Combination Drugs and Patent Strategy: Avoiding Gaps in Protection

Combination drug products pose unique challenges across jurisdictions when seeking approval, patent protection, patent listing, and enforcement. These risks arise as formulation, dosing, or regulatory classification diverge from single-entity assumptions. A panel of in-house counsel and experienced litigators will examine how these issues play out in practice, strategies for protecting exclusivity, and managing biosimilar or generic challenges.

• Examine recent developments in protecting combination products, such as Orange Book listing strategy, infringement theories, and lifecycle planning.
• Identify patent listing and claim scope vulnerabilities unique to combination products.
• Examine recent developments in combination drug protection including portfolio strategy and lifecycle planning.
• Evaluate the plausibility and prior art challenges of combination products in clinical trials.
• Assess enforcement options when approval pathways and infringement theories do not align.