works closely with the firm’s government enforcement team in defending clients in criminal investigations, including those based on the responsible corporate officer doctrine.
In approaching these matters, Bruce shares a special understanding of the manner in which in-house counsel grapple with issues confronting life science companies. He recently spent almost a year on a secondment as acting general counsel of a major business unit of Medtronic. Prior to that role, Bruce counseled Bristol-Myers Squibb on internal marketing proposals and applications for CME grants on a daily basis over the course of several years. With this perspective, Bruce seeks to tailor legal counsel that accomplishes the clients’ objectives while ensuring full compliance with all applicable laws.
Naturally Sourced Compounds
- Assisted Bristol-Myers Squibb on compliance issues and access-benefit sharing agreements arising under the Biodiversity Convention.
- Counseled Bayer Pharmaceuticals on international and domestic regulatory requirements and issues surrounding a drug product derived from natural sources.
- Conducted a biodiversity compliance assessment of, and developed internal compliance procedures for, the research division of an international food and nutrition company.
Pharmaceuticals
- On behalf of Johnson & Johnson, filed citizen petitions and assisted in preparation for Advisory Committee meetings on bioequivalence issues involving complex, extended release products.
- Advised AstraZeneca on Hatch-Waxman issues and prepared FDA filings relating to same labeling requirements and bioequivalence requirements for generic versions of inhaler products.
- On behalf of a major global pharmaceutical company, submitted petitions requesting FDA to take regulatory action on prescription inhaler products, OTC drugs, and tobacco products.
- Advised a major pharmaceutical company on valuation of a target company based on regulatory and Hatch-Waxman exclusivity issues surrounding the target’s key products, including drug-device products.
Biotech and Biologic Products
- Counseled a biotechnology company on numerous legal and legislative issues surrounding the development and implementation of new biosimilars approval pathway. For Johnson & Johnson, developed and published legal arguments outlining the basis for 12 years of statutory exclusivity for new biotech products in the biosimilars legislation.
- Represented Serono Laboratories in district court and appellate litigation seeking to enjoin FDA approval of a generic version of one of Serono’s complex protein products.
- Conducted a post-acquisition, internal investigation of GMP and promotional issues surrounding a biologic product with black box warnings concerning immunogenicity.
Medical Devices
- Served on secondment as acting general counsel of the Spine and Biologics division of Medtronic, focusing on a broad array of legal and regulatory issues.
With the firm’s government enforcement team, defended the chairman of a major medical device company against allegations of improper marketing of certain devices. - Counseled a large medical device company on various complex issues surrounding royalty agreements, consulting agreements and grant agreements.
Honors & Awards
- 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
Professional & Civic Activities
Since entering private practice, Bruce has continued to pursue his interest in significant public policy issues. He serves on the firm’s Pro Bono Committee and represents individuals and organizations in pro bono cases. Bruce 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. 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.
©1996-2012 Ropes & Gray LLP. All rights reserved.
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Education
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JD, cum laude, Georgetown University Law Center, 1988
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MSL (Public Policy), cum laude, Vermont Law School, 1981
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MA (Biology), cum laude, Claremont Graduate University, 1978
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BA (Biology), cum laude, Pomona College, 1977; Phi Beta Kappa
Bar Admissions
- District of Columbia, 1989
- California, 1988
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