Key Topics:

• Framing the Hatch-Waxman and BPCIA statutory schemes and the balance between innovation incentives, generic and biosimilar entry and commercial planning.
• Defining drugs and biologics
• Labeling: when is a drug a drug and not a biologic
• The Nuts and Bolts of the Hatch-Waxman Act and BPCIA
  • Their purpose
  • The distinct but interrelated roles of the FDA and the USPTO in drug and biologic development, including approval pathways (NDA/ANDA/BLA) and patent examination.
• Explore how innovators and follow-on sponsors use patents, listings, and timing (e.g., Paragraph IV certifications, patent dancing under BPCIA) to manage entry and competition.
• Assess strategies for extending product life (formulation, dosing, device, method-of-use) versus risks of invalidation or narrow scope.
• Evaluate coordination between regulatory filings and IP prosecution to optimize exclusivity windows.
• Practical hurdles—labeling carve-outs, patent thickets, and regulatory requirements—that affect entry and portfolio value
• How the Inflation Reduction Act (IRA) affects pricing, negotiation eligibility, launch timing, and lifecycle decisions for both small molecules and biologics.
• Consider the economic trade-offs of early vs. delayed generic/biosimilar entry in light of the IRA and revenue cliffs.

Speakers:
Howard S. Suh, Partner, Fox Rothschild
Ashley Ross, Partner, Kirkland & Ellis
 

Please note there is a cost to attend. CLE credits are available.