Arnold & Porter provides integrated and comprehensive counsel to global biopharma, biotech and medical device/diagnostic companies. It has a strong presence in regulatory and compliance areas relating to FDA legislative strategies and pharmaceutical, biologics and medical device companies, with experts such as Dan Kracov, Mahnu Davar and Allison Shuren. Howard Sklamberg’s expertise in global inspections and biomedical supply chains also contributes to the practice’s international reach. Demonstrating the practice’s tangible influence in government, Jeffrey Handwerker led the firm’s representation of PhRMA’s response to the Inflation Reduction Act as well as its constitutional challenges. The practice also leveraged its extensive expertise to advise life sciences businesses in novel challenges stemming from the development of Covid-19 vaccines, drugs, medical devices, and diagnostics. Additionally, the team’s activity branches to transactional matters, investigations and dispute resolutions, and IP and litigation strategies. Its successful representation of Sanofi and Regeneron in its case against Amgen is exemplary evidence of the latter. Key figures in the practice include Abeba Habtemariam, advising on regulatory, compliance, and legislative matters, and Kristin Hicks, who focuses on counseling and litigation. Giselle Joffre, Brian Dunphy and Todd Boudreau joined the life sciences and healthcare-focused Boston office in 2024, with Eva Temkin joining Washington DC’s regulatory practice.
Legal 500 Editorial commentary
- Profile
Accolades
Client satisfaction
Key clients
- Pharmaceutical Research and Manufacturers of America (PhRMA)
- Hologic Inc.
- Sanofi S.A.
- Regeneron Pharmaceuticals, Inc.
- Pharmacosmos Therapeutics, Inc.
- Sumitovant Biopharma, Inc.
- Avantor
- Johnson & Johnson
- Bayer CropScience LP
- Monsanto
Work highlights
- Leading Johnson & Johnson in a number of high-profile matters relating to the 340B program. J&J is the first company to publicly announce a switch to a rebate model.
- Served as lead counsel to defend Regeneron’s patents protecting EYLEA®, Regeneron’s flagship product, against U.S. patent office post-grant challenges and on appeal to the Federal Circuit.
- Represented Pharmacosmos A/S in a definitive merger agreement under which it acquired G1 Therapeutics Inc for a total equity value of approximately $405 million.
Lawyers
Hall of fame
The lawyers at the very top of the profession, widely known and respected by peers and clients for their longstanding involvement in market-leading work.
Daniel Kracov
Leading partners
The strongest partners in their field, leading on market-leading deals and endorsed by peers and clients alike.
Mahnu Davar
Next generation partners
Junior partners with significant recognition from clients and peers in the market and key roles on multiple matters.
Abeba Habtemariam
Kristin Hicks
Practice head
Dan Kracov; Allison Shuren; Mahnu Davar
Other key lawyers
Jeffrey Handwerker; Abeba Habtemariam; Eva Temkin; Howard Sklamberg; Kristin Hicks; Giselle Joffre; Brian Dunphy; Todd Boudreau