Life Cycle Management

Here Are Some Examples of How We Can Help:

• Create a Life Cycle Management (LCM) Plan to:
•  Generate a Patent Narrative integrating key patents/features
•  Identify new indications/therapies/eligible exclusivities
•  Identify alternative products for line extensions/enhanced pipelines
•  Identify new patents/regulatory submissions/arguments to extend exclusivity
•  Develop early strategies for potential Citizen Petitions
•  Assess new or additional dosage forms
•  Consider applicable regulatory exclusivities (including NCI/NCE/PTE/PMA/GAIN Act/Pediatric/Orphan)
•  Assess/enhance your product's "Effective Exclusivity" - leverage safety/other product features
   rendering it unique ("Complex") and potentially difficult to copy well past expiry of traditional exclusivities
•  Assess the Generic Challenge and Litigation Potential presented by your product:
• Identify potential for and hurdles to Generic Design Around of your product patents
• Identify IP and Regulatory issues and propose fixes
• Evaluate 505(b)(2) opportunities and threats
• Evaluate landscape of potential competitive branded/generic products
• Design/Organize/Implement an LCM Team
• Effectuate the LCM Plan
• Create and provide a Summary LCM Plan for Acquirer/Partner Confidential Bid Packages
• Perform Gap Analysis between where your Company is and where it could/should be