
Pharmaceuticals, Biologics, and Medical Devices
Through our firm’s global platform, we have represented across practice areas a wide range of companies in the pharmaceutical, biologic, and medical device industries—including large US and international pharmaceutical companies and their subsidiaries, startup and mature biopharmaceutical and biotechnology companies, large medical device manufacturers, as well as the various investors and academic and research institutions that interface with them.
Our capabilities span the entire spectrum of legal needs allowing us to provide integrated advice that results in efficiencies of both cost and precious management time. Underpinning our work is a deep understanding of the device and pharmaceutical markets from first-hand knowledge and in many instances in-house experience.
Our work includes matters involving:
- Transactions and strategic alliances
- Intellectual property
- Healthcare regulation and compliance
- Research and clinical trials
- Privacy and data monetization
- Food and Drug Administration
- Antitrust and competitor challenges
- Litigation and insurance coverage
- Export controls
- Foreign Corrupt Practices Act
- Patents and Hatch-Waxman cases
- Product liability
Our interdisciplinary team is a network of more than 100 lawyers experienced in solving the complex legal and regulatory issues facing pharmaceutical, biotechnology, healthcare, and medical device companies around the world. We apply cutting-edge technological and business savvy to these rapidly evolving sectors within the global healthcare industry.
We have structured some of the largest and most sophisticated drug development deals in the world. We negotiate technology transfers, research and development licenses, joint venture, and other collaborative arrangements, as well as marketing, supply, and distribution deals for clients across these industries. We help protect and enforce intellectual property rights worldwide using our technical training and experience in a wide variety of scientific disciplines. We understand the need for a close working relationship with our client’s management and scientific teams at all stages of research, development, licensing and marketing of their technology, products, and services. We frequently represent venture capital investors in evaluating the intellectual property of potential portfolio companies. Many of our lawyers have worked in clinical and research laboratories, hospitals, or in pharmaceutical and other healthcare companies and have an appreciation of the business dynamics that must be considered when developing workable solutions to complex business issues.
Additionally, we represent major universities, academic medical centers, and research institutions in connection with protection and licensing of intellectual property, Bayh-Dole issues, National Institute of Health and other federal grants, and Institutional Review Board research oversight. Our Corporate and Tax lawyers are experienced as to the issues surrounding formation of new research institutes, as well as state, municipal, and private bond offerings on behalf of educational institutions. We regularly represent technology companies who sponsor research at, or acquire technology from, academic and research institutions and government laboratories.
Lastly, our team is client-focused and practical in its approach. We strive to understand our clients’ goals so that we can efficiently tailor the use of our global platform to achieve those goals in a manner that addresses all relevant legal and regulatory issues.
Thought Leadership
Congress created a new framework around payment stablecoins but has done more than regulate a digital asset class—it has quietly set in motion a potential transformation of the regulation of core payment systems.
The US Commerce Department’s Bureau of Industry and Security has introduced a major revision of the Export Administration Regulations, 15 C.F.R. Part 730 et seq., through an Interim Final Rule extending EAR-based licensing controls on entities designated on the Entity List or Military End Users List or subject to EAR § 744.8 to affiliates in which they have a 50% or greater ownership interest directly or indirectly.
The One Big Beautiful Bill Act makes major changes to the Internal Revenue Code’s clean energy tax provisions, particularly to the provisions that were extended, expanded, and established as part of the 2022 Inflation Reduction Act.
On 3 September 2025, The Nasdaq Stock Market LLC (Nasdaq) announced a series of proposed amendments to its listing initial and continued standards aimed at strengthening market integrity.