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?

This session brings together senior in-house patent litigators involved in some of the most influential recent pharma and biotech cases, to examine how life sciences litigation strategy is shifting and what in-house teams should be preparing for next.

• Review key cases and court decisions from the past year, and what they reveal about where pharma and biotech patent litigation is evolving.
• How PTAB procedural developments are changing risk assessment, sequencing, and settlement strategy.
• Review venue selection within the US and consider when long-arm litigation can create leverage.