Danish pharmaceutical giant Novo Nordisk has filed a patent infringement lawsuit against U.S. telehealth company Hims & Hers Health. At the center of the dispute is the handling—and legitimacy—of compounded versions of the obesity drug Wegovy. This case goes beyond a routine corporate lawsuit, bringing into sharp relief a broader issue: the tension between pharmaceutical intellectual property and access to medical care.
What Are Compounded Drugs?
The specific issue in this case concerns compounded versions of Wegovy that Hims had planned to sell. Compounded drugs are medications prepared by pharmacies based on a physician’s prescription, with dosages or formulations customized for individual patients. In the United States, such compounding has been permitted under certain conditions, particularly when brand-name drugs are in short supply.
In fact, demand for some medications—including obesity treatments—surged sharply in recent years, leading to periods of supply shortages. During those times, regulators effectively allowed competing products and compounded drugs to enter the market in order to prioritize patient access. However, once supply constraints eased, compounded drugs continued to circulate, bringing underlying tensions with pharmaceutical manufacturers to the surface.
Novo Nordisk’s “Turning Point”
Until now, Novo Nordisk has pursued compounded pharmacies primarily through trademark infringement claims, citing counterfeit products or misleading advertising. This marks the first time the company has directly asserted patent infringement in the United States. Statements from the company’s chief legal officer suggest that frustration within the industry over the expansion of compounded drugs has reached a breaking point.
Particularly noteworthy is Hims’ plan to offer an oral tablet. If tablets were introduced alongside injectables, differentiation from the branded drug would become even more difficult, potentially representing a “line crossed” that threatened Novo Nordisk’s core business model.
Hims’ Rebuttal and the Question of Access to Care
Hims, for its part, has strongly criticized the lawsuit as an “attack on access to personalized medicine.” From a pricing perspective, compounded drugs are often offered at a fraction of the cost of brand-name products. In the case of obesity treatment—where insurance coverage is frequently limited—such alternatives can represent a vital option for patients.
This underscores a fundamental dilemma: while patent protection incentivizes innovation, it can also increase financial and supply burdens on patients. The protection of intellectual property and the expansion of medical access exist in a constant state of tension.
Broader Impact on the Industry
As experts have noted, this lawsuit is likely to have a chilling effect not only on Hims but also on other compounding pharmacies and related businesses. If the risk of patent infringement damages becomes more explicit, many providers may reconsider offering compounded drugs containing semaglutide.
At the same time, the outcome of this case could serve as a catalyst for redefining the role and regulation of compounded drugs in the United States. With the interests of pharmaceutical companies, regulators, healthcare providers, and patients intersecting, close attention will be needed to see what balance ultimately emerges.
Conclusion
This lawsuit is not merely a patent dispute; it raises a fundamental question about who can provide medicines, and under what conditions. Patents designed to protect innovation and systems intended to deliver healthcare broadly are not easily reconciled. Yet the societal debate surrounding this issue is likely to grow increasingly important in the years ahead.