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.
L'éditorial du Legal 500
Distinctions
La satisfaction du client: Qualité de l’avocat et de l’équipe
La satisfaction du client: Facturation et efficacité
La satisfaction du client: Connaissance du secteur
La satisfaction du client: NPS ®
Clients clés
- 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
- LigaChem Biosciences
- AprilBio
Points forts
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.
Responsable de la pratique
Dan Kracov; Allison Shuren; Mahnu Davar
Autres avocats clés
Jeffrey Handwerker; Abeba Habtemariam; Eva Temkin; Howard Sklamberg; Kristin Hicks; Giselle Joffre; Brian Dunphy; Todd Boudreau