Imagine a product that is sufficiently similar to infringe a patent, yet sufficiently different to mislead consumers. This is precisely what occurred in the case involving semaglutide-based products Ozempic and Wegovy, developed by Novo Nordisk, and compounded semaglutide products that were, at one point, offered on the platform of Hims & Hers Health. 

Patent Law and the Scope of Exclusive Protection

A patent is a subjective right whose object is an invention from any field of technology that is new, involves an inventive step, and is industrially applicable. This right authorizes its holder to prohibit or permit others to economically exploit the invention. As such, a patent is an exclusive absolute right that protects its holder in relation to the commercial use of the patented invention.

In exercising their exclusive right to economically exploit a protected invention, the patent holder is entitled to prevent any third party, without consent, from:

• manufacturing, offering, placing on the market, or using a product made according to the protected invention, or importing or storing such a product for those purposes;
• applying a process protected by the patent;
• offering a process protected by the patent;
• manufacturing, offering, placing on the market, using, importing, or storing for such purposes a product directly obtained by a patented process;
• offering and supplying products that constitute essential elements of the invention to persons not authorized to use that invention, if the supplier knows or should have known that the product is intended for use in another’s invention.

Any unauthorized undertaking of the above acts constitutes patent infringement, and legal protection may be sought not only against the direct infringer but also against intermediaries whose services were used in the infringement.

Thus, offering a product similar to a protected invention or containing its elements may, depending on the circumstances, constitute infringement. This further implies that comparative advertising referring directly or indirectly to a competitor’s patented product may simultaneously qualify as an act of offering a product and evidence of patent infringement. However, from a patent law perspective, a product may be sufficiently similar to trigger liability, yet not sufficiently identical to justify marketing claims. The notion that a product can be legally “the same” but commercially “different” is particularly evident in the pharmaceutical industry.

Pharmaceutical Products Between Patent Protection and Advertising Rules

In the pharmaceutical industry, patents may protect molecules, compositions, and pharmaceutical products with new indications, provided they are new, inventive, and industrially applicable. The manufacture and commercialization of products similar to patented ones, or the use of patented processes, may constitute infringement.

Where products are identical and literally infringe patent claims, determining infringement is straightforward. However, in cases involving similar products, especially in pharmaceuticals, assessing the degree of similarity sufficient for infringement can be challenging. In such cases, the doctrine of equivalents is applied.

The doctrine of equivalents holds that a product or process that is substantially equivalent to a patented invention infringes the patent. Patent protection extends beyond the literal wording of claims to cover equivalents that capture the essence of the invention. This doctrine is particularly relevant in pharmaceuticals, where a generic medicine may avoid literal infringement yet function in substantially the same way and achieve the same result as the original one.

In pharmaceutical disputes, the doctrine is assessed through two tests. The “function–way–result” test examines whether the product or process that infringes the patented invention and the patented invention perform the same task in substantially the same way and achieve substantially the same result, which is why they are considered the same, even if there are differences in name, shape, or form. The test of insubstantial differences, on the other hand, examines whether the differences between an element from the claim and the contested element are insubstantial to a person skilled in the art.

When it comes to advertising, given the importance of medicines, in addition to general rules in most countries, including the Republic of Serbia, this field is also subject to specific conditions.

Accordingly, in addition to the general rule prohibiting misleading advertising, under which any advertising that in any way, including its manner of presentation, misleads or is likely to mislead the recipients of the advertising message, and which, due to its misleading nature, may affect their economic behavior or, for that reason, harms or is likely to harm a competitor of the advertiser, there are also special rules, i.e., prohibitions on advertising certain types of medicines to the general public. Thus, for example, in the Republic of Serbia, the advertising of medicines for diabetes and other metabolic diseases to the general public is prohibited.

Novo Nordisk and Hims & Hers Health: Between Litigation and Cooperation

Novo Nordisk is a Danish multinational pharmaceutical company known for the development and production of the active substance semaglutide, for which it also holds patents, as well as the brands under which it places on the market medicines containing semaglutide, such as the well-known Ozempic, Wegovy, and Rybelsus.

Hims & Hers Health is an American company that operates as a telemedicine (telehealth) platform, that is, a digital intermediary between patients and healthcare services. Within the scope of its activities, Hims & Hers Health, through its platform, placed on the market and sold compounded semaglutide injections and oral products containing semaglutide, and subsequently, at the beginning of 2026, openly announced a compounded oral semaglutide tablet priced at 49 dollars as an alternative to the oral drug Wegovy, whose starting price is three times higher (149 dollars).

While Novo Nordisk acts as an innovator and rights holder in the pharmaceutical industry, Hims & Hers Health represents a digital intermediary that enables access to therapies for end users, whereby the conflict between them does not take place only at the level of patents, but also at the level of distribution, marketing, and product positioning on the market.

Otherwise, these two companies had previously established cooperation, which was terminated in June 2025. Novo Nordisk issued a public statement on this matter, stating that the termination of cooperation occurred due to misleading promotion and the sale of illegitimate, copied versions of the drug Wegovy by Hims & Hers Health, thereby putting patient safety at risk. Novo Nordisk further stated that Hims & Hers Health did not comply with the law prohibiting the mass sale of compounded medicines under the false pretext of personalization, and that, based on the investigation it conducted, the active pharmaceutical substance semaglutide contained in copied medicines sold by telemedicine platforms and compounding pharmacies originates from foreign suppliers from China, which have never been approved or authorized by the Food and Drug Administration (FDA) and which may contain unsafe and unauthorized foreign ingredients.

At the beginning of February 2026, only a few days after Hims & Hers Health announced a compounded oral semaglutide tablet in a price range significantly lower than Novo Nordisk’s Wegovy, Novo Nordisk also filed a patent infringement lawsuit against Hims & Hers Health before the United States District Court for the District of Delaware, claiming that Hims & Hers Health, without authorization, places on the market and sells compounded semaglutide injections and oral products containing its patented molecule, thereby infringing its U.S. Patent No. 8,129,343. This patent covers the semaglutide compound itself, pharmaceutical compositions containing it, and methods of treatment using those compositions. In its statement, Novo Nordisk emphasized that the patent infringement lawsuit was filed with the aim of protecting patients from unsafe imitation versions of the medicines Wegovy and Ozempic.

As stated in the lawsuit and in the public announcement of the initiation of these proceedings, as well as in earlier statements issued upon the initial termination of cooperation, Hims & Hers Health unlawfully mass-advertised unapproved semaglutide versions that infringe Novo Nordisk’s patent and simultaneously mislead consumers and healthcare professionals regarding the clinical benefits and safety of these unapproved medicines.

Mass advertising by Hims & Hers Health and compounding pharmacies flooded the market with copies of the medicines Wegovy and Ozempic, which constitutes not only acts of patent infringement, but also misleading advertising and unauthorized exploitation of the reputation that Novo Nordisk’s products have acquired on the market. Compounded semaglutide products may contain dangerous impurities or inaccurate quantities of active ingredients, which may lead to life-threatening immune reactions, hospitalization, serious drug interactions, and overdosing. According to testing conducted by Novo Nordisk, injectable semaglutide medicines produced in pharmacies contained impurities of up to 86%, while oral compounded semaglutide medicines contained impurities of up to 75%. Even in small quantities, such impurities may negatively affect the safety and efficacy of medicine, including adverse immune reactions such as anaphylactic shock.

However, in the context of determining patent infringement and the application of the doctrine of equivalents, we will not have the opportunity to see a judicial outcome, given that Novo Nordisk voluntarily withdrew the patent infringement lawsuit against Hims & Hers Health. The dispute was resolved amicably by re-establishing cooperation between the companies.

According to the agreement concluded between the pharmaceutical company and the telemedicine platform, Ozempic and Wegovy are now available on the Hims & Hers Health platform. In return, Hims & Hers Health stated in its announcement that it will no longer advertise compounded products intended for the treatment of type 2 diabetes and obesity on its platform or in its marketing activities, and that existing patients will be enabled to transition to FDA-approved medicines when their physicians assess this as clinically justified.

Parallel Disputes and Legal Tension Between Patent and Advertising

The issue of misleading advertising has remained open, given the class action lawsuit filed against Hims & Hers Health by two consumers, Andrew Donoho and Gloria Ferguson, before a Federal Court in Illinois, alleging that Hims & Hers Health misled customers by advertising its “compounded semaglutide” as a product that has the “same active ingredient as Ozempic and Wegovy.” The lawsuit was filed in February 2026, shortly after Novo Nordisk initiated the patent dispute.

For their part, the consumers claim that the practice of describing the compounded product of Hims & Hers Health as a product with the “same active ingredient” as Novo Nordisk’s medicines is misleading, because although both products contain semaglutide, the synthetic manufacturing process of Hims & Hers Health’s compounded product allegedly creates a materially different active ingredient with additional peptide impurities, whereby the claim of the “same active ingredient” becomes inaccurate and misleading.

Having this in mind, the Donoho and Ferguson case, which is primarily based on claims under the Illinois Consumer Fraud and Deceptive Business Practices Act, focuses on the manner in which Hims & Hers Health presents its compounded product to consumers, and not on its equivalence with Novo Nordisk’s products and patent.

Although one of the proceedings (patent infringement) has been resolved amicably by re-establishing business cooperation between the opposing parties, an interesting question remains open regarding the conflict of legal regimes applicable to patent infringement and misleading advertising, as well as their mutual influence and interaction.

In its lawsuit, Novo Nordisk, by applying the doctrine of equivalents, emphasized the similarity of the compounded semaglutide-containing products advertised by Hims & Hers Health, claiming that their placement on the market infringes its patent rights. In contrast, the consumers who initiated the class action emphasize the sufficient differences between the compounded semaglutide-containing products advertised by Hims & Hers Health and Novo Nordisk’s products Ozempic and Wegovy, such that describing them as products with the “same active ingredient as Ozempic and Wegovy” misleads consumers.

This situation indicates a structural tension in the way the same product is differently qualified depending on the legal context. Within patent law, the emphasis is on similarity in terms of the scope of protection of the active substance, whereas in the domain of market communication and advertising, differences between products intended for the treatment of type 2 diabetes and obesity are emphasized.

Such a dual perspective raises the question of the relationship between different legal regimes applicable to the same pharmaceutical product. The outcome of the patent dispute could, in principle, contribute to a more precise determination of the boundaries of innovation protection in the context of compounded products distributed via modern telemedicine platforms.

At the same time, collective consumer protection proceedings may contribute to clarifying the standards of comparative advertising in the pharmaceutical sector, particularly in conditions where prescription drug names function as reference indicators that consumers associate with safety, efficacy, and regulatory approval.

Given that the patent dispute has been resolved amicably, it remains to be seen what scope the class action proceedings for the protection of consumers against misleading advertising will have, considering that these proceedings are ongoing.

At first glance, the apparent contradiction that a single product can simultaneously be sufficiently similar and sufficiently different is, in fact, an understandable consequence of the different legal regimes applicable to patent protection and consumer protection. Claims from the consumer class action regarding differences between products leading to misleading advertising would not, as such, without additional arguments and evidence, be sufficient in a patent dispute to establish the absence of patent infringement. The reason lies in the different thresholds of similarity set by these two legal regimes. Patent law protects innovation even in cases where there is no complete chemical identity between the protected invention and the infringing product, but rather functional equivalence in terms of the same function, the same mode of operation, and the same result.

In addition to the aforementioned proceedings, the overall legal exposure of Hims & Hers Health is further complemented by an investor class action filed in June 2025 before the United States District Court for the Northern District of California, alleging that the company’s executives violated the Securities Exchange Act of 1934. The plaintiffs claimed that the company’s executives made materially inaccurate and misleading statements, omitting to disclose that compounded drugs for type 2 diabetes and obesity jeopardize patient safety and that there was a significant risk of termination of cooperation with Novo Nordisk, which ultimately occurred in June 2025, while the shares of Hims & Hers Health dropped by more than 34% in a single day. In this way, the same description of the product that in the patent dispute served as an argument for similarity with the protected invention becomes, in the investor dispute, an argument for misleading the capital market, because the company’s executives failed to disclose to investors the risks that directly arose from that similarity. Just like the consumer class action initiated this year, the investor-initiated dispute is still ongoing.

Intertwining of Patent, Market, and Investment Risk in the Pharmaceutical Industry

As we have seen, the case of Novo Nordisk and Hims & Hers Health shows that the same pharmaceutical product may have different legal qualifications depending on the context in which it is observed – as a subject of patent protection, as an object of market communication, or as a factor of investment risk. What in one regime constitutes a basis for the protection of rights may, in another, be a source of liability. Such multilayered complexity indicates an increasing intertwining of patent, regulatory, consumer, and financial law in the modern pharmaceutical industry, in which the boundaries between innovation, market presentation, and legal responsibility are becoming increasingly fluid.

This article is to be considered as exclusively informative, with no intention to provide legal advice. If you should need additional information, please contact us directly.