Sanofi and Regeneron invested years of research efforts and hundreds of millions of dollars in developing Dupixent, the first and only FDA-approved biologic medicine for the treatment of moderate-to-severe atopic dermatitis, a type of eczema and a debilitating life-long disease. When Amgen-owned Immunex threatened patent litigation, Sanofi and Regeneron turned to Lauren Fornarotto and her team at McKool Smith to protect their groundbreaking drug.
Her background is perfect for her role as one of two lead partners building out the firm’s pharmaceutical practice. Growing up, math, science, and especially chemistry were her favorite subjects, so pursuing a bachelor’s degree in chemical engineering and interning at the pharmaceutical giant Merck were logical next steps.
Less obvious was the occupation to which that career path would ultimately lead: the law.
Professors at Cooper Union teaching engineering and law classes initially prompted Fornarotto to consider the possibility of becoming a lawyer. Training programs at ABB Lummus Global Inc., where she worked as a chemical process engineer after completing her undergraduate studies at New York-based Cooper on a full-tuition scholarship, heightened her interest.
“The company had a lot of proprietary technology, and I was introduced to the patent process for protecting that technology,” says Fornarotto, who grew up in the New York City borough of Staten Island. “We had some lectures about the patent process and inventions, which interested me, and supported my thinking that I was a better fit as a lawyer than a chemical engineer.”
“I want McKool Smith to be known as the go-to firm for the pharmaceutical industry’s highest-stakes cases, those with life-changing drugs that might be taken off the market or with large amounts of money on the line,” she says.
With a specialty in intellectual property and complex commercial litigation, Fornarotto, who made partner in 2018, has already handled cases in U.S. District Court, the Court of Appeals for the Federal Circuit, and the International Trade Commission as well as inter partes review proceedings before the Patent Trial and Appeal Board.
Lawdragon: Tell me more about the Dupixent case. Was the inter partes review the end of the matter?
Lauren Fornarotto: No, after we won the IPR and invalidated all of Immunex’s patent claims at the PTAB, Immunex appealed and I argued the appeal in the Federal Circuit in August. Recently, the Federal Circuit issued its precedential decision affirming our IPR win, which felt really great both personally and because of my fantastic clients. Dupixent is a breakthrough treatment, and you’ve probably seen commercials for it. Kristin Davis, who played Charlotte on “Sex and the City,” has spoken recently about how Dupixent is helping her child’s eczema.
LD: Interesting. I’ve always thought one of the fun parts of intellectual property litigation is that you have the opportunity to take amazingly technical processes and innovations and put them in layman’s terms for judges and juries.
LF: I totally agree. That’s one of the reasons I love patent litigation. I do other disciplines as well; I try my hand in any kind of patent case because I'm open to learning new technologies. But in the pharmaceutical space in particular, I feel like I have a good ability to understand and grasp the science and then break it down in understandable terms to a judge and a jury and give rational, reasonable explanations that they can buy into.
LD: Patent law definitely seems to be a thread running through much of your professional experiences. Did you always know this was the type of law you wanted to focus on?
LF: I went to Cardozo thinking that I would certainly focus on patent law, though I didn’t know if I’d become a patent litigator or prosecutor. I knew I wanted to do something with patents, but you don't even take patent law in your first year of law school. So after law school, I started out at Cravath because I could do general litigation there, and try patent litigation. I also sampled some other areas of the law, but I quickly confirmed my initial thinking that of all the areas I sampled, what I most enjoyed and was most passionate about was patent litigation.
LD: Once you realized that, what prompted you to move to McKool Smith?
LF: It was two-fold, really. I wanted to get more early-on litigation and trial experience, which was part of it. While Cravath is obviously fantastic, and the generalist model was particularly appealing when I was in law school, I wanted the ability as I gained experience to focus the majority of my practice on patent litigation. I wanted to go to a place where I could both focus on patent litigation and also get some real hands-on litigation experience: depositions, hearings, trials, etc., and I found that in McKool.
LD: And obviously you’ve been able to develop your pharmaceutical expertise, too, building on your science and chemistry background. What is it that you love about that space?
LF: At McKool, it’s a growing practice where I was able to be in on the ground floor. When I came into the firm, it was, and it still remains, a goal to build out that practice. The biologic space, especially, is a burgeoning one; there are a lot of antibody drugs out there right now. That's, I think, the new wave of pharmaceutical cases and I was able to be part of that and help get us this huge case, which so far, we've been successful in. To be – at a pretty young age – one of the leaders in this practice is a phenomenal thing.
LD: It seems like you're in the enviable position of being able to sell to the firm what a monstrous opportunity this is.
LF: The great thing about McKool, not just in the patent space, is that the firm is extremely entrepreneurial and always looking to grow and adapt with the times. So if they see an opportunity, they give their attorneys, including me, the freedom and the leeway to run with a new practice area.
LD: That’s one of the areas where McKool truly excels. There are lots of firms with star power, but one thing they often struggle with is building the bridge to exciting new talent and giving that talent a voice. Whereas McKool has shown a willingness to let you take the ball in the pharmaceutical practice, for instance, and run with it.
LF: That’s so true. I think everyone here feels invested in the firm, not just monetarily, but also in wanting to see it succeed, and that starts at the top. I worked with Mike McKool on a case while I was an associate, and he supported me all along the way, gave me opportunities to argue, and took the time to give me feedback. What impressed me the most was that he cares about every single person who works for the firm, everybody he comes across from any level. I just couldn't believe that somebody as busy and high up and impressive as he is would give somebody like me the attention and care that he did, but I'm not unique in that. That's how he treats everybody he works with.
Mike and the other top-ranked trial lawyers at the firm, like Doug Cawley and Ted Stevenson, they all support the next generation. They not only help train us and teach us how to be great litigators, hopefully as good as them one day, but they give us the freedom to grow and have our own successes.