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.

Products acquired through M&A often face litigation without the institutional knowledge needed to defend them. Inventors may be gone, records incomplete, and invention stories fragmented - all of which become critical weaknesses once litigation begins. This presentation will provide practical insight on how to prepare acquired products for litigation before disputes arise.

For US-based in-house teams, patent disputes are increasingly shaped by what happens in key jurisdictions abroad. Actions in the UPC, the UK, and China are now being used deliberately to influence injunction risk, royalty negotiations, and settlement outcomes in US-led disputes. For MedTech companies, cross-border disputes often intersect with regulatory approvals and global device supply chains, adding additional strategic considerations. This session focuses on how US legal teams and their counsel are integrating global forums into their overall litigation and licensing strategy.

• When and where to consider cross-border litigation in tech patent cases.
• How US-based teams are using UPC litigation in cases such as ParTec v. NVIDIA to create early leverage and pressure global settlement.
• When injunction risk in Europe meaningfully alters the US damages-focused analysis, and how US teams factor in that risk.
• How court-led rate setting in the UK (global FRAND determinations) and China (manufacturing and sales-based jurisdictional leverage) is used by US companies to narrow valuation gaps and restart stalled negotiations.

Courts are applying heightened scrutiny to damages theories in pharmaceutical and biotech patent disputes, requiring closer alignment with regulatory realities, real-world market behaviour, and contemporaneous internal documents. This session explores how in-house teams and litigators are adjusting damages strategy in light of changing acceptance around lost-profits and reasonable-royalty analysis.

• How to prove but-for causation where launch timing, labelling, or market access is uncertain (Amarin v. Hikma, 2024; Jazz v. Avadel, 2023-2024).
• When to rely on internal forecasts and marketing records to test expert damages opinions (GSK v. Teva, 2021; Acorda v. Roxane, 2019).
• Using damages analysis to guide settlement strategy and risk communication.

Join this session to hear litigators across pharma, biotech, MedTech and technology discuss how courts are deciding preliminary injunctions in recent patent cases. The workshop focuses on when to best leverage preliminary injunctions and compares outcomes and strategy across different key jurisdictions.

• Review initial preliminary injunction outcomes from the UPC, and compare preliminary injunction success across key jurisdictions, including the UK, Canada, Brazil, and Germany.
• Consider how DOJ and PTO statements of interest, such as in Radian Memory System, LLC v. Samsung Electronics Co. (E.D. Texas), may influence preliminary injunction strategy in the US.
• How preliminary injunction strategy plays out in MedTech disputes, including cases such as Insulet Corp. v. EOFlow Co. (D. Mass. 2023), where injunctions can hinge on regulatory status, product launch timing, and supply disruption in device markets.