Patent Protection for Drugs and Biologics

• Summarizing the patenting process for drugs and biologics
• Strategies for building patent protection for drugs and biologics
  • Understanding the potential implications of the proposed Patent Eligibility Restoration Act (PERA)
• Applying for and achieving extension of patent term for time spent in the drug approval process
  • Patent Term Extension (“PTE”)
  • Patent Term Adjustment (“PTA”)
• Reviewing the 271(e)(1) “safe harbor” provision
• Distinguishing the patenting process for drugs from that of biologics
• Identifying the respective roles of the FDA and the PTO in the protection of drugs and biological products Trademarks
• Overview of selecting a brand name for a proposed drug product
• Roles of the USPTO and FDA in the drug naming process
• Identifying the PTO and FDA clearances necessary for trade name/trademark approval on your product
• How does the branding process work for your product