Life Sciences & Healthcare
In a dynamic environment where changing regulatory requirements, long product cycles, complex intellectual property rights and cost pressure on healthcare pose constant challenges for our clients, we offer you access to our extensive team of savvy experts. Not only are they legally qualified; they also have a deep understanding of the relevant technical and business-related issues in the life sciences and healthcare sectors.
Life Sciences is a key consulting area for our firm, where we have special expertise and proven track record, providing you with comprehensive support with pharmaceuticals, biotech, healthcare, medtech and digital health.
Areas of Expertise
Our specialists can advise you in the following areas in particular:
- Developing intellectual property strategies, patent management and exploitation of intellectual property rights, supplementary protection certificates and extensions of paediatric rights; freedom-to-operate investigations;
- National and cross-border M&A and private equity transactions and financing for pharmaceutical, biotech, healthcare and medtech companies as well as structuring and implementing joint ventures and other cooperation agreements;
- Hospital financing and cooperations;
- Distribution and supply agreements, cooperation agreements, license agreements, manufacturing agreements, research and development agreements, employee invention agreements;
- Patent litigation (infringement proceedings, invalidity proceedings, assignment and ownership disputes, licensing disputes);
- Other commercial arbitration and litigation in the field of life sciences and health care;
- Regulatory advice and compliance regarding the Therapeutic Products Act (regulatory data protection, advice on pharmaceutical products, cooperations with HCPs and HCOs etc.);
- Advertising law regarding therapeutic products, trademark law and other labelling issues regarding pharmaceuticals, biotech and medtech;
- Pricing of therapeutic products and representation before the Federal Office of Public Health
- Competition law advice (price differentiation, distribution channel planning etc.);
- E-health, data management, data protection strategies, advice in connection with digital business ideas and online platforms;
- Outsourcing projects;
- Product recall procedures
Team
- Renato Bucher
- Lukas Bühlmann
- Ulrike Ciesla
- Frédéric Cottier
- Kevin M. Hubacher
- Markus Frank Huber
- L. Mattias Johnson
- Mark Montanari
- Michael Reinle
- Michael Ritscher
- Marc A. Schamaun
- Daniel Schoch
- Peter Schramm
- Kilian Schärli
- Andrea Sieber
- Mona Stephenson
- Julie Wynne
- Nadine von Büren-Maier
- Daniel Donauer
- Louisa Galbraith
- Noemi Bünter
- Ada Sofie Altobelli
- Andrea Heiniger
- Cédric Saladin
- Franziska Schweizer
“MLL Legal has outstanding expertise in Swiss regulatory law and, in my view, is the go-to-firm whenever you have a question in this field. You will receive a well-founded opinion/recommendation on specific questions/for a certain case within a very short time that is supported by case law and related publications and that provides a valuable basis for decisions your client has to made”
Publications
The Healtcare Law Review: Switzerland
7th Edition, 2023, Editor Ulrich Grau, Chapter 13, p. 139 - 152- EN
Arzneimittelrechtliche Werberegulierung
MLL Legal (Hrsg.), Praxishandbuch Produktregulierung, Bern 2023, S. 563 ff.- DE
Schweizerische Chemikalienregulierung
MLL Legal (Hrsg.), Praxishandbuch Produktregulierung, Bern 2023, S. 377 ff.- DE
Schweizerische Cannabisregulierung
MLL Legal (Hrsg.), Praxishandbuch Produktregulierung, Bern 2023, S. 313 ff.- DE
Firm News
Pharma and Life Science Day 2023
Das Praxishandbuch “Produktregulierung” von MLL Legal ist da!
11 practice groups ranked in the Chambers Europe Edition 2023
8th LESI YMC Pan-American Conference on 24 February 2023
New Partner Announcement: Welcome to Arnaud Martin and Marc Schamaun
News Portal
Swiss Regulatory Framework for the Sale of E-Cigarettes (Vapes) Today and Under the New Tobacco Products Act as of 2024
Due to numerous new forms of consumption, the tobacco market has changed in recent years. New products such as electronic cigarettes (e-cigarettes), disposable vapes and other nicotine-containing products for oral use are now available to consumers as alternatives to conventional (nicotine-containing) cigarettes and are one of the reasons why the number of cigarette packs sold in Switzerland is declining. These alternative products are becoming increasingly popular.
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Revision: Cannabis Regulation – New Authorization Mechanism for Dealing With Medical Cannabis
On 1 August 2022, not only the annual national holiday could be celebrated extensively in Switzerland. Particularly noteworthy is also the entry into force of the new requirements for the regulation of medical cannabis.
Cannabis was qualified as a prohibited narcotic in Switzerland until the end of summer 2022 – without further specification in relation to a medical application. Accordingly, the cultivation, importation, production, and marketing of cannabis required an exemption permit from the Federal Office of Public Health (FOPH).
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Legal Framework for the Use of Psychedelics in Switzerland
Just in time for summer, the miniseries «How to Change Your Mind» will be launched in July on the Netflix streaming platform. In this documentary series, author Michael Pollan and Co. analyse the history and applications of psychedelic substances such as LSD, psilocybin, MDMA and mescaline. According to experts, research with psychedelics (also known as hallucinogens) or related substances will increase worldwide in the coming years. The market launch of drugs containing MDMA for post-traumatic stress disorder (PTSD) or psilocybin for the treatment of depression is expected in the next five to ten years[1]. The legal framework regarding the use of psychedelics in patients is very pragmatic in Switzerland and unique internationally. Switzerland is a leader in the research and use of psychedelics in psychiatry and is considered an innovation driver in this field. Nevertheless, the regulatory hurdles for researchers and patients are still extremely high. In this article we elaborate on the requirements under which psychedelics may be used in Switzerland today.
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Little-Known Pitfall in Application for Paediatric Extensions or Paediatric SPCs
When filing applications for paediatric extensions and paediatric SPCs in Switzerland, it must be kept in mind that Switzerland is not a member state of the European Union and thus has a separate and independent system when it comes to the approval of medicinal products. Paediatric extensions and paediatric SPCs are only granted in Switzerland based on respective Swiss marketing authorizations issued by the competent authority Swissmedic. The relevant provisions in the Swiss Patent Act provide for some very particular conditions that the respective marketing authorizations must meet in order to serve as a basis for the grant of a paediatric extension or paediatric SPC. Those conditions are unique to Switzerland and therefore little-known abroad.
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LexCast: Happy New Year From the MLL NexGen Incubator – Find Out What 2022 Has in Store for You!
As 2021 draws to an end MLL looks forward to 2022 and wonders what it holds. Listen to our specialists from across our offices talking about what legal trends they see coming in the year ahead.
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