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

Resolving high stakes disputes in the biotech, pharma and medical device sectors

Learn about our life sciences IP litigation practice

Unprecedented experience representing clients in tech and life sciences

Learn more about our patent litigation practice

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


  • 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
Group contacts
Sanya Sukduang  Partner Washington, DC
Jonathan Davies  Partner Washington, DC
Dr. Michelle Rhyu  Partner Palo Alto
Jon Graves  Senior Counsel Reston
Adam Pivovar  Partner Washington, DC
Eamonn Gardner  Partner Colorado