Just over a year ago on these pages, I started to take a look at the patent franchises protecting the defining drugs of our time, Novo Nordisk and Eli Lilly’s diabetes/weight-loss blockbusters, Ozempic/Wegovy and Mounjaro/Zepbound. At this point, there is at least someone you know that has been taking one of these miracle drugs, if only because it is impossible not to notice the physical changes in their appearance after the measurable weight loss these drugs engender. If you had bought Eli Lilly stock, for example, after reading my June 2023 column, you would now be enjoying a near-doubling of your money invested, with no end in sight. The same is true of Novo Nordisk stock, with the valuation of the company now exceeding the GDP of its home nation, Denmark. In short, getting folks to eat less in good business, or at least a way for these pharmaceutical companies to share profits with the soda and snack behemoths that have addicted our society to sugary products over the past 100 years. And there is no end in sight to the market opportunity for these drugs, even as price remains a barrier to some, and insurance companies try to resist paying for them as much as they can.
With such a significant market opportunity at play, it is no surprise that the patent battles around this class of drugs started early. Let’s consider Novo Nordisk’s patent 8,536,122, the soonest-to-expire patent listed in the Orange Book for Wegovy, Novo’s semaglutide weight-loss drug. The ‘122 patent is a prototypical compound patent, with an expiration date of March 2026, which describes and claims “new GLP-1 compounds which can be administered less than once daily, e.g. once every second or third day preferably once weekly, while retaining an acceptable clinical profile” — thereby helping to mitigate the problem of “needle-phobia” in patients. Novo has already asserted the ‘122 patent against a number of generic challengers; it is related to patents that have been asserted against other generics as well. And on top of Novo’s assertions, Mylan chose to seek IPR of the ‘122 patent in March 2023. Fortunately for Novo, the PTAB denied institution on Mylan’s petition in an institution decision that could double as a organic chemistry final exam.
With the IPR challenge deflected for now, the action of interest with respect to the ‘122 and Novo’s other asserted patents has shifted back to the district courts. Primary attention must be paid to the ongoing MDL litigation before Delaware’s Chief Judge Colm Connolly, which is heading for trial by the end of this calendar year. The MDL consolidated six cases that were pending across two jurisdictions, Delaware and West Virginia. With all but the West Virginia case against Mylan pending in Delaware, it is not surprising that the MDL panel centralized the case before Connolly, whom the panel expected to “steer this litigation on a prudent and expeditious course.” The court has lived up to that mandate, shepherding the case through multiple claim construction proceedings, various attempts to streamline the claims asserted, into the current expert discovery phase and the lead-up to trial in the coming months. For those hoping for a quick answer to whether generics will be able to enter the market, it looks like it will take a Federal Circuit decision, probably by the end of 2026 at the earliest, to give some further insight into that question — pending settlement, of course. That timeline assumes that the bench trial decision comes sometime in early 2025 and the Federal Circuit appeal process doesn’t stretch too far into 2027, which it very well might.
At the same time, anyone with an X handle or a television has probably seen ads for cheaper versions of Novo’s drug in particular. In fact, the last time I was in a car wash, there was a flyer on the desk from a local pharmacy offering compounded semaglutide — the active ingredient in Ozempic/Wegovy — for a fraction of the branded drug price. Why is this happening, and what is Novo trying to do about it? It is happening because the demand for semaglutide has been so high that it was placed on the FDA’s Drug Shortages list as of May 2023. As a result, “compounders may be able to prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act.” And because Novo does not have full control of the pipeline for semaglutide base, compounded semaglutide has been on the market, available for consumers from pharmacies that advertise in car washes, as well as through slickly marketed online pharmacies. Since at least some of those sales enjoy a safe harbor from patent infringement claims, Novo has been reduced to aggressive employment of trademark and false advertising claims against certain providers, as well as attempts to argue that compounded semaglutide products on the market suffer from impurities and can cause side effects. To date, those claims have been more successful in generating headlines than shutting down legitimate compounders, but expect Novo to keep pressing its claims for as long as it can.
Ultimately, the battles between Novo (and Lilly) against compounders are just skirmishes at the margins of the higher-stakes battle in process and still to come with generics hoping for a slice of the weight-loss money-generation pie. In addition to keeping a close eye on the MDL heading to trial, we can also expect to see the brands looking to expand their patent portfolios protecting these blockbusters. Already, Novo’s patents around the injectable device used by Ozempic/Wegovy give its products a competitive advantage over the compounded alternatives that require a plain-old syringe and needle. All eyes will be on Delaware — and eventually the CAFC — to see if the generics are able to prevail.
Please feel free to send comments or questions to me at gkroub@kskiplaw.com 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 gkroub@kskiplaw.com or follow him on Twitter: @gkroub.
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