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Service Offerings

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Service Offerings
Summary
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
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News & Events
Industry Developments
October 9, 2008
January 23, 2009
Presentations/Articles
Follow-On Biologics: Interaction Between Patent and Regulatory Protections
Session on Follow-On Biologics: Understanding the Role of Patents in Health Care Reform and Related Consequences for Life Cycle Strategies, 10th Anniversary Maximizing Pharmaceutical Patent Life Cycles (American Conference Institute), New York.
October 7, 2009
Intellectual Property Supersession: Biotech Intellectual Property at the Crossroads
Biotechnology Industry Organization International Convention (BIO 2009), Atlanta, Georgia
May 18, 2009
December 1, 2008
August 3, 2007
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