Vastused küsimustele

Hello, Andrew!

Aet Viispert (head of the department of marketing authorisations) answered:

Determination of whether the patent is applicable is the responsibility of the applicant/marketing authorisation holder. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

The competent authorities responsible for the authorisation of medicines cannot assess the marketing authorisation applications and make decisions  based on the patent or SPC status of the reference medicinal product.

Carmen Katariina Sikk

Agency of Medicines
Head of Communications

Tel 737 4140

[email protected]

Hi I’m a journalist with Reuters in Shanghai, I write about health and pharma.

I’ve heard there may be some countries where there is no patent on semaglutide. Do you know if any companies in those countries are producing oral pill or injectible versions of semaglutide drugs (i.e. rybelsus generic/biosimilar) for consumers that are sold to people based in countries with patent protection (i.e. directly or via third-party distributors) like Estonia, and are there any examples you can share? Or how common such a phenomenon is, what countries are involved?

Appreciate your time,

-Andrew