Adapted by:
Pablo Martínez-Juarez
WriterEnvironmental economist and science journalist. For a few years, I worked as a researcher on the economics of climate change adaptation. Now I write about that and much more.
Alba Mora
WriterAn established tech journalist, I entered the world of consumer tech by chance in 2018. In my writing and translating career, I've also covered a diverse range of topics, including entertainment, travel, science, and the economy.
Novo Nordisk is the Danish pharmaceutical company that developed semaglutide, the active ingredient in the widely-used Ozempic medication. Notably, the company has failed to pay the maintenance fee for its patent for several years.
A million-worth oversight. According to a Science article, Novo Nordisk hasn’t paid the maintenance fee for the semaglutide patent, which currently is around $270 per year, since 2018. Semaglutide is the basis for drugs such as Ozempic and Wegovy.
According to the Canadian Patent Database, the status of this patent is now “expired and beyond the period of reversal.” Under Canadian law, companies have a 12-month grace period to submit claims and pay late fees (currently an additional $110). This window has long passed.
Implications. Earlier this month, Sandoz CEO Richard Saynor announced plans to launch a generic version of a glucagon-like peptide 1 (GLP-1) drug in Canada. GLP-1 is the hormone that semaglutide mimics to deliver its antidiabetic and weight-loss benefits.
According to the Science article, competition in the generic drug market can be incredibly intense. Companies focused on generic medications actively seek to challenge patents, looking for weaknesses that could lead to their invalidation. This allows them entry into new markets.
Currently, few markets are as enticing as that for GLP-1 drugs, including Ozempic, Wegovy, and Rybelsus. Originally developed for diabetes treatment, these drugs have gained immense popularity for their weight-loss effects. It’s caused a significant transformation not only in the pharmaceutical landscape but also economically.
A permeable border. Notably, Canada is the second-largest market for semaglutide, following the U.S. This is likely not because Canadians are heavy consumers of the drug, but rather due to cross-border business dynamics.
Misery loves company. The patent expiry in Canada wouldn’t only impact Novo Nordisk but could also significantly hurt its main competitor in the diabetes and weight loss treatment sector. The introduction of a generic competitor would affect U.S. company Eli Lilly, the manufacturer of Zepbound and Mounjaro.
These drugs are based on tirzepatide, a compound that works similarly to GLP-1 and another hormone known as gastric inhibitory polypeptide.
Was it a mistake? Patents are a fundamental pillar of the pharmaceutical industry. Determining whether the situation arose from a simple error or a calculated strategy won’t be easy.
If it was a mistake, it wouldn’t be a mere oversight. According to the Science article, the company expressed its reluctance to pay the maintenance fee for the Canadian patent for semaglutide in writing back in 2017. The boom of Ozempic didn’t occur until years later, suggesting that the company may not have anticipated its success and viewed the cost of maintaining a patent in Canada as excessive.
Image | Haberdoedas
Related | FDA Officially Bans All Compounding Pharmacies From Making and Selling Generic Ozempic
View 0 comments