Pharmaceutical law - legal pharma

About this practice area

Marketing authorizations, sale and marketing of medicinal products, the activity of pharmacies and pharmaceutical wholesalers, clinical trials – the list of issues subject to stringent regulations is endless. More often than not, handling these issues requires expert legal knowledge.

We help our Clients navigate the complex regulation environment. We solve complicated problems related to data and market exclusivity. We successfully apply our expertise in matters related to pharmaceutical law and industrial property law, clinical trials and liability for failures in clinical trials, and restrictions and bans on advertising, including under European legislation.

We perfectly understand that entrepreneurs need legal advice tailored to the demands of the pharmaceutical sector. Thanks to many years of experience in providing legal services to pharmaceutical companies, our solutions are sound and workable. 

What we do?
  • We help our Clients with registration procedures.
  • We advise on issues related to data and market exclusivity.
  • We handle court proceedings concerning failures in clinical trials.
  • We advise on advertising and marketing strategies.
  • We draw up expert opinions on matters relevant to the industry.
  • We represent Clients in court and administrative court proceedings.
  • We help our Clients challenge unlawful regulations as unconstitutional or incompatible with EU law.
  • We offer legal services in parallel import cases and advise on the issues at the point of convergence of pharmaceutical law and intellectual property law.
Cooperation benefits

In the pharmaceutical sector, the usual routine is often disrupted when complex challenges arise. When attempting to overcome and understand them, both expertise across various areas of law and a flexible approach are required. Using solutions from abroad as a point of reference, or, as a last resort, calling into question the established domestic solutions, might also be necessary.

Over the years, we have cooperated with pharmaceutical companies with a diverse range of business profiles, handling many different cases. This enables us to solve even the most uncommon problems our Clients face.  If it turns out that the case involves patents or there is a risk of infringement of competition law, we provide legal services in these areas, as well.

What sets us apart from our competitors is our professional approach, comprehensive services, and an in-depth understanding of the needs and challenges facing the pharmaceutical sector.

Why choose us?
  • We offer legal counsel on various matters relevant to the pharmaceutical sector.
  • Legal services that our team provides for the pharmaceutical sector also involve matters related to intellectual property law and competition law.
  • We have experience in working for manufacturers of both original and generic drugs.
  • We are not afraid to implement unconventional solutions.
  • We are easily available and offer convenient forms of communication.


Related articles

11 Apr 2024

NGT plants: what future for crop, food, and feed protection in the EU?

The European Union is in the process of drawing up a regulation on plants and foods obtained through the so-called new genome techniques (NGT). According to the proposed new regulation, NGT plants are those obtained through specific genetic modifications: guided mutagenesis, cisgenesis or a combination thereof.

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.

05 Mar 2023

Profound changes to the regulatory data protection rules are expected any day now

As a part of the Pharmaceutical Strategy for Europe, the European Commission (EC) announced that it would launch a package revising the general pharmaceutical legislation, as well as the regulations on orphan medicinal products and paediatric medicines.

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.