Pharmaceutical Law Group focuses on advising research-based life sciences companies, trade associations, and investors on the strategic interaction of FDA regulations and intellectual property law.
Areas of Expertise
- Market Protection Strategies
- Hatch-Waxman Act
- Orange Book listings
- Orphan Drug Exclusivity
- Pediatric Exclusivity
- 180-day Exclusivity
- Follow-on Biologics
Service Offerings
- Legal analysis of the application of market protection provisions on particular products; legal consultation on the operation of the Hatch-Waxman Act
- Advice to investors about anticipated market protection
- Opinions regarding Orange Book listings
- Expert witness consultation in litigation
- Corporate education on the interaction of FDA regulation and intellectual property