In the first-ever government lawsuit against a pharmaceutical company for patent infringement, Gilead Sciences won a resounding victory when a federal jury sided with the company and against the US government in a precedent-setting trial.

Gilead’s win lifted the uncertainty from the pharmaceutical industry’s relationship with the CDC, the industry’s long-time government partner in clinical trials.

The government alleged that Gilead violated its IP rights connected to two HIV-prevention drugs: Gilead’s Truvada and Descovy. 

The US Department of Justice argued that CDC researchers developed the idea of using the drugs in pre-exposure prophylaxis (PrEP). The government sought a $1 billion judgment against Gilead and filed its lawsuit in 2019. 

Gilead argued the invalidity of the patents, pointing to evidence demonstrating the idea of using the drugs to prevent HIV infection predated the government’s claim to have innovated the approach. The jury sided with Gilead. 

Gilead’s May 2023 victory followed its November 2022 win in the US Court of Federal Claims, also led by WilmerHale, which found that the government breached three material transfer agreements relating to studies of Gilead’s Truvada® drug. Ron Machen (pictured) and David Bassett led the WilmerHale teams that secured the landmark victory.

In a long-awaited victory, incarcerated people who are deaf or hard of hearing will receive life-saving emergency notifications in Massachusetts correctional facilities. Following eight years of litigation culminating in a trial in August, United States District Court Judge Richard G. Stearns ruled that the Massachusetts Department of Correction's (DOC) violated the Americans with Disabilities Act and the Rehabilitation Act by failing to provide an effective emergency alarm system and evacuation procedures for people in custody who are deaf or hard of hearing.

The case, Briggs, et al. v. Department of Correction, et al., was brought by plaintiffs represented by WilmerHale (led by Partner Lisa Pirozzolo, pictured), Prisoners’ Legal Services of Massachusetts, Disability Law Center, and Washington Lawyers’ Committee for Civil Rights and Urban Affairs. The legal team argued that because many housing units and common areas in DOC facilities rely exclusively on audible alarms, deaf and hard-of-hearing individuals face a significant risk of death or serious injury because of their inability to hear safety announcements and fire alarms. Multiple class members testified at the trial about instances when they were left behind in their cells or did not evacuate promptly during fire drills because they did not hear the alarm..

The court ordered the DOC to develop comprehensive policies for each prison to ensure that deaf and hard-of-hearing prisoners can receive lifesaving emergency notifications on equal terms with people without disabilities.

The alarm system and evacuation plan were the remaining claims not addressed by a comprehensive settlement agreement approved by the court in 2019 in the Briggs litigation, which remedied a wide range of issues faced by incarcerated people with hearing disabilities.

WilmerHale represented Apple in the multi-billion-dollar and widely watched month-long trial of Masimo Corp. v. Apple Inc. Apple was accused of wrongly acquiring trade secrets from Masimo for pulse oximetry technology incorporated into the enormously popular Apple Watch. The dispute was one of the highest-stakes trade secret cases ever in terms of the magnitude of the plaintiff’s demands.

Apple’s courtroom team was led by Joe Mueller, Co-Chair of WilmerHale’s Trial Practice. Major cross and direct examinations were conducted by other members of the Trial Practice: Brittany Amadi, Sarah Frazier, Nina Garcia, Mark Selwyn and Amy Wigmore. Many other members of the Trial Practice made critical contributions to the overall case both before and during trial, including Partners Joshua Lerner, Richard “Chip” O’Neill, Nora Passamaneck and Thomas Sprankling.

At the conclusion of the evidence, Judge James Selna of the US District Court of the Central District of California granted judgment as a matter of law (JMOL) in Apple’s favor on about half the trade secret claims—eliminating claims for which Masimo sought over a billion dollars. The remaining claims went to the jury, and after extensive deliberations, the jury publicly reported that they were deadlocked—but with six jurors favoring Apple, and only a single holdout in favor of Masimo. Judge Selna declared a hung jury on the remaining claims: “Mistrial Declared in Masimo’s $1.85B IP Fight Against Apple.” That decision did not alter his earlier JMOL ruling in favor of Apple.

The trial included testimony from a variety of top executives from both Apple and Masimo. The central witness for Masimo was its founder and Chief Executive Officer. Apple called a broad range of fact witnesses including engineers who led the development of features in the Apple Watch, a top marketing executive, and an industrial designer who helped develop the external design of the Watch.

The net outcome was WilmerHale achieved one of the largest defendant decisions (the JMOL victory) in any trade secret case ever, and came one juror from a clean sweep on all claims.

When 25 generic pharmaceutical companies submitted applications to the FDA to sell generic forms of the blockbuster drug Eliquis®, Bristol-Myers Squibb (BMS) and Pfizer called on WilmerHale to help uphold their business-critical patents. Eliquis®, a novel anticoagulant that is used to treat and reduce the risk of blood clots and stroke in certain patients, is one of most significant assets for the two companies, generating approximately $5 billion annually in US sales.

With the BMS and Pfizer patents on the drug’s active ingredient, apixaban, not set to expire until 2026 and another patent covering a formulation of apixaban in effect until 2031, a WilmerHale team led by Partner Amy Wigmore (pictured) filed infringement suits against all 25 of the generics. By the time the suits were consolidated, the Eliquis® case was one of the largest Abbreviated New Drug Application (ANDA) suits ever filed. Over time, the team was able to negotiate favorable settlements with 22 of the companies, and only three remained by the time of the fall 2019 federal bench trial in Delaware.

At trial, the WilmerHale team methodically tackled the generics’ two highly technical validity challenges, including one asserting that “pharmaceutically acceptable salt forms” of apixaban couldn’t exist. With the typical WilmerHale flair for demonstratives, the team called on the former chair of Harvard’s chemistry department to describe how one of his students was able to make three different apixaban salts in under five hours and ran a video showing the salt forming like snow in a flask. Next, a Philadelphia cardiologist and a Princeton medicinal chemist testified to the pharmaceutical safety of the salts. In a withering cross-examination, the team presented the generics’ expert with numerous household items, including toothpaste, that contain chemicals with the same properties.

The generics’ formulation challenge fared no better. Experts witnesses for BMS and Pfizer presented detailed testimony demonstrating infringement and validity of the asserted patents, and WilmerHale attorneys effectively neutralized the defendants’ non-infringement and invalidity arguments through rigorous cross-examination of multiple defense experts. Judge Stark’s 87-page post-trial opinion rejected each argument raised by the generics, finding the Pfizer and BMS patents valid and infringed. The verdict likely prevents these generics from entering the market until at least 2031, protecting tens of millions of our clients’ revenue.

In a landmark antitrust trial, Partner Hallie Levin (pictured) led a WilmerHale team to a resounding victory for clients T-Mobile and Deutsche Telekom. Attorneys General from 13 states and the District of Columbia sought to enjoin the merger of T-Mobile and Sprint, but, in a February 2020 decision, the United States District Court for the Southern District of New York unambiguously rejected the plaintiffs’ arguments and credited the testimony and evidence presented by T-Mobile’s legal team.

This team developed the crucial strategy, unusual for antitrust litigation, that focused on the credibility of T-Mobile’s executives and argued, through the extensive use of T-Mobile’s normal course-of business documents, that the plaintiffs’ theories were inconsistent with T-Mobile’s longstanding “Un-carrier” business model.

“As a trial lawyer, I was always convinced that, despite the predictive nature of antitrust law and its emphasis on economic analysis, the real-world facts should and would matter here,” Levin later told The American Lawyer Litigation Daily. “And the real-world evidence in this case is unambiguously that New T-Mobile will enhance, not lessen, competition.”

In finding for WilmerHale’s clients, the court relied heavily on the testimony of T-Mobile’s then-CEO, John Legere, and its then-President and current CEO, Mike Sievert—who were questioned by Levin during the trial—finding that the trial evidence “credibly presented by T-Mobile executives” reflected “a company [New T-Mobile] reinforced with a massive infusion of spectrum, capacity, capital, and other resources, and chomping to take on its new market peers and rivals in head-on competition.”