Hatch-Waxman Expertise

RatnerPrestia attorneys have extensive expertise handling patent-related issues involving the complex web of laws and regulations under the Hatch-Waxman Act. Group members have provided all aspects of pre-litigation counseling, for example:

  • Assessing patent portfolios.
  • Conducting freedom-to-operate searches and assessments.
  • Analyzing ANDAs.
  • Strategically evaluating Orange Book listed patents to prepare for anticipated Paragraph IV challenges.
  • Conducting prior art searches.
  • Patent validity opinions and infringement opinions.
  • FDA labeling strategies and issues related to “Section viii labeling carve-outs.”
  • Filing of FDA Citizen’s Petitions.
  • Strategies and analyses regarding non-patent exclusivities:
    • Marketing exclusivities (5-year and 3-year exclusivities).
    • Pediatric exclusivity.
    • Orphan Drug exclusivity.
    • Data exclusivity outside of the U.S.
  • Representation of clients as Delaware counsel in Paragraph IV (ANDA) litigation.