Pharma & Biotech 2026 - Agenda

Recent court decisions in Skinny Label cases show that liability increasingly focuses on post-launch conduct and real-world use, not label text alone. A panel of leading in-house counsel and litigators with innovative, biosimilar, and regulatory perspectives will address shifting litigation strategy.

• How branded and biosimilar companies should align legal, regulatory, and commercial behaviour.
• Analyse GSK v. Teva (Coreg) and the evidentiary role of marketing materials, sales conduct, and physician messaging.
• Discuss the original ruling in Amarin Pharma v. Hikma (Fed. Cir. 2024) , and examine the significance of Supreme Court review.
• Clarify evolving boundaries of permissible conduct for medical affairs, market access, and commercial teams.
• Compare with decisions made in other key jurisdictions including Canada and Europe.

Gain firsthand insight into how judges from the PTAB and federal courts in key jurisdictions are approaching pharmaceutical and biotech patent disputes. This session offers a rare opportunity to hear directly from the decision-makers on litigation strategy, evidentiary expectations, and what most influences outcomes in complex patent cases.

Hatch-Waxman case outcomes are often decided by early choices that shape risk, cost, and leverage long before trial. This session offers a structured review of how companies are building and defending Hatch-Waxman cases, from the first Paragraph IV notice through to final judgement.

• Identify strategic decision points from Paragraph IV notice to trial, and where early decisions most influence outcomes.
• Review recent key Hatch-Waxman cases, such as Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC (Fed. Cir. 2025), and Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC (Fed. Cir. 2025); examine how their outcomes have influenced litigation strategy.
• Managing evidence, discovery scope, and expert strategy.
• Compare US Hatch-Waxman litigation strategy to parallel approaches in Canada and other key jurisdictions, including differences in timing, remedies and leverage.

Under Director Squires’ leadership, the PTAB has seen reduced reliance on discretionary denials and a recalibrated role for inter partes review. This session brings together former PTAB faculty and experienced PTAB litigators to examine how institution standards are being applied in practice, why certain challenges are proving less viable than before, and when alternatives such as ex parte re-examination may offer a more effective path.

• Why challengers are re-assessing IPR risk and turning to ex parte re-examination, including trade-offs around timing, estoppel, and examiner workload.
• How patent owners are using PTAB uncertainty to influence parallel litigation and settlement leverage.
• Practical guidance on selecting and sequencing invalidity tools in the current PTAB environment
• Consider venues in alternative jurisdictions such as the EPO and UPC.

As life sciences patent disputes increasingly span multiple jurisdictions and rely on a wider range of venues beyond the traditional US forums, litigation in the ITC, UPC and Brazil are becoming increasingly viable options. This session compares the benefits of these jurisdictions and sequencing forums to maximise leverage, manage risk, and protect market access across the ITC, UPC and Brazil.

• Deciding between the ITC, UPC, and Brazil based on speed, remedies, and procedural posture.
• When ITC Section 337 actions provide strategic advantage alongside or instead of Hatch-Waxman or BPCIA litigation.
• How the UPC and Brazilian courts offer injunction pressure unavailable in US proceedings.
• How venue choice affects discovery scope, timing, and settlement leverage in pharma and biologics patent disputes.
• Coordinating US, European, and Brazilian actions to manage estoppel, delay, and strategic enforcement.

A practical discussion on how in-house teams decide not to sue despite apparent infringement. Focused on risk, cost, precedent, and internal decision-making rather than legal theory.

Discuss disputes where manufacturing processes, scale, or technical constraints ultimately dictated infringement and validity outcomes.

How the Canadian and American court system deals with medical treatment and dosage cases, including Janssen Inc. v. Pharmascience Inc. (Supreme Court of Canada).

Discuss how assignor estoppel shapes litigation strategy for biotech companies facing founder-originated patents, and discover the most effective defence, settlement, and risk management strategies.

Discuss the strategic deployment of European litigation venues for US pharma companies, including the UK High Court litigation, UPC proceedings and EPO
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oppositions, and compare the impacts on injunction risk, cost exposure, and global settlement dynamics.

Discuss how life sciences companies prepare for future patent disputes by refining early-stage litigation strategy, anticipating procedural risk, and strengthening internal readiness to improve outcomes.