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.
On 3 February 2025, the United States reached agreements with Canada and Mexico to pause tariffs on imports from those countries in exchange for actions on border security, illegal drugs, and immigration.
The Hon. Jim Chalmers MP, Federal Treasurer and the Hon. Clare O'Neil MP, Minister for Housing, Minister for Homelessness issued a joint media release on 16 February 2025 titled "Albanese Government clamping down on foreign purchase of established homes and land banking".
We welcome your email, but please understand that if you are not already a client of K&L Gates LLP, we cannot represent you until we confirm that doing so would not create a conflict of interest and is otherwise consistent with the policies of our firm. Accordingly, please do not include any confidential information until we verify that the firm is in a position to represent you and our engagement is confirmed in a letter. Prior to that time, there is no assurance that information you send us will be maintained as confidential. Thank you for your consideration.
