The rise of the 505(b)(2) pathway is changing how branded pharmaceutical and biotech companies approach lifecycle management and litigation. Unlike ANDA generics, 505(b)(2) applicants can enter earlier with differentiated products while relying on branded data, creating a hybrid competitive threat that often falls outside traditional Orange Book assumptions. Join this workshop to hear a discussion around defence strategies from a panel of experts from the generic and innovator industries.

• How in-house teams can identify and defend against 505(b)(2) challenges.
• Distinguish ANDA generics from 505(b)(2) applicants and the implications for defence strategy.
• Identify early warning signs through development activity, regulatory engagement, and competitor monitoring.
• Analyse how formulation, dosing, and delivery changes are used to avoid listed patents.

In this fireside conversation, a senior USPTO official discusses current patent policy priorities, PTAB practice, and how the Office is approaching emerging technologies and global enforcement pressures.

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.

This judges’ panel offers candid insight into how courts approach patent disputes involving complex technologies, including software, electronics, and standards-based products. Drawing on recent decisions and, judges from key US jurisdictions will discuss what most influences outcomes from claim construction and technical tutorials to expert testimony and damages models.

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.

Ten years on from the enactment of the DTSA, trade secret law has become a core pillar of U.S. IP enforcement. Over that period, courts have clarified key aspects of the statute, including reasonable measures, extraterritorial reach, damages, and the interaction between federal and state trade secret claims. At the same time, in-house counsel, litigators, and policymakers have increasingly questioned whether the DTSA is operating as originally intended, or whether targeted reform is now needed to address cost, overreach, and changing business realities. This debate will assess whether the DTSA remains fit for purpose as it enters its second decade.

• How DTSA jurisprudence has evolved since 2016, including court treatment of reasonable measures and trade secret identification.
• Concerns around litigation cost, discovery burden, and overbroad claims in modern DTSA cases.
• How courts are applying the DTSA’s extraterritorial provisions under 18 U.S.C. § 1837.
• Whether recent enforcement outcomes and damages awards align with congressional intent.
• Review the Uniform Law Commission’s Drafting Committee’s decisions in updating the Uniform Trade Secrets Act (UTSA).

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.