Hatch-Waxman Litigation
We partner with clients to protect their commercial interests in breakthrough technologies that are changing the world
Why Cooley
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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
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We regularly represent research-based pharmaceutical companies on product exclusivity issues, including defending against generic challengers in Hatch-Waxman proceedings
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We understand the important strategic and regulatory issues that are unique to pharmaceutical litigation
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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
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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
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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
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
Chambers, 2024
Group contacts
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