Patexia Insights 215: Benefits and Challenges of Multidistrict Litigations in Hatch-Waxman cases

When several ANDA filers seek approval for the same drug, a branded pharmaceutical company may struggle to bring Hatch-Waxman Act patent infringement lawsuits against all challengers in a single court due to venue limitations. In recent years, multidistrict litigations (MDLs) have become a tool for companies to consolidate these cases into a single venue for managing pretrial proceedings.

By bringing together cases that share common factual issues, MDLs streamline pretrial processes, minimizing redundancy in discovery and motion practice. This approach not only conserves time and resources for all parties involved but also promotes more consistent legal outcomes, making MDLs an increasingly attractive option in Hatch-Waxman litigation.

Historical Context and the Impact of TC Heartland

Historically, MDLs were rarely used in Hatch-Waxman cases, with fewer than a dozen being formed before 2019. However, from 2019 to 2021, the legal landscape began to shift, with a notable increase in centralization motions concerning brand-name drugs. The 2017 Supreme Court decision in TC Heartland narrowed venue options for patent infringement cases, fueling this trend. In response, brand-name pharmaceutical companies have increasingly turned to MDLs to consolidate litigation in favorable jurisdictions, allowing them to manage multiple ANDA cases more efficiently and avoid the complications of litigating in various districts.

Advantages of Using MDLs in Hatch-Waxman Cases

Using MDLs begins with determining whether the cases share common questions of fact, such as similar patent claims or related issues involving the same drug. These cases, often pending in different federal districts, can be consolidated through a motion filed with the Judicial Panel on Multidistrict Litigation (JPML). Once the JPML approves the motion, a designated court, known as the transferee court, manages the consolidated pretrial proceedings. This approach allows for streamlined coordination, reducing redundancy, and ensuring consistent legal outcomes.

For brand-name drug manufacturers facing numerous ANDA filings from different generic companies, managing these cases in a single forum through an MDL helps avoid inconsistent rulings across jurisdictions and simplifies the overall litigation strategy. Additionally, the strategic selection of venue (especially important after the TC Heartland decision) enables companies to centralize cases in more favorable jurisdictions, giving them greater control over the litigation process and improving their chances of achieving favorable outcomes.

MDLs tend to offer fewer advantages for Hatch-Waxman defendants, as the discovery process directed at defendants is unlikely to have been repetitive if the cases had been handled separately. However, defendants can still gain some advantages, such as cost savings by allowing parties to share resources like expert witnesses and discovery materials. Defendants with lesser stakes in the case might opt to take a more passive role, allowing those with greater exposure to lead the litigation.

Potential Challenges of MDLs and the Remand Process

While MDLs offer numerous benefits in Hatch-Waxman cases, they also present challenges that can complicate the litigation process. One major challenge is the potential loss of control over individual cases. In an MDL, cases are consolidated under a single court for pretrial proceedings, with a lead counsel or steering committee typically appointed to manage the litigation. This centralized approach can dilute the influence of individual plaintiffs or defendants, as decisions are often made with the collective group in mind rather than tailored to each party's specific interests. Additionally, the MDL process may lead to a one-size-fits-all approach to discovery and pretrial motions, potentially weakening unique arguments or evidence of specific parties that might not fit into broader case strategy.

The necessity for cases in MDLs to be sent back to the original venue for trial (unless an agreement or waiver is in place) introduces practical challenges. Litigators should consider these challenges and formulate strategies to manage them, particularly since the trial court will have to apply claim constructions that it did not establish and might not fully support. The remand process can delay the resolution of cases, especially in Hatch-Waxman cases, where consistent determinations of patent validity are crucial.This transition can disrupt the momentum built during the MDL phase and create inconsistencies, as the original court may not be as familiar with the case details as the MDL judge. The logistical complexities of coordinating a smooth remand across multiple jurisdictions can result in delays, increased costs, and greater uncertainty for the parties involved.

The Crucial Role of Expert Witnesses in MDLs

Expert witnesses play an essential role in the success of ANDA litigations, particularly within the context of MDLs. The vast amounts of data related to drug development and manufacturing that must be analyzed in these cases present significant challenges. Expert witnesses, often supported by teams of junior experts, use advanced analytical tools to provide insights that support the legal positions of the parties involved. In MDLs, having experts provide consistent interpretations during pretrial proceedings, including Markman hearings for claim construction, helps avoid conflicting arguments that could arise if different courts were handling similar cases separately. Well-developed scientific theories of the case and credible expert witness testimony can also help narrow the issues at trial. Their ability to present complex scientific data in a clear, understandable manner is crucial for ensuring that the nuances of the case are effectively communicated to the court.

The balance between judicial efficiency and the need for consistent legal outcomes is a central concern in Hatch-Waxman MDLs. While MDLs can streamline complex litigation, the remand process may undermine this efficiency. This highlights the need for careful strategic planning when considering the use of MDLs in Hatch-Waxman litigation.

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