POLAND Law and Practice Contributed by: Krystyna Szczepanowska-Kozłowska, Marcin Ziarkowski, Krzysztof Popławski and Kacper Sobolewski, A&O Shearman
As explained by the CJEU, if the same patent protects several products, then several SPCs can be obtained, provided that each of these products is protected by the basic patent and is contained in the medicinal product for which marketing authorisations have been issued. If the patent protects a combination of products and each product separately, then on the basis of the same patent and marketing authorisation, a certificate can be issued both for the combination of active ingredi ‑ ents and for the individual active ingredient. An SPC can only be granted for those active ingredients that have been mentioned in the claims of the basic patent. However, if the patent only protects a combination of active substances and does not protect the individual substances separately, then it is not possible to issue an SPC that protects one of the substances on its own. An SPC applies after the expiry of the basic patent. The duration of the SPC cannot exceed five years from the date on which the SPC takes effect. The term of the SPC in a specific case is determined by calculat ‑ ing the period that elapsed between the date of filing of the basic patent and the date of the first marketing authorisation granted for the product in the EU, and then subtracting five years from that period. 4.2 Paediatric Extensions Regulation (EC) No 469/2009 allows for a six-month extension of the SPC. The granting of the so-called paediatric extension depends on whether the appli ‑ cation for marketing authorisation of the medicinal product in the EU includes the results of all the stud ‑ ies conducted and the details of all the information collected in accordance with the approved paediatric investigation plan, pursuant to Article 36 of Regulation (EC) No 1901/2006 on medicinal products for paedi ‑ atric use. 4.3 Paediatric-Use Marketing Authorisations Paediatric use marketing authorisation (PUMA) is available in Poland on the basis of Regulation (EC) No 1901/2006; therefore, the procedure to obtain it is identical in all EU member states. PUMA is granted through existing marketing authorisation procedures and only applies to medicinal products developed
exclusively for paediatric medicines no longer covered by intellectual property rights. However, the applica ‑ tion must include a paediatric investigation plan on the quality, safety and efficacy of the medicine among children. PUMA benefits from eight years of data exclusivity, plus an additional two years of marketing exclusivity. 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 indi ‑ cation, meaning that each indication with an orphan designation confers an independent ten-year exclu ‑ sivity 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 popula ‑ tion are fully met. Extensions are granted following a positive compliance assessment conducted by the Paediatric Committee and Committee for Medicinal Products for Human Use. Under the Polish civil procedure, a party subject to a wrongful injunction is entitled to claim damages from the patentee. Third parties have no standing to seek such compensation. A preliminary injunction is generally immediately enforceable. Where it provides for the seizure of goods, service is effected by a bailiff; otherwise, the court serves the injunction. Although this is not standard, the court may condition enforcement on the applicant providing security, either of its own motion or at the obliged party’s request. 5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief When granting a PI, the court sets a deadline (no long ‑ er than two weeks) for the claimant to commence the
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