ACI’s Hatch-Waxman and BPCIA Proficiency Series

Partner Steve Maebius will present on a panel titled, “Small and Large Molecule Drug Patents and Other Related IP Protections and Mechanisms,” on Thursday, October 7, 2021 during ACI’s upcoming virtual three-week program. The program will provide an in-depth review of the IP basics relative to small molecules and biologics, as well as the regulation and litigation fundamentals of the Hatch-Waxman and Biologics Price Competition and Innovation (BPCIA) Acts.

Steve and his fellow panelists will discuss patent protections for drugs and biologics as well as trademark, trade name, and trade dress protections. The topics to be discussed include:

• Patent process for drugs and biologics
• Strategies for protecting patents for drugs and biologics
• Applying for and achieving extensions of patent terms for time spent in the drug approval process
• Patent Term Extension (“PTE”) and Patent Term Adjustment (“PTA”)
• The 271(e)(1) “safe harbor” provision
• Differences between the patenting process for drugs and biologics
• Selecting a brand name for a proposed drug product
• Duties of USPTO and FDA in drug naming process
• PTO and FDA clearances necessary for trade name and trademark approval of a product
• Importance of trade dress
• Branding process for a product

For more information and to register please visit the program website.