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.

SEP disputes continue to shape the US tech patent landscape, dominated by discussions over fair rate settings and royalty negotiations. Disputes often focus on whether parties will take a licence and on what terms, with litigation being used to apply pressure, test valuation positions, and move stalled negotiations forward. In this session, we will cover how these disputes are playing out and how companies are using litigation to shape outcomes.

• How SEP holders and implementers decide when to license, litigate, or hold out, and how US litigation strategy is shaping royalty outcomes.
• Review how rate setting negotiations play out, and how the interpretation of fair rates is evolving.
• How parallel enforcement, including actions in Brazil, is used to increase pressure and break stalled negotiations.
• How streaming platform disputes (e.g. DivX v. Netflix / Amazon) demonstrate the use of litigation to force royalty discussions and resolve holdout.
• The role of codec technologies (HEVC, VVC, AV1, AAC) and implementation patents in shaping SEP licensing and enforcement strategy.

Biologics litigation is evolving beyond classic biosimilar disputes, driven by higher-value products, an uptake in branded-vs-branded disputes, and growing injunction risk. This session brings together leading litigators and in-house counsel to examine how strategy is changing.

• How biologics disputes are starting earlier and outside traditional biosimilar timelines, (e.g. Novo Nordisk v. Eli Lilly), and what this means for launch and portfolio strategy.
• Examine the rise of branded-vs-branded cases like Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., and how innovator enforcement and defence strategies are adapting.
• Review recent BPCIA cases and outcomes, including Hikma/Richter v. Amgen.
• Consider parallel proceedings in Europe and other jurisdictions and examine how they’re increasingly shaping U.S. biologics litigation decisions.

As PTAB challenges have become harder to initiate and sustain, this session considers when and how this could be used for plaintiffs and defendants. In sectors like MedTech, where device manufacturing, component supply chains, and the importation of medical technologies are central to disputes, the ITC can present a particularly strategic forum. This session examines when Section 337 investigations offer real strategic advantage, and when their speed and remedies create more risk than value.

• How and when the ITC offers strategic advantages over other forums.
• How parties are sequencing ITC investigations with PTAB proceedings and district court actions, in light of discretionary denial risk and parallel-proceeding dynamics.
• How SEP and FRAND arguments are treated at the ITC, including limits on injunctive relief, public-interest considerations, and how these issues affect leverage for both implementers and SEP holders.
• Compare outcomes of tech disputes at the UPC and ITC; review recent decisions and consider the benefits the UPC’s higher injunction rates.