Practices

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

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Webinars

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

Recognition

  • 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.

Chambers