Subject: Ed: Journalist query - semaglutide
From: "Carmen Katariina Sikk" <[email-masked]>
To: Kärolin Jenas <[email-masked]>
Date: Wed, 3 Jul 2024 09:29:21 +0300

Saatja: Carmen Katariina Sikk
Saatmisaeg: kolmapäev, 3. juuli 2024 09:28
Adressaat: 'Silver, Andrew (Reuters)' <[email-masked]>
Teema: Vs: Journalist query - semaglutide

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-masked]
<mailto:[email-masked]>

Saatja: Silver, Andrew (Reuters) <[email-masked]
<mailto:[email-masked]> >
Saatmisaeg: esmaspäev, 1. juuli 2024 18:19
Adressaat: Carmen Katariina Sikk <[email-masked]
<mailto:[email-masked]> >
Teema: Journalist query - semaglutide

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