South African patent ruling in favour of Astellas Pharma

On 13 July 2026, the South African patent court ruled in favour of Astellas Pharma, the Japan-headquartered pharmaceutical company represented by intellectual property law firm Adams & Adams (Russell Bagnall and Sophia Smallbones) against generic drugmaker Cipla thereby preventing them from selling their generic product, Urton.

At the centre of the dispute was a formulation patent for mirabegron, the active ingredient in Astellas’ overactive bladder treatment, marketed as Betmiga in South Africa and Myrbetriq in most other countries.

One of the issues that the court was required to understand is how food affects the body’s absorption of mirabegron and how the invention sought to overcome problems with such food effects. The case highlighted the importance of the role of expert witnesses in helping courts understand highly technical inventions.

Judgment was delivered six weeks after the conclusion of a two-week trial. For companies operating in South Africa’s pharmaceutical sector, the case serves as an important reminder that robust patent strategy, scientific expertise and early legal intervention remain essential to protecting innovation and managing litigation risk.

Cipla have since brought an application for leave to appeal against the decision.  The operation and execution of the decision is suspended pending a determination of the application for leave to appeal.