POLAND LAW AND PRACTICE Contributed by: Krystyna Szczepanowska-Kozłowska, Marcin Ziarkowski, Krzysztof Popławski and Kacper Sobolewski, A&O Shearman, A. Pedzich Sp. k .
an offering. An offering also includes submitting a bid in a tender procedure. In the case of patents for use, the trigger point that allows for filing a lawsuit for infringement is offering the product for protected use, even if that use has been removed from the SmPC. In practice, such a case may occur when a product is reimbursed outside the protected use or when a bid is submitted in a tender concerning the protected use despite skinny labelling. 2.2 Regulatory Data and Market Exclusivity The data exclusivity period is eight years from the date of granting the first marketing authori - sation in Poland, the EU or a state party to the agreement on the European Economic Area (the EEA). However, the market exclusivity is ten years. This period is calculated in the same way as for the data exclusivity period. The market exclusivity period may be extended for up to 12 months if an approval or authorisa - tion is issued to add a new indication or indi - cations within the eight-year data exclusivity period. The extension of the market exclusiv - ity is conditional on a positive assessment by the President of the Office for Registration of Medicinal Products, Medical Devices and Bioc - idal Products (the Polish Drug Authority), which shows that the new indications constitute sig - nificant clinical benefits. An application for registration of a product con - taining a substance with well-established medi - cal use in the territory of an EU state or a state party to the EEA agreement may be submitted after at least ten years have elapsed since the first systematic and documented use of this substance in a medicinal product and its prov - en efficacy and acceptable level of safety. If the
application includes new therapeutic indications based on significant non-clinical or clinical stud - ies for such a substance, an additional one-year exclusivity period is granted from the date of the decision on this matter. The data exclusivity periods described above, resulting from Polish law, apply to reference medicinal products for which a marketing authorisation has been obtained in the national or mutual recognition procedures. In the case of authorisations obtained in the centralised proce - dure, Regulation 726/2004, laying down com - munity procedures for granting authorisations, applies directly. This Regulation provides for a similar eight-year period of data exclusivity and a ten-year period of market exclusivity, which may be extended to eleven years if, during the first eight years of exclusivity, the holder obtained authorisation for one or more therapeutic indica - tions that bring significant clinical benefits com - pared to existing therapies. 2.3 Acceptable Pre-Launch Preparations Polish law provides for the so-called Bolar exemption. The Bolar exemption is defined very broadly in Polish law and allows for the use of an invention consisting of making, using, storing, keeping, offering, putting on the market, export - ing or importing. These activities can be under - taken to perform the acts that are required by law to obtain marketing authorisation. According to the law, the Bolar exemption can be invoked not only by the person who applies for the regis - tration of a medicinal product but also by a third party, eg, a manufacturer of an active substance. The Bolar exemption can be invoked if the appli - cation was filed in the countries constituting the territory of the EEA, as well as in other countries.
228 CHAMBERS.COM
Powered by FlippingBook