Novo Nordisk Settles Ozempic Patent Case

The Danish company Novo Nordisk and Viatris' Mylan Pharmaceuticals have settled their patent dispute before the Patent Trial and Appeal Board (PTAB or the Board) involving the weight-loss drugs Ozempic and Wegovy.

Mylan’s partner, the Indian company Natco Pharma, also settled with Novo Nordisk.

As Reuters reported,

Novo has separately sued Viatris and other companies for patent infringement in federal court to block proposed generics of the drugs. Novo and Viatris told a Delaware judge last Wednesday that they had settled Novo's lawsuit against Viatris there over its proposed generic of Ozempic.

The drugs are popular because, according to the Centers for Disease Control and Prevention (CDC), about 42% of American adults are obese.

According to CNBC,

Ozempic recorded global sales of $14 billion in 2023, marking a 66% increase year-on-year, and is projected to reach $17-18 billion in 2024. Wegovy, meanwhile, generated $4.5 billion in sales last year.

As The Guardian reports,

The Danish drugmaker’s market value has soared over the past year, making it the most valuable company in Europe, on the back of the success of its obesity and diabetes injections Wegovy and Ozempic, used by celebrities including Elon Musk and Oprah Winfrey. However, the company is facing increasing competition from its US rival Eli Lilly’s drugs Zepbound and Mounjaro.

As the New York Times reported, Ozempic and other new weight-loss drugs are often hard for patients to find – or afford.

In the scramble to find Ozempic, patients are seeking out telehealth platforms, medical spas, and compounding pharmacies for what some tout as “generic” versions of the drug. But Novo Nordisk, the company that makes Ozempic, does not sell semaglutide for compounding purposes, and a generic form of the drug approved by the Food and Drug Administration doesn’t exist, a Novo Nordisk representative wrote in a statement.

Novo Nordisk originally developed the active ingredient semaglutide for the treatment of type 2 diabetes. In higher doses, it’s known as the weight-loss injection Wegovy. In 2021, the FDA approved Wegovy to treat obesity.

Mylan had filed a petition for inter partes review of Novo’s U.S. Patent No. 10,335,462 patent in March of 2023. On October 4, 2023, the Board instituted an inter partes review.

Mylan and Novo notified the Board of their settlement on October 2, 2024.

Novo Nordisk had sued Mylan for patent infringement involving Ozempic in the US.

Novo has also sued other companies for making “copycat” versions of its drugs, which it says are not as effective and may be dangerous.

Novo has filed at least 12 lawsuits against clinics, med spas, and compounding pharmacies in the US that claim to offer semaglutide, the active ingredient in Ozempic and Wegovy.

In October, scientists from Novo Nordisk published a peer-reviewed study on differences between its branded products and copied versions from compounding pharmacies, telehealth providers, and medical spas. The study concluded that copied products are inferior and may be unsafe.

As NBC News reported, in February, Novo settled two lawsuits against two businesses claiming to offer compounded versions of Ozempic and Wegovy. The two Florida businesses are now permanently banned from claiming that their compounded drugs are approved by the Food and Drug Administration (FDA).

As the Times reported,

Eli Lilly, which manufactures Mounjaro — a similar medication that is approved for treating diabetes but also induces weight loss — announced on Sept. 19 that it was taking legal action against some medical spas, wellness centers, and compounding pharmacies that sell compounded products claiming to be Mounjaro. And in October, Eli Lilly said it had filed a complaint before the U.S. International Trade Commission to stop companies from importing, selling, or distributing substances purporting to be the active ingredient in Mounjaro — and alleged that one such company was actually selling sugar alcohol.

Novo Nordisk is facing patent challenges around the world. The Boards of Appeal of the European Patent Office revoked two of its patents for semaglutide in tablet form. Generic drug manufacturers have challenged other semaglutide patents.

As The Guardian reports,

Patents for [weight loss drugs] Victoza and Saxenda have expired, according to Novo Nordisk. As a result, other drugmakers are working on generic versions. Israel’s Teva Pharmaceutical Industries, the world’s largest generic drugmaker, launched a generic version of Victoza in the US….

The move comes days after the US regulator, the Food and Drug Administration, tentatively approved London-based Hikma Pharmaceuticals’ generic version of Victoza.

Ozempic and Wegovy will lose patent protection in China in 2026, Europe and Japan in 2031, and the US in 2032.

In addition to enforcing its patent rights, Novo has also been litigating to protect its trademarks.

Novo has sent cease and desist letters and filed lawsuits against small clinics, medical spas, and compounding pharmacies, alleging false advertising and trademark infringement.

These letters and complaints allege that the defendants violated the Lanham Act by advertising compounded semaglutide drugs as equivalent to Ozempic or Wegovy.

Novo Nordisk claims that this causes patent “confusion” in patients and implies that Novo Nordisk sponsors those compounded drugs or supplies the semaglutide.

In most of the lawsuits, courts have entered preliminary injunction orders that include statements like the following:

Use of Novo Nordisk’s registered trademarks OZEMPIC®, WEGOVY®, and/or RYBELSUS®, in connection with compounded drugs purporting to contain semaglutide or in connection with the advertising, marketing, sale, or promotion of such drugs is likely to cause confusion and infringe Novo Nordisk’s trademark rights….

Statements to the effect that compounded drugs purporting to contain semaglutide are Novo Nordisk products, are associated with Novo Nordisk, have been approved by the U.S. Food and Drug Administration (“FDA”) and/or have been proven to achieve certain therapeutic results or effects are likely to be false and violate Section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a).

Defendants have been ordered to correct their advertising material to remedy this false impression.

The Food and Drug Administration (FDA) has warned the public about taking unapproved versions of weight-loss drugs that do not undergo the FDA’s review for safety, effectiveness, and quality before they are marketed.

Also,

FDA received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products. These dosing errors resulted from patients measuring and self-administering incorrect doses of the drug and, in some cases, healthcare professionals miscalculating doses of the drug.