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Practice Areas

Pharmaceutical Law Group PC

Representing and advising established and development-stage pharmaceutical and medical device manufacturers and distributors in a wide range of matters, including:

  • the requirements and strategies for pursuing marketing authorizations
  • the regulatory implications of Orphan Drug status and Treatment protocols
  • the requirements and obligations related to Investigational New Drug (IND) exemptions

Intellectual Property

Representing and advising biomedical technology companies and trade associations on a wide range of intellectual property issues, including:

  • patent and non-patent market exclusivity provisions of the Drug Price Competition and Patent Term Restoration Act of 1984
  • patent validity and enforceability analysis
  • the preparation and prosecution of patent applications

Technology Licensing

Advising and representing established and development-stage biomedical companies and trade associations on a wide range of technology licensing matters, including:

  • patent, trade secrets, know-how license agreements
  • integration of intellectual property law and food and drug regulatory law in structuring and negotiating technology license agreements
  • advising on intellectual property law and food and drug regulatory issues arising in proposed corporate transactions