What is it? Why is it important?
Pre-clinical research and clinical studies provide findings (e.g. inventions) that lead to new products. These products are intended for human health, including the prospect of gain (e.g. financial, reputation, awards).
A clinical study per se does not suffice to patent an invention. But based on proof of safety and efficacy, its data can be used to complete a patenting dossier (e.g. a patent is a licence conferring rights for a set period time that excludes others from making, using or selling the invention).
An applicant who wants to protect or patent an invention, requires that the invention is:
- New and previously undisclosed
- Not obvious for an expert in the field
- Able to be produced within an industrial setting
What do I need to do?
To acquire a marketing authorisation for drugs, the applicant must:
- Complete a Marketing Authorisation Application (MAA)
- Submit the application dossier to applicable competent authorities (e.g. Swiss and EU websites)
- Patent the product in order to protect the product against copying
- Provide authorities with evidences of product efficacy, safety, coequality or even superiority compared to potentially competing products
- Receive applicable authorisations from each area of interest, valid only in its respective territories
Only after authorities approve the product can it be sold on the open market.
For a given product, other criteria and considerations may decide whether to submit a MAA (e.g. robustness of the product business plan, return on investment, production capacities).
A marketing authorisation from the European Commission is valid for all EU countries including Iceland, Lichtenstein and Norway.
Countries or regions have their own laws and procedures for issuing licences. Without a patent, licence, or production-secret, anyone can copy an invention.
Prior to sharing data, material, or any relevant information, implement and sign a:
- Confidentiality Disclosure Agreement (CDA) between involved parties
- Data Transfer Agreement (DTA) or Material Transfer Agreement (MTA) for the transfer of data or material
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
EMA - see in particular
- Human regulatory / marketing authorisation
Swissmedic – see in particular
- Human medicines / Authorisation / New authorisation / Overview 2021 / Authorisation of human medicinal products