Hatch-Waxman Litigation

Our lawyers are adept at resolving high-stakes ANDA disputes

Why Cooley

Our patent litigators bring decades of experience with litigating Hatch-Waxman matters and have protected billions of dollars in sales for branded pharmaceutical companies

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

At Cooley, our practice seamlessly collaborates with patent prosecutors and life sciences lawyers

We’re adept at breaking down complex scientific subject matter to educate and persuade judges

Our litigators have PhDs and master’s degrees across scientific disciplines

Read more


Our Life Sciences Litigation webinar series has launched. Check out our first webinar, Learnings from 40 Years of Litigation Under the Hatch-Waxman Act.


  • Corporate Counsel: Top firm for outside counsel for IP litigation
  • Law360: Top firm at the Federal Circuit
  • BTI Consulting: Top performer in client service
  • BTI Consulting: IP Litigation Standouts
  • Managing IP: Patent Contentious IP Star
  • Managing IP: PTAB Litigation IP Star
  • Docket Navigator: Top law firm for PTAB proceedings

Powerful trial and USPTO representation of leading technology and life sciences companies.