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.