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

1.13 Use of Experiments Experiments are allowed in patent infringement pro ‑ ceedings. An experiment can also form part of expert opinion evidence if conducting it or assessing its results requires expert knowledge. The court deter ‑ mines the manner in which the experiment is to be carried out. The results of the experiments carried out outside the court proceedings can also be attached as so-called private documents. In such cases, they are subject to evaluation according to the rules applicable to other evidence. Theoretically, there are no obstacles to admitting evi ‑ dence in the form of an experiment in the invalidation proceedings before the PPO. However, in practice, this would involve admitting an expert, which the PPO is generally reluctant to do. On the other hand, it is not uncommon for the parties to submit documents describing the conduct and results of experiments, which, of course, the PPO can take into account when deciding the case. 1.14 Discovery/Disclosure The party claiming infringement is required to provide evidence that the patent has been violated, which entails proving that the defendant engaged in acts that constitute patent infringement. For instance, this could involve presenting samples of the goods made available in the market, along with documents con ‑ firming their purchase, or providing evidence of such products being offered, such as relevant information regarding the availability of medicinal products. To establish infringement, it is essential to demonstrate that these goods possess the features protected by the patent, which may include documents containing relevant analyses or expert opinions. The defendant must show that the products placed on the market do not have the features protected by the patent by presenting descriptions of products, pro ‑ cesses, or documents in the form of private opinions or analyses.

1.15 Defences and Exceptions to Patent Infringement Polish law does not contain a closed list of defences that can be raised in patent infringement proceedings. Patent infringement is precluded by the consent of the right holder (eg, in the form of a licence agreement) or by a statutory right to use the patent. Polish law allows the use of the patent in the following cases: • transit privilege (transit); • use of the invention for state purposes (subject to a decision by the relevant public authority); • use of the invention for research and experimen ‑ tal purposes, including assessment, analysis, or teaching; • Bolar exception; or • preparation of the medicine in a pharmacy based on an individual medical prescription. The accused infringer may invoke exhaustion as a defence. The defence cannot be based on the so- called free state-of-the-art. Due to the principle of bifurcation, the court cannot examine the invalidity of the patent on its own initia ‑ tive. However, raising the invalidity defence may – if the court deems it appropriate – lead to the suspen ‑ sion of the infringement proceedings until a decision on the invalidity claim is issued. 1.16 Stays and Relevance of Parallel Proceedings The court that adjudicates the infringement is bound by the decision to grant the patent. In theory, a paral ‑ lel proceeding for the invalidation of the patent does not affect the examination of the infringement case. However, the court may, at its discretion, suspend the infringement proceeding in such circumstances. There are no legal grounds to suspend the proceeding due to a parallel proceeding in another jurisdiction. The judgments of courts from other jurisdictions may only have a psychological effect. The court, generally, does not rely on the reasoning contained in the rulings issued in other jurisdictions in its decision.

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