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 and 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.

First enacted in 1979, and the basis of all modern US Trade Secret legal regulations, including the establishment of the DTSA, in August 2026 the Uniform Law Commission’s Drafting Committee’s will meet to discuss potential updates to the Uniform Trade Secrets Act (UTSA). Originally drafted to resolve inconsistencies in the treatment of trade secrets across state lines, there has since been debate as to whether the act still meets its original intentions. Proposed reforms aim to address this through key aspects of the statute, including reasonable measures, extraterritorial reach, damages, and the interaction between the UTSA and DTSA. This session will review recent changes to the UTSA, discuss ensuing strategy, and consider the effect on the DTSA, and how it may be adapted in response.

• How UTSA jurisprudence has evolved since its last amendment in 1985, including divergent state court approaches to reasonable measures, trade secret identification, and the "reasonable under the circumstances" standard.
• Concerns around inconsistencies in state-by-state adoption of the UTSA and whether it still achieves the uniformity it was designed to deliver.
• How courts are addressing the UTSA's limited extraterritorial reach, and the growing trend toward hybrid state-federal (UTSA-DTSA) filings to extend jurisdictional coverage.
• Review the Uniform Law Commission's Drafting Committee's proposed updates to the UTSA and consider how any resulting changes may require corresponding adaptation of the DTSA.

This presentation uses litigation and settlement data to examine how patent type, timing, and strategy influence settlement outcomes, retained exclusivity, and overall leverage across pharma patent litigation.

Join this session for a review of recent trade secret cases and outcomes across key jurisdictions in the US and further afield; examine how reasonable measure standards have evolved, and what courts are now accepting.

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.

In light of recent changes in PTAB practice under new USPTO Director John A. Squires, in-house teams are reassessing disclosure risk, IPR exposure, and long-term enforceability, particularly for manufacturing processes, algorithms, and data-driven know-how. This session focuses on how companies are making these calls in practice, and how patent strategy is directly shaping trade secret risk in later disputes.

• How PTAB institution trends, discretionary denial, and parallel-proceeding strategy are influencing decisions to rely more heavily on trade secrets.
• Where patent specifications, prosecution history, and expert positions have later been used to argue that information was disclosed and no longer secret.
• Managing the risk of over-disclosure in patent filings while preserving meaningful trade secret protection.
• When companies deliberately shift from patenting to trade secret protection over a product’s lifecycle, and what triggers that shift.

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.

Artificial intelligence is transforming the trade secret threat landscape. As companies deploy internal AI tools, enterprise search, co-pilots, and agentic systems, the risks posed are increasingly subtle, scalable, and harder-to-detect. Employees can extract and synthesise sensitive information without direct access to underlying repositories, and at a speed and scale that outpaces many legacy legal technical and compliance controls.  This session will examine the risks posed by internal use of artificial intelligence, consider how AI is changing the mechanics of trade secret misappropriation, and question how legal, technical, and governance frameworks must evolve in response.

• Examine how AI changes the mechanics of trade secret misappropriation, internal access, intent monitoring and proof.
• Explore how agentic AI may enable the collection summarisation and external extra-filtration of sensitive information.
• Address the growing tension between productivity and protection - how can companies embrace AI tools without unintentionally creating a machine assisted insider threat environment?
• Discuss emerging legal, technical, investigative and governance challenges, such as: When does an AI query constitute misappropriation? How should practitioners design reasonable measures, considering the risks posed by internal AI use?