POLAND TRENDS AND DEVELOPMENTS Contributed by: Krystyna Szczepanowska-Kozłowska, Marcin Ziarkowski, Krzysztof Popławski and Kacper Sobolewski, A&O Shearman, A. Pedzich Sp. k.
Overview 2024 has seen significant changes in Poland’s regulatory landscape for life sciences and phar - maceutical IP litigation. Key amendments to the Polish Civil Procedure Code (KPC) in 2023 introduced new require - ments for preliminary injunctions in IP cases, including urgency in filing motions and a more adversarial process. These changes have made it more time-consuming and challenging for rights holders to obtain preliminary injunctions in patent enforcement cases, with a notice - able decline in successful motions in 2024. This applies particularly to patent cases concerning the pharmaceutical sector. Additionally, below, one can find an overview of the most interesting case law in patent matters issued by the Supreme Administrative Court (the NSA), which concerns several fundamental issues regarding the assessment of an inven - tion’s patentability by the Polish Patent Office (UPRP). Polish IP Court’s Increasing Unwillingness to Grant PIs in Patent iInfringement Cases On 30 June 2023, significant amendments to the KPC came into force regarding PI proceed - ings in IP matters. After one and a half years, we can see the first results of this legislation. There is a general trend of increased scepticism and reluctance among the IP court to grant PIs in patent infringement cases. See below for an outline of the key changes introduced by these amendments: Assessment of patent invalidation risk by the IP court The amendments impose new formal require - ments for PI motions. Rights holders must now provide information about any ongoing invali -
dation proceedings or declare a lack of knowl - edge about such proceedings. Courts are now required to consider the likelihood of an exclu - sive right being invalidated when assessing the probability of a claim. This means that if there are ongoing invalidation proceedings, the court must take this into account when deciding on the PI. Unfortunately, we have observed a tendency for the IP court to assume from the outset that the risk of patent invalidation is high solely because invalidation proceedings are underway, without conducting a proper analysis of whether the request for patent invalidation has any substan - tive grounds. Urgency criterion The amendments have introduced a requirement for urgency in filing motions for PIs. Motions must now be filed within six months from the date the rights holder becomes aware of the infringement. This is intended to ensure prompt action and prevent delays in seeking legal pro - tection. The introduction of such a restrictive approach, which does not foresee any exceptions, must be assessed negatively. In complicated patent infringement cases, the preparation of proper evidence, including private expert opinions, can sometimes take a very long time. The six-month urgency criterion that was introduced means that rights holders now have to be very vigilant and think far ahead when devising their strategy for defending their patent portfolio. They must also prepare the necessary materials and evidence ‘blindly’ as soon as they hear any rumours about a possible infringement. Preparing for legal action only when an actual infringement activity materialises may result in the rights holder hav -
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