Service Offerings

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