IP Overview for Drugs and Biologics
Part 2 – Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry

Eric T. Romeo
Partner
Goodwin Procter LLP
Drugs
- Overview of Hatch-Waxman and reforms
- 30-month stay; patent extensions; ANDA filer exclusivity (180 day)
- Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes
- Reviewing fundamentals of applications
- Exploring the ANDA Paragraph IV Certification, and response to Notice Letters
- Examining ANDA Standards for approval and the concepts of sameness and bioequivalence
- Special considerations: local acting drugs, labeling carve outs and other nuances
- Understanding the role of the Orange Book in the drug approval process
- listings, de-listings and use codes
- Market exclusivities and protection
- Identifying the different types of exclusivities
- Regulatory exclusivity (FDA)/ (data) exclusivity
- NCE (new chemical entity)
- 5 years data exclusivity
- indication (new indication or use)
- 3 years marketing exclusivity
- NDF (new dosage formulation)
- ODE (orphan drug exclusivity)
- PED (pediatric exclusivity)
Biologics
- Overview of biosimilar legislation and regulations, i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
- Understanding the rationale for safety and efficacy concerns surrounding second generation biologics
- Exploring the concepts of “biosimilarity” or “interchangeability”
- FDA rule-making and guidance relative to biosimilars
- Other points for consideration: substitution, naming, patents, and additional nuances
- Examining biosimilar exclusivities
- “Shall we dance” — weighing the pros and cons of participating in the patent dance
- Deciding when to provide notice of commercial marketing