Life Sciences and Pharma IP 2026

POLAND Law and Practice Contributed by: Krystyna Szczepanowska-Kozłowska, Marcin Ziarkowski, Krzysztof Popławski and Kacper Sobolewski, A&O Shearman

ment on their dispute. Nevertheless, mediation is not a common option for life sciences disputes in Poland. In court proceedings, mediation is regulated by the Polish Civil Procedure Code, which provides for both court-annexed and out-of-court mediation. Court- annexed mediation may be initiated by the parties or suggested by the court at any stage of the proceed ‑ ings, and the parties may choose their own mediator or accept one appointed by the court. The parties may initiate out-of-court mediation before or after the com ‑ mencement of litigation, and they may select their own mediator and rules. The Polish legislator continuously updates the reg ‑ ulations to further encourage parties to engage in mediation and to streamline the resolution of disputes through this method. A significant step was taken in August 2025 with an amendment to the civil proce ‑ dure provisions, which introduced measures to sim ‑ plify mediation procedures, including the electronic signing of settlement agreements and expanded pow ‑ ers for court clerks to direct cases to mediation. It is expected that mediation will become a more popular method of ADR in Poland in the coming years. In trade mark opposition proceedings, the PPO imposes a mandatory two-month cooling-off period to allow the parties to seek an amicable settlement. This period may be extended up to six months on the joint request of the parties. During the cooling-off period, the PPO offers a way to resolve the dispute through voluntary mediation proceedings conducted jointly with the WIPO and following the WIPO’s media ‑ tion rules.

that pharma/biopharma settlements that involve potential or actual competitors and affect trade between EU member states may be subject to EU antitrust enforcement and national enforcement by the Office of Competition and Consumer Protection. In addition to EU competition rules, Poland has its own national competition law, which is largely aligned with EU law but may differ in interpretation or appli ‑ cation. The main national competition law provisions of the Act on Competition and Consumer Protection prohibit agreements that restrict or distort competition within the Polish market (Article 6) and the abuse of a dominant position (Article 9). The European Commission has shown an increasing interest and activity in the pharma/biopharma sec ‑ tor in recent years, especially in relation to potential anti-competitive practices, such as patent settle ‑ ments, pay-for-delay agreements and the abuse of patent rights. For example, in Lundbeck v Commission (2021), the CJEU held that the pay-for-delay agree ‑ ments at issue constituted restrictions of competition and upheld the EC’s decision to fine Lundbeck and the other parties EUR146 million. The Enforcement of Claims in Group Proceedings Act and the Code of Civil Procedure provide for a statutory collective redress procedure. Collective proceedings can be initiated by a group of at least ten individuals or legal entities whose claims are based on the same factual basis and can be pursued within a collective redress regime. Class actions are brought to the court by the group’s representative, who acts in their own name but on behalf of the whole group and must be represented by a professional attorney. Claims that can be examined include: • liability claims for damages caused by hazardous products; • claims for damages; • liability claims for non-performance or improper performance of contractual liability; • claims for unjust enrichment; 11. Collective Redress 11.1 Group Claims

10. Settlement/Antitrust 10.1 Considerations and Scrutiny

Some specific settlement/antitrust considerations in Poland may affect pharma/biopharma settlements. Poland is a member of the EU and, therefore, sub ‑ ject to EU competition rules, including Article 101 of the Treaty on the Functioning of the European Union, which prohibits agreements that restrict or distort competition within the internal market. This means

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