POLAND LAW AND PRACTICE Contributed by: Krystyna Szczepanowska-Kozłowska, Marcin Ziarkowski, Krzysztof Popławski and Kacper Sobolewski, A&O Shearman, A. Pedzich Sp. k .
subject of a marketing authorisation for another therapeutic use, cannot be considered the first marketing authorisation. In practice, this means that only in the case of a patent for the first medi - cal use can an SPC be granted. A medicinal product is a product consisting of a substance or a mixture of substances used for treatment, prevention, therapy or diagnosis. A product is protected by the basic patent as long as the product in its chemical form mentioned in the marketing authorisation remains protected by the basic patent. An application for an SPC must be filed in the country in which protection is sought within six months from the date of the marketing authori - sation for the medicinal product. If the marketing authorisation was issued before the patent was granted, then the application for the certificate must be filed within six months from the date of granting the patent. As explained by the CJEU, if the same patent protects several products, then several supple - mentary protection certificates can be obtained, provided that each of these products is protect - ed by the basic patent and is contained in the medicinal product for which marketing authori - sations have been issued. If the patent protects a mixture 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 mixture of active ingredients and for the active ingredi - ent, considered individually. An SPC can only be granted for those active ingredients that have been mentioned in the claims of the basic pat - ent. If the patent only protects a mixture of active substances and does not protect the individual substances separately, then it is impossible to
issue an SPC that protects one of the substanc - es in the mixture. 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 calculating 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, Regulation 469/2009 allows for the extension of the SPC by six months. The granting of the so- called paediatric extension depends on whether the application for marketing authorisation of the medicinal product in the EU includes the results of all the studies conducted and the details of all the information collected in accordance with the approved paediatric investigation plan, pur - suant to Article 36 of Regulation 1901/2006 on medicinal products for paediatric 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 that are no longer cov - ered by intellectual property rights. However, the application must include a paediatric inves - tigation plan regarding 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. subtracting five years from it. 4.2 Paediatric Extensions
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