Ozempic, Patents, and a possible costly oversight: Lessons from Novo Nordisk

Lately, it has become almost impossible to have a conversation about weight loss without the name semaglutide, more commonly known by its blockbuster brand, Ozempic, being mentioned. Once confined mostly to medical circles, this medication has now entered mainstream conversations, social media trends, and even the Madlanga Commission of Inquiry. Its popularity was recognized when it was mentioned during the Madlanga Commission of Inquiry, wherein a senior South African Police Service Officer, Brigadier Rachel Matjeng, referred to Ozempic in her testimony. In an attempt to demonstrate the existence of a romantic relationship with businessman Vusi Matlala, she stated that she had asked him to assist her in procuring the drug.

This reference at the Madlanga Commission illustrates how deeply Ozempic has penetrated public conversations. What was originally developed as a treatment for type 2 diabetes has become the “SI unit” for weight loss and lifestyle medicine.

In South Africa, Ozempic is classified as a Schedule 4 medication. In other words, it may only be obtained with a valid prescription from a medical practitioner and cannot be purchased over the counter. Furthermore, the South African Health Products Regulatory Authority (SAHPRA) on its website states that “Ozempic is not registered in South Africa for use in weight-loss”.

The commercial success of Ozempic has been extraordinary, to say the least. According to Future Market Insights, the global Ozempic market was valued at approximately USD 22.3 billion in 2025 and is projected to reach USD 58.4 billion by 2035. It accounts for about 30 percent of the GLP-1 diabetes treatment market. Other GLP-1 medications available in the market include Mounjaro, Trulicity and Wegovy. For Novo Nordisk, the Danish pharmaceutical company that developed and markets Ozempic, semaglutide has become an important component of its global revenue.

Such commercial success can hardly be achieved without robust intellectual property (IP) protection that keeps competitors at bay while ensuring that Novo Nordisk enjoys its exclusivity. Novo Nordisk invested heavily in securing patents covering several aspects of semaglutide, including the compound itself, manufacturing processes, delivery devices, formulations, and methods of use. These patents were filed and prosecuted in several jurisdictions. However, despite this robust IP strategy, it appears that Novo Nordisk made a costly mistake in Canada.

The lifespan of a patent is 20 years from the filing date, and can be extended in some jurisdictions. During this period, the patent owner enjoys exclusive rights to exploit the invention to the exclusion of others. To maintain this monopoly, patent owners are required to pay maintenance or renewal fees to keep their patents in force.

One may think of a maintenance fee as the price paid by a King (“patent owner”) to keep the drawbridge to his castle (“patent”) raised (“active”). As long as the maintenance fee is paid, competitors are kept outside the castle. Once payment stops, the drawbridge is lowered, and the castle becomes accessible to any interested party.

In Canada, patent maintenance fees are paid annually. If a payment is missed, the Canadian Patent Act makes provision for a grace period during which the patent owner may still make payment, together with a late fee. If the fee is not paid within this extended period, the patent lapses and cannot be revived.

A review of the Canadian Patent Database revealed that Novo Nordisk paid maintenance fees on its primary semaglutide patent until 2018. Thereafter, no further payments were made, even during the grace period. As a result, the patent lapsed. The outstanding amount for the maintenance fee was about CAD 400, an insignificant amount when compared to the billions of dollars generated by Ozempic annually.

At present, the status of Novo Nordisk’s patent in Canada is “Expired and beyond the period of reversal.” In other words, the patent cannot be enforced or reinstated in Canada. This opens the floodgate to competitors to flood the Canadian market with generics, subject to regulatory approval and data exclusivity rules.

The implications of this lapse are significant. Canada is among the top ten countries for Ozempic consumption globally. Losing patent protection in such a commercially important jurisdiction exposes Novo Nordisk to competition from generic manufacturers and potentially reduces its market share.

According to Novo Nordisk, its failure to pay the maintenance fee for its semaglutide patent in Canada was not an oversight but an intentional decision that was taken as part of its broader IP strategy. According to the company, all IP decisions are carefully considered, and exclusivity periods are allowed to expire as part of their normal lifecycle.

There have been speculations about the possible reasons why Novo Nordisk did not pay its maintenance fee, thereby allowing its semaglutide patent in Canada to lapse.  One possible reason could be the overlap between patent protection and Canada’s data exclusivity regime, wherein manufacturers are prohibited from relying on data from an innovative drug to introduce generics into the market for a certain time period. This time period for data exclusivity may run concurrently with patent protection. For Novo Nordisk’s semaglutide, it appears that this data exclusivity period extends until 2026, which is close to the expiry date of the semaglutide patent. Based on this, it may be argued that Novo Nordisk allowed its patent to lapse, taking into consideration the time period for its data exclusivity.

Regardless of the underlying reasons that Novo Nordisk may have, the above incident highlights the fragile nature of IP rights. A robust IP strategy can be undone by a single missed deadline.

From the above, the lesson is clear that IP is not only about securing rights through registration but also requires continuous monitoring and management to keep the IP active and in force. In an era where one drug can generate billions of dollars, the systems that protect those revenues must be treated as “Code Red” emergencies.

The lapse of Novo Nordisk’s Ozempic patent in Canada serves as a cautionary tale, especially in a global economy that is driven by innovation, competition, and regulation.  The difference between maintaining IP exclusivity and losing it may boil down to a few hundred dollars and possibly an overlooked invoice.