Patent Protection for Drugs and Biologics

• Summarizing the patenting process for drugs and biologics
• Patentability requirements and differing patent strategies for drugs and biologics
• Strategies for building patent protection for drugs and biologics
• 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
• Patent validity challenges and infringement proceedings for drugs and biologics under the Hatch-Waxman Act and Biologics Price Competition and Innovation Act (BPCIA)