POLAND Law and Practice Contributed by: Krystyna Szczepanowska-Kozłowska, Marcin Ziarkowski, Krzysztof Popławski and Kacper Sobolewski, A&O Shearman
arations, whether it applies to all registered indications or only to some of them.
product is protected by a basic patent that is still in force; • a marketing authorisation has been issued for the product as a medicinal product in accordance with the relevant EU regulations (ie, Directive 2001/83/ EC for medicinal products for human use and Directive 2001/82/EC for veterinary products); • the product has not been previously the subject of a certificate; and • the marketing authorisation is the first authorisation to market the given product as a medicinal prod ‑ uct. An SPC is granted to the entity entitled to the basic patent. The subject matter of SPC protection is any medicinal product protected by a basic patent in Poland (national or European). The basic patent can be a patent for a product, a process or an application of the product. However, the theoretical possibility of obtaining an SPC for a product protected by a patent for use was significantly limited by the CJEU’s interpretation of the concept of the first marketing authorisation in the Santen case (C-673/18). According to this judgment, marketing authorisation for a new use of an active ingredient or a combination of active ingredients, which had already been the 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 medical use can an SPC be granted. A medicinal product is a product consisting of a sub ‑ stance or a mixture of substances used for treatment, prevention, therapy or diagnosis. A product is pro ‑ tected by the basic patent as long as the product, in its chemical form specified in the marketing authorisa ‑ tion, 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 authorisation for the medici ‑ nal 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.
3. Biosimilar Market Entry 3.1 Infringing Acts For biosimilars, the situation is much like that of generic drugs. 3.2 Data and Regulatory Exclusivity The data exclusivity periods for biosimilars are the same as for generic drugs. To use the data of the ref ‑ erence product, the biological product must meet the same equivalence criteria applied to generic products. If these criteria are not met, particularly due to differ ‑ ences in the starting materials or manufacturing pro ‑ cesses of these products, the responsible entity must present the results of clinical or non-clinical studies. 3.3 Acceptable Pre-Launch Preparations For biosimilars, the situation is much like that of generic drugs. 3.4 Publicly Available Drug and Patent Information For biosimilars, the situation is much like that of generic drugs. 3.5 Reimbursement and Pricing/Linkage Markets For biosimilars, the situation is much like that of generic drugs.
4. Patent Term Extensions for Pharmaceutical Products
4.1 Supplementary Protection Certificates Supplementary Protection Certificates (SPCs) are available in Poland under Regulation (EC) No 469/2009. This protection is, therefore, identical in all EU member states. Granting an SPC is possible if: • the product constituting the active ingredient or a mixture of active ingredients of the medicinal
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