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Magdalena Anna Kotyrba-Hagenmaier
Principal Associate
Rechtsanwältin
Languages
German, English, Polish
Practice areas
- Commercial agreements
- Competition, EU and Trade
- Health and life sciences
- Intellectual property
- Regulatory investigations and enforcement
- Technology
Practice notes
Magdalena is a Principal Associate in Eversheds Sutherland’s Munich office and member both of its IP practice and the Health & Life Sciences sector group.
As member of our Health & Life Sciences sector group Magdalena advises companies from the life sciences industry on several topics, including contractual as well as regulatory matters, topics related to clinical and other trials, as well as questions related to healthcare compliance. She also advices her clients on questions in connection with manufacturing, marketing and distribution of life sciences products. Furthermore, she focuses on technology transfer related matters and convergence topics, such as health-apps.
Clients from a wide range of industry as well as from the life sciences industry (pharmaceuticals, medical devices, cosmetics, food, chemicals) appreciate her expertise with topics related to IP in general as well as such specifically regarding the negotiating, protecting and enforcing of their IP rights. An important part of her work is advising clients on specific R&D topics, such as IP protection from R&D projects, trials or from research collaborations between industry partners, but also between industry and universities/other research institutes. Magdalena’s scope of activity includes advising on technology transfer related questions and on IP and/or R&D contracts (e.g. granting rights to use, exploitation of IP rights, licensing, contract research).
Before joining Eversheds Sutherland, Magdalena worked for a boutique law firm focusing on pharmaceutical and competition law as well as in-house for an international pharmaceutical company in the area of R&D and healthcare compliance.
Magdalena is recommended by Legal500 Germany for health. Furthermore, she is recommended for Intellectual Property Law by Best Lawyers/Handelsblatt in the young talent category "Ones to Watch".
Magdalena's recent experience:
- US based technology group on the market access and CE-certification of a testing device in the European Union
- Otsuka on licensing agreements with global pharmaceutical company Mylan regarding the market access and commercialization of Deltyba™ (delamanid) for the treatment of multidrug-resistant tuberculosis (MDR-TB) in low- and middle-income countries
- UK based international pharmaceutical group on the defence of marketing campaigns attacked by a competitor on a multi-jurisdictional level
- US based international group in the area of motion control technologies on EU medical devices related topics and on self-tests for laymen
- Germany based biotech company developing and manufacturing active immunotherapies for patient-specific approaches to the treatment of diseases on different IP topics (IP transfer agreements, licensing, employee inventions)
- Owens & Minor on its sell of Movianto from a regulatory perspective (marketing authorizations and other licenses required by the German Medicinal Product Act)
- An international generic drug company on the defence of marketing authorizations being challenged by the originator pharmaceutical company due to alleged IP infringements in the generics marketing authorization application
- German research institution on IP and regulatory related topics in collaborations and trial agreements with research companies
- INEOS on the production of disinfectants in response to the Covid-19 crisis
- Several US and Europe based medical device manufacturers on IP related topics in pre- and post-CE-marketing trials
- Otsuka on the First-of-its-kind global Collaboration between the Gates Foundation and Johnson & Johnson, GSK and Evotec to develop transformative treatment regimens for Tuberculosis
- Medical devices distributor commercializing its Japanese parent company’s medical app to healthcare institutions in Europe, the Middle East and Africa
- European based generics company on license agreements and collaborations
- An US based medical device manufacturer on the negotiations of clinical trial agreements and post-CE trial agreements with universities or other German research institutions
- An international pharmaceutical company on legal matters in connection with market access programs by several national regulators regarding pharmaceuticals
- International research company on R&D-collaborations and negotiations with research institutes and universities on development and licensing of new technologies
- Otsuka on a licensing agreement with Russian pharmaceutical company R-Pharm to commercialize Deltyba™ (delamanid) for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) in the Russian Federation and the Commonwealth of Independent States (CIS)
Featured article
- Lexology Navigator: "Six months to go: FAQs on IVDR", November 2021
- Lexology Navigator: "An overview on the current German regulatory and liability framework of pharmaceuticals", February 2018
- Lexology Navigator: “Life sciences: product regulation and liability in Germany”, December 2018
- ILO – Healthcare & Life Sciences: “EU Medical Devices Regulation to apply from May 2020 – preparations underway”, July 2019
- ILO – Healthcare & Life Sciences: „One year to go: Q&A on EU Medical Devices Regulation“, August 2019
- FAZ: „Gesundheits-Apps und der Datenschutz“, December 2019
- ILO -Healthcre & Life Sciences: „COVID-19: impact on medical device industry in the European Union “, April 2020
- ILO -Healthcre & Life Sciences: „EU postpones MDR due to COVID-19: losses and opportunities for medical device sector“, April 2020
- ILO -Healthcre & Life Sciences: „Conducting clinical trials during COVID-19 crisis: FAQs “, May 2020
- ILO -Healthcre & Life Sciences: „IP in clinical trials“, August 2020
- ILO -Healthcre & Life Sciences: „Cybersecurity in healthcare sector – Q&A on data breaches in relation to medical devices“, August 2020
- FAZ: "Im Grünen Bereich. In Deutschland gibt es jetzt Lebensmittelampeln zur besseren Orientierung.", December 2020