Novo’s GLP-1 Patent Suit Against Hims Takes Aim at Compounding

Novo Nordisk A/S‘s lawsuit against Hims & Hers Health Inc. over compounded versions of the active ingredient in its blockbuster drugs Wegovy and Ozempic opens a new avenue for drugmakers to use patent law to confront copycat medicines sold through consumer-facing telehealth providers.

Hims and other telehealth companies first began selling compounded versions of Novo’s semaglutide—a GLP-1 drug used for weight loss and diabetes—during a supply shortage several years ago, generally at a steep discount to the branded drugs. The practice has continued even after the shortage ended, Novo and other brand-name drugmakers have said.

Novo’s suit, filed Feb. 9 in Delaware federal court to stop Hims’ competition with the blockbuster weight-loss drug Wegovy, “is a warning shot to all compounding pharmacies and platforms,” said Robin Feldman, a law professor at the University of California in San Francisco who studies pharmaceutical regulation and intellectual property. “Get out of our territory or we will come after you with both barrels.”

It shows compounding pharmacies and direct-to-consumer telehealth platforms have grown from “minuscule operations” into “real players” that brand-name drugmakers now view as worth targeting in patent litigation, said Jacob Sherkow, a University of Illinois law professor who studies patent law and drug regulation.

“This is the first patent-infringement lawsuit between a sponsored drug manufacturer and a compounding pharmacy—as far as I can tell—and that is just fascinating on a number of different levels,” he said.

Novo largely focused its earlier legal efforts against compounded semaglutide on trademark claims challenging how such products are marketed. Patent-infringement suits target the act of making or selling the drug itself, regardless of how it’s advertised, and can lead to hefty damages awards and court orders blocking sales.

Another legal battle involving compounding pharmacies highlights the broader industry tension. In January, Strive Specialties Inc., a compounding pharmacy, sued Novo and Eli Lilly & Co., alleging they engaged in anticompetitive conduct—including telehealth arrangements that Strive says discouraged providers and patients from prescribing or accessing compounded GLP-1 medicines.

Compounding Leaves Ambiguity

Semaglutide is the active ingredient in both Wegovy and Novo’s $19 billion diabetes treatment Ozempic. Compounded versions are custom-made formulations prepared by pharmacies, rather than treatments approved by the US Food and Drug Administration and sold by brand-name manufacturers. The FDA doesn’t approve specific compounded formulations, but pharmacies that prepare them remain subject to the agency’s rules and oversight.

Novo’s suit lies at a fault line between the FDA’s compounding framework and US patent law. Activity that may fit within FDA rules may still expose sellers to patent-infringement liability, attorneys said.

“Just because you can get compounded drugs on an app doesn’t mean those apps are not patent infringers,” Sherkow said.

There’s a long-standing ambiguity in federal law about how FDA compounding rules interact with patent rights, Feldman said. Congress created limited exemptions allowing pharmacies to compound certain drugs, she said, but it didn’t explicitly address whether those exemptions were meant to shield compounders from patent-infringement claims.

“There are two separate questions at stake,” Feldman said. “Can the government shut you down, and can the company shut you down?”

Hims seems to be facing pressure from both sides of that divide. The company last weekend abandoned plans to sell a compounded semaglutide pill following warnings from federal regulators as they adopt a tougher stance on copycat weight-loss drugs. Novo still proceeded with the lawsuit, which the company said extends beyond the pill to all uses of the drug, including injectable forms. Because Novo’s patent covers the semaglutide compound itself, rather than a method of treatment, the case doesn’t turn on how doctors prescribe the drug, patent lawyers said.

Hims responded to the Novo lawsuit by accusing the pharmaceutical industry of “weaponizing the US judicial system to limit consumer choice,” in a statement reported by Bloomberg News. The company pledged to fight to provide “choice, affordability, and access.”

Targeting Hims, the telehealth company behind the sales and fulfillment, rather than separate compounding facilities, also allows Novo to pursue a single defendant.

That reflects a strategic shift toward using patents on drug compounds to pursue centralized sellers, said Joshua Goldberg, a patent litigator at Nath Goldberg & Meyer who focuses on chemical and pharmaceutical patents. That approach that could make enforcement more efficient as telehealth platforms scale distribution of pharmacy-made drugs.

Sherkow, though, cautioned against reading the lawsuit as a sign of collapse for the young industry, instead framing it as evidence of its maturity.

“I don’t think this is the beginning of the end of telehealth pharmacies,” Sherkow said. “I think this is the end of the beginning.”

The case is Novo Nordisk A/S v. Hims & Hers Health Inc., D. Del., No. 26-cv-143.