Hatch-Waxman Litigation
We partner with clients to protect their commercial interests in breakthrough technologies that are changing the world
Why Cooley
-
Our patent litigators bring decades of experience litigating Hatch-Waxman disputes and have protected billions of dollars in sales for branded pharmaceutical companies in high-stakes Abbreviated New Drug Application (ANDA) matters
-
We regularly represent research-based pharmaceutical companies on product exclusivity issues, including defending against generic challengers in Hatch-Waxman proceedings
-
We understand the important strategic and regulatory issues that are unique to pharmaceutical litigation
-
Our lawyers advise clients in all aspects of Hatch-Waxman matters, such as reviewing Orange Book-listed patents, preparing for and litigating Paragraph IV challenges, and counseling regarding antitrust considerations in settlement agreements
-
Integrated within Cooley’s renowned life sciences practice, we have significant experience in related areas, such as antitrust laws and US Food and Drug Administration (FDA) and regulatory issues, and we collaborate seamlessly with our robust patent prosecution team
-
Our team is adept at breaking down complex scientific subject matter to educate and persuade judges, including by leveraging the knowledge of our 100+ IP professionals who hold doctorate and master’s degrees in science and engineering disciplines
Virtual events
Stay up to date with our Life Sciences Litigation webinar series, which features installments including
“Learnings from 40 Years of Litigation Under the Hatch-Waxman Act”
Recognition
- LMG Life Sciences: Hatch-Waxman Litigation Firm of the Year – Branded, 2024
- The American Lawyer: IP Litigation Department of the Year finalist (2023, 2025)
The Cooley attorneys are highly skilled and exceptionally talented, and understand our needs
This content is provided for general informational purposes only, and your access or use of the content does not create an attorney-client relationship between you or your organization and Cooley LLP, Cooley (UK) LLP, or any other affiliated practice or entity (collectively referred to as "Cooley"). By accessing this content, you agree that the information provided does not constitute legal or other professional advice. This content is not a substitute for obtaining legal advice from a qualified attorney licensed in your jurisdiction, and you should not act or refrain from acting based on this content. This content may be changed without notice. It is not guaranteed to be complete, correct or up to date, and it may not reflect the most current legal developments. Prior results do not guarantee a similar outcome. Do not send any confidential information to Cooley, as we do not have any duty to keep any information you provide to us confidential. When advising companies, our attorney-client relationship is with the company, not with any individual. This content may have been generated with the assistance of artificial intelligence (Al) in accordance with our Al Principles, may be considered Attorney Advertising and is subject to our legal notices.