Beyond the primary patent: How pharma can build competitive barriers

A medicine reaching the end of its primary patent term does not necessarily mean the market is open to generics. The complex patent landscape surrounding semaglutide shows how secondary patents covering indications, formulations and manufacturing processes can extend competitive barriers—and why careful freedom-to-operate analysis is critical before launch, says Ana Neves of Inventa.

There is no better product, more adapted to the patent system than medicines. The cycle of development of a medicine is long—at least around 8 to 10 years—and is full of traps. At any stage of the development the medicine may fail, forcing researchers back to square one.

Therefore, pharmaceutical companies, big or small, try to increase their return on investment by exploring the market to its fullest capacity. This is where the 20 years market exclusivity provided by patents makes a huge difference. Being able to keep competitors off the market gives original developers of a medicine an advantage and enables them to recover part of the investment made during development.

Recently, it has been reported that a series of medicines will become off patent resulting in a unique opportunity for generic companies and high savings for healthcare systems.

But is the path really free for generics?

On the one hand, the report that medicines will become off patent refers to the patents covering the active ingredient of each medicine. In reality, although the patent covering the chemical compound that carries the therapeutical activity is expiring, many other aspects of the medicine may be patent protected.

From dosage regimens to formulations and uses, many other aspects related to the medicine may still be covered by patent exclusivity and pose as a real obstacle to the market entry of generics.

Also, it is worth noting that depending on the country where the patent is valid, different expiry dates may apply.

Furthermore, exclusivity instruments may be in place such as pediatric exclusivity or supplementary certificates of protection.

Case study: Semaglutide’s patents

To illustrate how several patents can protect one single pharmaceutical, let us consider Semaglutide (the active compound ingredient in Novo Nordisk's Ozempic and Wegovy).

The primary patents for the molecule have already reached its expiry date:

EP1863839 (expired) / EP2322546 (expired) / US8536122 [2] / US8129343—Acylated GLP-1 compounds.

However, several secondary patents are still pending:

• Semaglutide in cardiovascular—EP3448416 (exp. 2037, expiry dates, patent families and patent searches conducted on Espacenet and the EPO) / US12569543—conditions;
• Semaglutide for use in the prevention or treatment of type 2 diabetes—EP3689365 (exp. 2033) / US10335462;
• Semaglutide for use in weight management—EP3694538 (exp. 2038) / US12029779;
• Stable pharmaceutical compositions of semaglutide comprising histidine as a stabiliser—EP3870213 (exp. 2039) / US2024415934;
• Semaglutide for use in non-alcoholic steatohepatitis—EP4142770 (exp. 2041) / US11478533.

It may seem that big pharma companies are unfairly monopolising a particular medicine. Well, they are, but they are not the only ones.

While the previous patents are intended to keep the market exclusivity of the original developer, generic companies are also working to obtain some leverage on the market.

In particular, for medicines that have attracted a lot of attention on the market, this will motivate other companies to develop technology and acquire rights over other aspects of medicine.

For example, for Semaglutide there are patent applications for:

• Method for synthesizing Sematuglide—WO2024159569 (Zhejiang Jiuzhou);
• Improved purification process of Semaglutide—WO4181946 (Dr. Reddys Labs);
• Process for the preparation of Semaglutide—US20260042809 (MSN Labs);
• Oral enhanced pharmaceutical composition comprising Semaglutide—WO2026038999 (Humanis Saglik).

These are just a few examples to illustrate that even after the expiry of the patent covering the molecule, many other patents exist, both from the original company and generics, that populate the patent landscape of any particular medicine.

Usually, original developers focus on patents targeting clinical indications or specific formulation aspects while generic companies file patents for improved route of synthesis or alternative pharmaceutical compositions. Regardless of the content, the aim is the same: to obtain an advantage on the market.

How can we know when a medicine is truly off-patent?

Understanding the patent status of a medicine requires search and analysis of the patents and of the legal framework affecting each jurisdiction. Conducting freedom to operate studies in each market of interest is usually the best course of action before launching any product.

Additionally, it may be of use to search for any litigation relating to generics and have an understanding of the track record of that particular jurisdiction on these matters.

Conclusions

The case study above is intended to give a perspective on how companies resort to patents to improve their chances on the market. Does this mean that the ‘more the merrier?’

No, not necessarily, but the more robust the patent strategy surrounding a product, the better the chances are that the position of the company in the market is stronger and able to face competitors trying to work around existing patent right. And the strategy is valid for both big pharma and generic companies.

Ana Neves is a Patent Consultant at Inventa. She can be contacted at aneves@inventa.com