Żaneta Zemła-Pacud, PhD

Attorney-at-lawOf counsel


Dr Zemła-Pacud deals with intellectual property and pharmaceutical law. Her academic interests also include protection of commercial secrets and regulatory data. Dr Zemła-Pacud advises Polish and foreign companies on innovation protection strategy, and provides opinions on cross-border IP and life science issues. She also conducts lectures, briefings, and training for business, patent attorneys, and the judiciary.

She plays a role in drafting legislation by providing opinions on legislative proposals. She also acts as a consultant to the Polish Patent Office and the WIPO. She is a founding member of the interdisciplinary academic network IP in Agriculture, a member of ATRIP, a GRUR foreign correspondent, and head of the research project  Regulatory Data Protection in European IP Law   Dr Zemła-Pacud has authored a number of publications on intellectual property law and life sciences innovation, including Komentarza do Ustawy – prawo własności przemysłowej (co-author), the monograph Patents as an Incentive to Innovation (co-editor), and the monograph Ochrona patentowa produktów leczniczych.

She was awarded a scholarship at the Munich Max Institute for Innovation and Competition and the Strasbourg Centre for International Intellectual Property Studies.

She is an assistant professor at the Institute of Law Studies at the Polish Academy of Sciences.

She speaks English and German fluently.

Related news

Blog 8
19 Dec 2023

Is orphan exclusivity a new IP right?

There has been no consensus so far on whether data and market exclusivity can be perceived as IP rights. Recently, the legal categorization of market exclusivity for orphan medicines was proposed by the District Court of Munich in a dispute over a biosimilar based on the active substance Eculizumab.

14 Sep 2023

The EMA has released official guidance on the protection of personal data and commercially confidential information in the Clinical Trials Information System (CTIS)

It is compulsory to use the Clinical Trials Information System (CTIS) when filing any new applications for clinical trials from 31 January 2023. The CTIS is a website designed for the implementation of Regulation 536/2014 on clinical trials. Although the regulation was adopted almost ten years ago, there is still uncertainty surrounding the implementation of the regulation’s requirements concerning greater transparency of clinical trials and, in particular, the scope of information to be published in the CTIS.

28 Dec 2022

Market exclusivity and its increasing relevance for the pharmaceutical industry

According to the last IQVIA survey, Protection Expiry and Journey into the Market. Pharmaceutical products in Europe, regulatory exclusivities and rewards provided the longest-lasting form of protection for 57% of the drugs studied. For 31% of innovative medicines, market exclusivity is the last form of protection to expire.

05 Jun 2022

Cannabis in Poland – significant changes in legislation, jurisprudence and on the market

The cannabis plant contains many different cannabinoids. The most popular one is THC, (Tetrahydrocannabinol), a substance triggering a narcotic effect. CBD (Cannabidiol) is the second most known cannabinoid  identified in cannabis. It is believed not to have negative psychoactive effects and indicates calming effects. As of 2019, clinical research on CBD included studies related among other things to anxiety and pain, but there is insufficient high-quality evidence that cannabidiol is effective for these conditions. Nevertheless, CBD can be and is used in many countries as an ingredient in food, especially dietary supplements and cosmetics.

14 Mar 2022

New proposal for a Polish act on clinical trials

Work is in progress on a proposal for an act on clinical trials of medicinal products for human use. The main purpose of the act is to transpose Regulation (EU) No. 536/2014 into Polish law and enforce it. The bill was first published for public consultation in April last year, and as of 17 January 2022, following the publication of statements submitted during the consultation process, has been forwarded to the European Union Affairs Committee.

24 Dec 2021

Advertising of dietary supplements - trends in recent case-law in Poland

Administrative authorities and courts are clarifying the scope of health claims considered unacceptable.

19 Oct 2021

Significant changes to Polish reimbursement law are on the way

A proposal for an amendment to the Reimbursement Act was published on 30 June 2021. The bill is currently undergoing public consultations and will be submitted to the Sejm for debate next year.

30 Jun 2021

Legal developments concerning medical devices

On 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices (MDR) came into force, and this means revolutionary changes in many areas of the medical devices industry. The regulation changes current regulations concerning clinical trials for the most technologically advanced products. It also introduces major amendments to rules on regulatory compliance of a device post marketing authorization and on classification of software as a medical device.

Meet our team