4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA

Director Christopher Gallo will be a speaker during module 1, “Key Agencies Overview: Understanding the Jurisdiction and Interplay of the FDA and the USPTO in the Patenting of Drugs, Biologics and Biosimilars,” at the 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA on October 8, 2024 hosted by American Conference Institute.

Session Overview

Understanding the respective roles and interplay of the FDA and PTO in the patenting and approval of drugs and biological products:

FDA

• FDA overview and organization
  • Department of Health and Human Services and the Commissioner
  • The 6 FDA Centers and the Office of Regulatory Affairs and their functions
• CDER (Drug) and CBER (Biologic) in-depth overview
• Defining the scope of the FDA’s jurisdiction with respect to drugs, biologics and biosimilars
• Examining how the FDA exercises its jurisdiction:
  • rule making
  • product decisions
  • enforcement
  • informal mechanisms
• Reviewing the laws that the FDA enforces relative to the patenting of drug and biological products
  • Food Drug & Cosmetic Act
  • Prescription Drug Marketing Act
  • Public Health Services Act
  • Hatch-Waxman Act
  • other applicable laws
• Defining drugs and biologics
• Labeling: when is a drug a drug and not a biologic
• Working with the FDA
  • Administrative Procedures Act
  • formal and informal dispute resolution mechanisms

The USPTO

• Review of the organizational structure of the PTO
• Patents: overview of drug and biological products that may be patented
• Who may apply for a patent? What are the requirements for patentability?
  • agency and inventorship
• What is the PTO’s jurisdiction in the patenting of drugs and biologics?
• What laws and regulations does the PTO enforce relative to the patenting of drugs and biologics?
• Patent Reform Legislation
• Trademarks vis-à-vis drugs, biologics and biosimilars