Paragraph IV Disputes

From personnel to policies, there have been changes at the USPTO and the Patent Trial and Review Board (PTAB).

UPSTO Director, John Squires, announced shortly after his appointment in the fall of 2025, that he will personally decide whether to institute an inter-partes review (IPR) or post-grant review (PGR). There has also been notice of proposed rulemaking to change IPR proceedings.

For innovators and patent challengers, it’s a critical time to assess how the new rules of the road will apply, and what petitions will actually make it through.

• Examining the PTAB’s evolving approach to IPRs and the implications for patent owners and challengers
  • Discretionary denials of IPRs at the PTAB and settled expectations
  • Use of the new voluntary Seach Disclosure Declaration (SDD) as a favorable discretionary factor

This session will examine how conception and improper inventorship can impact litigation down the line. Panelists will discuss best practices and offer an analysis of recent cases highlighting these considerations including Merck Serono S.A. v. Hopewell Pharma Ventures, Inc.

One of the goals of the Hatch-Waxman framework is to provide a clear pathway for generic drug entry. In recent years, some generic manufacturers have expressed concerns that Hatch-Waxman litigation is only the beginning as brands seek to assert patents on the same product through waves of litigation following the initial dispute. This panel will examine the need for balance between protecting patent rights and generic entry and the impact of serial litigation on Hatch-Waxman cases.

• Examining case study examples of waves of litigation on the same drug product
  • Assessing whether serial litigation could have been avoided
• Brand perspectives on protecting IP on patents not asserted in the initial Hatch-Waxman dispute
• Developing case management strategies and budgets in anticipation of further litigation
• Deciding when to launch a generic product against the risk of potential damages

• Exploring different scenarios in which you might consider seeking a jury trial
• Crafting an approach that enables the jury to fully consider complex patent cases
  • Adjusting budgets, staffing and litigation strategy
• Considering the statistical likelihood of success with a jury trial versus a bench trial
• Anticipating more scrutiny and stricter gatekeeping on admissibility of experts following EcoFactor v. Google
• Tracking trends in damages reversals
• Estimating damages post-launch

• Tracking recent trends, including an uptick in small molecule IP cases at the UPC
• Determining when and which patents to enforce at the UPC
• Examining the pros and cons of enforcing at the UPC
• Identifying trigger points for innovators to act against ‘imminent infringement’
• Exploring what constitutes ‘setting the stage’ by potential infringers
  • Boehringer Ingelheim v Zentiva
  • Identifying activities that brands should be monitoring, and Generics should exercise caution around
• UPC’s recent use of long-arm jurisdiction and what it means for non-UPC countries

This practical learning module will examine ethical dilemmas that can arise in patent litigation and how to avoid them.

• Flagging examples of inequitable conduct
• Navigating client communication
• Finding a balance between client interests and expectation and ethical obligations
• Reviewing what constitutes a Rule 11 violation

• Reviewing the mechanics of Medicare drug negotiations for maximum fair price under the IRA
  • Detailing the outcome of negotiations on the first 10 drugs selected with pricing that will go into effect in 2026 and subsequent rounds
• Examining how looming Medicare negotiations affect Hatch-Waxman litigation
• Perspectives on how Medicare negotiations are influencing on the types of drugs and patents being pursued by drug manufacturers
  • Strategies for lifecycle management on a shortened timeline

• Examining the Trump Administration’s recent policies aimed at limiting profit offshoring by drug manufacturers
• Calculating the financial impact of tariffs on drugs and API to further evaluate what products to make in the U.S. and the risk of sourcing from China and India
• Determining whether to build a manufacturing facility in the U.S. given the time, expense and fluctuating policy landscape
• Anticipating how these policies could impact the security of the drug supply, specifically for generic drug products
• Assessing the consequences for generic manufacturers
  • Whether the 180-day exclusivity continues to incentivize competition
  • Will some manufacturers pull out of the U.S. market?

• Clarifying whether the clinical trial itself is public-use-prior-art
• Determining whether patient confidentiality and other confidentiality agreements amongst clinical investigators eliminate the public use prong of prior art
• Examining how generics are using clinical trial summaries as evidence of obviousness to challenge patents through IPR and the district courts
• Navigating the tension between FDA disclosure rules for clinical trials and IP protection
• Understanding how patent examiners view clinical trials published on ClinicalTrials.gov
• Analyzing the Federal circuit’s assessment of the phrase “clinically proven effective” as support for patent claims in Bayer v. Mylan
• Devising filing strategies to maximize patent term while managing risk of invalidation
• Strategizing around dosing regimens that are disclosed prior to efficacy data
• Assessing how the district courts and CAFC have dealt with ongoing clinical trials and whether there is a reasonable expectation of success in the unpredictable arts

• Assessing what constitutes matters of interest for the U.S. Court of Appeals for the Federal Circuit
• Developing strategy and positioning your arguments
• Evaluating the statistical likelihood of success
• Perspectives on major missteps in preparing for oral argument
• Determining whether to engage appellate counsel at the trial court level
• Strategizing around when to settle and when to take the case through to judgement