POLAND Law and Practice Contributed by: Krystyna Szczepanowska-Kozłowska, Marcin Ziarkowski, Krzysztof Popławski and Kacper Sobolewski, A&O Shearman
1.17 Patent Amendment The PPO can limit a patent upon the patentee’s request. A patentee can file such a request even if there is an ongoing infringement proceeding, but this is not common practice. The court that hears the infringement case has to respect the patent as granted unless the PPO changes it. Alternatively, a patentee can request the limitation of a patent during an invalidity proceeding but only before the first hear ‑ ing. The PPO will not accept any requests for limita ‑ tion after the first hearing. 1.18 Court Arbiter The Regional Court in Warsaw – 22nd Intellectual Property Division – has exclusive jurisdiction in mat ‑ ters concerning inventions in both PI and infringe ‑ ment proceedings. The judges deciding in this court are specialised in intellectual property matters. They do not have a technical background or expertise. The cases and appeals (appeals are decided by the Court of Appeal in Warsaw, 7th Commercial and Intellectual Property Division) are decided by a single judge. A lawsuit for infringement may be filed if actions that constitute an infringement of the patent right are tak ‑ en, ie, making, offering, using, placing on the market, importing, exporting, or storing or keeping for those purposes. Obtaining a marketing authorisation alone does not constitute an infringement of the patent right, as it does not amount to an offer of the product. However, the Polish courts consider that entering a medicinal product on the reimbursement list qualifies as an offer. An offer also includes submitting a bid in a tender procedure. 2. Generic Market Entry 2.1 Infringing Acts In the case of patents for use, the trigger for filing a lawsuit for infringement is the offering of the product for protected use, even if that use has been removed from the Summary of Product Characteristics (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 authorisation in Poland, the EU or a state party to the agreement on the EEA. However, market exclusivity is ten years and this period is calculated in the same way as the data exclusivity period. The market exclusivity period may be extended for up to 12 months if an approval or authorisation is issued to add a new indication or indications within the eight-year data exclusivity period. The extension of the market exclusivity is conditional on a positive assessment by the President of the Office for Regis ‑ tration of Medicinal Products, Medical Devices and Biocidal Products (the Polish Drug Authority), which shows that the new indications constitute significant clinical benefits. An application for registration of a product containing a substance with well-established medical 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 docu ‑ mented use of this substance in a medicinal product and its proven efficacy and acceptable level of safety. If the application includes new therapeutic indications based on significant non-clinical or clinical studies 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 procedure, Regulation (EC) No 726/2004, laying down community 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 11 years if, during the first eight years of exclusiv ‑ ity, the holder obtained authorisation for one or more
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