Part 1- Patents and Related IP Protections and Mechanisms

Jonathan B. Roses
Shareholder
Wolf, Greenfield & Sacks, P.C.
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