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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
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