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

is required to take into account the likelihood of the patent being invalidated. Obtaining a marketing authorisation is insufficient for the court to issue a PI, as the decision to authorise a medicinal product for marketing does not con ‑ stitute patent infringement. It is necessary to show that the marketing authorisation holder (MAH) or any other entity undertake actions that constitute patent infringement. It is possible to request a PI even before an infringe ‑ ment occurs. Polish law allows claims to cease actions that threaten to infringe a patent right (eg, preparing to manufacture goods covered by the patent without authorisation). Such a claim may be secured. To prove this claim, one must show that future patent infringe ‑ ment is inevitable. As in the case of securing a claim for patent infringement, one must demonstrate a legal interest. The court usually grants a PI after hearing the alleged infringer. The proceedings are, therefore, inter partes, meaning that both parties are involved. The court should hold the hearing within one month from the date of receiving the motion for a PI. The obliged party may respond to the motion and present relevant evi ‑ dence within the time limit set by the court. There are two exceptions to inter partes proceedings, as outlined below. • The court may grant a PI without hearing the obliged party if an immediate decision on the appli ‑ cation is necessary. • Moreover, the court decides without the partici ‑ pation of the obliged party in the case of those methods of injunction that are entirely subject to execution by the court bailiff. One such method of injunction is the seizure of goods infringing the pat ‑ ent. Please note that, in the authors’ experience, courts now frequently grant the alleged infringer an opportunity to be heard even in such cases, relying on the general principles of civil procedure. In cases where the court rules on an PI without the participation of the obliged party (ex parte), they may learn about the pending proceedings by monitoring

court dockets. There may be a delay in court records being updated, although it usually does not exceed a few days. In anticipation of the possible submission of a PI and ex parte proceedings, the presumed infringer may file a protective letter with the court. Protective letters are not regulated under Polish law, and it is within the discretionary power of the judge to consider this let ‑ ter. In practice, judges often take protective letters into account, which means that the position and evi ‑ dence submitted by the obliged party can persuade the judge not to grant a PI. There is currently a fairly intense debate in Poland about whether protective let ‑ ters should be introduced into the legal system. A significant drawback of the Polish legal system in patent infringement cases is the excessive length of proceedings concerning motions for PIs. Although the courts are required to examine such motions without delay, preferably within seven days, applications for PIs are often adjudicated over several months. If the PI is granted ex parte, it is usually not served on the obliged party until enforcement begins, and in such cases, it is delivered by a bailiff during execu ‑ tion. In inter partes proceedings, however, the order is served on both parties. In both scenarios, the obliged party may appeal the PI. An appeal against an injunction must be filed within one week from the date of delivery of the decision granting a PI with a justification. If the PI is not grant ‑ ed, the applicant may also lodge an appeal against such an adverse decision with the second instance court. 1.4 Structure of Main Proceedings on Infringement/Validity The infringement proceedings are independent of the invalidity proceedings. In civil cases, the Regional Court in Warsaw, which handles intellectual property matters, is responsible for recognising patent infringe ‑ ment. Meanwhile, the PPO has the authority to invali ‑ date a national or European patent. The court is not required to suspend the patent infringement proceedings when there are ongoing

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