By Carolyn Rogers, associate, Reddie & Grose
Since their launch, Ozempic and Wegovy have dominated the headlines.
Both drugs are manufactured by Danish pharmaceutical company Novo Nordisk and contain the same active ingredient, semaglutide, which is a GLP-1 receptor agonist.
However, Ozempic is directed to the treatment of type 2 diabetes, whilst Wegovy is for the treatment of obesity.
Novo Nordisk’s patent portfolio comprises so-called “core patents” that cover the active ingredient semaglutide.
These patents, relevant to both Ozempic and Wegovy, are set to expire in China, India and Brazil in 2026.
In addition, as previously reported, a core patent in Canada has been allowed to lapse.
The expiry of core patents in these jurisdictions leads to “loss of exclusivity” for Novo Nordisk and allows biosimilar competitors to enter these markets.
This is significant as about a quarter of the world’s obese population are thought to live in India and China alone.
Why are the core patents only expiring in some countries?
In most countries, the term of a patent is 20 years from the date of filing.
Since PCT application WO2006/097537 directed to semaglutide was filed in early 2006, it therefore follows that the core patents in China, India and Brazil which stem from this application will expire in early 2026.
However, generics will not be able to enter the market this year in Europe, the US and Japan.
This is because Europe, the US and Japan have patent term extension mechanisms that can be used to extend the protection of semaglutide.
For example, in Europe, innovators can obtain Supplementary Protection Certificates (SPCs), to extend the term of patents directed to medicinal products or plant protection products.
The rationale underpinning SPCs is that there is a need to compensate for the amount of time it takes to obtain a marketing authorisation – often there is a significant portion of the 20 year patent term where the innovator cannot commercialise their product as they have not yet received marketing approval.
The length of extension is calculated as the time between the date of filing the patent and the date of the first relevant marketing authorisation, minus five years, up to a maximum of five years.
Consequently, Novo Nordisk’s loss of exclusivity in Europe is expected in 2031.
This means that generics companies can in principle be prevented from entering the market in Europe until 2031.
The strategies of generics companies, and also of Novo Nordisk, will therefore be jurisdiction specific.
Novo Nordisk’s patent portfolio is very complex
It is important to realise that Novo Nordisk does not just have core patents covering the active ingredient semaglutide.
Rather, they have an extensive patent portfolio covering all aspects of their current and planned commercial activity, including patents directed to formulations, dosing regimens, and different indications. These patents are often referred to as “secondary” or “follow-on” patents.
The value of secondary patents to originators is clear.
Whilst evidence indicates that these patents are more likely to be found invalid and should be easier to work around, they are nonetheless the basis for the vast majority of preliminary injunctions (at least in Europe) and a critical tool to delaying generic entry in patent linkage countries.
Novo Nordisk has been robustly enforcing its core patents. For example, in Europe, Novo Nordisk enforced their patent EP1863839 by obtaining 26 preliminary injunctions in October last year.
Novo Nordisk may also choose to enforce their secondary patents.
How will generics companies respond?
Secondary patents may be an issue for generics entering the marketing in China, India, Brazil and Canada later this year.
In addition, generics companies looking to commercialise semaglutide in Europe from 2031 will also be interested in pre-emptively “clearing the way”.
Generics companies may consider that some of the secondary patents are not relevant. For example, a number of Novo Nordisk’s patent families are directed to delivery devices.
These will only be relevant to generics companies also looking to commercialise delivery devices.
In addition, generic companies may develop workarounds and one common workaround is the adoption of so-called “skinny labels”.
This strategy enables generics companies to get their drugs approved for non-patented indications only.
Generic companies may also choose to go down the litigation route to invalidate Novo Nordisk’s patents.
In Europe, may generics companies have been using oppositions before the European Patent Office (EPO) as a mechanism to invalidate secondary patents.
The EPO’s Boards of Appeal revoked both EP2827845 and EP2827885 towards the end of 2024, which were relevant to solid oral dosage forms.
The Boards of Appeal also revoked EP2866825 that covered a long-acting semaglutide composition. However, EP3746111 and EP3870213 have been upheld at first instance before the Opposition Division.
Concluding thoughts
Despite the expiry in 2026 of Novo Nordisk’s core patents covering semaglutide in China, India, Brazil and Canada, this does not mean that the route to market in these jurisdictions will be easy for generics companies.
There may also be difficulties in 2031 when generics companies might expect to enter the European markets. We can expect to see workarounds and litigation of secondary patents.
Find out more about Reddie & Grose at reddie.co.uk
The art of continuity: Why joined-up care matters to both patients and GPs
