POLAND Law and Practice Contributed by: Krystyna Szczepanowska-Kozłowska, Marcin Ziarkowski, Krzysztof Popławski and Kacper Sobolewski, A&O Shearman
A&O Shearman ul. Grzybowska 56 00-844 Warsaw Poland
Tel: +48 22 820 6000 Fax: +48 22 820 6199 Email: warsaw_reception@aoshearman.com Web: www.aoshearman.com
1. Life Sciences and Pharma/ Biopharma Patent Litigation 1.1 Claimants/Plaintiffs to an Action
Although pharmacists, doctors, and healthcare regu ‑ latory authorities (HRAs) can theoretically be sued, such cases do not occur in practice. In the case of patent infringement, there is no obliga ‑ tion to notify HRAs or the PPO. In the case of invalida ‑ tion, the PPO knows about the ongoing proceedings ex officio because the application for patent invalida ‑ tion is filed with this body. 1.3 Preliminary Injunction Proceedings In matters of patent infringement, a preliminary injunc ‑ tion (PI) is available. Claims for patent infringement may be pursued after a patent is granted. In the case of European patents, this is possible after their valida ‑ tion in Poland, ie, after the publication of the transla ‑ tion of the European patent into Polish. Claims for patent infringement cannot be pursued based on a patent application. An entitled party who requests an injunction to pre ‑ vent patent infringement must prove the existence of a patent infringement claim and demonstrate a legal interest in granting the PI. However, a legal interest only exists if the motion for a PI was filed six months before the date on which the applicant became aware of the patent infringement. Although there are legis ‑ lative plans to remove this requirement, it currently remains in force and may significantly restrict the pos ‑ sibility of obtaining an injunction. In course of PI proceedings, the applicant is required to notify the court of any invalidation proceedings. When assessing the merits of the PI motion, the court
An infringement action should be brought before the court (specialised IP division of the Regional Court in Warsaw) by the patent holder. If several entities own the patent, each co-holder can bring an action inde ‑ pendently. An exclusive licensee who is registered in the patent register can also bring an action. The pat ‑ ent holder does not have to participate in the proceed ‑ ings if the action is brought by an exclusive licensee. Patent invalidation proceedings are conducted by the Polish Patent Office (PPO). Any entity, including the alleged infringer, can bring a motion for patent invali ‑ dation. A motion for invalidation in the public interest can also be brought by the Attorney General of the Republic of Poland or the President of the PPO. The PPO does not issue infringement or validity opin ‑ ions. 1.2 Defendants/Other Parties to an Action The decision to sue a particular entity for patent infringement depends on many factors, which may vary depending on the type of patent (product patent, process patent or use patent), as well as the mode of distributing the medicinal product. The most sued entities are those that offer medicinal products for sale.
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