IP Overview for Drugs and Biologics
Part 1 – Patents and Related IP Protections and Mechanisms

Alissa Lipton
Partner
Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)
Patent Protection for Drugs and Biologics
- Summarizing the patenting process 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