One sounds like a debutante roller coaster bearing seven loops and a top speed of 90 mph at the closest major theme park. The other bears a name Mitsubishi might choose if it ever started to sell a minivan in the U.S. market. Taken together, however, Eli Lilly’s Mounjaro and Novo Nordisk’s Wegovy represent what can seem like the biggest blockbuster drug releases of all time. From mentions at the Oscars to almost daily media stories about life-changing results for those lucky enough to snag a prescription, at this point it seems like nothing can diminish the popularity of the weight loss aids du jour. Supply challenges in the U.S. market? Not a problem. Insurance companies wary of the hordes of doctors and patients giving and getting off-label prescriptions? A manageable circumstance. Not even the concerns about sagging rear ends or advancing face-aging effects are acting as a deterrent. “Everybody is either on it or asking how to get on it,” New York dermatologist Paul Jarrod Frank told The New York Times. “We haven’t seen a prescription drug with this much cocktail and dinner chatter since Viagra came to the market.”
Unlike Viagra, of course, these new repurposed diabetes drugs turned weight-loss panaceas are not starting their sales life as limited to one-half of the human population as potential customers. The alarming statistics around obesity in the U.S. are well known. And unlike prior weight-loss treatments, which have ranged from the quacky and ineffective to the dangerous, both Mounjaro and Wegovy have proven effective for patients, with a tolerable side effect profile, which for now seems mostly limited to gastrointestinal issues as people adjust to the drug. Are there people for whom these drugs prove intolerable? Sure, but for every such story that gets told it seems like there are fifty other stories of people shedding kilos of weight as quickly as the crew on Jonah’s boat to Tarshish was throwing stuff overboard.
How do these drugs work? In unscientific terms, by tricking the body in a way where patients end up eating less, which eventually leads to them dropping some pounds. The speed of the weight loss, compared with its apparent ease in people for whom excess weight has seemed like a life sentence, explains why details like an annual list price of over $10,000 are waved away in the current discourse. It also explains why slow-but-steady weight loss purveyors like Weight Watchers are looking on in dread as customers flock to doctor’s offices for a weekly shot, as opposed to their local weight-loss center for a public weigh-in and affirmation session. In an interesting pivot, it looks like you can get Wegovy from Weight Watchers itself. Maybe Royal Caribbean will be next, with Mounjaro shots included on every week-long sailing excursion.
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Jokes aside, the economic opportunity presented by these drugs for both Eli Lilly and Novo Nordisk can’t be overstated. (Disclosure: the first patent trial of my career saw me as the most junior of associates on a team representing Novo against Teva in a case involving recombinant HGH, way back in 2003. In true Wegovy-style, there was a loss involved.) I am not a stock analyst, but I know enough to realize that when a company has to revise their guidance upward keyed off the strong performance of a drug, that is good news for the drug maker and its investors. One would expect that the news will only get better for these companies on the financial front as the last remaining sentient people become aware of the existence of these miracle weight-loss machines in a injection tube, coupled with what looks like inevitable study results showing that carrying around less excess weight is good for human bodies, for more than cosmetic reasons at least. In short, both Lilly and Novo are highly motivated to protect these blockbuster drugs and their current monopolistic pricing for as long as possible.
To do so, both companies are turning to their ready-and-able stable of patent attorneys, both in-house and at their preferred outside patent prosecution firms. While this is not the place for a deep-dive into their respective patent estates, there is no doubt that both companies are working hard to build broad and deep portfolios around these blockbuster drugs, ideally with expiration dates that will see today’s toddlers turn into tomorrow’s full-price paying customers. For branded-drug companies, patents are among the most potent tools to help the company reach that kind of ambitious commercial goal.
We can start with Mounjaro, which mimics two types of hormones that tell our brains that it is time to put the can of Pringles down. Lilly has already listed four patents in Mounjaro’s Orange Book patent listing, with expiration dates ranging from 2031 to 2039. In its most recent patent, Lilly obtained the following independent claim 1: “A pharmaceutical composition comprising tirzepatide, or a pharmaceutically acceptable salt thereof; NaCl at a concentration from 6.2 mg/mL to 9.5 mg/mL; and dibasic sodium phosphate.” Pretty straightforward, for a formulation of the active tirzepatide ingredient that provides “acceptable stability and acceptable patient injection site experience.” Put another way, the latest patent covers delivery of Mounjaro with a minimum of ouch effect upon injection.
Likewise, Novo already has five patents listed in the Orange Book for Wegovy, with expiration dates from 2026 to 2041. And like with Mounjaro, Novo’s latest listed patent also focuses on improved formulations that are “stable and comfortable to administer to the patient in need.” Here again, we find a simple looking claim 1 that could one day be called upon to defend tens of billions in revenue: “A liquid pharmaceutical composition comprising: 0.5 to 10 mg/mL semaglutide, 0.0% (w/w) to 0.1% (w/w) phenol, and 8.2 to 8.9 mg/mL sodium chloride.”
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In particular, Novo’s “inventors found that” certain Wegovy “compositions have improved properties in relation to injection pain experience,” resulting in the claimed inventions.
Ultimately, based on the most recent patents, fewer shots with fewer boo-boos is apparently the next frontier that Mounjaro and Wegovy patients can hope to see both Lilly and Novo conquer in the future. Which is a good thing for drugs that are apparently lifetime commitments for the patients on them, at least if those patients hope to make the weight loss permanent. For the purposes of this column, considering how these drug giants are patenting privation gives an interesting look at both where these drugs may be headed, as well as what IP strategies are following to keep their profits as fat as possible for as long as possible.
Please feel free to send comments or questions to me at [email protected] or via Twitter: @gkroub. Any topic suggestions or thoughts are most welcome.
Gaston Kroub lives in Brooklyn and is a founding partner of Kroub, Silbersher & Kolmykov PLLC, an intellectual property litigation boutique, and Markman Advisors LLC, a leading consultancy on patent issues for the investment community. Gaston’s practice focuses on intellectual property litigation and related counseling, with a strong focus on patent matters. You can reach him at [email protected] or follow him on Twitter: @gkroub.