POLAND LAW AND PRACTICE Contributed by: Krystyna Szczepanowska-Kozłowska, Marcin Ziarkowski, Krzysztof Popławski and Kacper Sobolewski, A&O Shearman, A. Pedzich Sp. k .
4.4 Orphan Medicines Extensions According to the provisions of Regulation (EC) No. 141/2000, medicinal products designated as orphan medicines benefit from a ten-year market exclusivity period, which is granted for a specific clinical indication, meaning that each indication with an orphan designation confers an independent ten-year exclusivity period. Once the period of market exclusivity for all the orphan designations has expired, the product ceases to be classified as an orphan medicine. Regulation (EC) No. 1901/2006 allows for an extension of this period. Two additional years can be granted if the requirements for use in the paediatric population are fully met. Extensions are granted following a positive compliance assessment conducted by the Paediatric Com - mittee and Committee for Medicinal Products for Human Use. Under the provisions of the code of civil pro - cedure, a party subject to a wrongful injunction is entitled to claim damages from the patentee. Third parties cannot claim such compensation. Generally, a PI is immediately enforceable. If the PI entails the seizure of goods, it is served by a bailiff. Otherwise, it is the court who serves the injunction. Although it is not a standard require - ment, the court can condition the enforcement of the issued PI on the entitled party paying a bond, either on its own initiative or at the request of the obliged party. While granting a PI, the court sets a deadline (no longer than two weeks) for the claimant to bring 5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief
the main action — failure to do so results in the revocation of the PI. It is at the court’s discretion to stay a PI pend - ing appeal on the request of a party subject to the PI. 5.2 Final Injunctive Relief Final injunctions are enforceable after the court’s ruling becomes final, which means it is not sub - ject to further appeal or cassation. However, the court may order the immediate enforceability of the injunction, even if it is still appealable if it finds that the delay will impede or seriously obstruct the enforcement of the judg - ment or put the claimant at risk of harm. In such cases, the court may also require the claim - ant to provide a bond to cover the defendant’s potential damages if the injunction is reversed or modified on appeal. The enforcement of the injunction is based on the enforceable ruling and an enforcement clause issued by the court. The enforcement is carried out by a bailiff, who acts upon the claim - ant’s request. 5.3 Discretion to Award Injunctive Relief (Final or Preliminary) The court may award damages in lieu of a final injunction: • at the infringer’s request; • if the infringement was not culpable (ie, nei - ther intentional nor negligent) conduct; • where awarding the injunction would place an undue burden on the party subject to it; and • only if pecuniary compensation is sufficient to satisfy the infringed party’s interest.
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