Hatch-Waxman Litigation

WIT has extensive experience working on cases involving Abbreviated New Drug Applications (ANDAs) and understands the complexities associated with the Hatch-Waxman Act. We represent world-class academics, industry executives, and former government regulators who were carefully selected for their knowledge, experience, and ability to communicate effectively.

In an era where innovation in life sciences is advancing rapidly, intellectual property litigation in the pharmaceutical industry has grown increasingly complex. WIT closely monitors the needs and challenges of its clients to identify the industry, regulatory, and technical experts needed. Our testifying experts have extensive experience working on matters before district courts and the U.S. Patent and Trademark Office (USPTO). These professionals are prepared to use their in-depth knowledge of scientific and regulatory principles to address the critical issues in our clients’ cases.

WIT’s Hatch-Waxman Practice

WIT understands the parties, opportunities, and risks associated with Hatch-Waxman proceedings and represents leading experts in life sciences and drug development to best advise our clients. Our expert team includes pharma professionals with diverse backgrounds in pharmaceutical sciences who can explain complex drug formulations, manufacturing processes, and the science behind the drug’s action.

The team features:

  • Former industry professionals including pharmaceutical executives who possess insider knowledge on market requirements, pharma processes, and industry needs
  • Regulatory experts who are familiar with FDA regulations and the specifics of the Hatch-Waxman Act, equipping them to provide context on regulatory compliance and standards for generic drug approvals
  • Chemists who can provide insights into the chemical composition of the drug, including active pharmaceutical ingredients and any unique aspects of their synthesis
  • Pharmacologists who understand how a drug works in the body, its efficacy, side effects, and the pharmacokinetics/pharmacodynamics of the drug
  • Manufacturing process experts who can testify about the processes involved in creating the drug and any complexities or proprietary methods used
Learn more about our experts
Check out our latest Hatch-Waxman Report featuring insights on Senior Judge Richard Andrews’ acitivites and cases.
Read the Report

Our Experts

WIT represents experts who understand the Hatch-Waxman Act and the underlying issues that make related cases so complex. Their expertise covers:

  • Chemical Analysis
  • Drug Formulation
  • FDA Compliance
  • Microbiology
  • Pharmaceutical Production
  • Pharmacokinetics
  • Pharmacodynamics
Learn more about our Hatch-Waxman experts.
Contact Us