With US courts continuing to refine the scope of § 271(e)(1) and the European Pharma Package proposing to extend and reshape Bolar exemptions across member states, this session examines the latest litigation and regulatory developments shaping how life sciences companies structure pre-approval activity on both sides of the Atlantic.

• Examine where the line is currently being drawn under § 271(e)(1), and what recent decisions including Jazz v. Avadel (Fed. Cir. May 2025) and Ascendis v. BioMarin (ITC, ongoing), tell us about the boundaries of protected pre-approval activity.
• How to structure pre-approval activity to make the most of safe harbor protection, and where its limitations continue to drive disputes.
• Discuss the European Pharma Package's proposed extension and reshaping of Bolar exemption means for originator and generic strategy, and how US companies are adapting their pre-approval strategies in response.

Damages remain a key driver of uncertainty in tech patent disputes. This debate explores practical ways damages analysis is evolving and where targeted reforms could improve predictability and settlement outcomes.

• Reasonable royalty and apportionment lessons from cases such as Ericsson v. D-Link and VirnetX.
• Use of comparable licences and portfolio evidence in complex tech products.
• Judicial gatekeeping and procedural tools shaping damages outcomes.
• Practical reforms that could improve damages predictability in tech cases.

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.