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.