Client Alert

Takeaways from Paul Hastings’ Completion of the First Zoom Hatch-Waxman Act Trial in DNJ

October 07, 2020

By Eric Dittmann, Isaac S. Ashkenazi, Dana Weir & Max Yusem

Even in disputes in which billions of dollars hang in the balance for clients, remote trials on video platforms such as Zoom are emerging as a viable way to try important cases during the COVID-19 pandemic. These remote trials present unique challenges for litigators who thrive on intimate courtroom interactions with judges, witnesses, and even opposing counsel, but also create new opportunities for trial lawyers and their teams, who are able to focus on the strengths of their case while showcasing their virtual technology skills.

Life sciences intellectual property litigators from Paul Hastings recently had the chance to test their own virtual mettle in an important pharmaceutical patent case involving valuable patent assets, Mitsubishi Tanabe Pharma Corporation, et al. v. Sandoz Inc., et al. (DNJ C.A. No. 17-5319), which is the first Hatch-Waxman litigation to be tried remotely from start to finish in the District of New Jersey, and one of the first nationally.

The first phase of the trial proceeded over five days of remote hearings in the District of New Jersey in front of Chief Judge Freda Wolfson. It encompassed testimony from six experts and a fact witness, as well as opening statements from both sides, all conducted over Zoom videoconferencing. Among many highlights, the mother of a young litigator was able to watch her son take testimony for the first time thanks to videoconferencing. It was both far different from “business as usual” for such litigation and also surprisingly similar. The experience afforded by this unique trial may serve as a useful template for similar future litigations.

Trial Background

The virtual trial, held from September 24 through October 2, represented the culmination of years of litigation by Paul Hastings LLP on behalf of its client Mitsubishi Tanabe Pharma Corporation (“MTPC”) regarding key Orange Book patents covering the blockbuster endocrinology drugs Invokana® and Invokamet®. Although a number of generic producers have sought to challenge patents covering these drugs, all except for Zydus Pharmaceuticals (USA) Inc. have ultimately relinquished their obviousness defenses.

Trial against Zydus was originally scheduled for May, but was postponed due to the COVID-19 pandemic. Paul Hastings had reached an agreement with opposing counsel to extend the original 7.5-year regulatory stay against the launch of the generic product from September 29, 2020, until 120 days after the end of the rescheduled trial (see more here).  In view of the continuing limitations on in-person trials imposed by the pandemic, the Court and both parties subsequently decided to proceed with a virtual trial in late September and early October (with additional expert testimony on October 29, 2020).

Value of a Third-Party Tech Vendor

This relatively untested new approach to trial required a great deal of additional preparation to successfully execute. A neutral third-party litigation services vendor, FTI Consulting, was retained to provide standardized technology set-ups, including laptops, monitors, and backgrounds. The equipment was sent to all witnesses, as well as the respective law firm and in-house trial teams, plus the judge, court reporter, and clerk, ensuring that everyone had equal access to all documents, evidence, and technical capabilities. This approach also allowed FTI to remotely monitor and control the equipment and to provide technical assistance as needed. The use of an independent technology vendor thus helped streamline the process and provided necessary support, and is recommended for any trials or more complex hearings that might go forward in a virtual setting.

Logistics Matter

In addition to the use of a qualified IT vendor, the trial illustrated the importance of audio logistical planning of the remote trial set-up, both for presenting attorneys and fact and expert witnesses, who may be delivering important arguments and testimony from a corner of their home. Issues such as sound quality for microphones and speakers and sight lines for the Zoom link—not to mention demonstratives and documents—are far different than they would be at court. It is obviously critical to ensure the Court will actually be able to properly see and hear everyone participating during the hearings. In view of the potential complexities and novelty of the video technology, it is important to have sufficient preparation time for attorneys and witnesses, not just as to substance, but also to ensure a level of comfort with presenting over Zoom and interacting with the provided setup. Technical run-throughs and tutorials should thus be incorporated into the overall preparations for virtual trials.

Prepare for Hiccups—and Low-Tech Solutions

Even with sufficient preparation and use of a qualified third-party vendor, some technical difficulties should still be expected, as is sometimes the case for Zoom meetings. These may include loss of audio, lack of response from the platform, or small technical glitches, such as being unable to mute or unmute the speakers. While such difficulties may interrupt the flow of a virtual trial in ways that do not happen during in-person trials, with sufficient preparation, they can be mitigated and resolved quickly so as not to impact the integrity or timing of testimony. Most often, the solutions may be quite low-tech and common sense, such as having alternate dial-in numbers easily available or using physical signals to alert others of any technical difficulties. It may also be advisable to develop redundant systems, such as employing a hot spot for back-up internet connectivity, and using alternative methods or dedicated systems for such important functions as muting.

Efficiencies of the Virtual Trial

Despite a few technical issues, the virtual trial described here actually proved more time-efficient than a standard in-person proceeding, as there were no delays for travel time either for the witnesses or attorneys. Additionally, breaks, including those for lunch, could be kept much shorter. A virtual hearing or trial may, therefore, potentially be a preferable option in cases where there are significant timing constraints, even if other options are available. Likewise, the virtual format allowed certain witnesses to testify remotely from different time zones, with Court in session earlier or later to accommodate the necessary time differences. Although this also may cause some challenges, and requires everyone to agree to such accommodations, it can ultimately prove to be both efficient and less disruptive than more traditional approaches.

Indeed, even with the return of some in-person trial capabilities, there are a number of reasons judges and litigants may prefer to conduct virtual trials. Courtrooms currently include a number of reflective plexiglass barriers, put in place to ensure health and safety, and all attendees are required to wear masks. These circumstances make it more difficult to clearly see and understand witnesses, attorneys, and the judge, which complicates the ability of everyone involved to evaluate and get a complete sense of the ongoing presentation. As such, a virtual trial may actually provide greater ability to efficiently communicate and present one’s case. Virtual trials are, thus, surprisingly closer to “normal” litigation at present than in-person trials.

Remember the Differences

Successful virtual trials do present a number of key differences, however, as contrasted with in-person appearances. Such differences must always be kept in mind both in preparing for trial and while it is ongoing. For starters, both attorneys and witnesses remain closely visible on camera and in view to other parties at all times in a way that might not have usually been the case. As such, their demeanor, actions, expression, and sometimes even their lip movements when muted can be seen by everyone participating in the hearing. Further, and similar to the differences between live theater and a television performance, the most appropriate lighting, backgrounds, clothing, and angles for Zoom are different than may be the case in person.

Like so many other facets of work and life, the pandemic has brought enormous disruptions to the civil justice system. Fortunately, for those who try cases for a living, the tools are available to continue functioning at a high level on behalf of clients. For those able to adapt and embrace virtual technology—and the special preparation that goes with it—remote trials can proceed quite smoothly and are, in many ways, preferable in the current circumstances.

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Practice Areas

Life Sciences and Healthcare

Intellectual Property


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Image: Isaac S. Ashkenazi
Isaac S. Ashkenazi

Partner, Litigation Department

Image: Eric W. Dittmann
Eric W. Dittmann

Partner, Litigation Department

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