Marta Sroka-Maleta

Practice Areas

Marta specializes in pharmaceutical law and intellectual property law. For over 15 years, she has been supporting entities from the pharmaceutical sector in the full spectrum of legal issues related to their business activities. She is often invited to participate in work on legislative changes in pharmaceutical law, reimbursement, and intellectual property law.

Marta supports clients in such matters as:

• strategies for new product launches and implementation of new business models, also including regulatory requirements, reimbursement schemes, and intellectual property rights;

• business development projects, especially developing and negotiating contracts typical for the pharmaceutical industry, such as license, supply, and distribution contracts;

• marketing authorization of medicinal products, reimbursement, parallel import and intervention import;

• inspections of supervisory authorities at wholesalers and manufacturing sites;

• preparing internal procedures for companies from the pharmaceutical sector;

• compliance audits;

• business activity of health care providers.

She represents clients in court and administrative proceedings, such as:

• court proceedings on intellectual property, in particular, patent disputes and infringement of trademark protection rights, as well as competition law;

• administrative proceedings before regulatory and supervisory authorities.

Marta conducts trainings in pharmaceutical law and intellectual property law for the pharmaceutical sector.

Professional Memberships

Warsaw Bar Association

Languages Spoken

Polish, English, Italian

Career

Since 2012, Marta has been a Partner at DBS.

Marta gained her experience in leading domestic and international law firms. In 2021-2023 she served as an external General Counsel for one of the Polish largest pharmaceutical companies and for almost two years was a member of the Polish Management Team and General Counsel EU Legal Team in the companies’ group.

Marta is often invited to speak at events for the life sciences sector (including top scientific conferences) and authors publications in magazines focusing on the pharmaceutical sector. Among others, in April 2025, she took part in an expert panel discussion organized by the Centre for Regulatory Impact Assessment of the University of Warsaw, concerning the regulations on interim injunction proceedings in IP matters introduced in 2023 and crucial for the life sciences sector. She is also a lecturer in postgraduate studies in Medical Law at the Jagiellonian University.

Publications

Chambers Global Practice Guide (Poland) - Healthcare: Medical Devices 2025 (co-author)

SPC Manufacturing Waiver – the possibility of manufacturing generic and biosimilar medicines “for stock” or for export during the innovative medicine’s protection period (Świat Przemysłu Farmaceutycznego 3/2021 – co-author)

The obligation to submit copies of manufacturing agreements to the GIF – the scope of data to be provided, the procedure to be followed, and how to protect trade secrets (Świat Przemysłu Farmaceutycznego 2/2022 – co-author)

Designing packaging for medicines using umbrella brands – what should you bear in mind? Legal aspects of umbrella branding (Świat Przemysłu Farmaceutycznego 1/2024 – co-author)

Repurposed medicines – significant incentives for pharmaceutical companies in the draft new EU regulations (Świat Przemysłu Farmaceutycznego 4/2024 – co-author)

Interim measures in Intellectual property cases – proposed legislative amendments and their implications for the pharmaceutical sector (Świat Przemysłu Farmaceutycznego 4/2025 – co-author)

Clients

Teva Pharmaceuticals Polska

Teva Operations Poland

Medicines for Poland (PZPPF)

Gentili Pharma

Medezin

Foundation - Centre of Medical Charity (pol. Centrum Dobroczynności Lekarskiej)

Awards