Eric Santoro had a good 2016—so good, in fact, that “good” isn’t a strong enough. His colleagues called it the “unicorn year” because of the number of legal battles that ended favorably for AstraZeneca.
Santoro works as senior counsel of global litigation at the biopharmaceutical firm, and he attributes the unicorn year to innovative strategies, strong leadership, and great support from his teammates. Going into 2016, he knew that numerous long-standing legal disputes might reach a resolution that year, including a government investigation, several high-stakes patent cases, a mass tort, and a class-action suit. “Obviously, it was a coincidence that so many lawsuits and investigations I’d been working on for many years all came to fruition in the same calendar year,” he says, “but I think it’s fair for me and my teams to take credit for the results we achieved.”
Here’s a look back at the incredible year’s biggest moments.
Patent Claim Dismissed
In South Carolina, two plaintiffs filed a patent-infringement case against AstraZeneca, asserting that one of the company’s drugs used their patented technology. The stakes were high—the plaintiffs sought approximately $2 billion. To win the case, AstraZeneca had to reference complex scientific materials that would be difficult to explain to a lay audience. “We knew that if we didn’t win summary judgment, there was a possibility of jury confusion about a highly scientific subject matter that could’ve resulted in an eye-popping verdict,” Santoro says. “But one of our corporate values is to ‘follow the science,’ and we knew the science was on our side. It was my job as the team leader to maintain confidence in our strategy and focus the team on winning the case and not get intimidated by the big damages numbers that our opponent was seeking.”
Prior to trial, AstraZeneca’s team successfully proved that the plaintiffs overestimated the scope of their patent. A federal judge granted AstraZeneca’s motion for summary judgment, and the case was dismissed
A Decade of Litigation Comes to a Close
“This one finally let us put the period at the end of the sentence for the long chain of litigation that had been pending since before I started at AstraZeneca in 2006,” Santoro says. The plaintiffs’ lawyers had gone from forum to forum as part of a series of class-action lawsuits asserting that AstraZeneca had unfair marketing practices. The last remaining case was in Delaware, where the plaintiffs’ lawyers assumed the law was the most accommodating. “Another one of our corporate values is to ‘play to win,’” Santoro says, “and I knew it was important to keep fighting and not settle, or we’d just be inviting copycat suits.”
The Delaware Supreme Court affirmed the dismissal of the case at the trial court level. “This was an important win, not just for AstraZeneca but for all the companies that get sued with suspect consumer protection claims under Delaware law,” Santoro says.
Several companies had tried to make generic copies of one of AstraZeneca’s growth drugs, a violation of AstraZeneca’s patent rights. So, AstraZeneca brought those companies to court. “At AstraZeneca, we are expected to be entrepreneurial, and with this particular case, I was really able to embrace the opportunity to be creative and courageous,” Santoro says. “Sometimes you need to be willing to take risks to achieve the best result for the company.”
After only one week of trial, Santoro improved AstraZeneca’s settlement position and settled the case. “I think there will always be companies that want to attack our patents and challenge our market exclusivity, but because we took this to trial, those companies will know that we believe in our intellectual property and we’re willing to defend it.”
Government Inquiry Resolved
After more than six years, AstraZeneca resolved a long-standing government inquiry. The inquiry required Santoro to collaborate with his colleagues around the globe in departments such as finance, compliance, and commercial—as well as with the company’s science units. “A government investigation is a real test in leadership because implicitly a lot of people’s integrity is being scrutinized, oftentimes unfairly, and you need to build trust throughout the global company and ensure cooperation from a lot of different people,” Santoro says. “So many global functions have a part in showing the regulators that this is a company of integrity that does the right thing and takes compliance seriously, and it was a very rewarding challenge to get everyone working together to achieve that goal.”
AstraZeneca’s resolution was an industry best because Santoro and his team were able to significantly mitigate both financial and reputational exposure, compared to other similarly situated pharmaceutical companies.
Liability Claims Dismissed
By the time the case reached the Ninth Circuit Court, AstraZeneca had already dealt with almost 2,000 product liability claims related to one of its highest-profile drugs. Those claims were dismissed prior to trial, but in October, about 270 claims resurfaced on appeal.
Conventional wisdom suggests that companies can’t engage in mass tort litigation without paying a settlement. But Santoro knew he could prove that the plaintiffs’ expert had formed an unreliable opinion—the expert couldn’t reasonably draw a connection between the drug and the plaintiffs’ injuries. Not only did the court dismiss the claims, but it also awarded AstraZeneca court costs. The Ninth Circuit then affirmed both of these rulings.
The case was a lesson on unfounded lawsuits. Santoro takes exception to the overzealous attitude of some plaintiffs’ lawyers, who file suit after suit, regardless of the validity of their claims. “At AstraZeneca, we are told to ‘put patients first,’” he says. “Baseless product-liability claims really diminish the public’s trust in the industry and the importance of therapies that we develop. That’s why a strong defense is so important. If you could have a result like this, where all the claims not only get dismissed without settlement but the court awards costs to you, it really sends a message.”
Inter Partes Review Denied
A competitor requested a review of the patent for one of AstraZeneca’s key products—a patent that AstraZeneca had been defending for years. Though the competitor had a superficially appealing argument, AstraZeneca made a superior case based on science. “This is another one where I emphasized following the science,” Santoro says. “We retained some of the best subject-matter experts in the world to help us understand the science and explain to the Patent Board that, even though the challengers’ arguments might have had some surface appeal, if you look below the surface, they really lack scientific merit.”
The Patent Trial and Appeal Board (PTAB) decided against the review. “The PTAB’s standard for instituting review is relatively low, so any time the board denies institution of an IPR, it’s a considerable victory,” Santoro says.
Freedom to Operate Case Dismissed
A competitor had accused AstraZeneca of infringing upon its intellectual property rights in a case that extended over more than five years. In December of 2015, AstraZeneca had a win—a federal judge dismissed the claim—but in December of 2016, the case arose again in the Federal Circuit Court of Appeals.
“This really came down to an issue of claim construction,” Santoro says. The other side tried to redirect the court’s attention to policy and motivation, but under Santoro’s leadership, AstraZeneca’s legal team maintained the focus on claim construction. “I think if you looked at the claims, what we were doing and the way we were selling, our product just didn’t infringe their patent,” Santoro says. The court agreed in a one-word affirmance.
“Sometimes your initial strategy isn’t the right one, and as leader, you need to be humble enough to recognize that, reevaluate, readjust, and get the team to reengage in the new plan,” Santoro says. “In this case, we were constantly reevaluating and readjusting for more than five years before we could claim victory. But, at the end, that one-word affirmance was very satisfying.”
An Enduring Lesson
With so many long-standing cases resolved, Santoro had the freedom to dedicate 2017 to new projects. Still, the unicorn year is not a distant memory; he’s carrying forward the lessons learned.
“AstraZeneca has strong core values,” he says. “Oftentimes, those values seem more applicable for people working in the commercial organization or the science unit, but I have come to appreciate that those values are very applicable in the litigation space as well. If we play to win, if we do the right thing, if we’re entrepreneurial, if we follow the science, and if we put patients first—if we do these things, it’s a recipe for success. It’s a recipe for success not just in business, and not just in science, but also in law.”
Covington & Burling LLP:
“Eric stands out for his exceptional judgment, his tenacious, pragmatic approach to litigation, and the exceptional results that he’s achieved for AstraZeneca.”
—Timothy C. Hester, Partner
Ice Miller LLP:
“Ice Miller LLP is proud to work with Eric Santoro and the AstraZeneca legal team to defend AstraZeneca’s products in a cost-efficient and creative manner, so AstraZeneca may focus on the science-led innovation which transforms the lives of patients worldwide.”